Respiratory Syncytial Virus
Conditions
Keywords
Immune Response, Respiratory Syncytial Virus, Vaccine-Mediated Protection, Neutralizing Antibody, Antibody Response
Brief summary
Background: Respiratory Syncytial Virus (RSV) is a virus that infects the lungs and breathing passages. Healthy adults who are infected generally have mild cold symptoms for a week or two. But it can also be serious, especially for infants and older adults. It can be spread by direct or indirect contact with respiratory secretions. Researchers want to study a new vaccine to prevent RSV. Objective: To see if a vaccine for RSV is safe and if it causes side effects. Eligibility: Healthy adults 18-50 years old Design: Volunteers were screened in a separate screening protocol. Subjects had 13 visits over 1 year. Some subjects received just vaccine. Some received vaccine mixed with alum adjuvant. All subjects received their dose by injection in the upper arm. They received up to two doses, one at the beginning of the study and another 12 weeks later. Subjects were monitored for 1 hour after injection and called to check on their safety 1 day after. Subjects recorded their temperature and side effects for 7 days after each vaccination. Subjects were provided with a thermometer to measure their temperature and a ruler to measure any changes if these occurred on their skin at the injection site. At all visits, subjects were checked for health changes or problems. They may have had blood drawn. At some visits, subjects had samples collected from their nose and mouth.
Detailed description
Study Design: This is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of VRC-RSVRGP084-00-VP vaccine alone or with alum adjuvant in a 2-injection regimen. The hypotheses are that the vaccine will be safe and tolerable for human administration, and will induce detectable immune response. The primary objective is to evaluate the safety and tolerability of the investigational vaccine at 3 dose levels administered alone or with alum adjuvant in healthy adults. Secondary objectives relate to humoral and cellular immunogenicity of the investigational vaccine regimen. Product Description: VRC-RSVRGP084-00-VP (DS-Cav1) was developed by VRC, NIAID and is composed of the respiratory syncytial virus (RSV) fusion (F) glycoprotein ectodomain assembled as a trimer stabilized in its prefusion native conformation with a foldon trimerization domain at the C-terminus and 4 internal mutations designated DS-Cav1 (4.1DHFR\_RSVAF). The sequence is based on the RSV A2 strain from subtype A. The product was provided at a concentration of 0.5 mg/mL in 3 mL glass vials filled to 1.2 mL. Adjuvant was an aluminum hydroxide suspension (alum) provided in a sterile, pyrogen-free suspension at a concentration of 5 mg/mL in 3 mL glass vials filled to 0.7 mL. The alum dose was 500 mcg and was field mixed. Subjects: Healthy adult subjects ages 18-50 years Study Plan: Subjects were randomized into DS-Cav1 or DS-Cav1 plus alum in each dose during the study. Dose continuation and dose escalation evaluations occurred to ensure the safety data support proceeding to the higher doses. Subjects were evaluated for safety and immune responses through blood and mucosal sample collection at specified timepoints throughout the study. VRC 317 Study Schema: * Group: 1; Subjects: 15; Dose: 50mcg; Day 0: DS-Cav1; Week 12 \[1\]: DS-Cav1 * Group: 2; Subjects: 15; Dose: 50mcg; Day 0: DS-Cav1 + alum; Week 12 \[1\]: DS-Cav1 + alum * Group: 3; Subjects: 15; Dose: 150mcg; Day 0: DS-Cav1; Week 12 \[1\]: DS-Cav1 * Group: 4; Subjects: 15; Dose: 150mcg; Day 0: DS-Cav1 + alum; Week 12 \[1\]: DS-Cav1 + alum * Group: 5; Subjects: 15; Dose: 500mcg; Day 0: DS-Cav;1 Week 12 \[1\]: DS-Cav1 * Group: 6; Subjects: 15; Dose: 500mcg; Day 0: DS-Cav1 + alum; Week 12 \[1\]: DS-Cav1 + alum All DS-Cav1 vaccinations were administered with needle and syringe into the deltoid muscle. Total Planned Subjects: 90 (Up to 100 subjects could have been enrolled if needed to evaluate safety or immunogenicity.) • \[1\] Week 12 dose: Optional for the last 5 subjects enrolled in each group who received the Day 0 injection and any additional subjects needed to evaluate safety or immunogenicity of a single injection. Duration: The study schedule required 13 clinic visits and a telephone contact after each injection.
Interventions
BIOLOGICALVRC-RSVRGP084-00-VP
VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.
Aluminum Hydroxide Suspension, alum, is an adjuvant.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* INCLUSION CRITERIA: 1. 18 to 50 years of age. 2. Willing and able to complete the informed consent process. 3. Available for clinic visits through 44 weeks after enrollment. 4. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 5. Willing to donate blood and mucosal samples to be stored and used for future research. 6. In good general health without clinically significant medical history. 7. Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than or equal to 40 within the 56 days prior to enrollment. Laboratory criteria within 56 days prior to enrollment: 8. White Blood Cell (WBC) and differential either within institutional normal range or accompanied by Principal Investigator (PI) or designee approval. 9. Platelets = 125,000-500,000/mm\^3. 10. Hemoglobin within institutional normal range. 11. Creatinine less than or equal to 1.1 x upper limit of normal (ULN). 12. Alanine aminotransferase (ALT) less than or equal to 1.25 x ULN. 13. Negative for HIV infection by an FDA approved method of detection. Criteria applicable to women of childbearing potential: 14. Negative result on a human chorionic gonadotropin pregnancy test on day of enrollment before receiving study product. 15. Agree to use effective means of birth control from at least 21 days before enrollment through 4 weeks after the last injection. *
Exclusion criteria
Criteria applicable to women of childbearing potential: 1. Breast-feeding or planning to become pregnant through 4 weeks after the last injection. Subject has received any of the following: 2. More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment. 3. Blood products within 16 weeks prior to enrollment. 4. Live attenuated vaccines within 4 weeks prior to enrollment. 5. Inactivated vaccines within 2 weeks prior to enrollment. 6. Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study. 7. Current allergen immunotherapy with antigen injections, unless on maintenance schedule. 8. Current anti-tuberculosis(TB) prophylaxis or therapy. Subject has any of the following: 9. Serious reactions to vaccines that preclude receipt of study injections as determined by the investigator. 10. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema. 11. Asthma that is not well controlled. 12. Diabetes mellitus (type I or II), with the exception of gestational diabetes. 13. Thyroid disease that is not well controlled. 14. Hypertension that is not well controlled. 15. Evidence of autoimmune disease or immunodeficiency. 16. Idiopathic urticaria within the past year. 17. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws. 18. Malignancy that is active or history of malignancy that is likely to recur during the study. 19. Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years. 20. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen. 21. Psychiatric condition that precludes compliance with the protocol; past or present psychoses; or within 5 years prior to enrollment, a history of suicide plan or attempt. 22. Any medical, psychiatric, or social condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject s ability to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration | Day 0 through Day 308 | Respiratory Syncytial Virus (RSV) cases were recorded in the study database from receipt of the first study product administration through the last study visit. |
| Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) | Day 0 through Day 28 after product administration | Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 28 days after each study product administration. At other time periods between study product administrations and when greater than 28 days after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity. |
| Number of Subjects With Serious Adverse Events (SAEs) | Day 0 through Day 308 | SAEs were reported from receipt of first study product administration through the last expected study visit at Day 308. The relationship between a SAE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity. |
| Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | 7 days after the first product administration (Day 7) | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the first study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Local Symptom is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). |
| Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | 7 days after the second product administration (Day 91) | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the second study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Local Symptom is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). |
| Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | 7 days after each product administration | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Local Symptom is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). |
| Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | 7 days after the first product administration (Day 7) | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the first study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Systemic Symptom is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). |
| Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | 7 days after the second product administration (Day 91) | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the second study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Systemic Symptom is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). |
| Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | 7 days after each product administration | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Systemic Symptom is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). |
| Number of Subjects With Abnormal Laboratory Measures of Safety | Day 0 through Day 308 | Any abnormal laboratory results recorded as unsolicited AEs are summarized. Safety laboratory parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, white blood cell (WBC) and red blood cell (RBC) counts, and neutrophil, lymphocyte, monocyte, eosinophil and basophil percents and counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete blood count (CBC) differential, platelet, creatinine and ALT results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), and at Days 7, 28, 84, 91 and 112. Institutional laboratory normals as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | 4 weeks after the second product administration (Week 16) | Neutralizing antibody titers were determined against a reporter RSV A2 virus (RSV A), and were summarized using geometric mean 50% inhibitory concentration (IC50). Negative samples were reported and IC50 titers were calculated using half the limit of detection. Measurements were normalized to international units per milliliter. |
| Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | 4 weeks after the first product administration (Week 4) | Neutralizing antibody titers were determined against a reporter RSV A2 virus (RSV A), and were summarized using geometric mean 50% inhibitory concentration (IC50). Negative samples were reported and IC50 titers were calculated using half the limit of detection. Measurements were normalized to international units per milliliter. |
Countries
United States
Participant flow
Recruitment details
Healthy adults were recruited from the Washington, D.C., metropolitan area.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: DS-Cav1 (50 mcg) DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12\*)
\*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.
VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. | 15 |
| Group 2: DS-Cav1 (50 mcg) + Alum DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\*)
\*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.
VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.
Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. | 15 |
| Group 3: DS-Cav1 (150 mcg) DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\*)
\*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.
VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. | 20 |
| Group 4: DS-Cav1 (150 mcg) + Alum DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\*)
\*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.
VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.
Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. | 15 |
| Group 5: DS-Cav1 (500 mcg) DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\*)
\*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.
VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. | 15 |
| Group 6: DS-Cav1 (500 mcg) + Alum DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\*)
\*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.
VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.
Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. | 15 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Moved from Area | 1 | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Group 2: DS-Cav1 (50 mcg) + Alum | Group 3: DS-Cav1 (150 mcg) | Group 4: DS-Cav1 (150 mcg) + Alum | Group 5: DS-Cav1 (500 mcg) | Group 6: DS-Cav1 (500 mcg) + Alum | Group 1: DS-Cav1 (50 mcg) | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized 18-20 years | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Age, Customized 21-30 years | 4 Participants | 9 Participants | 6 Participants | 8 Participants | 11 Participants | 4 Participants | 42 Participants |
| Age, Customized 31-40 years | 5 Participants | 6 Participants | 6 Participants | 4 Participants | 3 Participants | 9 Participants | 33 Participants |
| Age, Customized 41-50 years | 4 Participants | 4 Participants | 2 Participants | 3 Participants | 1 Participants | 2 Participants | 16 Participants |
| Body Mass Index (BMI) 18.5-24.9 kg/m^2 | 6 Participants | 8 Participants | 5 Participants | 7 Participants | 8 Participants | 5 Participants | 39 Participants |
| Body Mass Index (BMI) 25.0-29.9 kg/m^2 | 3 Participants | 9 Participants | 7 Participants | 7 Participants | 5 Participants | 8 Participants | 39 Participants |
| Body Mass Index (BMI) 30.0 kg/m^2 or over | 6 Participants | 3 Participants | 3 Participants | 1 Participants | 2 Participants | 2 Participants | 17 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 4 Participants | 0 Participants | 3 Participants | 3 Participants | 4 Participants | 15 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 1 Participants | 4 Participants | 0 Participants | 0 Participants | 1 Participants | 9 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 1 Participants | 2 Participants | 0 Participants | 4 Participants | 1 Participants | 0 Participants | 8 Participants |
| Race/Ethnicity, Customized Multiracial | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 11 Participants | 13 Participants | 9 Participants | 12 Participants | 10 Participants | 10 Participants | 65 Participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 8 Participants | 9 Participants | 8 Participants | 9 Participants | 49 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 7 Participants | 6 Participants | 7 Participants | 6 Participants | 46 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 20 | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 12 / 15 | 12 / 15 | 20 / 20 | 13 / 15 | 14 / 15 | 12 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 20 | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Primary
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Local Symptom is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time frame: 7 days after each product administration
Population: Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 15 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 4 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 11 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 15 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 4 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 11 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 15 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 10 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 5 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 15 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 10 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 5 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 8 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 20 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 12 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 8 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 12 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 20 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 15 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 15 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 3 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 12 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 3 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 12 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 1 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 10 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 4 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 1 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 4 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 10 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 15 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 15 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 1 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 14 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 12 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 3 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 3 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 12 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 15 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 67 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 95 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 1 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 27 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 94 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 1 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 27 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 1 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 67 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
Primary
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the first study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Local Symptom is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time frame: 7 days after the first product administration (Day 7)
Population: Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 9 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 9 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 15 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 6 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 6 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 15 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 10 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 5 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 10 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 15 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 5 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 15 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 9 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 11 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 20 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 20 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 9 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 11 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 7 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 15 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 8 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 15 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 8 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 7 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 7 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 15 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 8 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 15 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 7 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 8 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 6 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 9 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 14 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 1 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 15 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 9 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 6 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
Primary
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the second study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Local Symptom is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time frame: 7 days after the second product administration (Day 91)
Population: Population included all enrolled subjects who received the optional second study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=62).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 7 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 3 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 3 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 10 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 7 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 10 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 11 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 6 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 5 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 6 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 5 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 11 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 11 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 6 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 6 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 5 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 5 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 11 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 9 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 9 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 5 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 4 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 4 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 5 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 1 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 2 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 8 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 1 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 11 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 11 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 2 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 8 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | None | 10 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Mild | 7 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | None | 3 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Mild | 7 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | None | 3 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Mild | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Redness | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | None | 10 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Local Symptom | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Pain/Tenderness | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Swelling | Mild | 0 Participants |
Primary
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Systemic Symptom is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time frame: 7 days after each product administration
Population: Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 14 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 4 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 10 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 2 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 15 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 1 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 12 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 1 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 1 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 14 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 12 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 3 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 1 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 14 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 1 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 14 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 11 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 10 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 5 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 15 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 4 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 12 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 3 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 5 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 10 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 1 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 15 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 20 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 3 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 3 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 17 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 3 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 7 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 1 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 17 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 13 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 20 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 19 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 17 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 15 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 7 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 1 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 14 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 9 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 6 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 6 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 9 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 3 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 12 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 15 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 8 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 14 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 12 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 3 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 1 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 14 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 13 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 8 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 9 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 1 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 2 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 1 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 6 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 11 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 6 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 1 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 3 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 11 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 13 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 7 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 3 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 14 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 10 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 8 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 13 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 2 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 4 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 2 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 1 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 5 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 12 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 72 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 6 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 2 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 69 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 56 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 93 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 76 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 19 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 37 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 25 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 2 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 22 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 6 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 1 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 1 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 89 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 89 Participants |
Primary
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the first study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Systemic Symptom is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time frame: 7 days after the first product administration (Day 7)
Population: Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 2 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 15 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 2 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 13 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 14 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 13 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 14 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 1 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 15 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 1 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 3 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 12 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 4 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 15 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 2 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 15 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 13 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 2 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 11 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 13 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 14 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 4 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 1 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 11 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 19 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 2 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 19 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 1 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 20 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 15 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 5 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 17 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 3 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 1 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 18 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 20 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 9 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 6 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 15 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 12 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 5 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 3 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 10 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 1 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 9 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 14 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 6 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 15 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 5 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 11 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 4 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 14 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 2 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 13 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 13 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 12 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 1 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 2 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 1 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 10 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 3 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 14 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 6 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 11 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 1 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 4 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 5 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 2 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 15 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 10 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 9 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 13 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 14 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 13 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 2 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
Primary
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the second study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Systemic Symptom is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time frame: 7 days after the second product administration (Day 91)
Population: Population included all enrolled subjects who received the optional second study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=62).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 8 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 1 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 9 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 1 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 2 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 7 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 10 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 1 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 2 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 10 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 9 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 10 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 9 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 2 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 2 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 10 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 1 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 10 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 1 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 11 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 11 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 11 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 9 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 2 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 9 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 2 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 11 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 11 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 1 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 9 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 10 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 11 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 11 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 9 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 8 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 2 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 9 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 9 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 1 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 7 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 1 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 8 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 1 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 8 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 2 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 1 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 3 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 10 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 8 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 1 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 3 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 8 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 1 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 11 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 11 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 11 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 7 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | None | 9 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | None | 9 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Mild | 1 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Mild | 1 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Headache | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | None | 9 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Mild | 1 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Chills | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | None | 9 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Mild | 1 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Nausea | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | Mild | 4 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | None | 9 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Mild | 1 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Temperature | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Moderate | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Malaise | Severe | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | None | 7 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Any Systemic Symptom | None | 6 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Myalgia | Mild | 3 Participants |
Primary
Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration
Respiratory Syncytial Virus (RSV) cases were recorded in the study database from receipt of the first study product administration through the last study visit.
Time frame: Day 0 through Day 308
Population: Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant (N=95).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration | 1 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration | 0 Participants |
Primary
Number of Subjects With Abnormal Laboratory Measures of Safety
Any abnormal laboratory results recorded as unsolicited AEs are summarized. Safety laboratory parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, white blood cell (WBC) and red blood cell (RBC) counts, and neutrophil, lymphocyte, monocyte, eosinophil and basophil percents and counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete blood count (CBC) differential, platelet, creatinine and ALT results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), and at Days 7, 28, 84, 91 and 112. Institutional laboratory normals as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.
Time frame: Day 0 through Day 308
Population: Population included all enrolled subjects who had laboratory results available at any study visit post baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | ALT | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | Neutrophil Count | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | Hemoglobin | 3 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | WBC Count | 1 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | Lymphocyte Count | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | Eosinophil Count | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | Creatinine | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | Eosinophil Count | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | Creatinine | 1 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | Hemoglobin | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | ALT | 1 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | Lymphocyte Count | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | WBC Count | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | Neutrophil Count | 2 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | Hemoglobin | 1 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | Neutrophil Count | 1 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | Lymphocyte Count | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | Eosinophil Count | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | ALT | 1 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | Creatinine | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | WBC Count | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | Neutrophil Count | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | Lymphocyte Count | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | Hemoglobin | 1 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | WBC Count | 1 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | ALT | 1 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | Eosinophil Count | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | Creatinine | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | Neutrophil Count | 2 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | Creatinine | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | Eosinophil Count | 1 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | ALT | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | Lymphocyte Count | 1 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | WBC Count | 1 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects With Abnormal Laboratory Measures of Safety | Hemoglobin | 4 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | ALT | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | Hemoglobin | 1 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | Lymphocyte Count | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | Creatinine | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | WBC Count | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | Neutrophil Count | 1 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects With Abnormal Laboratory Measures of Safety | Eosinophil Count | 0 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects With Abnormal Laboratory Measures of Safety | Eosinophil Count | 1 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects With Abnormal Laboratory Measures of Safety | Neutrophil Count | 6 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects With Abnormal Laboratory Measures of Safety | Creatinine | 1 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects With Abnormal Laboratory Measures of Safety | Lymphocyte Count | 1 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects With Abnormal Laboratory Measures of Safety | ALT | 3 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects With Abnormal Laboratory Measures of Safety | Hemoglobin | 10 Participants |
| All DS-Cav1 Dose Groups | Number of Subjects With Abnormal Laboratory Measures of Safety | WBC Count | 3 Participants |
Primary
Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs)
Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 28 days after each study product administration. At other time periods between study product administrations and when greater than 28 days after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity.
Time frame: Day 0 through Day 28 after product administration
Population: Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) | Related to Study Product | 3 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) | Unrelated to Study Product | 3 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) | Related to Study Product | 3 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) | Unrelated to Study Product | 7 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) | Related to Study Product | 2 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) | Unrelated to Study Product | 12 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) | Related to Study Product | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) | Unrelated to Study Product | 7 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) | Unrelated to Study Product | 7 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) | Related to Study Product | 4 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) | Related to Study Product | 3 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) | Unrelated to Study Product | 6 Participants |
Primary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs were reported from receipt of first study product administration through the last expected study visit at Day 308. The relationship between a SAE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity.
Time frame: Day 0 through Day 308
Population: Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects With Serious Adverse Events (SAEs) | Related to Study Product | 0 Participants |
| Group 1: DS-Cav1 (50 mcg) | Number of Subjects With Serious Adverse Events (SAEs) | Unrelated to Study Product | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects With Serious Adverse Events (SAEs) | Related to Study Product | 0 Participants |
| Group 2: DS-Cav1 (50 mcg) + Alum | Number of Subjects With Serious Adverse Events (SAEs) | Unrelated to Study Product | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects With Serious Adverse Events (SAEs) | Related to Study Product | 0 Participants |
| Group 3: DS-Cav1 (150 mcg) | Number of Subjects With Serious Adverse Events (SAEs) | Unrelated to Study Product | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects With Serious Adverse Events (SAEs) | Related to Study Product | 0 Participants |
| Group 4: DS-Cav1 (150 mcg) + Alum | Number of Subjects With Serious Adverse Events (SAEs) | Unrelated to Study Product | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects With Serious Adverse Events (SAEs) | Related to Study Product | 0 Participants |
| Group 5: DS-Cav1 (500 mcg) | Number of Subjects With Serious Adverse Events (SAEs) | Unrelated to Study Product | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects With Serious Adverse Events (SAEs) | Unrelated to Study Product | 0 Participants |
| Group 6: DS-Cav1 (500 mcg) + Alum | Number of Subjects With Serious Adverse Events (SAEs) | Related to Study Product | 0 Participants |
Secondary
Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Neutralizing antibody titers were determined against a reporter RSV A2 virus (RSV A), and were summarized using geometric mean 50% inhibitory concentration (IC50). Negative samples were reported and IC50 titers were calculated using half the limit of detection. Measurements were normalized to international units per milliliter.
Time frame: 4 weeks after the first product administration (Week 4)
Population: Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant (N=95).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: DS-Cav1 (50 mcg) | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 0 (Baseline, Pre-Administration) | 777 titer |
| Group 1: DS-Cav1 (50 mcg) | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 4 | 4203 titer |
| Group 2: DS-Cav1 (50 mcg) + Alum | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 4 | 3486 titer |
| Group 2: DS-Cav1 (50 mcg) + Alum | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 0 (Baseline, Pre-Administration) | 689 titer |
| Group 3: DS-Cav1 (150 mcg) | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 4 | 5422 titer |
| Group 3: DS-Cav1 (150 mcg) | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 0 (Baseline, Pre-Administration) | 736 titer |
| Group 4: DS-Cav1 (150 mcg) + Alum | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 0 (Baseline, Pre-Administration) | 653 titer |
| Group 4: DS-Cav1 (150 mcg) + Alum | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 4 | 5513 titer |
| Group 5: DS-Cav1 (500 mcg) | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 4 | 7495 titer |
| Group 5: DS-Cav1 (500 mcg) | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 0 (Baseline, Pre-Administration) | 707 titer |
| Group 6: DS-Cav1 (500 mcg) + Alum | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 0 (Baseline, Pre-Administration) | 669 titer |
| Group 6: DS-Cav1 (500 mcg) + Alum | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 4 | 6083 titer |
Secondary
Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Neutralizing antibody titers were determined against a reporter RSV A2 virus (RSV A), and were summarized using geometric mean 50% inhibitory concentration (IC50). Negative samples were reported and IC50 titers were calculated using half the limit of detection. Measurements were normalized to international units per milliliter.
Time frame: 4 weeks after the second product administration (Week 16)
Population: Population included all enrolled subjects who received the optional second study injection of DS-Cav1 alone or with alum adjuvant (N=62).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: DS-Cav1 (50 mcg) | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 16 | 3844 titer |
| Group 1: DS-Cav1 (50 mcg) | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 0 (Baseline, Pre-Administration) | 866 titer |
| Group 2: DS-Cav1 (50 mcg) + Alum | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 16 | 2536 titer |
| Group 2: DS-Cav1 (50 mcg) + Alum | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 0 (Baseline, Pre-Administration) | 734 titer |
| Group 3: DS-Cav1 (150 mcg) | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 0 (Baseline, Pre-Administration) | 790 titer |
| Group 3: DS-Cav1 (150 mcg) | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 16 | 4201 titer |
| Group 4: DS-Cav1 (150 mcg) + Alum | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 16 | 4033 titer |
| Group 4: DS-Cav1 (150 mcg) + Alum | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 0 (Baseline, Pre-Administration) | 578 titer |
| Group 5: DS-Cav1 (500 mcg) | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 16 | 5193 titer |
| Group 5: DS-Cav1 (500 mcg) | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 0 (Baseline, Pre-Administration) | 680 titer |
| Group 6: DS-Cav1 (500 mcg) + Alum | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 16 | 4440 titer |
| Group 6: DS-Cav1 (500 mcg) + Alum | Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant | Week 0 (Baseline, Pre-Administration) | 839 titer |