Rabies Infection
Conditions
Keywords
Rabies vaccines, intradermal, human rabies immunoglobulins
Brief summary
Demonstrate non-inferiority of the immune response between new versus the currently recommended intradermal regimens of rabies vaccine when administered with or without rabies immunoglobulins in healthy subjects ≥ 1 years of age.
Interventions
BIOLOGICALRabies vaccine
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the 4-sites, 1-week regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8).
BIOLOGICALRabies vaccines + Rabies immunoglobulins
12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the 4-sites, 1-week regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle.
Sponsors
Novartis Vaccines
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males and females ≥ 1 years of age 2. Individuals/ individual's parents or legal guardians who have given written consent 3. Individuals in good health 4. Individuals who can comply with study procedures
Exclusion criteria
1. Behavioral or cognitive impairment or psychiatric disease. 2. Unable to comprehend and to follow all required study procedures for the whole period of the study. 3. History of illness or with an ongoing illness that may pose additional risk to the individual if he/she participates in the study. 4. Individuals ≥ 1 to ≤ 17 years of age, who have or ever had a malignancy. 5. Individuals ≥ 18 years of age, who have or who within the last 5 years, have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder. 6. Known or suspected impairment of the immune system (including but not limited to HIV, autoimmune disorders, immunosuppressive therapy as applicable). 7. Female of childbearing potential who has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry. 8. Female of childbearing potential, refusal to use an acceptable birth control method through day 50. 9. Female of childbearing potential, with a positive pregnancy test prior to enrollment. 10. Received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the previous 12 weeks. 11. Allergic to any of the vaccine components. 12. Allergic to any of the human rabies immunoglobulin components. 13. Contraindication or precaution against rabies vaccination. 14. Contraindication or precaution against man rabies immunoglobulin administration. 15. Planning to receive anti-malaria medications (e.g. Mefloquine) 14 days prior to day 1 vaccination through day 50. 16. Participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. 17. Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccines. 18. Body temperature ≥ 38.0°C (≥ 100.4°F) within 3 days of intended study vaccination. 19. Received rabies vaccines or rabies immunoglobulin or have been exposed to rabies. 20. Part of the study personnel or immediate family members of study personnel conducting this study. 21. Current or history of drug or alcohol abuse within the past 2 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences (4-sites, 1-week to That of 2-sites, TRC ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration) | Study day 50 (D50) | Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method. Non-inferiority of the immune response of the new 4-sites, 1-week ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended 2-sites, TRC ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs | Study Day 50 | Immunogenicity was assessed in terms of Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age at day 50 The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors. Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population. |
| Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age | At Days 8, 15, 91, 181 and 366 | Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors. Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population. |
| Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age | At Days 8, 15, 91, 181 and 366 | Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method. RVNA percentage of subjects with RVNA titer ≥ 0.5 IU/mL at study days 8, 15, 91, 181, and 366 following administration of the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC), with or without HRIG, in the whole study population. |
| Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | At Days 8, 15, 50, 91, 181 and 366 | Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age. RVNA GMCs with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG) |
| Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age | At Days 8, 15, 50, 91, 181 and 366 | Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age |
| Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age | At Days 8, 15, 50, 91, 181 and 366 | Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age |
| Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | From day 1 to day 3; from day 4 to day 7; from day 8 to day 14; from day 29 to day 35(2-sites, TRC PEP, ID regimen) | Number of subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Day 1 to Day 366 | Safety was assessed in terms of the Number of Subjects Reporting Unsolicited Adverse Events (AEs) |
| Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | At Days 8, 15, 50, 91, 181 and 366 | Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age |
| Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | At Days 8, 15,50, 91, 181 and 366 | Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age. Percentage of subjects with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG) |
Countries
Philippines, Thailand
Participant flow
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| 4-sites, 1-week WITHOUT HRIG 12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the 4-sites, 1-week regimen | 355 |
| 4-sites, 1-week WITH HRIG 12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the 4-sites, 1-week regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight | 88 |
| 2-sites, TRC WITHOUT HRIG 8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the 2-sites, TRC, updated Thai Red Cross regimen. | 354 |
| 2-sites, TRC WITH HRIG 8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the 2-sites, TRC, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly | 88 |
| Total | 885 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | ADMINISTRATIVE REASON | 2 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 | 0 | 0 |
| Overall Study | OTHER | 2 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | 4-sites, 1-week WITHOUT HRIG | 4-sites, 1-week WITH HRIG | 2-sites, TRC WITHOUT HRIG | 2-sites, TRC WITH HRIG | Total |
|---|---|---|---|---|---|
| Age, Continuous | 20.0 year STANDARD_DEVIATION 15 | 32.7 year STANDARD_DEVIATION 10.8 | 20.6 year STANDARD_DEVIATION 15.1 | 34.4 year STANDARD_DEVIATION 11.2 | 22.9 year STANDARD_DEVIATION 15.3 |
| Sex: Female, Male FEMALE | 202 Participants | 44 Participants | 179 Participants | 51 Participants | 476 Participants |
| Sex: Female, Male MALE | 153 Participants | 44 Participants | 175 Participants | 37 Participants | 409 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 292 / 356 | 78 / 85 | 298 / 353 | 82 / 89 |
| serious Total, serious adverse events | 5 / 356 | 1 / 85 | 4 / 353 | 2 / 89 |
Outcome results
Primary
Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences (4-sites, 1-week to That of 2-sites, TRC ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration)
Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method. Non-inferiority of the immune response of the new 4-sites, 1-week ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended 2-sites, TRC ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population.
Time frame: Study day 50 (D50)
Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TOTAL 4-sites, 1-week | Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences (4-sites, 1-week to That of 2-sites, TRC ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration) | 99 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences (4-sites, 1-week to That of 2-sites, TRC ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration) | 100 Percentages of Subjects |
95% CI: [-2.4, 0]Fisher Exact
Secondary
Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age
Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors. Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population.
Time frame: At Days 8, 15, 91, 181 and 366
Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age | Day 15 (N= 357, 361) | 18 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age | Day 181 (N= 357, 360) | 1.59 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age | Day 91 (N= 358, 362) | 2.32 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age | Day 366 (N= 356, 352) | 1.59 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age | Day 8 (N= 363, 362) | 0.23 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age | Day 366 (N= 356, 352) | 1.14 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age | Day 8 (N= 363, 362) | 0.14 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age | Day 15 (N= 357, 361) | 12 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age | Day 91 (N= 358, 362) | 3.68 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age | Day 181 (N= 357, 360) | 1.44 IU/mL |
95% CI: [0.84, 1.29]ANOVA
95% CI: [1.35, 2.1]ANOVA
95% CI: [0.54, 0.85]ANOVA
95% CI: [0.94, 1.59]ANOVA
95% CI: [1.27, 2.19]ANOVA
Secondary
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age
Time frame: At Days 8, 15, 50, 91, 181 and 366
Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for 4-sites, 1-week with HRIG and 2-sites TRC with HRIG Groups.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 15 (N= 65, 72) | 13 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 91 (N= 65, 72) | 1.01 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 8 (N= 66, 72) | 0.21 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 181 (N= 65, 71) | 0.88 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 50 (N= 65, 69) | 1.97 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 366 (N= 65, 69) | 0.68 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 1 (N= 66, 72) | 0.05 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 366 (N= 65, 69) | 0.59 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 1 (N= 66, 72) | 0.05 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 8 (N= 66, 72) | 0.17 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 15 (N= 65, 72) | 8.37 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 50 (N= 65, 69) | 6.37 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 91 (N= 65, 72) | 2.25 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 181 (N= 65, 71) | 1.05 IU/mL |
Secondary
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs
Immunogenicity was assessed in terms of Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age at day 50 The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors. Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population.
Time frame: Study Day 50
Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs | 4.58 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs | 10 IU/mL |
95% CI: [0.37, 0.58]ANOVA
Secondary
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age. RVNA GMCs with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)
Time frame: At Days 8, 15, 50, 91, 181 and 366
Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week with HRIG and 4-sites, 1-week without HRIG Groups.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 8 (N= 66, 150) | 0.21 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 15 (N= 65, 146) | 13 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 50 (N= 65, 146) | 1.97 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 91 (N= 65, 149) | 1.01 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 181 (N= 65, 146) | 0.88 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 366 (N= 65, 145) | 0.68 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 181 (N= 65, 146) | 1.92 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 8 (N= 66, 150) | 0.15 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 91 (N= 65, 149) | 2.28 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 15 (N= 65, 146) | 15 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 366 (N= 65, 145) | 1.42 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age | Day 50 (N= 65, 146) | 4.47 IU/mL |
95% CI: [-19.6, -1]Fisher Exact
95% CI: [-5.6, 2.6]Fisher Exact
95% CI: [-26, -7.1]Fisher Exact
95% CI: [-29, -7.1]Fisher Exact
95% CI: [-37.8, -13.2]Fisher Exact
Secondary
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age
Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age
Time frame: At Days 8, 15, 50, 91, 181 and 366
Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week without HRIG and 2-sites, TRC without HRIG Groups.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age | Day 15 (N= 292, 289) | 19 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age | Day 91 (N= 293, 290) | 2.54 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age | Day 8 (N= 297, 290) | 0.23 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age | Day 181 (N= 292, 289) | 1.73 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age | Day 50 (N= 292, 281) | 5.04 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age | Day 366 (N= 291, 283) | 1.73 IU/mL |
| TOTAL 4-sites, 1-week | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age | Day 1 (N=298, 290) | 0.05 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age | Day 366 (N= 291, 283) | 1.2 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age | Day 1 (N=298, 290) | 0.05 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age | Day 8 (N= 297, 290) | 0.13 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age | Day 15 (N= 292, 289) | 12 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age | Day 50 (N= 292, 281) | 10 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age | Day 91 (N= 293, 290) | 3.8 IU/mL |
| TOTAL 2-sites, TRC | Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age | Day 181 (N= 292, 289) | 1.5 IU/mL |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Safety was assessed in terms of the Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Time frame: Day 1 to Day 366
Population: Unsolicited Safety Set- All subjects in the Exposed Population who have post vaccination unsolicited adverse event records. The number of exposed set participants analyzed for safety is different from the Per Protocol Set (PPS) for immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y Any AEs;D1-366 | 157 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥6 to ≤17 Y Withdrawal from study due to AE;D1-366 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 1 to ≤ 5 Y SAE;D1-366 | 3 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 6 to ≤ 17 Y Deaths;D1-366 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 6 to ≤ 17 Y Any AEs;D1-366 | 58 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 6 to ≤ 17 Y SAE;D1-366 | 1 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 1 to ≤ 5 Y Any AEs;D1-366 | 45 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥6 to ≤ 17 Y At least possibly related SAEs;D1-366 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall population ≥ 1 Y SAE;D1-366 | 12 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall population ≥ 1 Y Any AEs;D1-366 | 260 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 1 to ≤ 5 Y At least possibly related SAEs;D1-366 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall population ≥1Y Withdrawal due to AE;D1-366 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y Withdrawal from study due to AE;D1-366 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y Deaths;D1-366 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 1 to ≤ 5 Y Deaths;D1-366 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall population ≥ 1 Y Deaths;D1-366 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y At least possibly related SAEs;D1-366 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y SAE;D1-366 | 8 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥1 to ≤ 5 Y Withdrawal from study due to AE;D1-366 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall ≥1Y Atleast possibly related SAEs;D1-366 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥6 to ≤ 17 Y At least possibly related SAEs;D1-366 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 1 to ≤ 5 Y Any AEs;D1-366 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 1 to ≤ 5 Y SAE;D1-366 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 1 to ≤ 5 Y At least possibly related SAEs;D1-366 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 1 to ≤ 5 Y Deaths;D1-366 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥1 to ≤ 5 Y Withdrawal from study due to AE;D1-366 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 6 to ≤ 17 Y Any AEs;D1-366 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 6 to ≤ 17 Y SAE;D1-366 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y SAE;D1-366 | 3 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 6 to ≤ 17 Y Deaths;D1-366 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥6 to ≤17 Y Withdrawal from study due to AE;D1-366 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y Any AEs;D1-366 | 71 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y At least possibly related SAEs;D1-366 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y Deaths;D1-366 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y Withdrawal from study due to AE;D1-366 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall population ≥ 1 Y Any AEs;D1-366 | 71 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall population ≥ 1 Y SAE;D1-366 | 3 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall ≥1Y Atleast possibly related SAEs;D1-366 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall population ≥ 1 Y Deaths;D1-366 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall population ≥1Y Withdrawal due to AE;D1-366 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 1 to ≤ 5 Y Deaths;D1-366 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥1 to ≤ 5 Y Withdrawal from study due to AE;D1-366 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y At least possibly related SAEs;D1-366 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall population ≥ 1 Y Any AEs;D1-366 | 280 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall ≥1Y Atleast possibly related SAEs;D1-366 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 1 to ≤ 5 Y SAE;D1-366 | 4 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall population ≥ 1 Y Deaths;D1-366 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall population ≥ 1 Y SAE;D1-366 | 14 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y SAE;D1-366 | 7 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 6 to ≤ 17 Y SAE;D1-366 | 3 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 1 to ≤ 5 Y Any AEs;D1-366 | 53 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥6 to ≤ 17 Y At least possibly related SAEs;D1-366 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y Deaths;D1-366 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y Any AEs;D1-366 | 156 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 6 to ≤ 17 Y Any AEs;D1-366 | 71 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 1 to ≤ 5 Y At least possibly related SAEs;D1-366 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 6 to ≤ 17 Y Deaths;D1-366 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall population ≥1Y Withdrawal due to AE;D1-366 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y Withdrawal from study due to AE;D1-366 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥6 to ≤17 Y Withdrawal from study due to AE;D1-366 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall population ≥1Y Withdrawal due to AE;D1-366 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥6 to ≤17 Y Withdrawal from study due to AE;D1-366 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y Any AEs;D1-366 | 72 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 1 to ≤ 5 Y Deaths;D1-366 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y SAE;D1-366 | 5 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall ≥1Y Atleast possibly related SAEs;D1-366 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y At least possibly related SAEs;D1-366 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 1 to ≤ 5 Y At least possibly related SAEs;D1-366 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y Deaths;D1-366 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 18 Y Withdrawal from study due to AE;D1-366 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 1 to ≤ 5 Y SAE;D1-366 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall population ≥ 1 Y Deaths;D1-366 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall population ≥ 1 Y Any AEs;D1-366 | 73 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 6 to ≤ 17 Y SAE;D1-366 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 6 to ≤ 17 Y Any AEs;D1-366 | 1 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥6 to ≤ 17 Y At least possibly related SAEs;D1-366 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Overall population ≥ 1 Y SAE;D1-366 | 5 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 1 to ≤ 5 Y Any AEs;D1-366 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥ 6 to ≤ 17 Y Deaths;D1-366 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | ≥1 to ≤ 5 Y Withdrawal from study due to AE;D1-366 | NA Subjects |
Secondary
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Number of subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Time frame: From day 1 to day 3; from day 4 to day 7; from day 8 to day 14; from day 29 to day 35(2-sites, TRC PEP, ID regimen)
Population: Solicited Safety Set- All subjects in the Exposed Population who provide post vaccination solicited adverse event data. The number of exposed set participants analyzed for safety is different from the Per Protocol Set (PPS) for immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 6 to ≤ 17 Y); Day 4 | 5 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 6 to ≤ 17 Y); Day 8 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 6 to ≤ 17 Y); Day 4 | 1 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 18 Y); Day 8 | 6 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 6 to ≤ 17 Y); Day 1 | 8 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 6 to ≤ 17 Y); Day 1 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 8 | 1 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 6 to ≤ 17 Y); Day 8 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 6 to ≤ 17 Y); Day 4 | 1 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 18 Y); Day 1 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 6 to ≤ 17 Y); Day 8 | 6 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 6 to ≤ 17 Y); Day 1 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 18 Y); Day 4 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 6 to ≤ 17 Y); Day 8 | 1 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 6 to ≤ 17 Y); Day 4 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 18 Y); Day 8 | 1 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 6 to ≤ 17 Y); Day 8 | 6 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 6 to ≤ 17 Y); Day 1 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 1 to ≤ 5 Y); Day 8 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 1 to ≤ 5 Y); Day 4 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 18 Y); Day 1 | 5 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 1 to ≤ 5 Y); Day 1 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration(≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 18 Y); Day 4 | 3 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 6 to ≤ 17 Y); Day 4 | 8 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration(≥ 1 to ≤ 5 Y); Day 8 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration(≥ 1 to ≤ 5 Y); Day 4 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 6 to ≤ 17 Y); Day 1 | 8 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration(≥ 1 to ≤ 5 Y); Day 1 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema(≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills (≥ 18 Y); Day 1 | 8 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema(≥ 1 to ≤ 5 Y); Day 8 | 1 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema(≥ 1 to ≤ 5 Y); Day 4 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 18 Y); Day 1 | 7 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 6 to ≤ 17 Y); Day 4 | 2 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness (≥ 1 to ≤ 5 Y); Day 8 | 7 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema(≥ 1 to ≤ 5 Y); Day 1 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 18 Y); Day 4 | 3 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 18 Y); Day 8 | 3 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 8 | 4 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills (≥ 18 Y); Day 4 | 1 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 6 to ≤ 17 Y); Day 4 | 6 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 4 | 1 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 1 | 3 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills (≥ 18 Y); Day 8 | 5 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 6 to ≤ 17 Y); Day 1 | 14 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 8 | 2 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 6 to ≤ 17 Y); Day 1 | 4 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 4 | 4 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 1 | 5 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea,( ≥ 18 Y); Day 1 | 8 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea ( ≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea ( ≥ 6 to ≤ 17 Y); Day 8 | 3 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea,( ≥ 18 Y); Day 4 | 4 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness (≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea ( ≥ 6 to ≤ 17 Y); Day 4 | 2 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea ( ≥ 6 to ≤ 17 Y); Day 1 | 4 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea,( ≥ 18 Y); Day 8 | 4 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness (≥ 1 to ≤ 5 Y); Day 4 | 8 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills(≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea,( ≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 6 to ≤ 17 Y); Day 4 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills(≥ 6 to ≤ 17 Y); Day 8 | 1 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills(≥ 6 to ≤ 17 Y); Day 4 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 18 Y); Day 1 | 23 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 18 Y); Day 4 | 8 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills(≥ 6 to ≤ 17 Y); Day 1 | 2 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability.( ≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 18 Y); Day 4 | 16 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness (≥ 1 to ≤ 5 Y); Day 1 | 15 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability.( ≥ 1 to ≤ 5 Y); Day 8 | 1 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability.( ≥ 1 to ≤ 5 Y); Day 4 | 3 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 18 Y); Day 8 | 20 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 6 to ≤ 17 Y); Day 1 | 3 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability.( ≥ 1 to ≤ 5 Y); Day 1 | 5 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 6 to ≤ 17 Y); Day 8 | 1 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 1 to ≤ 5 Y); Day 8 | 4 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 1 to ≤ 5 Y); Day 4 | 2 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 18 Y); Day 1 | 18 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 18 Y); Day 1 | 12 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 1 to ≤ 5 Y); Day 1 | 3 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting (≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 18 Y); Day 4 | 6 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting (≥ 1 to ≤ 5 Y); Day 8 | 1 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting (≥ 1 to ≤ 5 Y); Day 4 | 2 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 18 Y); Day 8 | 15 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 6 to ≤ 17 Y); Day 8 | 3 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting (≥ 1 to ≤ 5 Y); Day 1 | 4 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness (≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness (≥ 1 to ≤ 5 Y); Day 8 | 2 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness (≥ 1 to ≤ 5 Y); Day 4 | 7 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 18 Y); Day 1 | 24 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 6 to ≤ 17 Y); Day 8 | 3 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness (≥ 1 to ≤ 5 Y); Day 1 | 4 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 18 Y); Day 4 | 14 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 6 to ≤ 17 Y); Day 4 | 3 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 8 | 3 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 4 | 3 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 18 Y); Day 8 | 19 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 6 to ≤ 17 Y); Day 1 | 4 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 1 | 4 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 1 | 6 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 18 Y); Day 8 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 18 Y); Day 4 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 18 Y); Day 1 | 28 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 18 Y); Day 8 | 8 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 18 Y); Day 1 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 18 Y); Day 4 | 21 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 18 Y); Day 8 | 2 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 18 Y); Day 4 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 18 Y); Day 8 | 5 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 18 Y); Day 8 | 19 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 6 to ≤ 17 Y); Day 8 | 1 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 18 Y); Day 1 | 0 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 4 | 3 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 18 Y); Day 8 | 12 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 18 Y); Day 4 | 11 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 18 Y); Day 1 | 10 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 18 Y); Day 1 | 3 Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 4-sites, 1-week | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 18 Y); Day 4 | 4 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 18 Y); Day 4 | 3 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills (≥ 18 Y); Day 1 | 3 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills (≥ 18 Y); Day 4 | 2 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills (≥ 18 Y); Day 8 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea,( ≥ 18 Y); Day 1 | 3 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea,( ≥ 18 Y); Day 4 | 2 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea,( ≥ 18 Y); Day 8 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea,( ≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 18 Y); Day 1 | 12 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 18 Y); Day 4 | 7 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 18 Y); Day 8 | 5 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 18 Y); Day 1 | 7 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 18 Y); Day 4 | 5 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 18 Y); Day 8 | 3 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 18 Y); Day 1 | 6 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 18 Y); Day 4 | 10 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 18 Y); Day 8 | 8 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 18 Y); Day 1 | 11 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 18 Y); Day 4 | 6 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 18 Y); Day 8 | 8 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 18 Y); Day 1 | 3 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 18 Y); Day 8 | 4 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 18 Y); Day 1 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 18 Y); Day 4 | 1 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 18 Y); Day 8 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 18 Y); Day 1 | 4 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 18 Y); Day 4 | 2 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 18 Y); Day 8 | 1 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 18 Y); Day 1 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 18 Y); Day 4 | 2 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 18 Y); Day 8 | 3 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema(≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema(≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema(≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema(≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration(≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration(≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration(≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration(≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 18 Y); Day 1 | 6 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 18 Y); Day 4 | 4 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 18 Y); Day 8 | 1 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 18 Y); Day 1 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 18 Y); Day 4 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 18 Y); Day 8 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 18 Y); Day 1 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 18 Y); Day 4 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 18 Y); Day 8 | 0 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness (≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness (≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness (≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness (≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting (≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting (≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting (≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting (≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability.( ≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability.( ≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability.( ≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability.( ≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills(≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills(≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills(≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills(≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea ( ≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea ( ≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea ( ≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea ( ≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 18 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness (≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness (≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness (≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness (≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 18 Y); Day 1 | 6 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 18 Y); Day 4 | 8 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 18 Y); Day 8 | 7 Subjects |
| TOTAL 2-sites, TRC | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 18 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 18 Y); Day 8 | 4 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 6 to ≤ 17 Y); Day 29 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 18 Y); Day 1 | 4 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 6 to ≤ 17 Y); Day 8 | 6 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 18 Y); Day 1 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 18 Y); Day 4 | 4 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 18 Y); Day 29 | 9 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 1 | 3 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 18 Y); Day 8 | 8 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 6 to ≤ 17 Y); Day 29 | 6 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 18 Y); Day 29 | 27 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 18 Y); Day 8 | 15 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 6 to ≤ 17 Y); Day 29 | 6 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 18 Y); Day 1 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 18 Y); Day 4 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 18 Y); Day 4 | 17 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 18 Y); Day 8 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 18 Y); Day 29 | 4 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 18 Y); Day 1 | 19 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 6 to ≤ 17 Y); Day 1 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 18 Y); Day 1 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 18 Y); Day 4 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 18 Y); Day 29 | 12 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 6 to ≤ 17 Y); Day 29 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 18 Y); Day 8 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 18 Y); Day 29 | 5 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 18 Y); Day 8 | 15 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 6 to ≤ 17 Y); Day 4 | 3 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 1 | 3 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 4 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 18 Y); Day 4 | 15 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 8 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 6 to ≤ 17 Y); Day 1 | 5 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 29 | 6 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 18 Y); Day 1 | 11 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 6 to ≤ 17 Y); Day 8 | 3 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness (≥ 1 to ≤ 5 Y); Day 1 | 7 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness (≥ 1 to ≤ 5 Y); Day 4 | 3 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 18 Y); Day 29 | 6 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 6 to ≤ 17 Y); Day 8 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness (≥ 1 to ≤ 5 Y); Day 8 | 4 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 18 Y); Day 1 | 16 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness (≥ 1 to ≤ 5 Y); Day 29 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 18 Y); Day 8 | 15 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 6 to ≤ 17 Y); Day 29 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting (≥ 1 to ≤ 5 Y); Day 1 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting (≥ 1 to ≤ 5 Y); Day 4 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 18 Y); Day 4 | 10 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting (≥ 1 to ≤ 5 Y); Day 8 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting (≥ 1 to ≤ 5 Y); Day 29 | 5 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 18 Y); Day 1 | 13 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 18 Y); Day 29 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 1 to ≤ 5 Y); Day 1 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 1 to ≤ 5 Y); Day 4 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 18 Y); Day 29 | 7 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 6 to ≤ 17 Y); Day 4 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 1 to ≤ 5 Y); Day 8 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 6 to ≤ 17 Y); Day 4 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 1 to ≤ 5 Y); Day 29 | 4 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 18 Y); Day 8 | 15 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness (≥ 1 to ≤ 5 Y); Day 1 | 8 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability.( ≥ 1 to ≤ 5 Y); Day 1 | 3 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability.( ≥ 1 to ≤ 5 Y); Day 4 | 3 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 18 Y); Day 4 | 12 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability.( ≥ 1 to ≤ 5 Y); Day 8 | 5 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability.( ≥ 1 to ≤ 5 Y); Day 29 | 5 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 18 Y); Day 1 | 19 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness (≥ 1 to ≤ 5 Y); Day 4 | 9 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills(≥ 6 to ≤ 17 Y); Day 1 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills(≥ 6 to ≤ 17 Y); Day 4 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea,( ≥ 18 Y); Day 29 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 18 Y); Day 4 | 13 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills(≥ 6 to ≤ 17 Y); Day 8 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea,( ≥ 18 Y); Day 8 | 4 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness (≥ 1 to ≤ 5 Y); Day 8 | 8 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills(≥ 6 to ≤ 17 Y); Day 29 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea ( ≥ 6 to ≤ 17 Y); Day 1 | 3 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea,( ≥ 18 Y); Day 4 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 6 to ≤ 17 Y); Day 1 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea ( ≥ 6 to ≤ 17 Y); Day 4 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea ( ≥ 6 to ≤ 17 Y); Day 8 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea,( ≥ 18 Y); Day 1 | 3 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness (≥ 1 to ≤ 5 Y); Day 29 | 9 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea ( ≥ 6 to ≤ 17 Y); Day 29 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 1 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills (≥ 18 Y); Day 29 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 4 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 8 | 3 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills (≥ 18 Y); Day 8 | 4 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 6 to ≤ 17 Y); Day 1 | 7 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 29 | 4 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 1 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills (≥ 18 Y); Day 4 | 6 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 6 to ≤ 17 Y); Day 29 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 4 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 18 Y); Day 29 | 14 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 8 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills (≥ 18 Y); Day 1 | 5 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 6 to ≤ 17 Y); Day 4 | 10 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 29 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 18 Y); Day 8 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 18 Y); Day 4 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 6 to ≤ 17 Y); Day 1 | 9 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema(≥ 1 to ≤ 5 Y); Day 8 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 18 Y); Day 1 | 5 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema(≥ 1 to ≤ 5 Y); Day 1 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 29 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema(≥ 1 to ≤ 5 Y); Day 4 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 18 Y); Day 29 | 3 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema(≥ 1 to ≤ 5 Y); Day 29 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 6 to ≤ 17 Y); Day 4 | 8 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration(≥ 1 to ≤ 5 Y); Day 1 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration(≥ 1 to ≤ 5 Y); Day 4 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 18 Y); Day 4 | 5 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration(≥ 1 to ≤ 5 Y); Day 8 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 18 Y); Day 8 | 21 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration(≥ 1 to ≤ 5 Y); Day 29 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 18 Y); Day 1 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 6 to ≤ 17 Y); Day 8 | 6 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 1 to ≤ 5 Y); Day 1 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 1 to ≤ 5 Y); Day 4 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 18 Y); Day 29 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 8 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 1 to ≤ 5 Y); Day 8 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 6 to ≤ 17 Y); Day 8 | 11 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 1 to ≤ 5 Y); Day 29 | 8 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 18 Y); Day 8 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 6 to ≤ 17 Y); Day 29 | 3 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 6 to ≤ 17 Y); Day 1 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 6 to ≤ 17 Y); Day 4 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 18 Y); Day 4 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 6 to ≤ 17 Y); Day 8 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 6 to ≤ 17 Y); Day 29 | 8 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 18 Y); Day 1 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 6 to ≤ 17 Y); Day 1 | 7 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 6 to ≤ 17 Y); Day 1 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 6 to ≤ 17 Y); Day 4 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 18 Y); Day 29 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 4 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 6 to ≤ 17 Y); Day 8 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 6 to ≤ 17 Y); Day 8 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 6 to ≤ 17 Y); Day 29 | 2 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 18 Y); Day 8 | 11 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 6 to ≤ 17 Y); Day 4 | 1 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 6 to ≤ 17 Y); Day 1 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 6 to ≤ 17 Y); Day 4 | 0 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 18 Y); Day 4 | 8 Subjects |
| 2-sites, TRC WITHOUT HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 6 to ≤ 17 Y); Day 8 | 2 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills(≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 18 Y); Day 1 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 18 Y); Day 8 | 3 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea,( ≥ 18 Y); Day 4 | 3 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness (≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration(≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea ( ≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 18 Y); Day 1 | 3 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 18 Y); Day 29 | 10 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 18 Y); Day 4 | 3 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 18 Y); Day 4 | 5 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea ( ≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 18 Y); Day 8 | 4 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 18 Y); Day 8 | 14 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea,( ≥ 18 Y); Day 1 | 3 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 18 Y); Day 4 | 3 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 18 Y); Day 29 | 13 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration(≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea ( ≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 18 Y); Day 1 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 18 Y); Day 4 | 11 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 18 Y); Day 4 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea ( ≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 18 Y); Day 8 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 18 Y); Day 1 | 10 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills (≥ 18 Y); Day 29 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 18 Y); Day 29 | 1 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness (≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration(≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 18 Y); Day 1 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 18 Y); Day 29 | 11 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 18 Y); Day 1 | 5 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 18 Y); Day 4 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 18 Y); Day 8 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 18 Y); Day 8 | 16 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills (≥ 18 Y); Day 8 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 18 Y); Day 29 | 1 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 18 Y); Day 4 | 11 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration(≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 18 Y); Day 1 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 18 Y); Day 1 | 13 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills (≥ 18 Y); Day 4 | 4 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness (≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 18 Y); Day 29 | 4 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness (≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 18 Y); Day 29 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness (≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 18 Y); Day 8 | 6 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills (≥ 18 Y); Day 1 | 2 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness (≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 18 Y); Day 8 | 2 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting (≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 18 Y); Day 4 | 7 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting (≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 18 Y); Day 4 | 4 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting (≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Arthralgia (≥ 18 Y); Day 1 | 7 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 18 Y); Day 1 | 11 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting (≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 18 Y); Day 4 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 18 Y); Day 29 | 4 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 18 Y); Day 29 | 1 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 18 Y); Day 8 | 4 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 18 Y); Day 8 | 3 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss Of Appetite (≥ 18 Y); Day 1 | 2 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 18 Y); Day 8 | 9 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Rash (≥ 18 Y); Day 29 | 2 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema(≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea,( ≥ 18 Y); Day 8 | 3 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability.( ≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 18 Y); Day 4 | 6 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness (≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability.( ≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema(≥ 1 to ≤ 5 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 18 Y); Day 29 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability.( ≥ 1 to ≤ 5 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Generalized Myalgia (≥ 18 Y); Day 1 | 12 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site pain (≥ 18 Y); Day 29 | 9 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability.( ≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site induration (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema(≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema (≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills(≥ 6 to ≤ 17 Y); Day 1 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea,( ≥ 18 Y); Day 29 | 0 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness (≥ 1 to ≤ 5 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea (≥ 18 Y); Day 8 | 4 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills(≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomitting (≥ 18 Y); Day 4 | 1 Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema(≥ 1 to ≤ 5 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Chills(≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site swelling (≥ 6 to ≤ 17 Y); Day 8 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache (≥ 6 to ≤ 17 Y); Day 29 | NA Subjects |
| 2-sites, TRC WITH HRIG | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue (≥ 6 to ≤ 17 Y); Day 4 | NA Subjects |
Secondary
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age
Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method. RVNA percentage of subjects with RVNA titer ≥ 0.5 IU/mL at study days 8, 15, 91, 181, and 366 following administration of the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC), with or without HRIG, in the whole study population.
Time frame: At Days 8, 15, 91, 181 and 366
Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age | Day 15 (N= 357, 361) | 100 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age | Day 181 (N= 357, 360) | 93 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age | Day 91 (N= 358, 362) | 96 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age | Day 366 (N= 356, 352) | 90 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age | Day 8 (N= 363, 362) | 18 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age | Day 366 (N= 356, 352) | 83 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age | Day 8 (N= 363, 362) | 10 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age | Day 15 (N= 357, 361) | 100 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age | Day 91 (N= 358, 362) | 99 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age | Day 181 (N= 357, 360) | 93 Percentages of Subjects |
95% CI: [3.8, 13.9]Fisher Exact
95% CI: [-1, 1.6]Fisher Exact
95% CI: [-6, -1.4]Fisher Exact
95% CI: [-4.5, 3.2]Fisher Exact
95% CI: [1.3, 11.5]Fisher Exact
Secondary
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age. Percentage of subjects with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)
Time frame: At Days 8, 15,50, 91, 181 and 366
Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week with HRIG and 4-sites, 1-week without HRIG Groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 15 (N= 65, 146) | 100 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 91 (N= 65, 149) | 83 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 8 (N= 66, 150) | 8 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 181 (N= 65, 146) | 77 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 50 (N= 65, 146) | 95 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 366 (N= 65, 145) | 66 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 1 (N= 66, 151) | 0 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 366 (N= 65, 145) | 91 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 1 (N= 66, 151) | 0 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 8 (N= 66, 150) | 19 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 15 (N= 65, 146) | 100 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 50 (N= 65, 146) | 100 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 91 (N= 65, 149) | 98 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 181 (N= 65, 146) | 94 Percentages of Subjects |
Secondary
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Immunogenicity was assessed in terms of the number of subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age
Time frame: At Days 8, 15,50, 91, 181 and 366
Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for 4-sites, 1-week with HRIG and 2-sites, TRC with HRIG Groups
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 91 (N= 65, 72) | 83 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 1 (N= 66, 72) | 0 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 8 (N= 66, 72) | 8 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 15 (N= 65, 72) | 100 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 50 (N= 65, 69) | 95 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 181 (N= 65, 71) | 77 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 366 (N= 65, 69) | 66 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 181 (N= 65, 71) | 85 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 50 (N= 65, 69) | 100 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 1 (N= 66, 72) | 0 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 91 (N= 65, 72) | 99 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 8 (N= 66, 72) | 10 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 366 (N= 65, 69) | 70 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age | Day 15 (N= 65, 72) | 99 Percentages of Subjects |
Secondary
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age
Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age
Time frame: At Days 8, 15, 50, 91, 181 and 366
Population: Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is only applicable for the 4-sites, 1-week without HRIG and 2-sites, TRC without HRIG Groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age | Day 8 (N= 297, 290) | 21 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age | Day 15 (N= 292, 289) | 100 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age | Day 50 (N= 292, 281) | 100 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age | Day 91 (N= 293, 290) | 99 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age | Day 181 (N= 292, 289) | 96 Percentages of Subjects |
| TOTAL 4-sites, 1-week | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age | Day 366 (N= 291, 283) | 95 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age | Day 181 (N= 292, 289) | 96 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age | Day 8 (N= 297, 290) | 10 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age | Day 91 (N= 293, 290) | 100 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age | Day 15 (N= 292, 289) | 100 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age | Day 366 (N= 291, 283) | 87 Percentages of Subjects |
| TOTAL 2-sites, TRC | Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age | Day 50 (N= 292, 281) | 100 Percentages of Subjects |