Novel 2009 Influenza H1N1
Conditions
Keywords
Swine Flu, Flu, Vaccine, Adjuvant
Brief summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.
Interventions
BIOLOGICALMF59-eH1N1_f
MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
BIOLOGICALeH1N1_f
Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Children, adolescents, and adults 3 to 64 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
Exclusion criteria
* History of serious disease. * History of serious reaction following administration of vaccine or hypersensitivity to vaccine components. * Known or suspected impairment/alteration of immune function. * Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination. For additional entry criteria, please refer to protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age | Day 1 to day 387 | Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS). |
| Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | Day 1 to day 387 | Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HI GMRs, in 3 to <9 Years and 9 to 17 Years | Day 1 to day 387 | Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the the per-protocol set (PPS). |
| HI GMR, in Adults 18 to 64 Years | Day 1 to day 387 | Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the Per-Protocol Set (PPS). |
| Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | 7 days and 21 days after each vaccination | Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the per-protocol set (PPS). |
| Age Distribution at Baseline | Baseline | — |
| Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | 7 days after each vaccination | Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age). Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination. |
| Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | 7 days after each vaccination | Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age). Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination. The analyses were performed on the safety set. |
| Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | 7 days after each vaccination | Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to \<9 years of age). Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination |
| Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Day 1 to day 387 | Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS). |
Countries
Costa Rica
Participant flow
Recruitment details
Participants were enrolled at one center in Costa Rica.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| 2x7.5adj A/H1N1 7.5 mcg with MF59; two doses on day 1 | 56 |
| 7.5adj_1_8 A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8 | 56 |
| 7.5adj_1_22 A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22 | 168 |
| 15_1_22 A/H1N1 15 mcg no MF59; one dose on days 1 and 22 | 336 |
| 2x15_1_22 A/H1N1 15 mcg no MF59; two doses on days 1 and 22 | 168 |
| Total | 784 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Inappropriate enrolment | 0 | 0 | 0 | 4 | 0 |
| Overall Study | Lost to Follow-up | 5 | 0 | 1 | 8 | 5 |
| Overall Study | Unable to Classify | 0 | 0 | 1 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 8 | 4 | 4 |
Baseline characteristics
| Characteristic | Total | 2x15_1_22 | 15_1_22 | 7.5adj_1_22 | 7.5adj_1_8 | 2x7.5adj |
|---|---|---|---|---|---|---|
| Age, Customized 18 to 64 years | 392 subjects | 56 subjects 11 | 168 subjects 11.7 | 56 subjects 11.2 | 56 subjects 11.1 | 56 subjects 10.8 |
| Age, Customized 3 to < 9 years | 196 subjects | 56 subjects 1.9 | 84 subjects 1.7 | 56 subjects 1.7 | 0 subjects 0 | 0 subjects 0 |
| Age, Customized 9 to 17 years | 196 subjects | 56 subjects 2.5 | 84 subjects 2.3 | 56 subjects 2.5 | 0 subjects 0 | 0 subjects 0 |
| Sex/Gender, Customized Female (18 to 64 years) | 227 Subjects | 29 Subjects | 96 Subjects | 29 Subjects | 40 Subjects | 33 Subjects |
| Sex/Gender, Customized Female (3 to <9 years) | 98 Subjects | 23 Subjects | 46 Subjects | 29 Subjects | 0 Subjects | 0 Subjects |
| Sex/Gender, Customized Female (9 to 17 years) | 110 Subjects | 30 Subjects | 40 Subjects | 40 Subjects | 0 Subjects | 0 Subjects |
| Sex/Gender, Customized Male (18 to 64 years) | 165 Subjects | 27 Subjects | 72 Subjects | 27 Subjects | 16 Subjects | 23 Subjects |
| Sex/Gender, Customized Male (3 to < 9 years) | 98 Subjects | 33 Subjects | 38 Subjects | 27 Subjects | 0 Subjects | 0 Subjects |
| Sex/Gender, Customized Male (9 to 17 years) | 86 Subjects | 26 Subjects | 44 Subjects | 16 Subjects | 0 Subjects | 0 Subjects |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 49 / 54 | 41 / 56 | 48 / 56 | 119 / 159 | 35 / 54 | 46 / 53 | 67 / 84 | 43 / 57 | 40 / 55 | 61 / 84 | 41 / 54 |
| serious Total, serious adverse events | 2 / 54 | 0 / 56 | 1 / 56 | 4 / 159 | 1 / 54 | 1 / 53 | 1 / 84 | 0 / 57 | 2 / 55 | 0 / 84 | 0 / 54 |
Outcome results
Primary
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS).
Time frame: Day 1 to day 387
Population: The analysis was done on the per-protocol set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | HI Titer ≥40 on day 1 | 18 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | HI Titer ≥40 on day 8 | 93 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | HI Titer ≥40 on day 15 | 99 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | HI Titer ≥40 on day 22 | 98 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | HI Titer ≥40 on day 29 | 99 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | HI Titer ≥40 on Day 43 | 100 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | HI Titer ≥40 on Day 217 (N=111) | 91 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | HI Titer ≥40 on Day 387 (N=120) | 84 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | Seroconversion on day 8 | 86 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | Seroconversion on day 15 | 94 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | Seroconversion on day 22 | 94 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | Seroconversion on day 29 | 95 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | Seroconversion on day 43 | 95 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | Seroconversion on day 217 (N=111) | 81 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | Seroconversion on day 387 (N=120) | 75 Percentages of Subjects |
Primary
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).
Time frame: Day 1 to day 387
Population: The analysis was done on the per-protocol set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age | HI Titer ≥40 on day 1 | 26 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age | HI Titer ≥40 on day 22 | 83 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age | HI Titer ≥40 on day 29 | 95 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age | HI Titer ≥40 on day 43 | 92 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age | HI Titer ≥40 on day 217 (N=129) | 88 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age | HI Titer ≥40 on day 387 (N=136) | 80 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age | Seroconversion on day 22 | 79 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age | Seroconversion on day 29 | 92 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age | Seroconversion on day 43 | 87 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age | Seroconversion on day 217 (N=129) | 71 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age | Seroconversion on day 387 (N=136) | 63 Percentages of Subjects |
Secondary
Age Distribution at Baseline
Time frame: Baseline
Population: The overall number of baseline participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 15_1_22 | Age Distribution at Baseline | 3 to <9 years (N=0, 0, 56, 84, 56) | NA years | — |
| 15_1_22 | Age Distribution at Baseline | 18 to 64 years (N= 56, 56, 56, 168, 56) | 35.1 years | Standard Deviation 10.8 |
| 15_1_22 | Age Distribution at Baseline | 9 to 17 years (N=0, 0, 56, 84, 56) | NA years | — |
| 7.5adj_1_8 | Age Distribution at Baseline | 9 to 17 years (N=0, 0, 56, 84, 56) | NA years | — |
| 7.5adj_1_8 | Age Distribution at Baseline | 3 to <9 years (N=0, 0, 56, 84, 56) | NA years | — |
| 7.5adj_1_8 | Age Distribution at Baseline | 18 to 64 years (N= 56, 56, 56, 168, 56) | 38.6 years | Standard Deviation 11.1 |
| 7.5adj_1_22 | Age Distribution at Baseline | 9 to 17 years (N=0, 0, 56, 84, 56) | 13.1 years | Standard Deviation 2.5 |
| 7.5adj_1_22 | Age Distribution at Baseline | 3 to <9 years (N=0, 0, 56, 84, 56) | 5.5 years | Standard Deviation 1.7 |
| 7.5adj_1_22 | Age Distribution at Baseline | 18 to 64 years (N= 56, 56, 56, 168, 56) | 37.3 years | Standard Deviation 11.2 |
| 15_1_22 | Age Distribution at Baseline | 3 to <9 years (N=0, 0, 56, 84, 56) | 5.7 years | Standard Deviation 1.7 |
| 15_1_22 | Age Distribution at Baseline | 18 to 64 years (N= 56, 56, 56, 168, 56) | 37.0 years | Standard Deviation 11.7 |
| 15_1_22 | Age Distribution at Baseline | 9 to 17 years (N=0, 0, 56, 84, 56) | 12.8 years | Standard Deviation 2.3 |
| 2x15_1_22 | Age Distribution at Baseline | 9 to 17 years (N=0, 0, 56, 84, 56) | 13.1 years | Standard Deviation 2.5 |
| 2x15_1_22 | Age Distribution at Baseline | 3 to <9 years (N=0, 0, 56, 84, 56) | 5.4 years | Standard Deviation 1.9 |
| 2x15_1_22 | Age Distribution at Baseline | 18 to 64 years (N= 56, 56, 56, 168, 56) | 37.4 years | Standard Deviation 11 |
Secondary
HI GMR, in Adults 18 to 64 Years
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the Per-Protocol Set (PPS).
Time frame: Day 1 to day 387
Population: The analysis is done on the per-protocol set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 8 | 48 Ratio |
| 15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 387 (N=38,40,38,120,42) | 6.61 Ratio |
| 15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day (N=0,0,35,111,34) | NA Ratio |
| 15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 22 | 79 Ratio |
| 15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 15 | 115 Ratio |
| 15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 29 | 56 Ratio |
| 15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 43 | 44 Ratio |
| 7.5adj_1_8 | HI GMR, in Adults 18 to 64 Years | GMR on day 43 | 64 Ratio |
| 7.5adj_1_8 | HI GMR, in Adults 18 to 64 Years | GMR on day 29 | 76 Ratio |
| 7.5adj_1_8 | HI GMR, in Adults 18 to 64 Years | GMR on day 15 | 181 Ratio |
| 7.5adj_1_8 | HI GMR, in Adults 18 to 64 Years | GMR on day 8 | 35 Ratio |
| 7.5adj_1_8 | HI GMR, in Adults 18 to 64 Years | GMR on day (N=0,0,35,111,34) | NA Ratio |
| 7.5adj_1_8 | HI GMR, in Adults 18 to 64 Years | GMR on day 22 | 100 Ratio |
| 7.5adj_1_8 | HI GMR, in Adults 18 to 64 Years | GMR on day 387 (N=38,40,38,120,42) | 11 Ratio |
| 7.5adj_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 29 | 160 Ratio |
| 7.5adj_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 8 | 57 Ratio |
| 7.5adj_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 15 | 200 Ratio |
| 7.5adj_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 22 | 123 Ratio |
| 7.5adj_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 43 | 101 Ratio |
| 7.5adj_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day (N=0,0,35,111,34) | 30 Ratio |
| 7.5adj_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 387 (N=38,40,38,120,42) | 21 Ratio |
| 15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 22 | 85 Ratio |
| 15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 43 | 76 Ratio |
| 15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 15 | 138 Ratio |
| 15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 387 (N=38,40,38,120,42) | 12 Ratio |
| 15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day (N=0,0,35,111,34) | 16 Ratio |
| 15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 8 | 43 Ratio |
| 15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 29 | 83 Ratio |
| 2x15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 22 | 72 Ratio |
| 2x15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 387 (N=38,40,38,120,42) | 9.21 Ratio |
| 2x15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day (N=0,0,35,111,34) | 16 Ratio |
| 2x15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 43 | 65 Ratio |
| 2x15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 15 | 123 Ratio |
| 2x15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 8 | 63 Ratio |
| 2x15_1_22 | HI GMR, in Adults 18 to 64 Years | GMR on day 29 | 66 Ratio |
Secondary
HI GMRs, in 3 to <9 Years and 9 to 17 Years
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the the per-protocol set (PPS).
Time frame: Day 1 to day 387
Population: The analysis is done on the per-protocol set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 15_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 22 (3 to < 9 yrs; N=46,75,47) | 31 Ratio |
| 15_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 29 (3 to < 9 yrs; N=46,75,47) | 169 Ratio |
| 15_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 43 (3 to < 9 yrs; N=46,75,47) | 120 Ratio |
| 15_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 217 (3 to <9 yrs; N=41,66,40) | 19 Ratio |
| 15_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 387 (3 to <9 yrs; N=43,70,42) | 14 Ratio |
| 15_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 22 (9 to 17 yrs; N=45,74,52) | 42 Ratio |
| 15_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 29 (9 to 17 yrs; N=45,74,52) | 63 Ratio |
| 15_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 43 (9 to 17 yrs; N=45,74,52) | 44 Ratio |
| 15_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 217 (9 to 17 yrs; N=37,63,45) | 10 Ratio |
| 15_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 387 (9 to 17 yrs; N=37,66,47) | 7.22 Ratio |
| 7.5adj_1_8 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 217 (9 to 17 yrs; N=37,63,45) | 17 Ratio |
| 7.5adj_1_8 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 22 (3 to < 9 yrs; N=46,75,47) | 12 Ratio |
| 7.5adj_1_8 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 22 (9 to 17 yrs; N=45,74,52) | 52 Ratio |
| 7.5adj_1_8 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 387 (3 to <9 yrs; N=43,70,42) | 6.9 Ratio |
| 7.5adj_1_8 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 29 (3 to < 9 yrs; N=46,75,47) | 35 Ratio |
| 7.5adj_1_8 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 387 (9 to 17 yrs; N=37,66,47) | 16 Ratio |
| 7.5adj_1_8 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 43 (9 to 17 yrs; N=45,74,52) | 48 Ratio |
| 7.5adj_1_8 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 43 (3 to < 9 yrs; N=46,75,47) | 22 Ratio |
| 7.5adj_1_8 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 29 (9 to 17 yrs; N=45,74,52) | 70 Ratio |
| 7.5adj_1_8 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 217 (3 to <9 yrs; N=41,66,40) | 7.79 Ratio |
| 7.5adj_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 43 (9 to 17 yrs; N=45,74,52) | 59 Ratio |
| 7.5adj_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 217 (3 to <9 yrs; N=41,66,40) | 8.07 Ratio |
| 7.5adj_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 387 (3 to <9 yrs; N=43,70,42) | 5.94 Ratio |
| 7.5adj_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 22 (9 to 17 yrs; N=45,74,52) | 66 Ratio |
| 7.5adj_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 217 (9 to 17 yrs; N=37,63,45) | 13 Ratio |
| 7.5adj_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 29 (9 to 17 yrs; N=45,74,52) | 79 Ratio |
| 7.5adj_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 22 (3 to < 9 yrs; N=46,75,47) | 16 Ratio |
| 7.5adj_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 387 (9 to 17 yrs; N=37,66,47) | 13 Ratio |
| 7.5adj_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 29 (3 to < 9 yrs; N=46,75,47) | 53 Ratio |
| 7.5adj_1_22 | HI GMRs, in 3 to <9 Years and 9 to 17 Years | GMR on day 43 (3 to < 9 yrs; N=46,75,47) | 44 Ratio |
Secondary
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age). Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination. The analyses were performed on the safety set.
Time frame: 7 days after each vaccination
Population: The analysis is done on the safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Stayed Home postvac. 1 (N=53,55,56,157,54) | 2 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Erythema postvac. 2 (N=0,55,56,158,53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Vomiting postvac. 1 | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Induration postvac. 2 (N=0,55,56,158,53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Body Temp > 40 C postvac. 1 | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Nausea postvac. 1 | 7 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Swelling postvac. 2 (N=0,55,56,158,53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Chills postvac. 1 | 4 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Tenderness postvac. 2 (N=0,55,56,157853) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Arthralgia postvac. 1 | 4 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Other Reactions postvac. 2 (N=0,55,56,158, 53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Local Reactions postvac. 2 (N=0,55,56,158,53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Body Temp > 40 C postvac. 2 (N=0,55,56,158,53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Local Reactions postvac. 1 | 39 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Diarrhea postvac. 2 (N=0,55,56,158, 53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Erythema postvac. 1 | 3 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Analgesic/Antipyretic Used postvac. 1 | 14 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Vomiting postvac. 2 (N=0,55,56,158, 53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Induration postvac. 1 | 5 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Nausea postvac. 2 (N=0,55,56,158, 53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Swelling postvac. 1 | 3 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Other Reactions postvac. 1 | 14 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Chills postvac. 2 (N=0,55,56,158, 53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Tenderness postvac. 1 | 33 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Stayed Home postvaccination 2 (N=0,53,0,156,53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Arthralgia postvac. 2 (N=0,55,56,158, 53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Pain postvac. 1 | 36 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Myalgia postvac. 2 (N=0,55,56,158, 53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Systemic Reaction postvac. 1 | 34 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Fatigue postvac. 2 (N=0,55,56,158, 53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Headache postvac. 1 | 26 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Headache postvac. 2 (N=0,55,56,158, 53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Fatigue postvac. 1 | 17 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Systemic Reaction postvac. 2 (N=0,55,56,158,53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Myalgia postvac. 1 | 21 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Analgesi/Antipyr Used postvac 2 (N=0,55,56,158,53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Pain postvac. 2 (N=0,55,56,158,53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Diarrhea postvac. 1 | 2 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Vomiting postvac. 1 | 0 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Chills postvac. 2 (N=0,55,56,158, 53) | 8 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Erythema postvac. 2 (N=0,55,56,158,53) | 1 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Other Reactions postvac. 2 (N=0,55,56,158, 53) | 8 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Other Reactions postvac. 1 | 7 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Nausea postvac. 1 | 9 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Swelling postvac. 1 | 3 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Induration postvac. 2 (N=0,55,56,158,53) | 3 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Headache postvac. 2 (N=0,55,56,158, 53) | 18 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Myalgia postvac. 1 | 13 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Chills postvac. 1 | 3 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Arthralgia postvac. 2 (N=0,55,56,158, 53) | 5 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Swelling postvac. 2 (N=0,55,56,158,53) | 2 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Body Temp > 40 C postvac. 1 | 0 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Headache postvac. 1 | 18 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Arthralgia postvac. 1 | 1 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Tenderness postvac. 1 | 21 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Tenderness postvac. 2 (N=0,55,56,157853) | 16 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Body Temp > 40 C postvac. 2 (N=0,55,56,158,53) | 0 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Stayed Home postvac. 1 (N=53,55,56,157,54) | 1 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Pain postvac. 2 (N=0,55,56,158,53) | 19 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Diarrhea postvac. 2 (N=0,55,56,158, 53) | 1 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Myalgia postvac. 2 (N=0,55,56,158, 53) | 9 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Local Reactions postvac. 2 (N=0,55,56,158,53) | 21 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Systemic Reaction postvac. 2 (N=0,55,56,158,53) | 26 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Pain postvac. 1 | 23 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Local Reactions postvac. 1 | 26 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Stayed Home postvaccination 2 (N=0,53,0,156,53) | 2 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Analgesi/Antipyr Used postvac 2 (N=0,55,56,158,53) | 7 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Vomiting postvac. 2 (N=0,55,56,158, 53) | 1 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Diarrhea postvac. 1 | 1 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Erythema postvac. 1 | 0 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Fatigue postvac. 2 (N=0,55,56,158, 53) | 14 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Fatigue postvac. 1 | 16 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Nausea postvac. 2 (N=0,55,56,158, 53) | 8 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Systemic Reaction postvac. 1 | 31 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Induration postvac. 1 | 4 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Analgesic/Antipyretic Used postvac. 1 | 6 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Myalgia postvac. 1 | 16 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Other Reactions postvac. 1 | 12 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Analgesic/Antipyretic Used postvac. 1 | 12 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Stayed Home postvac. 1 (N=53,55,56,157,54) | 2 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Body Temp > 40 C postvac. 1 | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Local Reactions postvac. 2 (N=0,55,56,158,53) | 28 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Local Reactions postvac. 1 | 38 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Erythema postvac. 1 | 2 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Induration postvac. 1 | 5 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Swelling postvac. 1 | 5 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Tenderness postvac. 1 | 26 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Pain postvac. 1 | 32 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Systemic Reaction postvac. 1 | 31 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Headache postvac. 1 | 22 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Fatigue postvac. 1 | 16 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Fatigue postvac. 2 (N=0,55,56,158, 53) | 13 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Erythema postvac. 2 (N=0,55,56,158,53) | 2 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Induration postvac. 2 (N=0,55,56,158,53) | 4 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Swelling postvac. 2 (N=0,55,56,158,53) | 5 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Tenderness postvac. 2 (N=0,55,56,157853) | 24 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Arthralgia postvac. 1 | 6 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Chills postvac. 1 | 6 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Nausea postvac. 1 | 8 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Vomiting postvac. 1 | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Diarrhea postvac. 1 | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Pain postvac. 2 (N=0,55,56,158,53) | 24 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Systemic Reaction postvac. 2 (N=0,55,56,158,53) | 28 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Headache postvac. 2 (N=0,55,56,158, 53) | 18 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Myalgia postvac. 2 (N=0,55,56,158, 53) | 14 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Arthralgia postvac. 2 (N=0,55,56,158, 53) | 7 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Chills postvac. 2 (N=0,55,56,158, 53) | 5 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Nausea postvac. 2 (N=0,55,56,158, 53) | 5 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Vomiting postvac. 2 (N=0,55,56,158, 53) | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Diarrhea postvac. 2 (N=0,55,56,158, 53) | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Other Reactions postvac. 2 (N=0,55,56,158, 53) | 7 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Analgesi/Antipyr Used postvac 2 (N=0,55,56,158,53) | 7 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Stayed Home postvaccination 2 (N=0,53,0,156,53) | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Body Temp > 40 C postvac. 2 (N=0,55,56,158,53) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Body Temp > 40 C postvac. 2 (N=0,55,56,158,53) | 1 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Chills postvac. 2 (N=0,55,56,158, 53) | 5 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Headache postvac. 2 (N=0,55,56,158, 53) | 25 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Induration postvac. 1 | 6 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Local Reactions postvac. 2 (N=0,55,56,158,53) | 56 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Stayed Home postvaccination 2 (N=0,53,0,156,53) | 1 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Nausea postvac. 2 (N=0,55,56,158, 53) | 7 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Systemic Reaction postvac. 1 | 71 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Erythema postvac. 1 | 2 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Fatigue postvac. 1 | 32 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Fatigue postvac. 2 (N=0,55,56,158, 53) | 24 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Vomiting postvac. 2 (N=0,55,56,158, 53) | 2 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Myalgia postvac. 1 | 28 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Local Reactions postvac. 1 | 56 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Pain postvac. 1 | 41 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Other Reactions postvac. 1 | 13 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Diarrhea postvac. 2 (N=0,55,56,158, 53) | 4 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Analgesi/Antipyr Used postvac 2 (N=0,55,56,158,53) | 11 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Body Temp > 40 C postvac. 1 | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Analgesic/Antipyretic Used postvac. 1 | 13 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Myalgia postvac. 2 (N=0,55,56,158, 53) | 26 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Systemic Reaction postvac. 2 (N=0,55,56,158,53) | 53 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Arthralgia postvac. 1 | 10 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Tenderness postvac. 1 | 35 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Swelling postvac. 2 (N=0,55,56,158,53) | 7 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Diarrhea postvac. 1 | 8 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Other Reactions postvac. 2 (N=0,55,56,158, 53) | 11 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Chills postvac. 1 | 6 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Headache postvac. 1 | 42 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Induration postvac. 2 (N=0,55,56,158,53) | 4 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Arthralgia postvac. 2 (N=0,55,56,158, 53) | 16 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Tenderness postvac. 2 (N=0,55,56,157853) | 48 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Nausea postvac. 1 | 16 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Swelling postvac. 1 | 4 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Erythema postvac. 2 (N=0,55,56,158,53) | 5 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Pain postvac. 2 (N=0,55,56,158,53) | 45 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Stayed Home postvac. 1 (N=53,55,56,157,54) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Vomiting postvac. 1 | 1 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Chills postvac. 1 | 4 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Myalgia postvac. 1 | 12 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Analgesic/Antipyretic Used postvac. 1 | 4 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Tenderness postvac. 2 (N=0,55,56,157853) | 16 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Fatigue postvac. 1 | 15 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Body Temp > 40 C postvac. 2 (N=0,55,56,158,53) | 0 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Pain postvac. 2 (N=0,55,56,158,53) | 15 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Headache postvac. 1 | 12 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Systemic Reaction postvac. 2 (N=0,55,56,158,53) | 14 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Systemic Reaction postvac. 1 | 22 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Analgesi/Antipyr Used postvac 2 (N=0,55,56,158,53) | 6 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Headache postvac. 2 (N=0,55,56,158, 53) | 11 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Pain postvac. 1 | 16 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Fatigue postvac. 2 (N=0,55,56,158, 53) | 10 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Tenderness postvac. 1 | 14 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Myalgia postvac. 2 (N=0,55,56,158, 53) | 7 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Swelling postvac. 1 | 2 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Other Reactions postvac. 1 | 5 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Arthralgia postvac. 2 (N=0,55,56,158, 53) | 4 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Induration postvac. 1 | 3 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Chills postvac. 2 (N=0,55,56,158, 53) | 8 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Erythema postvac. 1 | 1 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Nausea postvac. 2 (N=0,55,56,158, 53) | 3 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Local Reactions postvac. 1 | 19 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Stayed Home postvaccination 2 (N=0,53,0,156,53) | 2 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Vomiting postvac. 2 (N=0,55,56,158, 53) | 1 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Body Temp > 40 C postvac. 1 | 0 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Diarrhea postvac. 2 (N=0,55,56,158, 53) | 1 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Stayed Home postvac. 1 (N=53,55,56,157,54) | 1 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Swelling postvac. 2 (N=0,55,56,158,53) | 5 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Diarrhea postvac. 1 | 3 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Arthralgia postvac. 1 | 2 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Induration postvac. 2 (N=0,55,56,158,53) | 3 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Vomiting postvac. 1 | 1 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Erythema postvac. 2 (N=0,55,56,158,53) | 1 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Other Reactions postvac. 2 (N=0,55,56,158, 53) | 7 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Nausea postvac. 1 | 13 Number of subjects |
| 2x15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Local Reactions postvac. 2 (N=0,55,56,158,53) | 17 Number of subjects |
Secondary
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to \<9 years of age). Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination
Time frame: 7 days after each vaccination
Population: The analysis is done on the safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Chills postvac. 1 | 3 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Body Temp > 40 C postvac.1 | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Tenderness postvac. 2 (N=55, 83, 54) | 15 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Nausea postvac. 1 | 5 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Diarrhea postvac. 2 (N=55, 83, 54) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Swelling postvac. 2 (N=55, 83, 54) | 8 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Vomiting postvac. 1 | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Swelling postvac. 1 | 3 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Induration postvac. 2 (N=55, 83, 54) | 8 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Diarrhea postvac. 1 | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Pain postvac. 2 (N=55, 83, 54) | 18 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Erythema postvac. 2 (N=55, 83, 54) | 3 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Other Reactions postvac. 1 | 10 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Vomiting postvac. 2 (N=55, 83, 54) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Local Reactions postvac. 2 (N=55, 83, 54) | 20 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Analges/Antipyr Used postvac. 1 (N=55, 83, 54) | 9 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Stayed Home postvac.1(N=55,83,54) | 1 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Tenderness postvac. 1 | 21 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Local Reactions postvac. 1 | 25 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Nausea postvac. 2 (N=55, 83, 54) | 5 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Pain postvac. 1 | 21 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Body Temp > 40 C postvac. 2 (N=55, 83, 54) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Chills postvac. 2 (N=55, 83, 54) | 2 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Systemic Reaction postvac. 1 | 24 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Analges/Antipyr Used postvac. 2 (N=55, 83, 54) | 4 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Arthralgia postvac. 2 (N=55, 83, 54) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Headache postvac. 1 | 7 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Erythema postvac. 1 | 1 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Myalgia postvac. 2 (N=55, 83, 54) | 3 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Fatigue postvac. 1 | 6 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Stayed Home postvac. 2 (N=55, 82, 54) | 1 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Fatigue postvac. 2 (N=55, 83, 54) | 1 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Myalgia postvac. 1 | 4 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Other Reactions postvac. 2 (N=55, 82, 54) | 5 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Headache postvac. 2 (N=55, 83, 54) | 5 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Arthralgia postvac. 1 | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Induration postvac. 1 | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Systemic Reaction postvac. 2 (N=55, 83, 54) | 13 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Analges/Antipyr Used postvac. 1 (N=55, 83, 54) | 8 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Local Reactions postvac. 1 | 31 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Erythema postvac. 1 | 0 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Induration postvac. 1 | 3 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Swelling postvac. 1 | 4 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Tenderness postvac. 1 | 23 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Pain postvac. 1 | 25 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Systemic Reaction postvac. 1 | 28 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Headache postvac. 1 | 12 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Fatigue postvac. 1 | 8 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Myalgia postvac. 1 | 8 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Arthralgia postvac. 1 | 2 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Chills postvac. 1 | 1 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Nausea postvac. 1 | 7 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Vomiting postvac. 1 | 1 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Diarrhea postvac. 1 | 0 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Other Reactions postvac. 1 | 10 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Stayed Home postvac.1(N=55,83,54) | 2 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Body Temp > 40 C postvac.1 | 0 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Local Reactions postvac. 2 (N=55, 83, 54) | 29 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Erythema postvac. 2 (N=55, 83, 54) | 1 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Induration postvac. 2 (N=55, 83, 54) | 1 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Swelling postvac. 2 (N=55, 83, 54) | 0 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Tenderness postvac. 2 (N=55, 83, 54) | 27 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Pain postvac. 2 (N=55, 83, 54) | 23 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Systemic Reaction postvac. 2 (N=55, 83, 54) | 22 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Headache postvac. 2 (N=55, 83, 54) | 12 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Fatigue postvac. 2 (N=55, 83, 54) | 5 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Myalgia postvac. 2 (N=55, 83, 54) | 2 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Arthralgia postvac. 2 (N=55, 83, 54) | 2 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Chills postvac. 2 (N=55, 83, 54) | 2 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Nausea postvac. 2 (N=55, 83, 54) | 5 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Vomiting postvac. 2 (N=55, 83, 54) | 1 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Diarrhea postvac. 2 (N=55, 83, 54) | 1 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Other Reactions postvac. 2 (N=55, 82, 54) | 7 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Analges/Antipyr Used postvac. 2 (N=55, 83, 54) | 6 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Stayed Home postvac. 2 (N=55, 82, 54) | 2 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Body Temp > 40 C postvac. 2 (N=55, 83, 54) | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Diarrhea postvac. 2 (N=55, 83, 54) | 2 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Systemic Reaction postvac. 2 (N=55, 83, 54) | 18 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Myalgia postvac. 1 | 6 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Erythema postvac. 1 | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Headache postvac. 2 (N=55, 83, 54) | 3 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Fatigue postvac. 1 | 5 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Stayed Home postvac. 2 (N=55, 82, 54) | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Fatigue postvac. 2 (N=55, 83, 54) | 2 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Headache postvac. 1 | 9 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Other Reactions postvac. 2 (N=55, 82, 54) | 7 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Myalgia postvac. 2 (N=55, 83, 54) | 5 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Systemic Reaction postvac. 1 | 17 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Local Reactions postvac. 1 | 20 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Arthralgia postvac. 2 (N=55, 83, 54) | 5 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Pain postvac. 1 | 17 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Analges/Antipyr Used postvac. 1 (N=55, 83, 54) | 6 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Chills postvac. 2 (N=55, 83, 54) | 1 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Tenderness postvac. 1 | 17 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Analges/Antipyr Used postvac. 2 (N=55, 83, 54) | 7 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Body Temp > 40 C postvac.1 | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Other Reactions postvac. 1 | 6 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Nausea postvac. 2 (N=55, 83, 54) | 1 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Local Reactions postvac. 2 (N=55, 83, 54) | 21 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Diarrhea postvac. 1 | 1 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Swelling postvac. 1 | 3 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Erythema postvac. 2 (N=55, 83, 54) | 1 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Vomiting postvac. 1 | 2 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Stayed Home postvac.1(N=55,83,54) | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Induration postvac. 2 (N=55, 83, 54) | 2 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Nausea postvac. 1 | 4 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Vomiting postvac. 2 (N=55, 83, 54) | 3 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Swelling postvac. 2 (N=55, 83, 54) | 2 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Chills postvac. 1 | 2 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Induration postvac. 1 | 1 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Tenderness postvac. 2 (N=55, 83, 54) | 16 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Body Temp > 40 C postvac. 2 (N=55, 83, 54) | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Pain postvac. 2 (N=55, 83, 54) | 19 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Arthralgia postvac. 1 | 2 Number of subjects |
Secondary
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age). Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination.
Time frame: 7 days after each vaccination
Population: The analysis is done on the safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Systemic Reaction postvac. 2 (N=52, 84, 55) | 18 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Vomiting postvac. 1 | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Diarrhea postvac. 2 (N=52, 84, 55) | 2 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Pain postvac. 2 (N=52, 84, 55) | 27 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Diarrhea postvac. 1 | 2 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Tenderness postvac. 1 | 26 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Tenderness postvac. 2 (N=52, 84, 55) | 20 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Other Reactions postvac. 1 | 11 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Erythema postvac. 1 | 1 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Swelling postvac. 2 (N=52, 84, 55) | 2 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Analgesic/Antipyretic Used postvac. 1 | 10 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Vomiting postvac. 2 (N=52, 84, 55) | 1 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Induration postvac. 2 (N=52, 84, 55) | 2 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Stayed Home postvac. 1 | 2 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Pain postvac. 1 | 32 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Erythema postvac. 2 (N=52, 84, 55) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Body Temp > 40 C postvac. 1 | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Local Reactions postvac. 1 | 37 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Local Reactions postvac. 2 (N=52, 84, 55) | 31 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Nausea postvac. 2 (N=52, 84, 55) | 3 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Systemic Reaction postvac. 1 | 24 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Analges/Antipyr Used postvac. 2 (N=52, 84, 55) | 1 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Chills postvac. 2 (N=52, 84, 55) | 2 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Headache postvac. 1 | 17 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Induration postvac. 1 | 1 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Arthralgia postvac. 2 (N=52, 84, 55) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Fatigue postvac. 1 | 9 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Myalgia postvac. 1 | 11 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Body Temp > 40 C postvac. 2 (N=52, 84, 55) | 0 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Myalgia postvac. 2 (N=52, 84, 55) | 8 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Arthralgia postvac. 1 | 2 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Other Reactions postvac. 2 (N=52, 84, 55) | 1 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Fatigue postvac. 2 (N=52, 84, 55) | 3 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Chills postvac. 1 | 1 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Swelling postvac. 1 | 1 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Headache postvac. 2 (N=52, 84, 55) | 12 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Nausea postvac. 1 | 3 Number of subjects |
| 15_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Stayed Home postvac. 2 (N=52, 84, 55) | 0 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Myalgia postvac. 2 (N=52, 84, 55) | 9 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Local Reactions postvac. 1 | 36 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Erythema postvac. 1 | 1 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Induration postvac. 1 | 6 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Swelling postvac. 1 | 4 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Tenderness postvac. 1 | 23 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Pain postvac. 1 | 30 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Systemic Reaction postvac. 1 | 36 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Headache postvac. 1 | 20 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Myalgia postvac. 1 | 15 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Arthralgia postvac. 1 | 2 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Chills postvac. 1 | 2 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Nausea postvac. 1 | 7 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Vomiting postvac. 1 | 1 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Diarrhea postvac. 1 | 0 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Other Reactions postvac. 1 | 10 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Analgesic/Antipyretic Used postvac. 1 | 10 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Stayed Home postvac. 1 | 1 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Body Temp > 40 C postvac. 1 | 0 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Local Reactions postvac. 2 (N=52, 84, 55) | 36 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Erythema postvac. 2 (N=52, 84, 55) | 3 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Induration postvac. 2 (N=52, 84, 55) | 3 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Swelling postvac. 2 (N=52, 84, 55) | 5 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Tenderness postvac. 2 (N=52, 84, 55) | 25 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Pain postvac. 2 (N=52, 84, 55) | 30 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Systemic Reaction postvac. 2 (N=52, 84, 55) | 29 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Headache postvac. 2 (N=52, 84, 55) | 16 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Fatigue postvac. 2 (N=52, 84, 55) | 6 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Fatigue postvac. 1 | 13 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Arthralgia postvac. 2 (N=52, 84, 55) | 4 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Chills postvac. 2 (N=52, 84, 55) | 2 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Nausea postvac. 2 (N=52, 84, 55) | 7 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Vomiting postvac. 2 (N=52, 84, 55) | 0 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Diarrhea postvac. 2 (N=52, 84, 55) | 3 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Other Reactions postvac. 2 (N=52, 84, 55) | 10 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Analges/Antipyr Used postvac. 2 (N=52, 84, 55) | 9 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Stayed Home postvac. 2 (N=52, 84, 55) | 1 Number of subjects |
| 7.5adj_1_8 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Body Temp > 40 C postvac. 2 (N=52, 84, 55) | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Diarrhea postvac. 2 (N=52, 84, 55) | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Systemic Reaction postvac. 2 (N=52, 84, 55) | 14 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Chills postvac. 1 | 1 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Induration postvac. 1 | 1 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Headache postvac. 2 (N=52, 84, 55) | 8 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Arthralgia postvac. 1 | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Stayed Home postvac. 2 (N=52, 84, 55) | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Fatigue postvac. 2 (N=52, 84, 55) | 9 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Myalgia postvac. 1 | 11 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Other Reactions postvac. 2 (N=52, 84, 55) | 4 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Myalgia postvac. 2 (N=52, 84, 55) | 7 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Headache postvac. 1 | 8 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Erythema postvac. 1 | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Arthralgia postvac. 2 (N=52, 84, 55) | 4 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Systemic Reaction postvac. 1 | 16 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Fatigue postvac. 1 | 11 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Chills postvac. 2 (N=52, 84, 55) | 3 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Pain postvac. 1 | 25 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Analges/Antipyr Used postvac. 2 (N=52, 84, 55) | 4 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Body Temp > 40 C postvac. 1 | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Nausea postvac. 2 (N=52, 84, 55) | 2 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Local Reactions postvac. 2 (N=52, 84, 55) | 27 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Stayed Home postvac. 1 | 2 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Tenderness postvac. 1 | 21 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Erythema postvac. 2 (N=52, 84, 55) | 1 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Analgesic/Antipyretic Used postvac. 1 | 7 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Local Reactions postvac. 1 | 29 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Induration postvac. 2 (N=52, 84, 55) | 4 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Other Reactions postvac. 1 | 8 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Vomiting postvac. 2 (N=52, 84, 55) | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Swelling postvac. 2 (N=52, 84, 55) | 3 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Diarrhea postvac. 1 | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Swelling postvac. 1 | 3 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Tenderness postvac. 2 (N=52, 84, 55) | 25 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Vomiting postvac. 1 | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Body Temp > 40 C postvac. 2 (N=52, 84, 55) | 0 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Pain postvac. 2 (N=52, 84, 55) | 26 Number of subjects |
| 7.5adj_1_22 | Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Nausea postvac. 1 | 5 Number of subjects |
Secondary
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).
Time frame: Day 1 to day 387
Population: The analysis is done on the per-protocol set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 43 (9 to 17 yrs; N=45,74,52) | 84 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 217 (9 to 17 yrs; N=37,63,45) | 100 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 43 (3 to <9 yrs; N=46,75,47) | 96 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 43 (3 to < 9 yrs; N=46,75,47) | 100 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 43 (9 to 17 yrs; N=45,74,52) | 100 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 217 (3 to <9 yrs;N=41,66,40) | 88 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 387 (9 to 17 yrs;N=37,66,47) | 59 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 29 (9 to 17 yrs; N=45,74,52) | 100 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 387 (3 to <9 yrs;N=43,70,42) | 77 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 29 (9 to 17 yrs; N=45,74,52) | 89 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 22 (9 to 17 yrs; N=45,74,52) | 98 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 1 (9 to 17 yrs;N=45,74,52) | 42 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 217 (3 to < 9 yrs; N=41,66,40) | 100 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 217 (9 to 17 yrs;N=37,63,45) | 68 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 22 (9 to 17 yrs; N=45,74,52) | 87 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 387 (3 to < 9 yrs; N=43,70,42) | 93 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 29 (3 to < 9 yrs; N=46,75,47) | 100 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 1 (3 to <9 yrs; N=46,75,47) | 24 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 22 (3 to <9 yrs; N=46,75,47) | 91 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 22 (3 to <9 yrs; N=46,75,47) | 93 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 387 (9 to 17 yrs; N=37,66,47) | 89 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 29 (3 to <9 yrs; N=46,75,47) | 98 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 387 (9 to 17 yrs; N=37,66,47) | 88 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 1 (3 to <9 yrs; N=46,75,47) | 23 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 22 (3 to <9 yrs; N=46,75,47) | 71 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 29 (3 to < 9 yrs; N=46,75,47) | 92 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 43 (3 to < 9 yrs; N=46,75,47) | 85 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 217 (3 to < 9 yrs; N=41,66,40) | 80 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 387 (3 to < 9 yrs; N=43,70,42) | 73 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 22 (3 to <9 yrs; N=46,75,47) | 69 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 29 (3 to <9 yrs; N=46,75,47) | 92 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 43 (3 to <9 yrs; N=46,75,47) | 84 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 217 (3 to <9 yrs;N=41,66,40) | 65 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 387 (3 to <9 yrs;N=43,70,42) | 56 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 1 (9 to 17 yrs;N=45,74,52) | 28 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 22 (9 to 17 yrs; N=45,74,52) | 96 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 29 (9 to 17 yrs; N=45,74,52) | 99 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 43 (9 to 17 yrs; N=45,74,52) | 99 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 217 (9 to 17 yrs; N=37,63,45) | 95 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 22 (9 to 17 yrs; N=45,74,52) | 88 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 29 (9 to 17 yrs; N=45,74,52) | 92 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 43 (9 to 17 yrs; N=45,74,52) | 91 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 217 (9 to 17 yrs;N=37,63,45) | 76 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 387 (9 to 17 yrs;N=37,66,47) | 70 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 43 (9 to 17 yrs; N=45,74,52) | 100 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 29 (3 to <9 yrs; N=46,75,47) | 96 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 22 (3 to <9 yrs; N=46,75,47) | 79 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 217 (9 to 17 yrs; N=37,63,45) | 98 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 22 (3 to <9 yrs; N=46,75,47) | 79 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 387 (3 to < 9 yrs; N=43,70,42) | 62 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 387 (9 to 17 yrs; N=37,66,47) | 89 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 217 (3 to < 9 yrs; N=41,66,40) | 78 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 387 (9 to 17 yrs;N=37,66,47) | 70 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 22 (9 to 17 yrs; N=45,74,52) | 94 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 43 (3 to < 9 yrs; N=46,75,47) | 96 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 217 (9 to 17 yrs;N=37,63,45) | 76 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 29 (9 to 17 yrs; N=45,74,52) | 94 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 1 (9 to 17 yrs;N=45,74,52) | 33 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 387 (3 to <9 yrs;N=43,70,42) | 50 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 29 (3 to < 9 yrs; N=46,75,47) | 96 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 22 (9 to 17 yrs; N=45,74,52) | 100 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 217 (3 to <9 yrs;N=41,66,40) | 65 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 1 (3 to <9 yrs; N=46,75,47) | 23 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | HI Titer ≥40 on day 29 (9 to 17 yrs; N=45,74,52) | 100 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 43 (3 to <9 yrs; N=46,75,47) | 94 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion on day 43 (9 to 17 yrs; N=45,74,52) | 92 Percentages of Subjects |
Secondary
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the per-protocol set (PPS).
Time frame: 7 days and 21 days after each vaccination
Population: The analysis is done on the per-protocol set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 22 | 95 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 15 | 98 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 8 | 95 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 8 | 100 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 387 (N=38,40,38,120,42) | 66 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 22 | 100 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 217 (N=0,0,35,111,34) | NA Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 29 | 100 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 1 | 20 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 43 | 85 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 43 | 98 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 15 | 100 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 29 | 95 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 217 (N=0,0,35,111,34) | NA Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 387 (N=38,40,38,120,42) | 76 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 217 (N=0,0,35,111,34) | NA Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 387 (N=38,40,38,120,42) | 90 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 8 | 91 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 15 | 100 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 29 | 98 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 29 | 93 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 8 | 80 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 43 | 93 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 387 (N=38,40,38,120,42) | 80 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 15 | 100 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 22 | 91 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 22 | 98 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 1 | 22 Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 217 (N=0,0,35,111,34) | NA Percentages of Subjects |
| 7.5adj_1_8 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 43 | 100 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 8 | 93 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 8 | 96 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 15 | 98 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 22 | 98 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 29 | 100 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 43 | 98 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 217 (N=0,0,35,111,34) | 97 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 387 (N=38,40,38,120,42) | 92 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 15 | 98 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 22 | 96 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 29 | 98 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 43 | 96 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 217 (N=0,0,35,111,34) | 94 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 387 (N=38,40,38,120,42) | 87 Percentages of Subjects |
| 7.5adj_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 1 | 13 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 29 | 95 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 22 | 98 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 22 | 94 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 217 (N=0,0,35,111,34) | 81 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 43 | 100 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 29 | 99 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 15 | 99 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 1 | 18 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 8 | 86 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 8 | 93 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 43 | 95 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 387 (N=38,40,38,120,42) | 84 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 387 (N=38,40,38,120,42) | 75 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 15 | 94 Percentages of Subjects |
| 15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 217 (N=0,0,35,111,34) | 91 Percentages of Subjects |
| 2x15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 15 | 98 Percentages of Subjects |
| 2x15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 387 (N=38,40,38,120,42) | 69 Percentages of Subjects |
| 2x15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 22 | 96 Percentages of Subjects |
| 2x15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 43 | 100 Percentages of Subjects |
| 2x15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 8 | 96 Percentages of Subjects |
| 2x15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 29 | 98 Percentages of Subjects |
| 2x15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 29 | 100 Percentages of Subjects |
| 2x15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 43 | 98 Percentages of Subjects |
| 2x15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 22 | 98 Percentages of Subjects |
| 2x15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 1 | 21 Percentages of Subjects |
| 2x15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 217 (N=0,0,35,111,34) | 88 Percentages of Subjects |
| 2x15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 15 | 100 Percentages of Subjects |
| 2x15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion on day 8 | 94 Percentages of Subjects |
| 2x15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 387 (N=38,40,38,120,42) | 83 Percentages of Subjects |
| 2x15_1_22 | Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | HI Titer ≥40 on day 217 (N=0,0,35,111,34) | 97 Percentages of Subjects |