Hantavirus Pulmonary Infection, Immunisation
Conditions
Keywords
Andes Virus DNA, ANDV DNA, Hantavirus, Immunogenicity, PharmaJet Stratis, Pulmonary Syndrome, Safety, Vaccine
Brief summary
This is a Phase 1, randomized, placebo controlled, double-blind, dose escalation trial of 48 males and non-pregnant females, 18-49 years old, inclusive, who are in good health and meet all eligibility criteria. This trial is designed to assess the safety, reactogenicity and immunogenicity of an Andes Virus (ANDV) DNA vaccine for the prevention of Hantavirus Pulmonary Syndrome (HPS). ANDV DNA vaccine or placebo will be administered using the PharmaJet Stratis(R) Needle-Free Injection System. The study duration is 23 months while the subject participation duration is 12 months. Subjects assigned to the 3 dose regimen will receive ANDV DNA vaccine on Days 1, 29 and 169, and placebo on Day 57. Subjects assigned to the 4 dose regimen will receive ANDV DNA on Days 1, 29, 57 and 169. Two doses (2 or 4 mg) of ANDV DNA vaccine will be evaluated. The primary objective of this study is to assess the safety and reactogenicity of the ANDV DNA vaccine by dosage cohort and treatment arm when administered using the PharmaJet Stratis(R) Needle-Free Injection system in normal, healthy adults.
Detailed description
This is a Phase 1, randomized, placebo controlled, double-blind, dose escalation trial of 48 males and non-pregnant females, 18-49 years old, inclusive, who are in good health and meet all eligibility criteria. This trial is designed to assess the safety, reactogenicity and immunogenicity of an Andes Virus (ANDV) DNA vaccine for the prevention of Hantavirus Pulmonary Syndrome (HPS). ANDV DNA vaccine or placebo will be administered using the PharmaJet Stratis(R) Needle-Free Injection System. The study duration is 23 months while the subject participation duration is 12 months. Subjects assigned to the 3 dose regimen will receive ANDV DNA vaccine on Days 1, 29 and 169, and placebo on Day 57. Subjects assigned to the 4 dose regimen will receive ANDV DNA on Days 1, 29, 57 and 169. Two doses (2 or 4 mg) of ANDV DNA vaccine will be evaluated. The primary objective of this study is to assess the safety and reactogenicity of the ANDV DNA vaccine by dosage cohort and treatment arm when administered using the PharmaJet Stratis(R) Needle-Free Injection system in normal, healthy adults. The secondary objective of this study is to assess the immunogenicity of the ANDV DNA vaccine by dosage cohort and treatment arm.
Interventions
BIOLOGICALAndes virus DNA vaccine
A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 2 mg or 4 mg doses using the PharmaJet Stratis Needle-Free Injection System.
OTHERPlacebo
Normal saline injections will be administered intramuscularly as matching placebo using the PharmaJet Stratis Needle-Free Injection System
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
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provide written informed consent before initiation of any study procedures. 2. Are able to understand and comply with planned study procedures and be available for all study visits/phone calls. 3. Males or non-pregnant females ages 18-49, inclusive. 4. Are in good health\*. \*As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, ER or urgent care for condition and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (apart from steroids as outlined in the Subject
Exclusion criteria
), herbals, vitamins, and supplements are permitted. 5. Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius). 6. Pulse is 47 to 105 beats per minute (bpm), inclusive. 7. Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive. 8. Diastolic blood pressure (BP) is 55 to 95 mm Hg, inclusive. 9. Have acceptable screening laboratories\* within 28 days prior to enrollment. \*Screening laboratory values that are outside acceptable range but are thought to be due to an acute condition or due to laboratory error may be repeated once. 10. Urine protein screen is negative or trace. 11. Drug screen for opiates is negative. 12. HgbA1C \< 6.3% at screening. 13. HIV - 1/2 antibody negative. 14. HCV antibody negative. 15. HBsAg negative. 16. Women of childbearing potential\*, must be using an effective method of contraception\*\* from 30 days prior to the first study vaccination until 90 days after the last study vaccination. \*Women of childbearing potential are defined as those who have not been sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with history of documented radiological confirmation test at least 90 days after the procedure (or with use of another birth control method if history of confirmation test not confirmed), AND are still menstruating or \< 1 year since the last menses if perimenoapausal. \*\*For this study, we define an effective contraceptive method as one that results in a failure rate of less than 1% per year when it is used consistently and correctly. This includes, but is not limited to, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with a vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives (the pill). 17. Women of childbearing potential\* must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each study vaccination. \*See definition of women of childbearing potential above. 18. Sexually active male participants whose partner is a woman of childbearing potential\* and has not had a vasectomy\*\* must agree not to father a child until 90 days after the last vaccination\*\*\*. * See definition of women of childbearing potential above. \*\*Performed \> 1 year prior to screening * Must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream or partner reports usage of occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. 19. Women agree to not donate eggs (ova, oocytes) and male subject agrees not to donate sperm from the start of screening onwards until at least 90 days after the last vaccination. 20. Agree not to participate in another clinical trial during the study period. 21. Agree not to donate blood to a blood bank for 3 months after receiving the last study vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Day 169 through Day 176 | Systemic adverse events solicited on a memory aid provided to participants included feverishness, malaise, fatigue, myalgia, headache, nausea, dizziness, and fever. Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the fourth vaccination. Systemic AEs were considered mild severity if they were noticeable but did not interfere with daily activity; events (other than headache) were considered moderate severity if they interfered with daily activity; events (other than headache) were considered severe severity if they caused significant interference and prevented daily activity. Headache events were considered moderate severity if they required any use of pain reliever or interfered with daily activity; headache events were severe if they prevented daily activity or required use of a prescription medication. |
| Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Day 29 through Day 36 | Local adverse events solicited on a memory aid provided to participants included pain, tenderness, erythema, erythema measurement (measuring \>0mm), induration, induration measurement (measuring \>0mm), skin discoloration, ecchymosis, and ecchymosis measurement (measuring \>0mm). Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the second vaccination. |
| Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Day 57 through Day 64 | Local adverse events solicited on a memory aid provided to participants included pain, tenderness, erythema, erythema measurement (measuring \>0mm), induration, induration measurement (measuring \>0mm), skin discoloration, ecchymosis, and ecchymosis measurement (measuring \>0mm). Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the third vaccination. |
| Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Day 169 through Day 176 | Local adverse events solicited on a memory aid provided to participants included pain, tenderness, erythema, erythema measurement, induration, induration measurement, skin discoloration, ecchymosis, and ecchymosis measurement. Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the fourth vaccination. |
| Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Day 1 through Day 8 | Systemic adverse events solicited on a memory aid provided to participants included feverishness, malaise, fatigue, myalgia, headache, nausea, dizziness, and fever. Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the first vaccination. |
| Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Day 29 through Day 36 | Systemic adverse events solicited on a memory aid provided to participants included feverishness, malaise, fatigue, myalgia, headache, nausea, dizziness, and fever. Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the second vaccination. |
| Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Day 57 through Day 64 | Systemic adverse events solicited on a memory aid provided to participants included feverishness, malaise, fatigue, myalgia, headache, nausea, dizziness, and fever. Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the third vaccination. |
| Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Day 8, Day 36, Day 64, Day 176 | Laboratory parameters include alanine aminotransferase (ALT), total bilirubin, creatinine, blood urea nitrogen (BUN), hemoglobin, absolute neutrophil count (ANC), sodium, potassium, white blood cells (WBC), and platelet count. Laboratory results were considered adverse events using the following thresholds: ALT 50 IU/L or greater; total bilirubin 1.30 mg/dL or greater; creatinine 0.81 mg/dL or greater (female) or 1.11 mg/dL or greater (male); BUN 24 mg/dL or greater; hemoglobin 11.6 g/dL or lower (female) or 13.2 g/dL or lower (male); ANC \<1.8 K/mcL; sodium 135 mmol/L or lower (decrease) or 146 mmol/L or greater (increase); potassium 3.0 mmol/L or lower (decrease) or 5.2 mmol/L or greater (increase); WBC 4.4 K/mcL or lower (decrease) or 13.1 K/mcL or greater (increase 18 to \<21 years) and 11.1 K/mcL or greater (increase 21 years or older); or platelets 134 K/mcL or below (decrease) or 467 K/mcL or greater (increase). |
| Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 337 | Day 1 through Day 337 | An adverse event was considered serious if it resulted in any of the following outcomes: death, a life-threatening adverse event (its occurrence places the participant at immediate risk of death), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Adverse events can be considered serious when they may jeopardize the patient or participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. |
| Number of Participants Reporting Vaccine-Related Serious Adverse Events (SAEs) From Day 1 Through Day 337 | Day 1 through Day 337 | An adverse event is considered serious if it results in any of the following outcomes: death, a life-threatening adverse event (its occurrence places the participant at immediate risk of death), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Adverse events can be considered serious when they may jeopardize the patient or participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. An adverse event was considered related to the study product if there was a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event. |
| Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | Day 1 through Day 197 | Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Unsolicited non-serious AEs were documented and reported from the time of first study vaccination through 28 days after the last study vaccination or after Day 169 if the fourth vaccination wasn't received. |
| Number of Participants Experiencing Vaccine-Related Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | Day 1 through Day 197 | Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Unsolicited non-serious AEs were documented and reported from the time of first study vaccination through 28 days after the last study vaccination or after Day 169 if the fourth vaccination wasn't received. An adverse event was considered related to the study product if there was a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event. |
| Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Day 1 through Day 8 | Local adverse events solicited on a memory aid provided to participants included pain, tenderness, erythema, erythema measurement (measuring \>0mm), induration, induration measurement (measuring \>0mm), skin discoloration, ecchymosis, and ecchymosis measurement (measuring \>0mm). Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the first vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 1, Day 57, Day 85, Day 197 | Venous blood was collected to perform a 50% pseudovirion neutralization assay (PsVNA) which was conducted with Andes Virus as the antigen. The geometric mean titer was calculated for each study arm from the results available at Day 1 prior to the first study vaccination, 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), and 28 days following the fourth study vaccination (Day 197). Results lower than the limit of detection (\<20) were reported and analyzed as 14.1 (which is 20/ sqrt(2)). |
| Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers | Day 57, Day 85, Day 197 | Venous blood was collected to perform a 50% plaque reduction neutralization test (PRNT) which was conducted with Andes Virus as the antigen. The number of participants with a titer greater than or equal to 20 was recorded for each study arm from the results available at 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), and 28 days following the fourth study vaccination (Day 197). |
| Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers | Day 57, Day 85, Day 197 | Venous blood was collected to perform a 50% pseudovirion neutralization assay (PsVNA) which was conducted with Andes Virus as the antigen. The number of participants with a titer greater than or equal to 20 was recorded for each study arm from the results available at 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), 28 days following the fourth study vaccination (Day 197). |
| Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers | Day 57, Day 85, Day 197 | Venous blood was collected to perform a 50% plaque reduction neutralization test (PRNT) which was conducted with Andes Virus as the antigen. A participant was considered to have seroconverted if their titer measured at least 40 if the baseline titer was less than 20, or if there was at least a 4-fold rise in titers from baseline if the baseline titer was greater than or equal to 20. The number of participants seroconverting was recorded for each study arm from the results at 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), and 28 days following the fourth study vaccination (Day 197). |
| Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers | Day 57, Day 85, Day 197 | Venous blood was collected to perform a 50% pseudovirion neutralization assay (PsVNA) which was conducted with Andes Virus as the antigen. A participant was considered to have seroconverted if their titer measured at least 40 if the baseline titer was less than 20, or if there was at least a 4-fold rise in titers from baseline if the baseline titer was greater than or equal to 20. The number of participants seroconverting was recorded for each study arm from the results at 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), and 28 days following the fourth study vaccination (Day 197). |
| Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 1, Day 57, Day 85, Day 197 | Venous blood was collected to perform a 50% plaque reduction neutralization test (PRNT) which was conducted with Andes Virus as the antigen. The geometric mean titer was calculated for each study arm from the results available at Day 1 prior to the first study vaccination, 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), and 28 days following the fourth study vaccination (Day 197). Results lower than the limit of detection (\<20) were reported and analyzed as 14.1 (which is 20/ sqrt(2)). |
Countries
United States
Participant flow
Recruitment details
The study population includes 48 males and non-pregnant females, 18-49 years old, inclusive, who are in good health, have not previously received the Hantavirus vaccine, have not been exposed to ANDV, and meet all other eligibility criteria. Participants were enrolled between 19FEB2019 and 04NOV2019 and received study vaccinations between 19FEB2019 and 08APR2020.
Participants by arm
| Arm | Count |
|---|---|
| 2 mg ANDV, 3 Dose Regimen 2 mg (2 injections of 0.5 ml (1 mg/0.5 ml each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.
Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 2 mg doses using the PharmaJet Stratis Needle-Free Injection System. | 10 |
| 2 mg ANDV, 4 Dose Regimen 2 mg (2 injections of 0.5 ml (1 mg/0.5 ml each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.
Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 2 mg doses using the PharmaJet Stratis Needle-Free Injection System. | 10 |
| 4 mg ANDV, 3 Dose Regimen 4 mg (2 injections of 0.5 ml (2 mg/0.5 ml each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.
Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 4 mg doses using the PharmaJet Stratis Needle-Free Injection System. | 10 |
| 4 mg ANDV, 4 Dose Regimen 4 mg (2 injections of 0.5 ml (2 mg/0.5 ml each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.
Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 4 mg doses using the PharmaJet Stratis Needle-Free Injection System. | 10 |
| Placebo 2 mg (2 injections of 0.5 ml (1 mg/0.5 ml each)) or 4 mg (2 injections of 0.5 ml (2 mg/0.5 ml each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Placebo: Normal saline injections will be administered intramuscularly as matching placebo using the PharmaJet Stratis Needle-Free Injection System | 8 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 2 mg ANDV, 3 Dose Regimen | 2 mg ANDV, 4 Dose Regimen | 4 mg ANDV, 3 Dose Regimen | 4 mg ANDV, 4 Dose Regimen | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 37.3 years STANDARD_DEVIATION 6.8 | 33.8 years STANDARD_DEVIATION 8.1 | 34.9 years STANDARD_DEVIATION 8.9 | 35.9 years STANDARD_DEVIATION 10.4 | 30.6 years STANDARD_DEVIATION 8.8 | 34.7 years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 10 Participants | 10 Participants | 8 Participants | 8 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 10 Participants | 8 Participants | 6 Participants | 5 Participants | 37 Participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 9 Participants | 7 Participants | 4 Participants | 33 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 1 Participants | 3 Participants | 4 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 8 |
| other Total, other adverse events | 10 / 10 | 10 / 10 | 10 / 10 | 10 / 10 | 8 / 8 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 1 / 10 | 0 / 8 |
Outcome results
Primary
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events
Laboratory parameters include alanine aminotransferase (ALT), total bilirubin, creatinine, blood urea nitrogen (BUN), hemoglobin, absolute neutrophil count (ANC), sodium, potassium, white blood cells (WBC), and platelet count. Laboratory results were considered adverse events using the following thresholds: ALT 50 IU/L or greater; total bilirubin 1.30 mg/dL or greater; creatinine 0.81 mg/dL or greater (female) or 1.11 mg/dL or greater (male); BUN 24 mg/dL or greater; hemoglobin 11.6 g/dL or lower (female) or 13.2 g/dL or lower (male); ANC \<1.8 K/mcL; sodium 135 mmol/L or lower (decrease) or 146 mmol/L or greater (increase); potassium 3.0 mmol/L or lower (decrease) or 5.2 mmol/L or greater (increase); WBC 4.4 K/mcL or lower (decrease) or 13.1 K/mcL or greater (increase 18 to \<21 years) and 11.1 K/mcL or greater (increase 21 years or older); or platelets 134 K/mcL or below (decrease) or 467 K/mcL or greater (increase).
Time frame: Day 8, Day 36, Day 64, Day 176
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 8 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 64 | 1 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 64 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 36 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 8 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 176 | 2 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC increase : Day 36 | 1 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 36 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 64 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 36 | 1 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 36 | 1 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 36 | 1 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 8 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Platelets increased : Day 64 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 64 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC increase : Day 8 | 1 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ALT : Day 176 | 2 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Sodium increase : Day 36 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 8 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 176 | 1 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 64 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | BUN : Day 176 | 1 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Sodium increase : Day 8 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ALT : Day 64 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 176 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ALT : Day 36 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 176 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 8 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Platelets increased : Day 8 | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 176 | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC increase : Day 36 | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 64 | 2 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 36 | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 8 | 1 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 8 | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 8 | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 36 | 1 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Platelets increased : Day 64 | 1 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 176 | 1 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 64 | 1 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC increase : Day 8 | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 36 | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 176 | 2 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 64 | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 64 | 3 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 176 | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ALT : Day 64 | 2 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 36 | 2 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 8 | 1 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ALT : Day 36 | 2 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 8 | 1 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 36 | 1 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Platelets increased : Day 8 | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Sodium increase : Day 36 | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 64 | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Sodium increase : Day 8 | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 176 | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ALT : Day 176 | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 176 | 1 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | BUN : Day 8 | 1 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | BUN : Day 36 | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 64 | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ALT : Day 36 | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ALT : Day 64 | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ALT : Day 176 | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 8 | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 36 | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 64 | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 176 | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 8 | 2 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 36 | 2 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 64 | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 176 | 3 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | BUN : Day 8 | 2 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | BUN : Day 36 | 2 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | BUN : Day 64 | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | BUN : Day 176 | 3 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 8 | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 36 | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 176 | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 8 | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 36 | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 64 | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 176 | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Sodium increase : Day 8 | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Sodium increase : Day 36 | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 8 | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 36 | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 64 | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 176 | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC increase : Day 8 | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC increase : Day 36 | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Platelets increased : Day 8 | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Platelets increased : Day 64 | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ALT : Day 176 | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 64 | 1 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | BUN : Day 8 | 4 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 176 | 1 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 176 | 3 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 36 | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Sodium increase : Day 8 | 1 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 64 | 4 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ALT : Day 64 | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Sodium increase : Day 36 | 1 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 36 | 4 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Platelets increased : Day 64 | 1 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 8 | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 8 | 5 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Platelets increased : Day 8 | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 36 | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 176 | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 64 | 1 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 64 | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 176 | 1 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 36 | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ALT : Day 36 | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC increase : Day 8 | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 64 | 1 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 8 | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 176 | 1 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 36 | 1 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 8 | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 8 | 1 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | BUN : Day 176 | 3 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | BUN : Day 64 | 4 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | BUN : Day 36 | 4 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC increase : Day 36 | 1 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 36 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 8 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 36 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 64 | 1 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 64 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 64 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Platelets increased : Day 8 | 1 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 176 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC increase : Day 36 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ALT : Day 64 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 176 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 64 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 64 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 36 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 36 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Sodium increase : Day 8 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ALT : Day 36 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 36 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ALT : Day 176 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 176 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Sodium increase : Day 36 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Platelets increased : Day 64 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Creatinine : Day 8 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 8 | 1 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Hemoglobin : Day 176 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC decrease : Day 8 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | ANC : Day 8 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | Total bilirubin : Day 176 | 0 participants |
| Placebo | Number of Participants Experiencing Clinical Safety Laboratory Adverse Events | WBC increase : Day 8 | 0 participants |
Primary
Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197
Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Unsolicited non-serious AEs were documented and reported from the time of first study vaccination through 28 days after the last study vaccination or after Day 169 if the fourth vaccination wasn't received.
Time frame: Day 1 through Day 197
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | No unsolicited AEs | 4 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | At least one unsolicited AE | 6 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | No unsolicited AEs | 2 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | At least one unsolicited AE | 8 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | No unsolicited AEs | 1 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | At least one unsolicited AE | 9 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | At least one unsolicited AE | 8 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | No unsolicited AEs | 2 Participants |
| Placebo | Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | No unsolicited AEs | 3 Participants |
| Placebo | Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | At least one unsolicited AE | 5 Participants |
Primary
Number of Participants Experiencing Vaccine-Related Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197
Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Unsolicited non-serious AEs were documented and reported from the time of first study vaccination through 28 days after the last study vaccination or after Day 169 if the fourth vaccination wasn't received. An adverse event was considered related to the study product if there was a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.
Time frame: Day 1 through Day 197
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Vaccine-Related Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | None | 8 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Vaccine-Related Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | At least one related unsolicited AE | 2 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Vaccine-Related Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | None | 8 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Vaccine-Related Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | At least one related unsolicited AE | 2 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Vaccine-Related Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | None | 8 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Experiencing Vaccine-Related Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | At least one related unsolicited AE | 2 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Vaccine-Related Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | At least one related unsolicited AE | 3 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Experiencing Vaccine-Related Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | None | 7 Participants |
| Placebo | Number of Participants Experiencing Vaccine-Related Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | None | 6 Participants |
| Placebo | Number of Participants Experiencing Vaccine-Related Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 | At least one related unsolicited AE | 2 Participants |
Primary
Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 337
An adverse event was considered serious if it resulted in any of the following outcomes: death, a life-threatening adverse event (its occurrence places the participant at immediate risk of death), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Adverse events can be considered serious when they may jeopardize the patient or participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Time frame: Day 1 through Day 337
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 337 | 0 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 337 | 0 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 337 | 0 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 337 | 1 Participants |
| Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 337 | 0 Participants |
Primary
Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176
Local adverse events solicited on a memory aid provided to participants included pain, tenderness, erythema, erythema measurement, induration, induration measurement, skin discoloration, ecchymosis, and ecchymosis measurement. Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the fourth vaccination.
Time frame: Day 169 through Day 176
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Ecchymosis (Measurement) | 3 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Induration | 7 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Tenderness | 6 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Induration (Measurement) | 7 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Ecchymosis | 3 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Erythema | 7 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Skin Discoloration | 2 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Erythema (Measurement) | 7 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Pain | 2 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Skin Discoloration | 3 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Induration (Measurement) | 8 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Erythema (Measurement) | 9 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Induration | 8 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Erythema | 9 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Ecchymosis (Measurement) | 3 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Tenderness | 9 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Pain | 8 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Ecchymosis | 3 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Induration (Measurement) | 7 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Pain | 2 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Tenderness | 8 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Erythema | 10 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Erythema (Measurement) | 10 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Induration | 7 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Skin Discoloration | 1 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Ecchymosis | 2 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Ecchymosis (Measurement) | 2 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Erythema (Measurement) | 6 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Induration (Measurement) | 7 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Erythema | 6 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Skin Discoloration | 1 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Tenderness | 5 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Ecchymosis (Measurement) | 3 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Ecchymosis | 3 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Pain | 4 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Induration | 7 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Pain | 1 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Erythema (Measurement) | 2 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Induration (Measurement) | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Erythema | 2 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Induration | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Ecchymosis (Measurement) | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Ecchymosis | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Skin Discoloration | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 | Tenderness | 1 Participants |
Primary
Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8
Local adverse events solicited on a memory aid provided to participants included pain, tenderness, erythema, erythema measurement (measuring \>0mm), induration, induration measurement (measuring \>0mm), skin discoloration, ecchymosis, and ecchymosis measurement (measuring \>0mm). Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the first vaccination.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Ecchymosis (measurement) | 2 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Induration | 4 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Tenderness | 7 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Induration (measurement) | 4 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Ecchymosis | 2 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Erythema | 7 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Skin Discoloration | 2 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Erythema (measurement) | 7 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Pain | 2 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Skin Discoloration | 2 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Induration (measurement) | 10 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Erythema (measurement) | 9 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Induration | 10 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Erythema | 9 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Ecchymosis (measurement) | 4 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Tenderness | 9 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Pain | 8 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Ecchymosis | 4 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Induration (measurement) | 7 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Pain | 7 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Tenderness | 6 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Erythema | 8 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Erythema (measurement) | 8 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Induration | 7 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Skin Discoloration | 2 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Ecchymosis | 3 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Ecchymosis (measurement) | 4 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Erythema (measurement) | 4 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Induration (measurement) | 7 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Erythema | 4 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Skin Discoloration | 2 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Tenderness | 7 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Ecchymosis (measurement) | 3 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Ecchymosis | 3 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Pain | 6 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Induration | 7 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Pain | 1 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Erythema (measurement) | 3 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Induration (measurement) | 3 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Erythema | 3 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Induration | 3 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Ecchymosis (measurement) | 2 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Ecchymosis | 2 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Skin Discoloration | 0 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 | Tenderness | 2 participants |
Primary
Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36
Local adverse events solicited on a memory aid provided to participants included pain, tenderness, erythema, erythema measurement (measuring \>0mm), induration, induration measurement (measuring \>0mm), skin discoloration, ecchymosis, and ecchymosis measurement (measuring \>0mm). Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the second vaccination.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Induration | 4 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Erythema | 7 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Ecchymosis | 1 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Erythema (measurement) | 7 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Skin discoloration | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Tenderness | 3 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Ecchymosis (measurement) | 1 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Pain | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Induration (measurement) | 4 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Induration (measurement) | 10 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Pain | 4 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Tenderness | 9 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Erythema | 9 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Erythema (measurement) | 9 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Induration | 10 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Skin discoloration | 2 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Ecchymosis | 3 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Ecchymosis (measurement) | 3 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Tenderness | 8 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Induration (measurement) | 6 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Pain | 7 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Ecchymosis (measurement) | 6 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Erythema | 8 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Induration | 6 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Erythema (measurement) | 8 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Skin discoloration | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Ecchymosis | 5 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Erythema (measurement) | 6 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Induration | 7 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Tenderness | 7 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Induration (measurement) | 7 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Skin discoloration | 2 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Pain | 4 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Ecchymosis (measurement) | 2 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Ecchymosis | 2 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Erythema | 5 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Erythema | 3 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Ecchymosis (measurement) | 0 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Tenderness | 2 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Ecchymosis | 0 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Pain | 1 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Induration (measurement) | 3 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Induration | 3 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Erythema (measurement) | 3 participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 | Skin discoloration | 0 participants |
Primary
Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64
Local adverse events solicited on a memory aid provided to participants included pain, tenderness, erythema, erythema measurement (measuring \>0mm), induration, induration measurement (measuring \>0mm), skin discoloration, ecchymosis, and ecchymosis measurement (measuring \>0mm). Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the third vaccination.
Time frame: Day 57 through Day 64
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Ecchymosis (Measurement) | 1 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Induration | 5 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Tenderness | 4 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Induration (Measurement) | 5 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Ecchymosis | 1 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Erythema | 7 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Skin Discoloration | 0 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Erythema (Measurement) | 7 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Pain | 2 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Skin Discoloration | 0 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Induration (Measurement) | 8 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Erythema (Measurement) | 10 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Induration | 8 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Erythema | 10 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Ecchymosis (Measurement) | 5 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Tenderness | 7 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Pain | 5 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Ecchymosis | 5 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Induration (Measurement) | 5 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Pain | 1 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Tenderness | 7 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Erythema | 6 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Erythema (Measurement) | 6 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Induration | 5 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Skin Discoloration | 1 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Ecchymosis | 1 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Ecchymosis (Measurement) | 1 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Erythema (Measurement) | 6 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Induration (Measurement) | 6 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Erythema | 6 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Skin Discoloration | 2 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Tenderness | 5 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Ecchymosis (Measurement) | 3 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Ecchymosis | 3 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Pain | 2 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Induration | 6 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Pain | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Erythema (Measurement) | 2 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Induration (Measurement) | 3 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Erythema | 2 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Induration | 3 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Ecchymosis (Measurement) | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Ecchymosis | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Skin Discoloration | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 | Tenderness | 1 Participants |
Primary
Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176
Systemic adverse events solicited on a memory aid provided to participants included feverishness, malaise, fatigue, myalgia, headache, nausea, dizziness, and fever. Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the fourth vaccination. Systemic AEs were considered mild severity if they were noticeable but did not interfere with daily activity; events (other than headache) were considered moderate severity if they interfered with daily activity; events (other than headache) were considered severe severity if they caused significant interference and prevented daily activity. Headache events were considered moderate severity if they required any use of pain reliever or interfered with daily activity; headache events were severe if they prevented daily activity or required use of a prescription medication.
Time frame: Day 169 through Day 176
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Feverishness | 2 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Malaise | 3 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Fatigue | 3 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Myalgia | 2 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Headache | 3 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Nausea | 0 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Dizziness | 0 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Fever | 0 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Fatigue | 4 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Nausea | 2 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Feverishness | 2 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Myalgia | 1 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Malaise | 1 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Fever | 0 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Headache | 2 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Dizziness | 0 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Dizziness | 1 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Fever | 0 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Myalgia | 1 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Nausea | 1 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Fatigue | 1 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Malaise | 1 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Feverishness | 0 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Headache | 1 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Malaise | 2 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Fatigue | 1 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Myalgia | 0 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Headache | 3 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Nausea | 2 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Fever | 0 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Feverishness | 0 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Dizziness | 2 Participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Myalgia | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Fever | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Fatigue | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Dizziness | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Feverishness | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Nausea | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Malaise | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 | Headache | 1 Participants |
Primary
Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8
Systemic adverse events solicited on a memory aid provided to participants included feverishness, malaise, fatigue, myalgia, headache, nausea, dizziness, and fever. Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the first vaccination.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Feverishness | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Malaise | 2 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Fatigue | 3 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Myalgia | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Headache | 3 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Nausea | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Diziness | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Fever | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Fatigue | 3 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Nausea | 1 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Feverishness | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Myalgia | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Malaise | 2 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Fever | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Headache | 4 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Diziness | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Diziness | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Fever | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Myalgia | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Nausea | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Fatigue | 4 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Malaise | 3 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Feverishness | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Headache | 4 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Malaise | 1 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Fatigue | 2 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Myalgia | 1 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Headache | 5 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Nausea | 1 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Fever | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Feverishness | 1 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Diziness | 0 participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Myalgia | 0 participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Fever | 0 participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Fatigue | 1 participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Diziness | 0 participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Feverishness | 0 participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Nausea | 1 participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Malaise | 0 participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 | Headache | 2 participants |
Primary
Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36
Systemic adverse events solicited on a memory aid provided to participants included feverishness, malaise, fatigue, myalgia, headache, nausea, dizziness, and fever. Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the second vaccination.
Time frame: Day 29 through Day 36
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Fever | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Dizziness | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Fatigue | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Malaise | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Headache | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Feverishness | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Nausea | 0 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Myalgia | 1 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Dizziness | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Fever | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Headache | 1 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Malaise | 1 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Myalgia | 1 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Fatigue | 5 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Feverishness | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Nausea | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Feverishness | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Malaise | 2 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Fatigue | 3 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Myalgia | 1 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Headache | 2 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Nausea | 0 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Dizziness | 2 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Fever | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Headache | 3 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Fatigue | 2 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Nausea | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Malaise | 2 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Fever | 1 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Dizziness | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Myalgia | 0 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Feverishness | 1 participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Myalgia | 0 participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Fatigue | 0 participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Headache | 0 participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Fever | 0 participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Dizziness | 0 participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Nausea | 0 participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Malaise | 0 participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 | Feverishness | 0 participants |
Primary
Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64
Systemic adverse events solicited on a memory aid provided to participants included feverishness, malaise, fatigue, myalgia, headache, nausea, dizziness, and fever. Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the third vaccination.
Time frame: Day 57 through Day 64
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Feverishness | 0 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Malaise | 0 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Fatigue | 1 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Myalgia | 0 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Headache | 2 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Nausea | 0 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Dizziness | 0 Participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Fever | 1 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Fatigue | 5 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Nausea | 2 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Feverishness | 1 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Myalgia | 2 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Malaise | 3 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Fever | 0 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Headache | 4 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Dizziness | 3 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Dizziness | 0 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Fever | 0 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Myalgia | 1 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Nausea | 0 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Fatigue | 2 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Malaise | 2 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Feverishness | 1 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Headache | 2 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Malaise | 1 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Fatigue | 2 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Myalgia | 1 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Headache | 2 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Nausea | 0 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Fever | 2 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Feverishness | 1 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Dizziness | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Myalgia | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Fever | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Fatigue | 1 Participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Dizziness | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Feverishness | 1 Participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Nausea | 1 Participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Malaise | 1 Participants |
| Placebo | Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 | Headache | 0 Participants |
Primary
Number of Participants Reporting Vaccine-Related Serious Adverse Events (SAEs) From Day 1 Through Day 337
An adverse event is considered serious if it results in any of the following outcomes: death, a life-threatening adverse event (its occurrence places the participant at immediate risk of death), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Adverse events can be considered serious when they may jeopardize the patient or participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. An adverse event was considered related to the study product if there was a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.
Time frame: Day 1 through Day 337
Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Vaccine-Related Serious Adverse Events (SAEs) From Day 1 Through Day 337 | 0 Participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Vaccine-Related Serious Adverse Events (SAEs) From Day 1 Through Day 337 | 0 Participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants Reporting Vaccine-Related Serious Adverse Events (SAEs) From Day 1 Through Day 337 | 0 Participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants Reporting Vaccine-Related Serious Adverse Events (SAEs) From Day 1 Through Day 337 | 0 Participants |
| Placebo | Number of Participants Reporting Vaccine-Related Serious Adverse Events (SAEs) From Day 1 Through Day 337 | 0 Participants |
Secondary
Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers
Venous blood was collected to perform a 50% plaque reduction neutralization test (PRNT) which was conducted with Andes Virus as the antigen. The geometric mean titer was calculated for each study arm from the results available at Day 1 prior to the first study vaccination, 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), and 28 days following the fourth study vaccination (Day 197). Results lower than the limit of detection (\<20) were reported and analyzed as 14.1 (which is 20/ sqrt(2)).
Time frame: Day 1, Day 57, Day 85, Day 197
Population: All participants in the intent-to-treat (ITT) population with valid results available at the given time point were included. Participants were included in the ITT population if they received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination for immunogenicity testing for which valid results (results are not missing and the laboratory did not deem the sample or results unfit for analysis) were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 1 | 14.1 titer |
| 2 mg ANDV, 3 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 57 | 14.1 titer |
| 2 mg ANDV, 3 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 85 | 14.1 titer |
| 2 mg ANDV, 3 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 197 | 32.9 titer |
| 2 mg ANDV, 4 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 1 | 14.1 titer |
| 2 mg ANDV, 4 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 197 | 68.5 titer |
| 2 mg ANDV, 4 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 57 | 24.6 titer |
| 2 mg ANDV, 4 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 85 | 45.9 titer |
| 4 mg ANDV, 3 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 197 | 50.4 titer |
| 4 mg ANDV, 3 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 57 | 37.3 titer |
| 4 mg ANDV, 3 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 85 | 28.2 titer |
| 4 mg ANDV, 3 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 1 | 14.1 titer |
| 4 mg ANDV, 4 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 1 | 14.1 titer |
| 4 mg ANDV, 4 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 57 | 24.6 titer |
| 4 mg ANDV, 4 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 197 | 217.7 titer |
| 4 mg ANDV, 4 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 85 | 34.8 titer |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 197 | 14.1 titer |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 85 | 14.1 titer |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 57 | 14.1 titer |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers | Day 1 | 14.1 titer |
Secondary
Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers
Venous blood was collected to perform a 50% pseudovirion neutralization assay (PsVNA) which was conducted with Andes Virus as the antigen. The geometric mean titer was calculated for each study arm from the results available at Day 1 prior to the first study vaccination, 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), and 28 days following the fourth study vaccination (Day 197). Results lower than the limit of detection (\<20) were reported and analyzed as 14.1 (which is 20/ sqrt(2)).
Time frame: Day 1, Day 57, Day 85, Day 197
Population: All participants in the intent-to-treat (ITT) population with valid results available at the given time point were included. Participants were included in the ITT population if they received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination for immunogenicity testing for which valid results (results are not missing and the laboratory did not deem the sample or results unfit for analysis) were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 1 | 14.1 titer |
| 2 mg ANDV, 3 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 57 | 22 titer |
| 2 mg ANDV, 3 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 85 | 14.1 titer |
| 2 mg ANDV, 3 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 197 | 112.5 titer |
| 2 mg ANDV, 4 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 1 | 14.1 titer |
| 2 mg ANDV, 4 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 197 | 230.5 titer |
| 2 mg ANDV, 4 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 57 | 35.6 titer |
| 2 mg ANDV, 4 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 85 | 67.1 titer |
| 4 mg ANDV, 3 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 197 | 234.8 titer |
| 4 mg ANDV, 3 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 57 | 200.1 titer |
| 4 mg ANDV, 3 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 85 | 119.4 titer |
| 4 mg ANDV, 3 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 1 | 14.1 titer |
| 4 mg ANDV, 4 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 1 | 14.1 titer |
| 4 mg ANDV, 4 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 57 | 68.8 titer |
| 4 mg ANDV, 4 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 197 | 808.2 titer |
| 4 mg ANDV, 4 Dose Regimen | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 85 | 186.1 titer |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 197 | 14.1 titer |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 85 | 14.1 titer |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 57 | 14.1 titer |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers | Day 1 | 14.1 titer |
Secondary
Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers
Venous blood was collected to perform a 50% plaque reduction neutralization test (PRNT) which was conducted with Andes Virus as the antigen. The number of participants with a titer greater than or equal to 20 was recorded for each study arm from the results available at 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), and 28 days following the fourth study vaccination (Day 197).
Time frame: Day 57, Day 85, Day 197
Population: All participants in the intent-to-treat (ITT) population with valid results available at the given time point were included. Participants were included in the ITT population if they received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination for immunogenicity testing for which valid results (results are not missing and the laboratory did not deem the sample or results unfit for analysis) were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers | Day 57 | 2 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers | Day 197 | 4 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers | Day 85 | 0 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers | Day 85 | 4 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers | Day 57 | 4 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers | Day 197 | 4 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers | Day 85 | 4 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers | Day 57 | 4 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers | Day 197 | 6 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers | Day 57 | 2 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers | Day 197 | 8 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers | Day 85 | 4 participants |
| Placebo | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers | Day 85 | 0 participants |
| Placebo | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers | Day 57 | 0 participants |
| Placebo | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers | Day 197 | 0 participants |
Secondary
Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers
Venous blood was collected to perform a 50% pseudovirion neutralization assay (PsVNA) which was conducted with Andes Virus as the antigen. The number of participants with a titer greater than or equal to 20 was recorded for each study arm from the results available at 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), 28 days following the fourth study vaccination (Day 197).
Time frame: Day 57, Day 85, Day 197
Population: All participants in the intent-to-treat (ITT) population with valid results available at the given time point were included. Participants were included in the ITT population if they received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination for immunogenicity testing for which valid results (results are not missing and the laboratory did not deem the sample or results unfit for analysis) were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers | Day 197 | 5 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers | Day 85 | 1 participants |
| 2 mg ANDV, 3 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers | Day 57 | 2 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers | Day 197 | 9 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers | Day 57 | 5 participants |
| 2 mg ANDV, 4 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers | Day 85 | 5 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers | Day 197 | 8 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers | Day 85 | 6 participants |
| 4 mg ANDV, 3 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers | Day 57 | 6 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers | Day 197 | 8 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers | Day 57 | 5 participants |
| 4 mg ANDV, 4 Dose Regimen | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers | Day 85 | 7 participants |
| Placebo | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers | Day 57 | 0 participants |
| Placebo | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers | Day 197 | 0 participants |
| Placebo | Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers | Day 85 | 0 participants |
Secondary
Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers
Venous blood was collected to perform a 50% plaque reduction neutralization test (PRNT) which was conducted with Andes Virus as the antigen. A participant was considered to have seroconverted if their titer measured at least 40 if the baseline titer was less than 20, or if there was at least a 4-fold rise in titers from baseline if the baseline titer was greater than or equal to 20. The number of participants seroconverting was recorded for each study arm from the results at 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), and 28 days following the fourth study vaccination (Day 197).
Time frame: Day 57, Day 85, Day 197
Population: All participants in the intent-to-treat (ITT) population with valid results available at the given time point were included. Participants were included in the ITT population if they received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination for immunogenicity testing for which valid results (results are not missing and the laboratory did not deem the sample or results unfit for analysis) were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers | Day 57 | 11.1 percentage of participants |
| 2 mg ANDV, 3 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers | Day 197 | 33.3 percentage of participants |
| 2 mg ANDV, 3 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers | Day 85 | 0 percentage of participants |
| 2 mg ANDV, 4 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers | Day 85 | 40 percentage of participants |
| 2 mg ANDV, 4 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers | Day 57 | 30 percentage of participants |
| 2 mg ANDV, 4 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers | Day 197 | 44.4 percentage of participants |
| 4 mg ANDV, 3 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers | Day 85 | 30 percentage of participants |
| 4 mg ANDV, 3 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers | Day 57 | 40 percentage of participants |
| 4 mg ANDV, 3 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers | Day 197 | 55.6 percentage of participants |
| 4 mg ANDV, 4 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers | Day 57 | 20 percentage of participants |
| 4 mg ANDV, 4 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers | Day 197 | 88.9 percentage of participants |
| 4 mg ANDV, 4 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers | Day 85 | 40 percentage of participants |
| Placebo | Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers | Day 85 | 0 percentage of participants |
| Placebo | Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers | Day 57 | 0 percentage of participants |
| Placebo | Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers | Day 197 | 0 percentage of participants |
Secondary
Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers
Venous blood was collected to perform a 50% pseudovirion neutralization assay (PsVNA) which was conducted with Andes Virus as the antigen. A participant was considered to have seroconverted if their titer measured at least 40 if the baseline titer was less than 20, or if there was at least a 4-fold rise in titers from baseline if the baseline titer was greater than or equal to 20. The number of participants seroconverting was recorded for each study arm from the results at 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), and 28 days following the fourth study vaccination (Day 197).
Time frame: Day 57, Day 85, Day 197
Population: All participants in the intent-to-treat (ITT) population with valid results available at the given time point were included. Participants were included in the ITT population if they received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination for immunogenicity testing for which valid results (results are not missing and the laboratory did not deem the sample or results unfit for analysis) were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 mg ANDV, 3 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers | Day 57 | 22.2 percentage of participants |
| 2 mg ANDV, 3 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers | Day 197 | 55.6 percentage of participants |
| 2 mg ANDV, 3 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers | Day 85 | 10 percentage of participants |
| 2 mg ANDV, 4 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers | Day 85 | 40 percentage of participants |
| 2 mg ANDV, 4 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers | Day 57 | 30 percentage of participants |
| 2 mg ANDV, 4 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers | Day 197 | 77.8 percentage of participants |
| 4 mg ANDV, 3 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers | Day 85 | 60 percentage of participants |
| 4 mg ANDV, 3 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers | Day 57 | 60 percentage of participants |
| 4 mg ANDV, 3 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers | Day 197 | 88.9 percentage of participants |
| 4 mg ANDV, 4 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers | Day 57 | 50 percentage of participants |
| 4 mg ANDV, 4 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers | Day 197 | 88.9 percentage of participants |
| 4 mg ANDV, 4 Dose Regimen | Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers | Day 85 | 70 percentage of participants |
| Placebo | Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers | Day 85 | 0 percentage of participants |
| Placebo | Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers | Day 57 | 0 percentage of participants |
| Placebo | Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers | Day 197 | 0 percentage of participants |