Zika Virus Infection
Conditions
Keywords
Flavivirus, Inactivated, Phase I, Vaccine, ZIKA, ZPIV
Brief summary
This study is randomized, double-blinded, placebo-controlled, Phase 1, dose de-escalation study to evaluate the safety, reactogenicity, and immunogenicity of Alum Adjuvanted Zika Virus Purified Inactivated Vaccine (ZPIV) administered to healthy male and non-pregnant female adult subjects. This study will enroll 90 healthy male and non-pregnant female subjects between the ages of 21 and 49 and will be conducted at Ponce Medical School Foundation, Inc.-CAIMED in Ponce, Puerto Rico. The duration of each subject's participation is approximately 26 months from recruitment through the last study visit. The entire study is expected to take approximately 49 months to complete. Two dose levels will be evaluated. Each subject will receive either placebo or 5 mcg (Group 1) or 2.5 mcg (Group 2) of ZPIV administered by intramuscular (IM) injection on Days 1 and 29. Solicited local and systemic reactogenicity data will be collected from all subjects through Day 8 after each vaccination. All subjects will be monitored for occurrence of unsolicited adverse events until 28 days after the second vaccination. The study will consist of a screening period of up to 28 days, a vaccination period in which subjects will receive a prime dose of vaccine on Day 1 followed by a boost on Day 29, and a follow-up period of 24 months post boost vaccination. Primary objectives are: 1) Assess the safety and reactogenicity of a homologous prime boost regimen of ZPIV given at two different dose levels. 2) Compare the safety and reactogenicity of ZPIV after each vaccination, between dosage groups, and by pre-vaccination flavivirus immune status.
Detailed description
This study is a single-center, randomized, double-blinded, placebo-controlled, Phase 1, dose de-escalation study to evaluate the safety, reactogenicity, and immunogenicity of a purified inactivated, alum-adjuvanted ZIKV vaccine (ZPIV) administered in a homologous prime-boost regimen to healthy male and non-pregnant female adult subjects living in a flavivirus-endemic area. This study will enroll 90 subjects between the ages of 21 and 49 and will be conducted at Ponce Medical School Foundation, Inc.-CAIMED in Ponce, Puerto Rico. The entire duration of each subject's participation is approximately 26 months including recruitment and collection of data on the safety and reactogenicity of the study vaccine and collection of samples for the assessment of immunogenicity. This study is expected to take approximately 49 months to complete. Two dose levels will be evaluated. Each subject will receive either placebo or 5 mcg (Group 1) or 2.5 mcg (Group 2) of ZPIV administered by intramuscular (IM) injection on Days 1 and 29. The study will consist of a screening period of up to 28 days, a vaccination period in which subjects will receive a prime dose of vaccine on Day 1 followed by a homologous boost on Day 29, and a follow-up period of 24 months post boost vaccination. The study will begin with enrollment of 2 sentinel subjects in Group 1 who will receive 5 mcg ZPIV open label. One sentinel subject will be vaccinated, followed for one day for safety and reactogenicity, and if no halting rules are met per determination of the PI and co-PI, then the second sentinel subject will receive 5 mcg ZPIV open-label. Both sentinels will be followed for safety through Day 8 and if no predefined halting rules are met and no safety concerns are identified, then enrollment of the Group 1 non-sentinel subjects will proceed in double-blind fashion. The same procedure will be used for administration of the boost vaccination to the Group 1 sentinels: 1 sentinel (can be either) will receive 5 mcg ZPIV open-label, be followed for one day for safety and reactogenicity, and if no halting rules are met, then the 2nd sentinel will receive the boost vaccine. Both sentinels will be followed until Day 8 after 2nd vaccination for safety and reactogenicity and if no halting rules are met, then boost vaccination of the Group 1 non-sentinel subjects can proceed. Enrollment of the 2.5 mcg ZPIV group (Group 2) can begin after or at the same time non-sentinel subjects in Group 1 receive the 1st dose of vaccine. As of December 18, 2017, the majority of non-sentinel subjects in Group 1 have already received the 1st dose and have been followed until Day 8 for safety and reactogenicity, and no halting rules have been met or safety concerns identified. As this is a dose de-escalation study, concurrent enrollment of some remaining non-sentinel subjects in Groups 1 is permitted after enrollment of Group 2 subjects has begun; also, no sentinel subjects will be used in Group 2. All subjects in Group 2 will receive study product or placebo in double-blind fashion. The original study design planned to enroll 40 ZPIV recipients and 5 placebo recipients in each Group. However, due a natural disaster (hurricane Maria), 11 subjects enrolled in Group 1 had loss of samples at key timepoints. To rebalance the number of evaluable subjects between Groups, Group 1 enrollment will be increased by 5 subjects and Group 2 enrollment will be decreased by 5 subjects, for a total enrollment of 50 subjects in Group 1 and 40 in Group 2. Treatment assignments for both groups will be assigned according to the originally planned 8:1 ratio of ZPIV: placebo. Without compromising the blind of the study, we can anticipate approximately 35 evaluable ZPIV recipients and approximately 5 evaluable placebo recipients in each group. All subjects will receive a homologous boost of ZPIV or placebo 28 days post-prime if no halting rules precluding second vaccination are met (Section 9). All subjects will be monitored for occurrence of unsolicited AEs until 28 days after the second vaccination SAEs, AESIs, and history of new medical conditions with onset after the first vaccination will be collected for the duration of the study. Blood for evaluation of antibodies to ZIKV by ELISA and neutralizing antibody assays will be collected at Visit 00, prior to each vaccination, and at multiple timepoints afterward. Primary objectives are: 1) Assess the safety and reactogenicity of a homologous prime boost regimen of ZPIV given at two different dose levels in a dose de-escalation format in healthy adult subjects who live in Puerto Rico, a flavivirus endemic area. 2) Compare the safety and reactogenicity profile of ZPIV after each vaccination, between dosage groups, and by pre-vaccination flavivirus immune status. Secondary Objectives are: 1) Assess the humoral immune response to a homologous prime-boost regimen of ZPIV after each dose of vaccine as determined by kinetics of the immune responses, seroconversion rates, and Geometric Mean Titers (GMT) overall, and compare results between dosage groups and by pre-vaccination flavivirus immune status. 2) Assess the durability of the humoral immune response to ZPIV at 6, 12, 18, and 24 months after the second vaccine administration overall, and compare results between dosage groups and by pre-vaccination flavivirus immune status.
Interventions
OTHERPlacebo
Placebo
Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Must be a male or non-pregnant, non-breastfeeding female between the age of 21 and 49 years, inclusive at the time of screening and enrollment. 2. Must be willing and able to read, sign and date the informed consent document before study related procedures are performed. 3. Must be willing and able to comply with study requirements and available for follow-up visits for the entire study. 4. Must have a means to be contacted by telephone. 5. Must have a body mass index (BMI) \> /= 18.1 and \< 35.0 kg/m2. 6. Must have acceptable\* screening laboratory findings within 28 days before enrollment. * Acceptable clinical laboratory parameters include: * Hemoglobin: women: \> /= 11.5 g/dL; men \> /= 13.5 g/dL * Hemotocrit: women: \> /= 34.5%; men \> /= 40.5% * White blood cell count: \> /= 3.500 cells/mm3 but \< /= 10,800 cells/mm3 * Platelets: \> /= 150,000 but \< /= 450,000 per mm3 * Urine dipstick (clean urine sample): protein \< 1+, glucose negative * Serum creatinine \< /= 1 x institutional upper limit of normal (ULN) * Blood urea nitrogen (BUN) \< 25 * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 1.25 x institutional ULN * Total bilirubin \< 1.25 x institutional ULN * Note: If laboratory screening tests are out of acceptable range, repeat of screening tests is permitted once, provided there is an alternative explanation for the out of range value. 7. Must be in good health based on the investigator's clinical judgment when considering findings from past medical history, medication use, vital signs, and an abbreviated physical examination. Note 1: Good health is defined by the absence of any medical condition described in the
Exclusion criteria
in a subject with a normal abbreviated physical exam and vital signs. If the subject has a preexisting condition not listed in
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Day 1 through Day 8 | The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Day 29 through Day 36 | The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Day 1 through Day 8 | The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Day 29 through Day 36 | The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Day 1 through Day 8 | The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Day 29 through Day 36 | The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Day 1 through Day 8 | The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Day 29 through Day 36 | The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants | Day 1 through Day 8 | The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants | Day 29 though Day 36 | The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Day 1 through Day 8 | The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Day 29 through Day 36 | The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Day 1 through Day 8 | The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Day 29 through Day 36 | The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Day 1 through Day 8 | The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Day 29 through Day 36 | The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Day 1 through Day 8 | The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Day 29 through Day 36 | The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Day 1 through Day 8 | The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Day 29 through Day 36 | The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Day 1 through Day 8 | The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Day 29 through Day 36 | The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants | Day 1 through Day 8 | The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants | Day 29 through Day 36 | The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Day 1 through Day 8 | The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Day 29 through Day 36 | The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Day 1 through Day 8 | The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Day 29 through Day 36 | The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant. |
| Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Day 1 through Day 57 | Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). If a condition was present at screening, it was not considered an AE unless the severity worsened. |
| Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Day 1 through Day 57 | Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). If a condition was present at screening, it was not considered an AE unless the severity worsened. |
| Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Day 1 through Day 57 | Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). If a condition was present at screening, it was not considered an AE unless the severity worsened. |
| Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Day 1 through Day 57 | Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). If a condition was present at screening, it was not considered an AE unless the severity worsened. |
| Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants | Day 1 through Day 57 | Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). Each participant was counted once per SOC. If a condition was present at screening, it was not considered an AE unless the severity worsened. |
| Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Day 1 through Day 57 | Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). If a condition was present at screening, it was not considered an AE unless the severity worsened. |
| Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Day 1 through Day 57 | Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). If a condition was present at screening, it was not considered an AE unless the severity worsened. |
| Frequency and Type of Serious Adverse Events (SAE) Considered Related to Study Vaccine for All Participants | Day 1 through Day 750 | SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. |
| Duration of Serious Adverse Events (SAE) Considered Related to Study Vaccine for All Participants | Day 1 through Day 750 | SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. |
| Frequency and Type of Adverse Events of Special Interest (AESI) Considered Related to Study Vaccine for All Participants | Day 1 through Day 750 | For this study Neurologic and Neuroinflammatory Disorders after the first vaccination were considered as Adverse Events of Special Interest (AESI). |
| Duration of Adverse Events of Special Interest (AESI) Considered Related to Study Vaccine for All Participants | Day 1 through Day 750 | For this study Neurologic and Neuroinflammatory Disorders after the first vaccination were considered as Adverse Events of Special Interest (AESI). |
| Frequency of New Onset Chronic Medical Conditions for All Participants | Day 1 through Day 750 | New onset chronic medical conditions (NOCMCs) were any new medical conditions reported from the first administration of study vaccine until the end of the study. |
| Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Day 1 through Day 8 | The number of participants experiencing each adverse event are listed. |
| Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Day 29 through Day 36 | The number of participants experiencing each adverse event are listed. |
| Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive Participants | Day 1 through Day 8 | The number of participants experiencing each adverse event are listed. |
| Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive Participants | Day 29 through Day 36 | The number of participants experiencing each adverse event are listed. |
| Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Day 1 through Day 8 | The number of participants experiencing each adverse event are listed. |
| Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Day 29 through Day 36 | The number of participants experiencing each adverse event are listed. |
| Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive and DENV Seropositive Participants | Day 1 through Day 8 | The number of participants experiencing each adverse event are listed. |
| Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive and DENV Seropositive Participants | Day 29 through Day 36 | The number of participants experiencing each adverse event are listed. |
| Comparison of the Frequency, Type, and Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive and DENV Seronegative Participants | Day 1 through Day 8 | The number of participants experiencing each adverse event and the median duration of adverse events are listed. |
| Comparison of the Frequency, Type, and Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive and DENV Seronegative Participants | Day 29 through Day 36 | The number of participants experiencing each adverse event and the median duration of adverse events are listed. |
| Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Day 1 through Day 8 | The number of participants experiencing each adverse event are listed. |
| Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Day 29 through Day 36 | The number of participants experiencing each adverse event will be listed |
| Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Day 1 through Day 8 | The number of participants experiencing each adverse event are listed. |
| Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Day 29 through Day 36 | The number of participants experiencing each adverse event are listed. |
| Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Day 1 through Day 8 | The median duration of adverse events are listed. |
| Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Day 29 through Day 36 | The median duration of adverse events are listed. |
| Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive Participants | Day 1 through Day 8 | The median duration of adverse events are listed. |
| Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive Participants | Day 29 through Day 36 | The median duration of adverse events are listed. |
| Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Day 1 through Day 8 | The median duration of adverse events are listed. |
| Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Day 29 through Day 36 | The median duration of adverse events are listed. |
| Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive and DENV Seropositive Participants | Day 1 through Day 8 | The median duration of adverse events are listed. |
| Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive and DENV Seropositive Participants | Day 29 through Day 36 | The median duration of adverse events are listed. |
| Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Day 1 through Day 8 | The median duration of adverse events are listed. |
| Comparison of the Duration and Type Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Day 29 through Day 36 | The median duration of adverse events are listed. |
| Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Day 1 through Day 8 | The median duration of adverse events are listed. |
| Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Day 29 through Day 36 | The median duration of adverse events are listed. |
| Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for All Participants | Day 1 through Day 750 | Comparisons of the number of participants who withdrew early and who discontinued treatment are presented. |
| Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive Participants | Day 1 through Day 750 | Comparisons of the number of participants who withdrew early and who discontinued treatment are presented. |
| Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative Participants | Day 1 through Day 750 | Comparisons of the number of participants who withdrew early and who discontinued treatment are presented. |
| Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive and DENV Seropositive Participants | Day 1 through Day 750 | Comparisons of the number of participants who withdrew early and who discontinued treatment are presented. |
| Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive and DENV Seronegative Participants | Day 1 through Day 750 | Comparisons of the number of participants who withdrew early and who discontinued treatment are presented. |
| Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seropositive Participants | Day 1 through Day 750 | Comparisons of the number of participants who withdrew early and who discontinued treatment are presented. |
| Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seronegative Participants | Day 1 through Day 750 | Comparisons of the number of participants who withdrew early and who discontinued treatment are presented. |
Countries
Puerto Rico
Participant flow
Recruitment details
Participants were healthy males and non-pregnant females between 21 and 49 years old, inclusively. They were recruited from the community at large around the clinic site. The enrollment period occurred between 21MAR2017 and 18JUL2019.
Participants by arm
| Arm | Count |
|---|---|
| 2.5 mcg ZPIV 2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29. Zika Virus Purified Inactivated Vaccine (ZPIV): Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant using a 2015 Puerto Rico isolate (PRVABC59 strain). | 36 |
| 5 mcg ZPIV 5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29. Zika Virus Purified Inactivated Vaccine (ZPIV): Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant using a 2015 Puerto Rico isolate (PRVABC59 strain). | 45 |
| Placebo Placebo administered intramuscularly on Day 1 and Day 29. Normal saline (0.9% sodium chloride injection, USP) is a clear to colorless, sterile, nonpyrogenic, isotonic solution. | 10 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Failure to Meet Randomization Criteria | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 4 | 8 | 3 |
| Overall Study | Physician Decision | 3 | 2 | 0 |
| Overall Study | Subject Unable to Attend Clinical Visit | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 0 |
Baseline characteristics
| Characteristic | 5 mcg ZPIV | Total | 2.5 mcg ZPIV | Placebo |
|---|---|---|---|---|
| Age, Continuous | 30.5 years STANDARD_DEVIATION 8 | 30.7 years STANDARD_DEVIATION 8.4 | 31.4 years STANDARD_DEVIATION 9 | 28.6 years STANDARD_DEVIATION 8 |
| Baseline Flavivirus Immune Status Baseline ZIKV Seronegative and DENV Seronegative | 10 Participants | 19 Participants | 8 Participants | 1 Participants |
| Baseline Flavivirus Immune Status Baseline ZIKV Seronegative and DENV Seropositive | 33 Participants | 68 Participants | 26 Participants | 9 Participants |
| Baseline Flavivirus Immune Status Baseline ZIKV Seropositive and DENV Seronegative | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Baseline Flavivirus Immune Status Baseline ZIKV Seropositive and DENV Seropositive | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Baseline Flavivirus Immune Status Unknown | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Baseline ZIKV Immune Status Baseline ZIKV Seronegative | 43 Participants | 87 Participants | 34 Participants | 10 Participants |
| Baseline ZIKV Immune Status Baseline ZIKV Seropositive | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Baseline ZIKV Immune Status Unknown | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| BMI | 26.51 kg/m^2 STANDARD_DEVIATION 3.73 | 27.23 kg/m^2 STANDARD_DEVIATION 4.01 | 27.59 kg/m^2 STANDARD_DEVIATION 4.09 | 29.20 kg/m^2 STANDARD_DEVIATION 4.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 45 Participants | 91 Participants | 36 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 18 Participants | 57 Participants | 34 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 15 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 15 Participants | 19 Participants | 2 Participants | 2 Participants |
| Region of Enrollment Puerto Rico | 45 participants | 91 participants | 36 participants | 10 participants |
| Sex: Female, Male Female | 25 Participants | 49 Participants | 18 Participants | 6 Participants |
| Sex: Female, Male Male | 20 Participants | 42 Participants | 18 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 45 | 1 / 10 |
| other Total, other adverse events | 20 / 35 | 29 / 45 | 5 / 10 |
| serious Total, serious adverse events | 2 / 35 | 1 / 45 | 1 / 10 |
Outcome results
Primary
Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants
The number of participants experiencing each adverse event are listed.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all participants with available results who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 2 Participants |
| 2.5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 0 Participants |
| 2.5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 1 Participants |
| 2.5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Vaccine-related Grade 3 local, systemic, or laboratory: Any Event | 0 Participants |
| 2.5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 4 Participants |
| 2.5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 1 Participants |
| 2.5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 1 Participants |
| 2.5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 1 Participants |
| 5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 1 Participants |
| 5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 0 Participants |
| 5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 1 Participants |
| 5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 1 Participants |
| 5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 0 Participants |
| 5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 0 Participants |
| 5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Vaccine-related Grade 3 local, systemic, or laboratory: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 1 Participants |
| 5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 1 Participants |
| 5 mcg ZPIV | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 4 Participants |
| Placebo | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 1 Participants |
| Placebo | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 1 Participants |
| Placebo | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 1 Participants |
| Placebo | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 1 Participants |
| Placebo | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 1 Participants |
| Placebo | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 1 Participants |
| Placebo | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 1 Participants |
| Placebo | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 0 Participants |
| Placebo | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 0 Participants |
| Placebo | Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Vaccine-related Grade 3 local, systemic, or laboratory: Any Event | 0 Participants |
Primary
Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for All Participants
Comparisons of the number of participants who withdrew early and who discontinued treatment are presented.
Time frame: Day 1 through Day 750
Population: The Safety Analysis population includes all participants with available results who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for All Participants | Withdrew from Study | 10 Participants |
| 2.5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for All Participants | Discontinuation of Study Vaccination | 3 Participants |
| 5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for All Participants | Withdrew from Study | 13 Participants |
| 5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for All Participants | Discontinuation of Study Vaccination | 2 Participants |
| Placebo | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for All Participants | Withdrew from Study | 4 Participants |
| Placebo | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for All Participants | Discontinuation of Study Vaccination | 1 Participants |
Primary
Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seronegative Participants
Comparisons of the number of participants who withdrew early and who discontinued treatment are presented.
Time frame: Day 1 through Day 750
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seronegative Participants | Withdrew from Study | 2 Participants |
| 2.5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seronegative Participants | Discontinuation of Study Vaccination | 0 Participants |
| 5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seronegative Participants | Withdrew from Study | 2 Participants |
| 5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seronegative Participants | Discontinuation of Study Vaccination | 0 Participants |
| Placebo | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seronegative Participants | Withdrew from Study | 0 Participants |
| Placebo | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seronegative Participants | Discontinuation of Study Vaccination | 0 Participants |
Primary
Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seropositive Participants
Comparisons of the number of participants who withdrew early and who discontinued treatment are presented.
Time frame: Day 1 through Day 750
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seropositive Participants | Withdrew from Study | 7 Participants |
| 2.5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seropositive Participants | Discontinuation of Study Vaccination | 3 Participants |
| 5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seropositive Participants | Withdrew from Study | 10 Participants |
| 5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seropositive Participants | Discontinuation of Study Vaccination | 2 Participants |
| Placebo | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seropositive Participants | Withdrew from Study | 4 Participants |
| Placebo | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seropositive Participants | Discontinuation of Study Vaccination | 1 Participants |
Primary
Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative Participants
Comparisons of the number of participants who withdrew early and who discontinued treatment are presented.
Time frame: Day 1 through Day 750
Population: The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative Participants | Withdrew from Study | 9 Participants |
| 2.5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative Participants | Discontinuation of Study Vaccination | 3 Participants |
| 5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative Participants | Withdrew from Study | 12 Participants |
| 5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative Participants | Discontinuation of Study Vaccination | 2 Participants |
| Placebo | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative Participants | Withdrew from Study | 4 Participants |
| Placebo | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative Participants | Discontinuation of Study Vaccination | 1 Participants |
Primary
Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive and DENV Seronegative Participants
Comparisons of the number of participants who withdrew early and who discontinued treatment are presented.
Time frame: Day 1 through Day 750
Population: The Safety Analysis population includes all baseline ZIKV seropositive and DENV seronegative participants who received at least one study vaccination. No subjects met the baseline ZIKV seropositive and DENV seronegative criteria.
Primary
Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive and DENV Seropositive Participants
Comparisons of the number of participants who withdrew early and who discontinued treatment are presented.
Time frame: Day 1 through Day 750
Population: The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive and DENV Seropositive Participants | Withdrew from Study | 0 Participants |
| 2.5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive and DENV Seropositive Participants | Discontinuation of Study Vaccination | 0 Participants |
| 5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive and DENV Seropositive Participants | Withdrew from Study | 1 Participants |
| 5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive and DENV Seropositive Participants | Discontinuation of Study Vaccination | 0 Participants |
| Placebo | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive and DENV Seropositive Participants | Withdrew from Study | 0 Participants |
| Placebo | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive and DENV Seropositive Participants | Discontinuation of Study Vaccination | 0 Participants |
Primary
Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive Participants
Comparisons of the number of participants who withdrew early and who discontinued treatment are presented.
Time frame: Day 1 through Day 750
Population: The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive Participants | Withdrew from Study | 0 Participants |
| 2.5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive Participants | Discontinuation of Study Vaccination | 0 Participants |
| 5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive Participants | Withdrew from Study | 1 Participants |
| 5 mcg ZPIV | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive Participants | Discontinuation of Study Vaccination | 0 Participants |
| Placebo | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive Participants | Withdrew from Study | 0 Participants |
| Placebo | Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive Participants | Discontinuation of Study Vaccination | 0 Participants |
Primary
Comparison of the Duration and Type Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants
The median duration of adverse events are listed.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 52.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Duration and Type Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 1 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 1 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 2 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 1 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 11 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 1 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 2 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 2 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Malaise (General Unwell Feeling) | 5 Days |
| Unknown | Comparison of the Duration and Type Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | — Days |
Primary
Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants
The median duration of adverse events are listed.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all participants with available results who received at least one study vaccination and experienced an event as reported in Outcome Measure 41.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 2 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 3 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 2.5 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 1.5 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 4 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 7 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 2 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 4 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 2 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 2 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 2 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 1 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 2 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 3 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 1.5 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 1 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 1 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 3 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 1 Days |
| Unknown | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants | Vaccine-related Grade 3 local, systemic, or laboratory: Any Event | — Days |
Primary
Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seronegative Participants
The median duration of adverse events are listed.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 53.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 4 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 4 Days |
| Unknown | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | — Days |
Primary
Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants
The median duration of adverse events are listed.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 51.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 2 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 3 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 7 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 2 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 1.5 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 2 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 2 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 1 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 4 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 2 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 2 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 3 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 3 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 1 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 1 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 1.5 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 1 Days |
| Unknown | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | — Days |
Primary
Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants
The median duration of adverse events are listed.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 45.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 2 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 2.5 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 4 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 1.5 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 7 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 3 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 2 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 1 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 4 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 2 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 2 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 1 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 1.5 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 1 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 3 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 2 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 3 Days |
| Placebo | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 1 Days |
| Unknown | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Vaccine related Grade 3 local, systemic or laboratory: Any Event | — Days |
Primary
Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive and DENV Seropositive Participants
The median duration of adverse events are listed.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 47.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vaccine related Grade 3 local\, systemic or laboratory AE: Any Event | — |
| Unknown | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | — |
Primary
Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive Participants
The median duration of adverse events are listed.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 43.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive Participants | Vaccine related Grade 3 local, systemic or laboratory AE | — |
| Unknown | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity | — |
Primary
Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants
The median duration of adverse events are listed.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all participants with available results who received at least one study vaccination and experienced an event as reported in Outcome Measure 42.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 1 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 1 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 5.5 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 7.5 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 1 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 3 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 10 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Myalgia (Body Aches/Muscular Pain) | 5.5 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 2 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 2 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 1 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Malaise (General Unwell Feeling) | 7.5 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Nausea | 3 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Vomiting | 1 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 2 Days |
| Unknown | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | — Days |
Primary
Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants
The median duration of adverse events are listed.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 54.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Vomiting | 1 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 3.5 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 10 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 4 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 1 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 3 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 10 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 10 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 1 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Malaise (General Unwell Feeling) | 10 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Nausea | 3 Days |
| Unknown | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | — Days |
Primary
Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants
The median duration of adverse events are listed.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 46.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 1 Days |
| 2.5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 1 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 5.5 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 7.5 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 1 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 3 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 10 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 5.5 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 2 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 1 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Malaise (General Unwell Feeling) | 7.5 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Nausea | 3 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Vomiting | 1 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 2 Days |
| 5 mcg ZPIV | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 2 Days |
| Unknown | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | — Days |
Primary
Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive and DENV Seropositive Participants
The median duration of adverse events are listed.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV positive and DENV seropositive participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 48.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vaccine related Grade 3 local, systemic, or laboratory AE: Any Event | — |
| Unknown | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | — |
Primary
Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive Participants
The median duration of adverse events are listed.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 44.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | — |
| Unknown | Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | — |
Primary
Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seronegative Participants
The number of participants experiencing each adverse event are listed.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 1 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
Primary
Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants
The number of participants experiencing each adverse event are listed.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 1 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 2 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 1 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 3 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 3 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 1 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 1 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 1 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 1 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 1 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 1 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 1 Participants |
Primary
Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants
The number of participants experiencing each adverse event are listed.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Vaccine related Grade 3 local, systemic or laboratory: Any Event | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 4 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 1 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 1 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 1 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 2 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Vaccine related Grade 3 local, systemic or laboratory: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 3 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 1 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 1 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 1 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 1 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 1 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 1 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Vaccine related Grade 3 local, systemic or laboratory: Any Event | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 1 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 1 Participants |
Primary
Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive and DENV Seropositive Participants
The number of participants experiencing each adverse event are listed.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 0 Participants |
Primary
Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive Participants
The number of participants experiencing each adverse event are listed.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive Participants | Vaccine related Grade 3 local, systemic or laboratory AE | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive Participants | Vaccine related Grade 3 local, systemic or laboratory AE | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity | 0 Participants |
Primary
Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants
The number of participants experiencing each adverse event are listed.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all participants with available results who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 1 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 1 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Vomiting | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Malaise (General Unwell Feeling) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Myalgia (Body Aches/Muscular Pain) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Nausea | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 2 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 5 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Myalgia (Body Aches/Muscular Pain) | 2 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 3 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 3 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Malaise (General Unwell Feeling) | 2 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Nausea | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Vomiting | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 2 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 1 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Vomiting | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Myalgia (Body Aches/Muscular Pain) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Malaise (General Unwell Feeling) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Nausea | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 0 Participants |
Primary
Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants
The number of participants experiencing each adverse event are listed.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Vomiting | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Malaise (General Unwell Feeling) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Nausea | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Malaise (General Unwell Feeling) | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Nausea | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Vomiting | 1 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Nausea | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Vomiting | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Malaise (General Unwell Feeling) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 0 Participants |
Primary
Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants
The number of participants experiencing each adverse event will be listed
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Malaise (General Unwell Feeling) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 1 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 1 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 4 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 3 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 3 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Malaise (General Unwell Feeling) | 1 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Malaise (General Unwell Feeling) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 0 Participants |
Primary
Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants
The number of participants experiencing each adverse event are listed.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 1 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 1 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Malaise (General Unwell Feeling) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Nausea | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Vomiting | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 3 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 3 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Malaise (General Unwell Feeling) | 2 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Nausea | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 5 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 2 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Vomiting | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 2 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 1 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 2 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fatigue (Tiredness) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Arthralgia (Joint Pain) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Vomiting | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Pain | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Fever | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Tenderness | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Myalgia (Body Aches/Muscular Pain) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Nausea | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Abdominal Pain | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Headache | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Malaise (General Unwell Feeling) | 0 Participants |
| Placebo | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative Participants | Grade 2 or greater local or systemic reactogenicity: Feverishness (Chills/Shivering/Sweating) | 0 Participants |
Primary
Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive and DENV Seropositive Participants
The number of participants experiencing each adverse event are listed.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV positive and DENV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vaccine related Grade 3 local, systemic, or laboratory AE: Any Event | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vaccine related Grade 3 local, systemic, or laboratory AE: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive and DENV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 0 Participants |
Primary
Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive Participants
The number of participants experiencing each adverse event are listed.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| 2.5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive Participants | Vaccine related Grade 3 local, systemic or laboratory AE: Any Event | 0 Participants |
| 5 mcg ZPIV | Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive Participants | Grade 2 or greater local or systemic reactogenicity: Any Event | 0 Participants |
Primary
Comparison of the Frequency, Type, and Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive and DENV Seronegative Participants
The number of participants experiencing each adverse event and the median duration of adverse events are listed.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seropositive and DENV seronegative participants who received at least one study vaccination. No participants met the baseline ZIKV seropositive and DENV seronegative criteria.
Primary
Comparison of the Frequency, Type, and Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive and DENV Seronegative Participants
The number of participants experiencing each adverse event and the median duration of adverse events are listed.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seropositive and DENV seronegative participants who received at least one study vaccination. No participants met the baseline ZIKV seropositive and DENV seronegative criteria.
Primary
Duration of Adverse Events of Special Interest (AESI) Considered Related to Study Vaccine for All Participants
For this study Neurologic and Neuroinflammatory Disorders after the first vaccination were considered as Adverse Events of Special Interest (AESI).
Time frame: Day 1 through Day 750
Population: The Safety Analysis population includes all participants with available results who received at least one study vaccination. No AESIs were reported.
Primary
Duration of Serious Adverse Events (SAE) Considered Related to Study Vaccine for All Participants
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect.
Time frame: Day 1 through Day 750
Population: The Safety Analysis population includes all participants with available results who received at least one study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2.5 mcg ZPIV | Duration of Serious Adverse Events (SAE) Considered Related to Study Vaccine for All Participants | 0 Participants |
| 5 mcg ZPIV | Duration of Serious Adverse Events (SAE) Considered Related to Study Vaccine for All Participants | 0 Participants |
| Placebo | Duration of Serious Adverse Events (SAE) Considered Related to Study Vaccine for All Participants | 0 Participants |
Primary
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants
The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pruritus | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Erythema | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Tenderness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pruritus | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Erythema | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Any Local Symptom | None | 15 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pruritus | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Erythema | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pain | None | 22 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pruritus | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Induration | None | 33 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Any Local Symptom | Moderate | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pruritus | None | 34 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Induration | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Tenderness | None | 21 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Induration | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Induration | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pain | Mild | 11 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Induration | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Any Local Symptom | Mild | 18 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Ecchymosis | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pain | Moderate | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Tenderness | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Ecchymosis | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Any Local Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Ecchymosis | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Tenderness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Ecchymosis | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Erythema | None | 32 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Tenderness | Mild | 13 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Ecchymosis | None | 35 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Erythema | Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Any Local Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Tenderness | None | 29 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Any Local Symptom | None | 22 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Any Local Symptom | Mild | 22 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Any Local Symptom | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Any Local Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Any Local Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pain | None | 28 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pain | Mild | 16 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pain | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Erythema | None | 45 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Erythema | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Erythema | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Erythema | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Erythema | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Induration | None | 44 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Induration | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Induration | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Induration | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Induration | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pruritus | None | 43 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pruritus | Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pruritus | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pruritus | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pruritus | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Ecchymosis | None | 45 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Ecchymosis | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Ecchymosis | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Ecchymosis | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Ecchymosis | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Tenderness | Mild | 15 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Tenderness | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Tenderness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Tenderness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Tenderness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pruritus | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Erythema | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Tenderness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pruritus | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Erythema | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Any Local Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Ecchymosis | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Any Local Symptom | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Ecchymosis | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Tenderness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Ecchymosis | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Any Local Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Ecchymosis | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Tenderness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Induration | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Ecchymosis | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Induration | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Induration | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pain | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Induration | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Induration | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Any Local Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pruritus | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Erythema | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Tenderness | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pruritus | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Erythema | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Any Local Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Pruritus | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants | Erythema | Moderate | 0 Participants |
Primary
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants
The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | None | 5 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | None | 5 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | None | 6 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | None | 6 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | None | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Mild | 6 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | None | 5 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Mild | 5 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | None | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | None | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | None | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | None | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Mild | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Moderate | 0 Participants |
Primary
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants
The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | None | 10 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | None | 17 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | None | 24 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Moderate | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | None | 25 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | None | 14 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Mild | 7 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Mild | 14 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Moderate | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | None | 23 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Mild | 11 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | None | 26 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | None | 22 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | None | 17 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Mild | 15 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | None | 22 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Mild | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | None | 33 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | None | 32 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | None | 31 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | None | 33 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Mild | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Moderate | 0 Participants |
Primary
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants
The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Moderate | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | None | 20 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Mild | 13 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | None | 15 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | None | 32 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | None | 34 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Moderate | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Mild | 17 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | None | 31 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | None | 22 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | None | 33 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Mild | 10 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | None | 42 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | None | 21 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Mild | 15 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | None | 43 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Mild | 21 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | None | 41 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | None | 28 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | None | 43 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Mild | 14 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | None | 27 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Mild | 1 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Moderate | 0 Participants |
Primary
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants
The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all participants who received at least one study vaccination. No participants met the baseline ZIKV seropositive and DENV seronegative criteria.
Primary
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants
The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | None | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | None | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
Primary
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants
The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Not reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Not reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Not reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | None | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Not reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Not reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Not reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Not reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | None | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Not reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Not reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Not reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Not reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Not reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Not reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Not reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Not reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Not reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Not reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Not reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Not reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Not reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Not reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Mild | 0 Participants |
Primary
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants
The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all participants with available results who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pruritus | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Erythema | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Tenderness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pruritus | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Erythema | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Any Local Symptom | None | 17 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pruritus | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Erythema | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pain | None | 20 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pruritus | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Induration | None | 31 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Any Local Symptom | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pruritus | None | 30 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Induration | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Tenderness | None | 25 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Induration | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Induration | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pain | Mild | 12 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Induration | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Any Local Symptom | Mild | 15 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Ecchymosis | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Tenderness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Ecchymosis | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Any Local Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Ecchymosis | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Tenderness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Ecchymosis | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Erythema | None | 31 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Tenderness | Mild | 7 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Ecchymosis | None | 32 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Erythema | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Any Local Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Tenderness | None | 34 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Any Local Symptom | None | 33 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Any Local Symptom | Mild | 7 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Any Local Symptom | Moderate | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Any Local Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Any Local Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pain | None | 36 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pain | Mild | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pain | Moderate | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Erythema | None | 43 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Erythema | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Erythema | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Erythema | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Erythema | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Induration | None | 43 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Induration | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Induration | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Induration | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Induration | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pruritus | None | 42 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pruritus | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pruritus | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pruritus | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pruritus | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Ecchymosis | None | 43 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Ecchymosis | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Ecchymosis | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Ecchymosis | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Ecchymosis | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Tenderness | Mild | 6 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Tenderness | Moderate | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Tenderness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Tenderness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Tenderness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pruritus | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Erythema | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Tenderness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pruritus | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Erythema | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Any Local Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Ecchymosis | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Any Local Symptom | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Ecchymosis | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Tenderness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Ecchymosis | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Any Local Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Ecchymosis | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Tenderness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Induration | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Ecchymosis | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Induration | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Induration | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pain | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Induration | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Induration | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Any Local Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pruritus | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Erythema | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Tenderness | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pruritus | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Erythema | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Any Local Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Pruritus | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants | Erythema | Moderate | 0 Participants |
Primary
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants
The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants with available results who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | None | 4 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | None | 7 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | None | 7 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | None | 4 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Mild | 4 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Mild | 4 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | None | 7 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | None | 8 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | None | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | None | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | None | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | None | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | None | 7 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pain | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Ecchymosis | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Induration | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Local Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Erythema | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Tenderness | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Pruritus | Moderate | 0 Participants |
Primary
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants
The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants with available results who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | None | 13 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | None | 16 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | None | 22 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | None | 22 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | None | 18 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Mild | 7 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Mild | 10 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | None | 22 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Mild | 5 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | None | 23 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | None | 26 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | None | 25 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Moderate | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | None | 26 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Moderate | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | None | 31 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | None | 31 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | None | 30 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | None | 31 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Moderate | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Ecchymosis | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pain | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Induration | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Tenderness | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Erythema | Moderate | 0 Participants |
Primary
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants
The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seronegative participants with available results who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | None | 31 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | None | 17 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Mild | 6 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Mild | 11 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Mild | 14 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | None | 20 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | None | 25 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | None | 30 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | None | 30 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | None | 29 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | None | 32 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | None | 41 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | None | 41 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Mild | 6 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Moderate | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | None | 34 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Mild | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Moderate | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | None | 40 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | None | 41 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | None | 33 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Mild | 5 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Moderate | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Local Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Ecchymosis | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Tenderness | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Pruritus | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Erythema | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Induration | Severe | 0 Participants |
Primary
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants
The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 29 though Day 36
Population: The Safety Analysis population includes all participants who received at least one study vaccination. No participants met the baseline ZIKV seropositive and DENV seronegative criteria.
Primary
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants
The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants with available results who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | None | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | None | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | None | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Ecchymosis | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pain | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Induration | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Tenderness | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Erythema | Moderate | 0 Participants |
Primary
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants
The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Not reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Not reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Not reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Not reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | None | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Not reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | None | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Not reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Not reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | None | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Not reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Not reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Not reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Not reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Not reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Not reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Not reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Not reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Not reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Not reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Not reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Tenderness | Not reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Erythema | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Not reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Local Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pruritus | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Not reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Induration | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Pain | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Ecchymosis | Severe | 0 Participants |
Primary
Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants
The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Abdominal Pain | None | 35 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Nausea | None | 33 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Nausea | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Nausea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Nausea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Nausea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Vomiting | None | 34 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Vomiting | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Vomiting | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Vomiting | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Vomiting | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Diarrhea | None | 35 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Diarrhea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Diarrhea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Diarrhea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Diarrhea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Abdominal Pain | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Abdominal Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Abdominal Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Abdominal Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Rash | None | 34 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Rash | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Rash | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Rash | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Rash | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fever | None | 34 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fever | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fever | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fever | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fever | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Any Systemic Symptom | None | 21 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Any Systemic Symptom | Mild | 11 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Any Systemic Symptom | Moderate | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Any Systemic Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Feverishness | None | 33 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Feverishness | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Feverishness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Feverishness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Feverishness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fatigue | None | 32 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fatigue | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fatigue | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fatigue | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fatigue | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Malaise | None | 32 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Malaise | Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Malaise | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Malaise | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Malaise | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Myalgia | None | 30 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Myalgia | Mild | 4 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Myalgia | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Myalgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Myalgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Arthralgia | None | 32 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Arthralgia | Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Arthralgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Arthralgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Arthralgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Headache | None | 25 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Headache | Mild | 9 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Headache | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Headache | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Headache | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Rash | None | 45 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Rash | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Arthralgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Rash | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Myalgia | None | 41 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Rash | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Rash | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fever | None | 44 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Myalgia | Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fever | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fever | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fever | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Myalgia | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fever | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Any Systemic Symptom | None | 25 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Myalgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Any Systemic Symptom | Mild | 17 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Headache | None | 33 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Any Systemic Symptom | Moderate | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Any Systemic Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Myalgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Feverishness | None | 43 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Feverishness | Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Feverishness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Arthralgia | None | 42 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Feverishness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Feverishness | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Headache | Mild | 11 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fatigue | None | 37 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Arthralgia | Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fatigue | Mild | 7 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fatigue | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Headache | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Nausea | None | 40 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Nausea | Mild | 5 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fatigue | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Nausea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Nausea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Arthralgia | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Nausea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fatigue | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Vomiting | None | 45 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Vomiting | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Vomiting | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Vomiting | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Headache | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Vomiting | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Malaise | Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Diarrhea | None | 43 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Diarrhea | Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Arthralgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Diarrhea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Malaise | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Diarrhea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Diarrhea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Malaise | None | 43 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Abdominal Pain | None | 44 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Abdominal Pain | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Malaise | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Abdominal Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Abdominal Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Headache | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Abdominal Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Malaise | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Vomiting | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Malaise | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Abdominal Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Rash | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Headache | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fatigue | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Rash | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Malaise | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Nausea | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Rash | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Myalgia | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Headache | Mild | 3 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Rash | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Arthralgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Diarrhea | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fever | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Nausea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Malaise | Mild | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fever | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Myalgia | Mild | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Abdominal Pain | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fever | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Headache | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Nausea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fever | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fatigue | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Diarrhea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Myalgia | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Nausea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Any Systemic Symptom | None | 5 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Arthralgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Rash | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Any Systemic Symptom | Mild | 4 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Nausea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Diarrhea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Any Systemic Symptom | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Myalgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Abdominal Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Any Systemic Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Headache | None | 6 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Vomiting | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fatigue | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Abdominal Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Feverishness | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Myalgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Vomiting | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Feverishness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Headache | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Arthralgia | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Feverishness | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Diarrhea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Vomiting | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Feverishness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Arthralgia | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Malaise | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Feverishness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Malaise | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Vomiting | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fatigue | None | 6 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Abdominal Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Diarrhea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Fatigue | Mild | 3 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants | Arthralgia | Mild | 0 Participants |
Primary
Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants
The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | None | 7 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | None | 5 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | None | 7 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | None | 7 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | None | 4 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | None | 6 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Mild | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | None | 9 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | None | 9 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | None | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | None | 9 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | None | 9 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | None | 9 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | None | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | None | 9 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | None | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | None | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | None | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Mild | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Mild | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Mild | 0 Participants |
Primary
Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants
The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | None | 22 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | None | 17 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | None | 25 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | None | 23 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | None | 24 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | None | 23 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | None | 25 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Mild | 7 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | None | 26 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | None | 19 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Mild | 6 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Moderate | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | None | 26 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | None | 25 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | None | 25 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | None | 25 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | None | 33 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | None | 18 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Mild | 13 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | None | 30 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | None | 32 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | None | 23 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Mild | 9 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Moderate | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | None | 33 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | None | 27 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Mild | 5 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | None | 32 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | None | 29 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Mild | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | None | 32 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | None | 33 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | None | 33 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | None | 32 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Mild | 2 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Mild | 3 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | None | 6 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | None | 7 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Mild | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Mild | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Mild | 3 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | None | 5 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | None | 5 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Severe | 0 Participants |
Primary
Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants
The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | None | 21 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | None | 33 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | None | 31 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | None | 32 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | None | 24 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | None | 33 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Mild | 9 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | None | 32 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | None | 33 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | None | 32 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | None | 34 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | None | 31 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Moderate | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Mild | 10 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | None | 34 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | None | 29 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Mild | 4 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | None | 24 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Mild | 17 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Moderate | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | None | 42 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | None | 36 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Mild | 6 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | None | 42 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | None | 40 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | None | 41 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | None | 32 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Mild | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | None | 38 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Mild | 5 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | None | 43 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | None | 41 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | None | 43 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | None | 43 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | None | 42 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Mild | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Mild | 4 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Mild | 3 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | None | 6 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Mild | 3 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | None | 6 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | None | 10 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Moderate | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | None | 5 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Mild | 1 Participants |
Primary
Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants
The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seropositive and DENV seronegative participants who received at least one study vaccination. No subjects met the baseline ZIKV seropositive and DENV seronegative criteria.
Primary
Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants
The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | None | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | None | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Mild | 0 Participants |
Primary
Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants
The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | None | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | None | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Moderate | 0 Participants |
Primary
Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants
The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all participants with available results who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Vomiting | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Myalgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Rash | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Vomiting | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Myalgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Feverishness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Vomiting | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Myalgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Any Systemic Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Any Systemic Symptom | None | 26 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Arthralgia | None | 32 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Rash | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Vomiting | None | 32 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Arthralgia | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Feverishness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Nausea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Arthralgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fever | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Nausea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Arthralgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Rash | None | 32 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Nausea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Arthralgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fatigue | None | 31 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Nausea | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Headache | None | 26 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fever | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Nausea | None | 30 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Headache | Mild | 6 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Abdominal Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Headache | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Headache | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fatigue | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Headache | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Abdominal Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fatigue | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fever | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Abdominal Pain | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fatigue | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fever | None | 32 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Abdominal Pain | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fatigue | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Feverishness | None | 32 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Abdominal Pain | None | 31 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Malaise | None | 31 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Any Systemic Symptom | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Diarrhea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Malaise | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Rash | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Diarrhea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Malaise | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Feverishness | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Diarrhea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Malaise | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Any Systemic Symptom | Mild | 5 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Diarrhea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Malaise | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Rash | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Diarrhea | None | 32 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Myalgia | None | 30 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Feverishness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Vomiting | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Myalgia | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fever | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Vomiting | None | 42 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Any Systemic Symptom | None | 36 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Any Systemic Symptom | Mild | 5 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Any Systemic Symptom | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Any Systemic Symptom | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Feverishness | None | 42 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Feverishness | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Feverishness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Feverishness | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Feverishness | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fatigue | None | 40 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fatigue | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fatigue | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fatigue | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fatigue | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Malaise | None | 40 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Malaise | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Malaise | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Malaise | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Malaise | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Myalgia | None | 39 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Myalgia | Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Myalgia | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Myalgia | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Myalgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Arthralgia | None | 41 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Arthralgia | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Arthralgia | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Arthralgia | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Arthralgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Headache | None | 39 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Headache | Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Headache | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Headache | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Headache | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Nausea | None | 41 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Nausea | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Nausea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Nausea | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Nausea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Vomiting | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Vomiting | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Vomiting | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Vomiting | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Diarrhea | None | 42 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Diarrhea | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Diarrhea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Diarrhea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Diarrhea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Abdominal Pain | None | 42 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Abdominal Pain | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Abdominal Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Abdominal Pain | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Abdominal Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Rash | None | 43 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Rash | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Rash | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Rash | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Rash | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fever | None | 41 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fever | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fever | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fever | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Rash | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Vomiting | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Myalgia | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Feverishness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Vomiting | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Malaise | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fever | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Diarrhea | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Malaise | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Rash | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Diarrhea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Malaise | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Feverishness | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Diarrhea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Malaise | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Any Systemic Symptom | Mild | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Diarrhea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Malaise | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Rash | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Diarrhea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fatigue | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Abdominal Pain | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fatigue | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Abdominal Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fatigue | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fever | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Abdominal Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fatigue | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Any Systemic Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Abdominal Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fatigue | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fever | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Headache | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Abdominal Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Headache | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Headache | Mild | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Feverishness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Headache | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Headache | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Fever | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Nausea | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Arthralgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Rash | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Nausea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Arthralgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Feverishness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Nausea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Arthralgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Any Systemic Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Nausea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Arthralgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Rash | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Nausea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Arthralgia | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Myalgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Vomiting | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Myalgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Feverishness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Vomiting | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Myalgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Any Systemic Symptom | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Vomiting | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants | Myalgia | Mild | 0 Participants |
Primary
Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants
The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | None | 7 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | None | 6 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | None | 7 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | None | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | None | 6 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | None | 9 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | None | 8 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | None | 9 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | None | 10 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | None | 8 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | None | 9 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | None | 9 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | None | 8 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | None | 9 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | None | 8 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | None | 8 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | None | 9 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | None | 9 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Mild | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Feverishness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fatigue | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Malaise | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Myalgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Arthralgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Mild | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Headache | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nausea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Vomiting | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Diarrhea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Abdominal Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Rash | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | None | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Fever | Severe | 0 Participants |
Primary
Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants
The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | None | 23 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | None | 22 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | None | 23 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | None | 22 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | None | 23 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | None | 23 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | None | 22 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | None | 23 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | None | 19 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | None | 19 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | None | 22 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Mild | 4 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | None | 22 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | None | 23 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | None | 31 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | None | 30 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | None | 31 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | None | 31 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | None | 31 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | None | 30 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | None | 27 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | None | 31 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | None | 30 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | None | 30 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | None | 30 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | None | 29 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | None | 30 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Myalgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Headache | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Rash | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Fever | Severe | 0 Participants |
Primary
Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants
The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | None | 30 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | None | 31 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | None | 31 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | None | 29 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | None | 31 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Mild | 5 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | None | 30 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | None | 31 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | None | 31 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | None | 25 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Mild | 6 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | None | 30 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | None | 29 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | None | 25 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | None | 31 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | None | 40 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | None | 40 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | None | 40 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | None | 41 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | None | 38 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | None | 39 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | None | 35 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | None | 40 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | None | 38 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | None | 39 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Mild | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | None | 37 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | None | 38 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | None | 39 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Mild | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Feverishness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fatigue | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Malaise | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Myalgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Arthralgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | None | 8 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Mild | 1 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Headache | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Nausea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Vomiting | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Diarrhea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Abdominal Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Rash | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | None | 9 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants | Fever | Severe | 0 Participants |
Primary
Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants
The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seropositive and DENV seronegative participants who received at least one study vaccination. No subjects met the baseline ZIKV seropositive and DENV seronegative criteria.
Primary
Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants
The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any Systemic Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Nausea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Headache | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fever | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Myalgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Malaise | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Rash | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Fatigue | Severe | 0 Participants |
Primary
Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants
The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as None, while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as Not Reported. Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Myalgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Myalgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Myalgia | None | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Myalgia | Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Myalgia | Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Myalgia | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Myalgia | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Myalgia | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Myalgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Myalgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Not Reported | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | None | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Myalgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Myalgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Myalgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Myalgia | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Diarrhea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Malaise | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Abdominal Pain | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fever | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Headache | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Fatigue | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Nausea | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Feverishness | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | Mild | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Any Systemic Symptom | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Moderate | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Arthralgia | None | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Rash | Not Reported | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Vomiting | Severe | 0 Participants |
| Placebo | Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants | Myalgia | Not Reported | 0 Participants |
Primary
Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants
Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). If a condition was present at screening, it was not considered an AE unless the severity worsened.
Time frame: Day 1 through Day 57
Population: The Safety Analysis population includes all participants with available results who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Any SOC: Severe | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Nervous System Disorders : Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Immune System Disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Investigations : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Musculoskeletal and Connective Tissue Disorders : Severe | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Immune System Disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Respiratory, Thoracic, and Mediastinal Disorders : Mild | 4 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Musculoskeletal and Connective Tissue Disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Infections and Infestations : Mild | 9 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Cardiac Disorders : Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Musculoskeletal and Connective Tissue Disorders : Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Infections and Infestations : Moderate | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Skin and Subcutaneous Tissue Disorders : Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Metabolism and nutrition disorders: Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Infections and Infestations : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Reproductive System and Breast Disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Metabolism and nutrition disorders: Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Metabolism and nutrition disorders: Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Injury, Poisoning and Procedural Complications : Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Cardiac Disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Investigations : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Injury, Poisoning and Procedural Complications : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Psychiatric disorders: Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Investigations : Mild | 4 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Reproductive System and Breast Disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Cardiac Disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Any SOC: Mild | 21 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Reproductive System and Breast Disorders : Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Eye Disorders : Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Skin and Subcutaneous Tissue Disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Renal and urinary disorders: Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Eye Disorders : Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Eye Disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Injury, Poisoning and Procedural Complications : Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Renal and urinary disorders: Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Gastrointestinal Disorders : Mild | 4 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Renal and urinary disorders: Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Gastrointestinal Disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Gastrointestinal Disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Respiratory, Thoracic, and Mediastinal Disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Psychiatric disorders: Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | General Disorders and Administration Site Conditions : Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Any SOC: Moderate | 6 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Psychiatric disorders: Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | General Disorders and Administration Site Conditions : Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Skin and Subcutaneous Tissue Disorders : Severe | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Nervous System Disorders : Severe | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | General Disorders and Administration Site Conditions : Severe | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Respiratory, Thoracic, and Mediastinal Disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Nervous System Disorders : Moderate | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Immune System Disorders : Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Reproductive System and Breast Disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Gastrointestinal Disorders : Moderate | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Injury, Poisoning and Procedural Complications : Mild | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Gastrointestinal Disorders : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Any SOC: Mild | 27 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Any SOC: Moderate | 12 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Any SOC: Severe | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Cardiac Disorders : Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Cardiac Disorders : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Cardiac Disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Eye Disorders : Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Eye Disorders : Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Gastrointestinal Disorders : Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | General Disorders and Administration Site Conditions : Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | General Disorders and Administration Site Conditions : Moderate | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | General Disorders and Administration Site Conditions : Severe | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Immune System Disorders : Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Immune System Disorders : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Immune System Disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Infections and Infestations : Mild | 9 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Infections and Infestations : Moderate | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Infections and Infestations : Severe | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Injury, Poisoning and Procedural Complications : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Injury, Poisoning and Procedural Complications : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Investigations : Mild | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Investigations : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Investigations : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Metabolism and nutrition disorders: Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Metabolism and nutrition disorders: Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Metabolism and nutrition disorders: Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Musculoskeletal and Connective Tissue Disorders : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Musculoskeletal and Connective Tissue Disorders : Moderate | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Musculoskeletal and Connective Tissue Disorders : Severe | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Nervous System Disorders : Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Nervous System Disorders : Moderate | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Nervous System Disorders : Severe | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Psychiatric disorders: Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Psychiatric disorders: Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Psychiatric disorders: Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Renal and urinary disorders: Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Renal and urinary disorders: Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Renal and urinary disorders: Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Reproductive System and Breast Disorders : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Reproductive System and Breast Disorders : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Eye Disorders : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Respiratory, Thoracic, and Mediastinal Disorders : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Respiratory, Thoracic, and Mediastinal Disorders : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Respiratory, Thoracic, and Mediastinal Disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Skin and Subcutaneous Tissue Disorders : Mild | 7 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Skin and Subcutaneous Tissue Disorders : Moderate | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Skin and Subcutaneous Tissue Disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Any SOC: Severe | 1 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Nervous System Disorders : Mild | 2 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | General Disorders and Administration Site Conditions : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Gastrointestinal Disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Nervous System Disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | General Disorders and Administration Site Conditions : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Respiratory, Thoracic, and Mediastinal Disorders : Mild | 1 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Any SOC: Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Psychiatric disorders: Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | General Disorders and Administration Site Conditions : Mild | 1 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Skin and Subcutaneous Tissue Disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Psychiatric disorders: Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Gastrointestinal Disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Respiratory, Thoracic, and Mediastinal Disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Psychiatric disorders: Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Gastrointestinal Disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Any SOC: Mild | 5 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Renal and urinary disorders: Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Eye Disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Skin and Subcutaneous Tissue Disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Renal and urinary disorders: Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Eye Disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Respiratory, Thoracic, and Mediastinal Disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Renal and urinary disorders: Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Injury, Poisoning and Procedural Complications : Severe | 1 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Cardiac Disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Investigations : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Injury, Poisoning and Procedural Complications : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Nervous System Disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Investigations : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Reproductive System and Breast Disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Investigations : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Injury, Poisoning and Procedural Complications : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Cardiac Disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Metabolism and nutrition disorders: Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Infections and Infestations : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Eye Disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Metabolism and nutrition disorders: Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Infections and Infestations : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Reproductive System and Breast Disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Metabolism and nutrition disorders: Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Infections and Infestations : Mild | 3 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Cardiac Disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Musculoskeletal and Connective Tissue Disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Immune System Disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Skin and Subcutaneous Tissue Disorders : Mild | 1 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Musculoskeletal and Connective Tissue Disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Immune System Disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Reproductive System and Breast Disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Musculoskeletal and Connective Tissue Disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants | Immune System Disorders : Mild | 0 Participants |
Primary
Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants
Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). If a condition was present at screening, it was not considered an AE unless the severity worsened.
Time frame: Day 1 through Day 57
Population: The Safety Analysis population includes all participants baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Eye disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nervous system disorders : Severe | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Infections and infestations : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Cardiac disorders : Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Skin and subcutaneous tissue disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Infections and infestations : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Cardiac disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nervous system disorders : Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Infections and infestations : Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Cardiac disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Immune system disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Gastrointestinal disorders : Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Psychiatric disorders : Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Immune system disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Gastrointestinal disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Skin and subcutaneous tissue disorders : Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Immune system disorders : Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Gastrointestinal disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Investigations : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | General disorders and administration site conditions : Severe | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | General disorders and administration site conditions : Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Psychiatric disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | General disorders and administration site conditions : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Musculoskeletal and connective tissue disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Musculoskeletal and connective tissue disorders : Severe | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Investigations : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Skin and subcutaneous tissue disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Investigations : Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any SOC : Mild | 5 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Injury, poisoning and procedural complications : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any SOC : Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any SOC : Severe | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nervous system disorders : Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Injury, poisoning and procedural complications : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Eye disorders : Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Musculoskeletal and connective tissue disorders : Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Eye disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Psychiatric disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Injury, poisoning and procedural complications : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Immune system disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Cardiac disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Investigations : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Musculoskeletal and connective tissue disorders : Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Musculoskeletal and connective tissue disorders : Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nervous system disorders : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nervous system disorders : Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Psychiatric disorders : Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Psychiatric disorders : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any SOC : Mild | 5 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any SOC : Moderate | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any SOC : Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Eye disorders : Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Eye disorders : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Eye disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Cardiac disorders : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Cardiac disorders : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Gastrointestinal disorders : Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Gastrointestinal disorders : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Gastrointestinal disorders : Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | General disorders and administration site conditions : Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | General disorders and administration site conditions : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | General disorders and administration site conditions : Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Immune system disorders : Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Immune system disorders : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Infections and infestations : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Infections and infestations : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Infections and infestations : Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Injury, poisoning and procedural complications : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Injury, poisoning and procedural complications : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Injury, poisoning and procedural complications : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Investigations : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Investigations : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Musculoskeletal and connective tissue disorders : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nervous system disorders : Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Psychiatric disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Skin and subcutaneous tissue disorders : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Skin and subcutaneous tissue disorders : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Skin and subcutaneous tissue disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Psychiatric disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Infections and infestations : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Eye disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nervous system disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Infections and infestations : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Eye disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Skin and subcutaneous tissue disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Injury, poisoning and procedural complications : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any SOC : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Injury, poisoning and procedural complications : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any SOC : Mild | 1 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Musculoskeletal and connective tissue disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Injury, poisoning and procedural complications : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Musculoskeletal and connective tissue disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Investigations : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Psychiatric disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Eye disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Investigations : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Skin and subcutaneous tissue disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Musculoskeletal and connective tissue disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | General disorders and administration site conditions : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nervous system disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | General disorders and administration site conditions : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Gastrointestinal disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Investigations : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | General disorders and administration site conditions : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Gastrointestinal disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Psychiatric disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Immune system disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Gastrointestinal disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Nervous system disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Immune system disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Cardiac disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Any SOC : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Immune system disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Cardiac disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Skin and subcutaneous tissue disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Infections and infestations : Mild | 1 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants | Cardiac disorders : Mild | 0 Participants |
Primary
Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants
Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). If a condition was present at screening, it was not considered an AE unless the severity worsened.
Time frame: Day 1 through Day 57
Population: The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | General disorders and administration site conditions : Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nervous system disorders : Moderate | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | General disorders and administration site conditions : Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Respiratory, thoracic and mediastinal disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any SOC : Severe | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nervous system disorders : Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | General disorders and administration site conditions : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Reproductive system and breast disorders : Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Musculoskeletal and connective tissue disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Infections and infestations : Mild | 8 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Respiratory, thoracic and mediastinal disorders : Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Musculoskeletal and connective tissue disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Infections and infestations : Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Cardiac disorders : Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Musculoskeletal and connective tissue disorders : Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Infections and infestations : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Investigations : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Metabolism and nutrition disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Injury, poisoning and procedural complications : Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Reproductive system and breast disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Metabolism and nutrition disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Injury, poisoning and procedural complications : Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Cardiac disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Metabolism and nutrition disorders : Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Injury, poisoning and procedural complications : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Skin and subcutaneous tissue disorders : Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Investigations : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Investigations : Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Renal and urinary disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Cardiac disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Reproductive system and breast disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Renal and urinary disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Eye disorders : Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Skin and subcutaneous tissue disorders : Severe | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Renal and urinary disorders : Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Eye disorders : Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any SOC : Mild | 16 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Psychiatric disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Eye disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Skin and subcutaneous tissue disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Psychiatric disorders : Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Gastrointestinal disorders : Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Respiratory, thoracic and mediastinal disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Psychiatric disorders : Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Gastrointestinal disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any SOC : Moderate | 4 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nervous system disorders : Severe | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Gastrointestinal disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Psychiatric disorders : Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Investigations : Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Investigations : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Metabolism and nutrition disorders : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Respiratory, thoracic and mediastinal disorders : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Reproductive system and breast disorders : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Reproductive system and breast disorders : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any SOC : Mild | 21 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any SOC : Moderate | 9 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any SOC : Severe | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Cardiac disorders : Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Cardiac disorders : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Cardiac disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Eye disorders : Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Eye disorders : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Eye disorders : Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Gastrointestinal disorders : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Gastrointestinal disorders : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Gastrointestinal disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | General disorders and administration site conditions : Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | General disorders and administration site conditions : Moderate | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | General disorders and administration site conditions : Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Infections and infestations : Mild | 7 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Infections and infestations : Moderate | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Infections and infestations : Severe | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Injury, poisoning and procedural complications : Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Injury, poisoning and procedural complications : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Injury, poisoning and procedural complications : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Investigations : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Metabolism and nutrition disorders : Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Metabolism and nutrition disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Musculoskeletal and connective tissue disorders : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Musculoskeletal and connective tissue disorders : Moderate | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Musculoskeletal and connective tissue disorders : Severe | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nervous system disorders : Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nervous system disorders : Moderate | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nervous system disorders : Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Psychiatric disorders : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Psychiatric disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Renal and urinary disorders : Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Renal and urinary disorders : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Renal and urinary disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Reproductive system and breast disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Respiratory, thoracic and mediastinal disorders : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Respiratory, thoracic and mediastinal disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Skin and subcutaneous tissue disorders : Mild | 6 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Skin and subcutaneous tissue disorders : Moderate | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Skin and subcutaneous tissue disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Musculoskeletal and connective tissue disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | General disorders and administration site conditions : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any SOC : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nervous system disorders : Mild | 2 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Gastrointestinal disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Respiratory, thoracic and mediastinal disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nervous system disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Gastrointestinal disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any SOC : Mild | 4 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Nervous system disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Gastrointestinal disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | General disorders and administration site conditions : Mild | 1 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Psychiatric disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Eye disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Skin and subcutaneous tissue disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Psychiatric disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Eye disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Respiratory, thoracic and mediastinal disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Psychiatric disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Eye disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Reproductive system and breast disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Renal and urinary disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Cardiac disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Metabolism and nutrition disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Renal and urinary disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Cardiac disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Skin and subcutaneous tissue disorders : Mild | 1 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Renal and urinary disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Investigations : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Injury, poisoning and procedural complications : Severe | 1 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Reproductive system and breast disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Investigations : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Investigations : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Injury, poisoning and procedural complications : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Cardiac disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Metabolism and nutrition disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Injury, poisoning and procedural complications : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Infections and infestations : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Reproductive system and breast disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Metabolism and nutrition disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Infections and infestations : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Any SOC : Severe | 1 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Musculoskeletal and connective tissue disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Infections and infestations : Mild | 2 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Skin and subcutaneous tissue disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Musculoskeletal and connective tissue disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | General disorders and administration site conditions : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants | Respiratory, thoracic and mediastinal disorders : Mild | 1 Participants |
Primary
Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants
Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). If a condition was present at screening, it was not considered an AE unless the severity worsened.
Time frame: Day 1 through Day 57
Population: The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Nervous system disorders : Moderate | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Immune system disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Nervous system disorders : Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Immune system disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Cardiac disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Musculoskeletal and connective disorders : Severe | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Musculoskeletal and connective disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Infections and infestations : Mild | 9 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Any SOC : Mild | 21 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Musculoskeletal and connective disorders : Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Infections and infestations : Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Mild | 4 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Metabolism and nutrition disorders: Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Infections and infestations : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Eye disorders : Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Skin and cutaneous tissue disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Metabolism and nutrition disorders: Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Injury, poisoning and procedural complications : Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Reproductive system and breast disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Metabolism and nutrition disorders: Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Injury, poisoning and procedural complications : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Eye disorders : Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Investigations : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Investigations : Mild | 4 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Any SOC : Severe | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Investigations : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Reproductive system and breast disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Eye disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Injury, poisoning and procedural complications : Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Reproductive system and breast disorders : Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Gastrointestinal disorders : Mild | 4 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Skin and cutaneous tissue disorders : Mild | 3 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Renal and urinary disorders: Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Gastrointestinal disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Cardiac disorders : Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Renal and urinary disorders: Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Gastrointestinal disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Renal and urinary disorders: Mild | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Psychiatric disorders: Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | General disorders and administration site conditions : Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Skin and cutaneous tissue disorders : Severe | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Psychiatric disorders: Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | General disorders and administration site conditions : Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Psychiatric disorders: Mild | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | General disorders and administration site conditions : Severe | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Cardiac disorders : Moderate | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Nervous system disorders : Severe | 2 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Immune system disorders : Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Any SOC : Moderate | 5 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Gastrointestinal disorders : Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Musculoskeletal and connective disorders : Severe | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Skin and cutaneous tissue disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Any SOC : Mild | 26 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Any SOC : Moderate | 11 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Any SOC : Severe | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Cardiac disorders : Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Cardiac disorders : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Cardiac disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Eye disorders : Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Eye disorders : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Eye disorders : Severe | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Gastrointestinal disorders : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Gastrointestinal disorders : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | General disorders and administration site conditions : Mild | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | General disorders and administration site conditions : Moderate | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | General disorders and administration site conditions : Severe | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Immune system disorders : Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Immune system disorders : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Immune system disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Infections and infestations : Mild | 8 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Infections and infestations : Moderate | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Infections and infestations : Severe | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Injury, poisoning and procedural complications : Mild | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Injury, poisoning and procedural complications : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Injury, poisoning and procedural complications : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Investigations : Mild | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Investigations : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Investigations : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Metabolism and nutrition disorders: Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Metabolism and nutrition disorders: Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Metabolism and nutrition disorders: Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Musculoskeletal and connective disorders : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Musculoskeletal and connective disorders : Moderate | 4 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Nervous system disorders : Mild | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Nervous system disorders : Moderate | 3 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Nervous system disorders : Severe | 2 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Psychiatric disorders: Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Psychiatric disorders: Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Psychiatric disorders: Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Renal and urinary disorders: Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Renal and urinary disorders: Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Renal and urinary disorders: Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Reproductive system and breast disorders : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Reproductive system and breast disorders : Moderate | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Reproductive system and breast disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Mild | 1 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Skin and cutaneous tissue disorders : Mild | 7 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Skin and cutaneous tissue disorders : Moderate | 2 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Nervous system disorders : Mild | 2 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Immune system disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Any SOC : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Nervous system disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | General disorders and administration site conditions : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Mild | 1 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Nervous system disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | General disorders and administration site conditions : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Cardiac disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Psychiatric disorders: Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | General disorders and administration site conditions : Mild | 1 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Skin and cutaneous tissue disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Psychiatric disorders: Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Gastrointestinal disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Psychiatric disorders: Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Infections and infestations : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Cardiac disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Renal and urinary disorders: Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Gastrointestinal disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Skin and cutaneous tissue disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Renal and urinary disorders: Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Gastrointestinal disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Respiratory, thoracic and mediastinal disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Renal and urinary disorders: Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Eye disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Any SOC : Severe | 1 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Investigations : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Reproductive system and breast disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Investigations : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Injury, poisoning and procedural complications : Severe | 1 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Eye disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Injury, poisoning and procedural complications : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Any SOC : Mild | 5 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Metabolism and nutrition disorders: Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Injury, poisoning and procedural complications : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Reproductive system and breast disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Metabolism and nutrition disorders: Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Infections and infestations : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Eye disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Metabolism and nutrition disorders: Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Infections and infestations : Mild | 3 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Skin and cutaneous tissue disorders : Mild | 1 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Musculoskeletal and connective disorders : Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Immune system disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Reproductive system and breast disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Musculoskeletal and connective disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Investigations : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Musculoskeletal and connective disorders : Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Immune system disorders : Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants | Cardiac disorders : Severe | 0 Participants |
Primary
Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants
Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). Each participant was counted once per SOC. If a condition was present at screening, it was not considered an AE unless the severity worsened.
Time frame: Day 1 through Day 57
Population: The Safety Analysis population includes all baseline ZIKV seropositvie and DENV seronegative participants who received at least one study vaccination. No subjects met the baseline ZIKV seropositive and DENV seronegative criteria.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants | Any SOC: Mild | — |
| Unknown | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants | Any SOC: Moderate | — |
| Unknown | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants | Any SOC: Severe | — |
Primary
Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants
Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). If a condition was present at screening, it was not considered an AE unless the severity worsened.
Time frame: Day 1 through Day 57
Population: The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any SOC: Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any SOC: Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any SOC: Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Infections and infestations: Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Infections and infestations: Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Infections and infestations: Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Infections and infestations: Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any SOC: Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Infections and infestations: Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Infections and infestations: Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any SOC: Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any SOC: Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any SOC: Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any SOC: Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Infections and infestations: Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Infections and infestations: Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Any SOC: Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants | Infections and infestations: Moderate | 0 Participants |
Primary
Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants
Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). If a condition was present at screening, it was not considered an AE unless the severity worsened.
Time frame: Day 1 through Day 57
Population: The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Any SOC: Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Any SOC: Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Any SOC: Severe | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Infections and infestations: Mild | 0 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Infections and infestations: Moderate | 1 Participants |
| 2.5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Infections and infestations: Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Infections and infestations: Severe | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Any SOC: Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Infections and infestations: Mild | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Infections and infestations: Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Any SOC: Moderate | 0 Participants |
| 5 mcg ZPIV | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Any SOC: Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Any SOC: Moderate | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Any SOC: Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Infections and infestations: Severe | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Infections and infestations: Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Any SOC: Mild | 0 Participants |
| Placebo | Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants | Infections and infestations: Moderate | 0 Participants |
Primary
Frequency and Type of Adverse Events of Special Interest (AESI) Considered Related to Study Vaccine for All Participants
For this study Neurologic and Neuroinflammatory Disorders after the first vaccination were considered as Adverse Events of Special Interest (AESI).
Time frame: Day 1 through Day 750
Population: The Safety Analysis population includes all participants with available results who received at least one study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2.5 mcg ZPIV | Frequency and Type of Adverse Events of Special Interest (AESI) Considered Related to Study Vaccine for All Participants | 0 Participants |
| 5 mcg ZPIV | Frequency and Type of Adverse Events of Special Interest (AESI) Considered Related to Study Vaccine for All Participants | 0 Participants |
| Placebo | Frequency and Type of Adverse Events of Special Interest (AESI) Considered Related to Study Vaccine for All Participants | 0 Participants |
Primary
Frequency and Type of Serious Adverse Events (SAE) Considered Related to Study Vaccine for All Participants
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect.
Time frame: Day 1 through Day 750
Population: The Safety Analysis population includes all with available results who received at least one study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2.5 mcg ZPIV | Frequency and Type of Serious Adverse Events (SAE) Considered Related to Study Vaccine for All Participants | 0 Participants |
| 5 mcg ZPIV | Frequency and Type of Serious Adverse Events (SAE) Considered Related to Study Vaccine for All Participants | 0 Participants |
| Placebo | Frequency and Type of Serious Adverse Events (SAE) Considered Related to Study Vaccine for All Participants | 0 Participants |
Primary
Frequency of New Onset Chronic Medical Conditions for All Participants
New onset chronic medical conditions (NOCMCs) were any new medical conditions reported from the first administration of study vaccine until the end of the study.
Time frame: Day 1 through Day 750
Population: The Safety Analysis population includes all participants with available results who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2.5 mcg ZPIV | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline ZIKV Seropositive | 0 Participants |
| 2.5 mcg ZPIV | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline ZIKV Seronegative | 1 Participants |
| 2.5 mcg ZPIV | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline ZIKV Seronegative and DENV Seronegative | 0 Participants |
| 2.5 mcg ZPIV | Frequency of New Onset Chronic Medical Conditions for All Participants | All Participants | 1 Participants |
| 2.5 mcg ZPIV | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline Seropositive and DENV Seronegative | 0 Participants |
| 2.5 mcg ZPIV | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline ZIKV Seropositive and DENV Seropositive | 0 Participants |
| 2.5 mcg ZPIV | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline ZIKV Seronegative and DENV Seropositive | 1 Participants |
| 5 mcg ZPIV | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline ZIKV Seronegative and DENV Seronegative | 0 Participants |
| 5 mcg ZPIV | Frequency of New Onset Chronic Medical Conditions for All Participants | All Participants | 0 Participants |
| 5 mcg ZPIV | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline Seropositive and DENV Seronegative | 0 Participants |
| 5 mcg ZPIV | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline ZIKV Seronegative and DENV Seropositive | 0 Participants |
| 5 mcg ZPIV | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline ZIKV Seropositive | 0 Participants |
| 5 mcg ZPIV | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline ZIKV Seronegative | 0 Participants |
| 5 mcg ZPIV | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline ZIKV Seropositive and DENV Seropositive | 0 Participants |
| Placebo | Frequency of New Onset Chronic Medical Conditions for All Participants | All Participants | 0 Participants |
| Placebo | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline ZIKV Seronegative | 0 Participants |
| Placebo | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline Seropositive and DENV Seronegative | 0 Participants |
| Placebo | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline ZIKV Seronegative and DENV Seronegative | 0 Participants |
| Placebo | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline ZIKV Seropositive and DENV Seropositive | 0 Participants |
| Placebo | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline ZIKV Seropositive | 0 Participants |
| Placebo | Frequency of New Onset Chronic Medical Conditions for All Participants | Baseline ZIKV Seronegative and DENV Seropositive | 0 Participants |