Group B Streptococcus
Conditions
Keywords
Group B streptococcus, GBS, Vaccine, Group B streptococcus (GBS) disease
Brief summary
This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.
Interventions
BIOLOGICALGroup B streptococcus (GBS) vaccine- low dose
BIOLOGICALGroup B streptococcus (GBS) vaccine- High dose
BIOLOGICALPlacebo- Saline
Sponsors
GlaxoSmithKline
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy females 18-40 years of age inclusive.
Exclusion criteria
* Individuals who are pregnant or nursing. * Individuals who have had a previous immunization with a vaccine containing streptococcus antigens or any vaccine within 30 days of enrollment through 30 days of study completion. * Individuals with a history of severe allergic reactions after previous vaccination * Individuals with designated blood tests that are not within normal range
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 and Day 61 | The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL as determined by ELISA at day 61 across cohorts 1 and 2 for potential use in pregnant women. |
| Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 and Day 61 | Serotype-specific (Ia, Ib & III) group B streptococcus (GBS) IgG antibody levels in healthy subjects for potential use in pregnant woman was assessed in terms of Geometric Mean Concentrations (GMCs) at Day 61 in cohorts 1 and 2. |
| Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Day 61/Day 1 | Geometric mean ratios (GMRs) relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels measured at Day 61 for subjects across cohorts 1 and 2. |
| Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 and Day 361 | The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL at day 361 across all the cohorts for potential use in non-pregnant women. |
| Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day 1 and Day 361 | Serotype-specific (Ia, Ib & III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant woman was assessed in terms of GMCs at Day 361 across all cohorts. |
| Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day 1 and day 361 | GMRs relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant women, measured at Day 361 across all cohorts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 1 and Day 721 | GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across all cohorts 1 and 2. |
| Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Day 1 to Day 7 | Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving trivalent GBS vaccine from day 1 to day 7 for subjects across cohorts 1 and 2. |
| Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 1 and Day 721 | GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across cohorts 3 and 4. |
| Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Day 1 to Day 7 | Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving GBS vaccine from day 1 to day 7 for subjects in cohorts 3 and 4. |
| Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Day 1 through Day 721 | Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 1 and 2. |
| Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Day 1 through Day 721 | Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 3 and 4. |
| Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1 and Day 721 | The persistence of Serotype-specific (Ia, Ib & III) GBS IgG antibody response was assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohorts 1 and 2. |
| Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1 and Day 721 | The persistence of Serotype-specific (Ia, Ib & III) GBS IgG antibody response assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohort 3 and 4. |
Countries
Belgium
Participant flow
Recruitment details
Subjects were enrolled at one center in Belgium
Pre-assignment details
Group1: 5 µg-1Inj-No Adj, 5 µg-2Inj-No Adj, 20 µg-1Inj-No Adj, 20 µg-2Inj-No Adj (Cohort 1), 5 µg-1Inj-Alum, 5 µg-2Inj-Alum, 20 µg-1Inj-Alum, 20 µg-2Inj-Alum (Cohort 2). Group 2: 5 µg-1Inj-MF59\_F, 5 µg-2Inj-MF59\_F, 20 µg-1Inj-MF59\_F, 20 µg-2Inj-MF59\_F (Cohort 3), 5 µg-1Inj-MF59\_H, 5 µg-2Inj-MF59\_H, 20 µg-1Inj-MF59\_H, 20 µg-2Inj-MF59\_H (Cohort 4)
Participants by arm
| Arm | Count |
|---|---|
| 5μg-1 Inj - No Adj Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart | 40 |
| 5μg-2 Inj - No Adj Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart | 40 |
| 20 μg-1 Inj - No Adj Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart | 39 |
| 20 μg-2 Inj - No Adj Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart | 40 |
| 5μg-1 Inj - Alum Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart | 40 |
| 5μg-2 Inj - Alum Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart | 40 |
| 20 μg-1 Inj - Alum Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart | 39 |
| 20 μg-2 Inj- Alum Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart | 40 |
| Placebo - Group 1 Subjects received two injections of placebo administered 1 month apart t | 20 |
| 5μg-1 Inj -MF59_H Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart | 40 |
| 5μg-2 Inj -MF59_H Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart | 40 |
| 20 μg-1 Inj -MF59_H Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart | 40 |
| 20 μg-2 Inj -MF59_H Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart | 40 |
| 5μg-1 Inj -MF59_F Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart | 40 |
| 5μg-2 Inj -MF59_F Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart | 40 |
| 20 μg-1 Inj -MF59_F Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart | 40 |
| 20 μg-2 Inj-MF59_F Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart | 40 |
| Placebo - Group 2 Subjects received two injections of placebo administered 1 month apart | 20 |
| Total | 678 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 2 | 2 | 2 | 5 | 0 | 0 | 3 | 1 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 2 | 1 | 1 | 1 | 0 | 3 | 2 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | 5μg-1 Inj - No Adj | 5μg-2 Inj - No Adj | 20 μg-1 Inj - No Adj | 20 μg-2 Inj - No Adj | 5μg-1 Inj - Alum | 5μg-2 Inj - Alum | 20 μg-1 Inj - Alum | 20 μg-2 Inj- Alum | Placebo - Group 1 | 5μg-1 Inj -MF59_H | 5μg-2 Inj -MF59_H | 20 μg-1 Inj -MF59_H | 20 μg-2 Inj -MF59_H | 5μg-1 Inj -MF59_F | 5μg-2 Inj -MF59_F | 20 μg-1 Inj -MF59_F | 20 μg-2 Inj-MF59_F | Placebo - Group 2 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 24.3 years STANDARD_DEVIATION 5.5 | 26.2 years STANDARD_DEVIATION 7.2 | 25.5 years STANDARD_DEVIATION 5 | 24.1 years STANDARD_DEVIATION 4.6 | 26.5 years STANDARD_DEVIATION 6.2 | 25.1 years STANDARD_DEVIATION 5.3 | 25.1 years STANDARD_DEVIATION 6.3 | 24.3 years STANDARD_DEVIATION 6 | 23.5 years STANDARD_DEVIATION 3.2 | 23.4 years STANDARD_DEVIATION 4.1 | 23.5 years STANDARD_DEVIATION 5.7 | 23.5 years STANDARD_DEVIATION 5.2 | 24.7 years STANDARD_DEVIATION 6.1 | 23.6 years STANDARD_DEVIATION 5 | 24.9 years STANDARD_DEVIATION 5.9 | 22.7 years STANDARD_DEVIATION 4 | 22.9 years STANDARD_DEVIATION 5.8 | 23.5 years STANDARD_DEVIATION 5.3 | 24.3 years STANDARD_DEVIATION 5.5 |
| Sex: Female, Male Female | 40 Participants | 40 Participants | 39 Participants | 40 Participants | 40 Participants | 40 Participants | 39 Participants | 40 Participants | 20 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 20 Participants | 678 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 37 / 40 | 38 / 40 | 38 / 39 | 39 / 40 | 39 / 40 | 39 / 40 | 39 / 39 | 39 / 39 | 18 / 19 | 38 / 40 | 37 / 40 | 40 / 40 | 40 / 40 | 39 / 40 | 39 / 40 | 40 / 40 | 40 / 40 | 18 / 20 |
| serious Total, serious adverse events | 1 / 40 | 1 / 40 | 0 / 39 | 2 / 40 | 6 / 40 | 2 / 40 | 2 / 39 | 0 / 40 | 2 / 20 | 2 / 40 | 2 / 40 | 0 / 40 | 3 / 40 | 3 / 40 | 2 / 40 | 6 / 40 | 2 / 40 | 1 / 20 |
Outcome results
Primary
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361
Serotype-specific (Ia, Ib & III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant woman was assessed in terms of GMCs at Day 361 across all cohorts.
Time frame: Day 1 and Day 361
Population: Analysis was done on Co-Primary PPS
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 5µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 4.03 µg/mL |
| 5µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.15 µg/mL |
| 5µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 5.86 µg/mL |
| 5µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.62 µg/mL |
| 5µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 3.05 µg/mL |
| 5µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.13 µg/mL |
| 5µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.12 µg/mL |
| 5µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 3.78 µg/mL |
| 5µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 3.7 µg/mL |
| 5µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.45 µg/mL |
| 5µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.091 µg/mL |
| 5µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 2.71 µg/mL |
| 20 µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 4 µg/mL |
| 20 µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.36 µg/mL |
| 20 µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.099 µg/mL |
| 20 µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 2.86 µg/mL |
| 20 µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.089 µg/mL |
| 20 µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 2.45 µg/mL |
| 20 µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.077 µg/mL |
| 20 µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 2.78 µg/mL |
| 20 µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 4.6 µg/mL |
| 20 µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.45 µg/mL |
| 20 µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 3.82 µg/mL |
| 20 µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.11 µg/mL |
| 5µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 1.77 µg/mL |
| 5µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.1 µg/mL |
| 5µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.53 µg/mL |
| 5µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 3.13 µg/mL |
| 5µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 5.83 µg/mL |
| 5µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.15 µg/mL |
| 5µg-2 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.12 µg/mL |
| 5µg-2 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 5.22 µg/mL |
| 5µg-2 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.16 µg/mL |
| 5µg-2 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 4.48 µg/mL |
| 5µg-2 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 4.59 µg/mL |
| 5µg-2 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.62 µg/mL |
| 20 µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 3.38 µg/mL |
| 20 µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.54 µg/mL |
| 20 µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 1.77 µg/mL |
| 20 µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 3.78 µg/mL |
| 20 µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.09 µg/mL |
| 20 µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.12 µg/mL |
| 20 µg-2 Inj- Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.12 µg/mL |
| 20 µg-2 Inj- Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 2.94 µg/mL |
| 20 µg-2 Inj- Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 2.45 µg/mL |
| 20 µg-2 Inj- Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.079 µg/mL |
| 20 µg-2 Inj- Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 3.46 µg/mL |
| 20 µg-2 Inj- Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.37 µg/mL |
| Placebo - Group 1 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 0.81 µg/mL |
| Placebo - Group 1 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 0.26 µg/mL |
| Placebo - Group 1 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 0.13 µg/mL |
| Placebo - Group 1 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.25 µg/mL |
| Placebo - Group 1 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.1 µg/mL |
| Placebo - Group 1 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.16 µg/mL |
| 5µg-1 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.1 µg/mL |
| 5µg-1 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.54 µg/mL |
| 5µg-1 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 3.62 µg/mL |
| 5µg-1 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.12 µg/mL |
| 5µg-1 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 2.67 µg/mL |
| 5µg-1 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 2.33 µg/mL |
| 5µg-2 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.43 µg/mL |
| 5µg-2 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 3.81 µg/mL |
| 5µg-2 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 3.04 µg/mL |
| 5µg-2 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 2.67 µg/mL |
| 5µg-2 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.079 µg/mL |
| 5µg-2 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.1 µg/mL |
| 20 µg-1 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 2.13 µg/mL |
| 20 µg-1 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.07 µg/mL |
| 20 µg-1 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 1.88 µg/mL |
| 20 µg-1 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 2.06 µg/mL |
| 20 µg-1 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.27 µg/mL |
| 20 µg-1 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.058 µg/mL |
| 20 µg-2 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.11 µg/mL |
| 20 µg-2 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 5.53 µg/mL |
| 20 µg-2 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 7.19 µg/mL |
| 20 µg-2 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.067 µg/mL |
| 20 µg-2 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.36 µg/mL |
| 20 µg-2 Inj - MF59_H | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 4.5 µg/mL |
| 5µg-1 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.15 µg/mL |
| 5µg-1 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 3.18 µg/mL |
| 5µg-1 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.44 µg/mL |
| 5µg-1 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 2.65 µg/mL |
| 5µg-1 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 2.62 µg/mL |
| 5µg-1 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.1 µg/mL |
| 5µg-2 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 4.99 µg/mL |
| 5µg-2 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 5.19 µg/mL |
| 5µg-2 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.11 µg/mL |
| 5µg-2 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.11 µg/mL |
| 5µg-2 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.46 µg/mL |
| 5µg-2 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 7.32 µg/mL |
| 20 µg-1 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 2.67 µg/mL |
| 20 µg-1 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 3.9 µg/mL |
| 20 µg-1 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 3.07 µg/mL |
| 20 µg-1 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.078 µg/mL |
| 20 µg-1 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.36 µg/mL |
| 20 µg-1 Inj - MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.077 µg/mL |
| 20 µg-2 Inj- MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.45 µg/mL |
| 20 µg-2 Inj- MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 3.51 µg/mL |
| 20 µg-2 Inj- MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.093 µg/mL |
| 20 µg-2 Inj- MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 3.64 µg/mL |
| 20 µg-2 Inj- MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.09 µg/mL |
| 20 µg-2 Inj- MF59_F | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 4.41 µg/mL |
| Placebo - Group 2 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ia) | 0.31 µg/mL |
| Placebo - Group 2 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ia) | 0.34 µg/mL |
| Placebo - Group 2 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(Serotype Ib) | 0.1 µg/mL |
| Placebo - Group 2 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype III) | 0.076 µg/mL |
| Placebo - Group 2 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day1(serotype III) | 0.068 µg/mL |
| Placebo - Group 2 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Day361(Serotype Ib) | 0.18 µg/mL |
Primary
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61
Serotype-specific (Ia, Ib & III) group B streptococcus (GBS) IgG antibody levels in healthy subjects for potential use in pregnant woman was assessed in terms of Geometric Mean Concentrations (GMCs) at Day 61 in cohorts 1 and 2.
Time frame: Day 1 and Day 61
Population: Analysis was done on Primary PPS
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 5µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ib; N=37,33,34,35,34,32,34,32,17 ) | 0.15 µg/mL |
| 5µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype III; N=40,37,35,38,36,37,37,37,17) | 3.27 µg/mL |
| 5µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61 (Serotype Ia; N=40,38,35,38,37,37,38,37,17) | 20 µg/mL |
| 5µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ia; N=40,33,33,35,33,32,34,35,17) | 0.62 µg/mL |
| 5µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype III; N=40,38,35,38,37,36,38,38,17) | 0.13 µg/mL |
| 5µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype Ib;N=39,38,35,38,37,37,38,36,16) | 6.75 µg/mL |
| 5µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype III; N=40,37,35,38,36,37,37,37,17) | 3.23 µg/mL |
| 5µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype III; N=40,38,35,38,37,36,38,38,17) | 0.089 µg/mL |
| 5µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61 (Serotype Ia; N=40,38,35,38,37,37,38,37,17) | 11 µg/mL |
| 5µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype Ib;N=39,38,35,38,37,37,38,36,16) | 4.56 µg/mL |
| 5µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ib; N=37,33,34,35,34,32,34,32,17 ) | 0.11 µg/mL |
| 5µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ia; N=40,33,33,35,33,32,34,35,17) | 0.51 µg/mL |
| 20 µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ib; N=37,33,34,35,34,32,34,32,17 ) | 0.11 µg/mL |
| 20 µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype III; N=40,38,35,38,37,36,38,38,17) | 0.087 µg/mL |
| 20 µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype III; N=40,37,35,38,36,37,37,37,17) | 2.31 µg/mL |
| 20 µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype Ib;N=39,38,35,38,37,37,38,36,16) | 4.26 µg/mL |
| 20 µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ia; N=40,33,33,35,33,32,34,35,17) | 0.38 µg/mL |
| 20 µg-1 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61 (Serotype Ia; N=40,38,35,38,37,37,38,37,17) | 15 µg/mL |
| 20 µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61 (Serotype Ia; N=40,38,35,38,37,37,38,37,17) | 18 µg/mL |
| 20 µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ia; N=40,33,33,35,33,32,34,35,17) | 0.45 µg/mL |
| 20 µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ib; N=37,33,34,35,34,32,34,32,17 ) | 0.11 µg/mL |
| 20 µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype Ib;N=39,38,35,38,37,37,38,36,16) | 4.45 µg/mL |
| 20 µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype III; N=40,38,35,38,37,36,38,38,17) | 0.077 µg/mL |
| 20 µg-2 Inj - No Adj | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype III; N=40,37,35,38,36,37,37,37,17) | 2.35 µg/mL |
| 5µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ia; N=40,33,33,35,33,32,34,35,17) | 0.48 µg/mL |
| 5µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype III; N=40,38,35,38,37,36,38,38,17) | 0.099 µg/mL |
| 5µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ib; N=37,33,34,35,34,32,34,32,17 ) | 0.15 µg/mL |
| 5µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype Ib;N=39,38,35,38,37,37,38,36,16) | 4.72 µg/mL |
| 5µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype III; N=40,37,35,38,36,37,37,37,17) | 1.49 µg/mL |
| 5µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61 (Serotype Ia; N=40,38,35,38,37,37,38,37,17) | 14 µg/mL |
| 5µg-2 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype Ib;N=39,38,35,38,37,37,38,36,16) | 3.85 µg/mL |
| 5µg-2 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ia; N=40,33,33,35,33,32,34,35,17) | 0.57 µg/mL |
| 5µg-2 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype III; N=40,38,35,38,37,36,38,38,17) | 0.15 µg/mL |
| 5µg-2 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype III; N=40,37,35,38,36,37,37,37,17) | 4.3 µg/mL |
| 5µg-2 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ib; N=37,33,34,35,34,32,34,32,17 ) | 0.12 µg/mL |
| 5µg-2 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61 (Serotype Ia; N=40,38,35,38,37,37,38,37,17) | 9.99 µg/mL |
| 20 µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ib; N=37,33,34,35,34,32,34,32,17 ) | 0.12 µg/mL |
| 20 µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61 (Serotype Ia; N=40,38,35,38,37,37,38,37,17) | 9.64 µg/mL |
| 20 µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype III; N=40,37,35,38,36,37,37,37,17) | 1.4 µg/mL |
| 20 µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype Ib;N=39,38,35,38,37,37,38,36,16) | 3.92 µg/mL |
| 20 µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype III; N=40,38,35,38,37,36,38,38,17) | 0.09 µg/mL |
| 20 µg-1 Inj - Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ia; N=40,33,33,35,33,32,34,35,17) | 0.54 µg/mL |
| 20 µg-2 Inj- Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype III; N=40,38,35,38,37,36,38,38,17) | 0.12 µg/mL |
| 20 µg-2 Inj- Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype Ib;N=39,38,35,38,37,37,38,36,16) | 2.06 µg/mL |
| 20 µg-2 Inj- Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ib; N=37,33,34,35,34,32,34,32,17 ) | 0.081 µg/mL |
| 20 µg-2 Inj- Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61 (Serotype Ia; N=40,38,35,38,37,37,38,37,17) | 6.49 µg/mL |
| 20 µg-2 Inj- Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype III; N=40,37,35,38,36,37,37,37,17) | 3.28 µg/mL |
| 20 µg-2 Inj- Alum | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ia; N=40,33,33,35,33,32,34,35,17) | 0.37 µg/mL |
| Placebo - Group 1 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype III; N=40,37,35,38,36,37,37,37,17) | 0.1 µg/mL |
| Placebo - Group 1 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype III; N=40,38,35,38,37,36,38,38,17) | 0.1 µg/mL |
| Placebo - Group 1 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ia; N=40,33,33,35,33,32,34,35,17) | 0.25 µg/mL |
| Placebo - Group 1 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61(Serotype Ib;N=39,38,35,38,37,37,38,36,16) | 0.24 µg/mL |
| Placebo - Group 1 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 1 (Serotype Ib; N=37,33,34,35,34,32,34,32,17 ) | 0.16 µg/mL |
| Placebo - Group 1 | Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Day 61 (Serotype Ia; N=40,38,35,38,37,37,38,37,17) | 0.25 µg/mL |
Primary
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype
Geometric mean ratios (GMRs) relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels measured at Day 61 for subjects across cohorts 1 and 2.
Time frame: Day 61/Day 1
Population: Analysis was done on Primary PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 5µg-1 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype Ib; N=37,33,33,35,34,32,34,31,16 | 47 Ratios |
| 5µg-1 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype III | 26 Ratios |
| 5µg-1 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | serotype Ia; N=40,33,32,35,33,32,34,35,17 | 32 Ratios |
| 5µg-2 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | serotype Ia; N=40,33,32,35,33,32,34,35,17 | 28 Ratios |
| 5µg-2 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype Ib; N=37,33,33,35,34,32,34,31,16 | 46 Ratios |
| 5µg-2 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype III | 36 Ratios |
| 20 µg-1 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype Ib; N=37,33,33,35,34,32,34,31,16 | 39 Ratios |
| 20 µg-1 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype III | 26 Ratios |
| 20 µg-1 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | serotype Ia; N=40,33,32,35,33,32,34,35,17 | 37 Ratios |
| 20 µg-2 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype III | 30 Ratios |
| 20 µg-2 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | serotype Ia; N=40,33,32,35,33,32,34,35,17 | 45 Ratios |
| 20 µg-2 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype Ib; N=37,33,33,35,34,32,34,31,16 | 47 Ratios |
| 5µg-1 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype Ib; N=37,33,33,35,34,32,34,31,16 | 38 Ratios |
| 5µg-1 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype III | 15 Ratios |
| 5µg-1 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | serotype Ia; N=40,33,32,35,33,32,34,35,17 | 36 Ratios |
| 5µg-2 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | serotype Ia; N=40,33,32,35,33,32,34,35,17 | 23 Ratios |
| 5µg-2 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype Ib; N=37,33,33,35,34,32,34,31,16 | 32 Ratios |
| 5µg-2 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype III | 30 Ratios |
| 20 µg-1 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype Ib; N=37,33,33,35,34,32,34,31,16 | 33 Ratios |
| 20 µg-1 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype III | 16 Ratios |
| 20 µg-1 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | serotype Ia; N=40,33,32,35,33,32,34,35,17 | 25 Ratios |
| 20 µg-2 Inj- Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | serotype Ia; N=40,33,32,35,33,32,34,35,17 | 19 Ratios |
| 20 µg-2 Inj- Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype Ib; N=37,33,33,35,34,32,34,31,16 | 23 Ratios |
| 20 µg-2 Inj- Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype III | 30 Ratios |
| Placebo - Group 1 | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | serotype Ia; N=40,33,32,35,33,32,34,35,17 | 1.01 Ratios |
| Placebo - Group 1 | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype III | 1.13 Ratios |
| Placebo - Group 1 | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Serotype Ib; N=37,33,33,35,34,32,34,31,16 | 1.55 Ratios |
Primary
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361
GMRs relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant women, measured at Day 361 across all cohorts.
Time frame: Day 1 and day 361
Population: Analysis was done on Co-Primary PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 5µg-1 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 28 Ratios |
| 5µg-1 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 24 Ratios |
| 5µg-1 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 9.13 Ratios |
| 5µg-2 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 30 Ratios |
| 5µg-2 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 37 Ratios |
| 5µg-2 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 10 Ratios |
| 20 µg-1 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 9.89 Ratios |
| 20 µg-1 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 27 Ratios |
| 20 µg-1 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 26 Ratios |
| 20 µg-2 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 35 Ratios |
| 20 µg-2 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 15 Ratios |
| 20 µg-2 Inj - No Adj | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 38 Ratios |
| 5µg-1 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 23 Ratios |
| 5µg-1 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 14 Ratios |
| 5µg-1 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 17 Ratios |
| 5µg-2 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 30 Ratios |
| 5µg-2 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 11 Ratios |
| 5µg-2 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 38 Ratios |
| 20 µg-1 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 8.93 Ratios |
| 20 µg-1 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 27 Ratios |
| 20 µg-1 Inj - Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 20 Ratios |
| 20 µg-2 Inj- Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 9.54 Ratios |
| 20 µg-2 Inj- Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 30 Ratios |
| 20 µg-2 Inj- Alum | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 31 Ratios |
| Placebo - Group 1 | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 3.97 Ratios |
| Placebo - Group 1 | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 0.93 Ratios |
| Placebo - Group 1 | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 1.4 Ratios |
| 5µg-1 Inj - MF59_H | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 23 Ratios |
| 5µg-1 Inj - MF59_H | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 22 Ratios |
| 5µg-1 Inj - MF59_H | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 6.75 Ratios |
| 5µg-2 Inj - MF59_H | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 7.15 Ratios |
| 5µg-2 Inj - MF59_H | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 37 Ratios |
| 5µg-2 Inj - MF59_H | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 35 Ratios |
| 20 µg-1 Inj - MF59_H | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 35 Ratios |
| 20 µg-1 Inj - MF59_H | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 27 Ratios |
| 20 µg-1 Inj - MF59_H | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 7.99 Ratios |
| 20 µg-2 Inj - MF59_H | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 65 Ratios |
| 20 µg-2 Inj - MF59_H | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 20 Ratios |
| 20 µg-2 Inj - MF59_H | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 54 Ratios |
| 5µg-1 Inj - MF59_F | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 6.17 Ratios |
| 5µg-1 Inj - MF59_F | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 26 Ratios |
| 5µg-1 Inj - MF59_F | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 26 Ratios |
| 5µg-2 Inj - MF59_F | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 45 Ratios |
| 5µg-2 Inj - MF59_F | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 45 Ratios |
| 5µg-2 Inj - MF59_F | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 16 Ratios |
| 20 µg-1 Inj - MF59_F | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 49 Ratios |
| 20 µg-1 Inj - MF59_F | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 7.29 Ratios |
| 20 µg-1 Inj - MF59_F | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 38 Ratios |
| 20 µg-2 Inj- MF59_F | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 9.83 Ratios |
| 20 µg-2 Inj- MF59_F | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 35 Ratios |
| 20 µg-2 Inj- MF59_F | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 38 Ratios |
| Placebo - Group 2 | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ib) | 1.75 Ratios |
| Placebo - Group 2 | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype Ia) | 0.9 Ratios |
| Placebo - Group 2 | Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | Day361/Day1(Serotype III) | 1.24 Ratios |
Primary
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1
The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL as determined by ELISA at day 61 across cohorts 1 and 2 for potential use in pregnant women.
Time frame: Day 1 and Day 61
Population: Analysis was done on primary Per Protocol Set (PPS) - The subjects who received the vaccine correctly; provided evaluable serum samples at baseline and Day 61; and had no major protocol violations as defined prior to analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ib; N=37,33,34,35,34,32,34,32,17) | 24 percentage of subjects |
| 5µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (SerogroupIII;N=40,37,35,38,36,37,37,37,17) | 70 percentage of subjects |
| 5µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ia) | 98 percentage of subjects |
| 5µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ia;N=40,33,33,35,33,32,34,35,17) | 38 percentage of subjects |
| 5µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup III;N=40,38,35,38,37,36,38,38,17) | 18 percentage of subjects |
| 5µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ib;N=39,38,35,38,37,37,38,36,16) | 82 percentage of subjects |
| 5µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (SerogroupIII;N=40,37,35,38,36,37,37,37,17) | 81 percentage of subjects |
| 5µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup III;N=40,38,35,38,37,36,38,38,17) | 13 percentage of subjects |
| 5µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ia) | 97 percentage of subjects |
| 5µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ib;N=39,38,35,38,37,37,38,36,16) | 95 percentage of subjects |
| 5µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ib; N=37,33,34,35,34,32,34,32,17) | 12 percentage of subjects |
| 5µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ia;N=40,33,33,35,33,32,34,35,17) | 30 percentage of subjects |
| 20 µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ib; N=37,33,34,35,34,32,34,32,17) | 18 percentage of subjects |
| 20 µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup III;N=40,38,35,38,37,36,38,38,17) | 11 percentage of subjects |
| 20 µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (SerogroupIII;N=40,37,35,38,36,37,37,37,17) | 77 percentage of subjects |
| 20 µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ib;N=39,38,35,38,37,37,38,36,16) | 83 percentage of subjects |
| 20 µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ia;N=40,33,33,35,33,32,34,35,17) | 30 percentage of subjects |
| 20 µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ia) | 91 percentage of subjects |
| 20 µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ia) | 95 percentage of subjects |
| 20 µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ia;N=40,33,33,35,33,32,34,35,17) | 29 percentage of subjects |
| 20 µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ib; N=37,33,34,35,34,32,34,32,17) | 17 percentage of subjects |
| 20 µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ib;N=39,38,35,38,37,37,38,36,16) | 84 percentage of subjects |
| 20 µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup III;N=40,38,35,38,37,36,38,38,17) | 13 percentage of subjects |
| 20 µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (SerogroupIII;N=40,37,35,38,36,37,37,37,17) | 79 percentage of subjects |
| 5µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ia;N=40,33,33,35,33,32,34,35,17) | 30 percentage of subjects |
| 5µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup III;N=40,38,35,38,37,36,38,38,17) | 16 percentage of subjects |
| 5µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ib; N=37,33,34,35,34,32,34,32,17) | 26 percentage of subjects |
| 5µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ib;N=39,38,35,38,37,37,38,36,16) | 78 percentage of subjects |
| 5µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (SerogroupIII;N=40,37,35,38,36,37,37,37,17) | 67 percentage of subjects |
| 5µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ia) | 97 percentage of subjects |
| 5µg-2 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ib;N=39,38,35,38,37,37,38,36,16) | 86 percentage of subjects |
| 5µg-2 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ia;N=40,33,33,35,33,32,34,35,17) | 38 percentage of subjects |
| 5µg-2 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup III;N=40,38,35,38,37,36,38,38,17) | 28 percentage of subjects |
| 5µg-2 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (SerogroupIII;N=40,37,35,38,36,37,37,37,17) | 86 percentage of subjects |
| 5µg-2 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ib; N=37,33,34,35,34,32,34,32,17) | 16 percentage of subjects |
| 5µg-2 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ia) | 95 percentage of subjects |
| 20 µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ib; N=37,33,34,35,34,32,34,32,17) | 24 percentage of subjects |
| 20 µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ia) | 87 percentage of subjects |
| 20 µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (SerogroupIII;N=40,37,35,38,36,37,37,37,17) | 70 percentage of subjects |
| 20 µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ib;N=39,38,35,38,37,37,38,36,16) | 84 percentage of subjects |
| 20 µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup III;N=40,38,35,38,37,36,38,38,17) | 16 percentage of subjects |
| 20 µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ia;N=40,33,33,35,33,32,34,35,17) | 35 percentage of subjects |
| 20 µg-2 Inj- Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup III;N=40,38,35,38,37,36,38,38,17) | 18 percentage of subjects |
| 20 µg-2 Inj- Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ib;N=39,38,35,38,37,37,38,36,16) | 64 percentage of subjects |
| 20 µg-2 Inj- Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ib; N=37,33,34,35,34,32,34,32,17) | 9 percentage of subjects |
| 20 µg-2 Inj- Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ia) | 84 percentage of subjects |
| 20 µg-2 Inj- Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (SerogroupIII;N=40,37,35,38,36,37,37,37,17) | 76 percentage of subjects |
| 20 µg-2 Inj- Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ia;N=40,33,33,35,33,32,34,35,17) | 20 percentage of subjects |
| Placebo - Group 1 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (SerogroupIII;N=40,37,35,38,36,37,37,37,17) | 12 percentage of subjects |
| Placebo - Group 1 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup III;N=40,38,35,38,37,36,38,38,17) | 12 percentage of subjects |
| Placebo - Group 1 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ia;N=40,33,33,35,33,32,34,35,17) | 18 percentage of subjects |
| Placebo - Group 1 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ib;N=39,38,35,38,37,37,38,36,16) | 19 percentage of subjects |
| Placebo - Group 1 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 1 (Serogroup Ib; N=37,33,34,35,34,32,34,32,17) | 18 percentage of subjects |
| Placebo - Group 1 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | Day 61 (Serogroup Ia) | 18 percentage of subjects |
Primary
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2
The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL at day 361 across all the cohorts for potential use in non-pregnant women.
Time frame: Day 1 and Day 361
Population: Analysis was done on Co-primary PPS - The subjects who received the vaccine correctly; provided evaluable serum samples at baseline and Day 361; and had no major protocol violations as defined prior to analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 85 percentage of subjects |
| 5µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 85 percentage of subjects |
| 5µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 95 percentage of subjects |
| 5µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 38 percentage of subjects |
| 5µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 18 percentage of subjects |
| 5µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 24 percentage of subjects |
| 5µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 84 percentage of subjects |
| 5µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 28 percentage of subjects |
| 5µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 78 percentage of subjects |
| 5µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 92 percentage of subjects |
| 5µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 14 percentage of subjects |
| 5µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 13 percentage of subjects |
| 20 µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 15 percentage of subjects |
| 20 µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 12 percentage of subjects |
| 20 µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 88 percentage of subjects |
| 20 µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 28 percentage of subjects |
| 20 µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 91 percentage of subjects |
| 20 µg-1 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 82 percentage of subjects |
| 20 µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 86 percentage of subjects |
| 20 µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 97 percentage of subjects |
| 20 µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 13 percentage of subjects |
| 20 µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 29 percentage of subjects |
| 20 µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 17 percentage of subjects |
| 20 µg-2 Inj - No Adj | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 95 percentage of subjects |
| 5µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 86 percentage of subjects |
| 5µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 16 percentage of subjects |
| 5µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 35 percentage of subjects |
| 5µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 76 percentage of subjects |
| 5µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 92 percentage of subjects |
| 5µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 26 percentage of subjects |
| 5µg-2 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 39 percentage of subjects |
| 5µg-2 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 15 percentage of subjects |
| 5µg-2 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 30 percentage of subjects |
| 5µg-2 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 92 percentage of subjects |
| 5µg-2 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 100 percentage of subjects |
| 5µg-2 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 95 percentage of subjects |
| 20 µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 24 percentage of subjects |
| 20 µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 35 percentage of subjects |
| 20 µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 87 percentage of subjects |
| 20 µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 16 percentage of subjects |
| 20 µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 100 percentage of subjects |
| 20 µg-1 Inj - Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 79 percentage of subjects |
| 20 µg-2 Inj- Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 18 percentage of subjects |
| 20 µg-2 Inj- Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 9 percentage of subjects |
| 20 µg-2 Inj- Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 89 percentage of subjects |
| 20 µg-2 Inj- Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 22 percentage of subjects |
| 20 µg-2 Inj- Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 89 percentage of subjects |
| 20 µg-2 Inj- Alum | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 75 percentage of subjects |
| Placebo - Group 1 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 18 percentage of subjects |
| Placebo - Group 1 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 12 percentage of subjects |
| Placebo - Group 1 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 20 percentage of subjects |
| Placebo - Group 1 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 14 percentage of subjects |
| Placebo - Group 1 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 18 percentage of subjects |
| Placebo - Group 1 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 46 percentage of subjects |
| 5µg-1 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 24 percentage of subjects |
| 5µg-1 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 86 percentage of subjects |
| 5µg-1 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 30 percentage of subjects |
| 5µg-1 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 14 percentage of subjects |
| 5µg-1 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 78 percentage of subjects |
| 5µg-1 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 92 percentage of subjects |
| 5µg-2 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 11 percentage of subjects |
| 5µg-2 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 29 percentage of subjects |
| 5µg-2 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 95 percentage of subjects |
| 5µg-2 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 15 percentage of subjects |
| 5µg-2 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 100 percentage of subjects |
| 5µg-2 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 82 percentage of subjects |
| 20 µg-1 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 87 percentage of subjects |
| 20 µg-1 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 5 percentage of subjects |
| 20 µg-1 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 6 percentage of subjects |
| 20 µg-1 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 16 percentage of subjects |
| 20 µg-1 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 92 percentage of subjects |
| 20 µg-1 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 76 percentage of subjects |
| 20 µg-2 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 8 percentage of subjects |
| 20 µg-2 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 95 percentage of subjects |
| 20 µg-2 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 97 percentage of subjects |
| 20 µg-2 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 28 percentage of subjects |
| 20 µg-2 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 26 percentage of subjects |
| 20 µg-2 Inj - MF59_H | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 100 percentage of subjects |
| 5µg-1 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 14 percentage of subjects |
| 5µg-1 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 29 percentage of subjects |
| 5µg-1 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 69 percentage of subjects |
| 5µg-1 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 23 percentage of subjects |
| 5µg-1 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 95 percentage of subjects |
| 5µg-1 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 87 percentage of subjects |
| 5µg-2 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 100 percentage of subjects |
| 5µg-2 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 97 percentage of subjects |
| 5µg-2 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 19 percentage of subjects |
| 5µg-2 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 92 percentage of subjects |
| 5µg-2 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 38 percentage of subjects |
| 5µg-2 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 14 percentage of subjects |
| 20 µg-1 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 76 percentage of subjects |
| 20 µg-1 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 6 percentage of subjects |
| 20 µg-1 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 11 percentage of subjects |
| 20 µg-1 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 100 percentage of subjects |
| 20 µg-1 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 89 percentage of subjects |
| 20 µg-1 Inj - MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 21 percentage of subjects |
| 20 µg-2 Inj- MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 90 percentage of subjects |
| 20 µg-2 Inj- MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 100 percentage of subjects |
| 20 µg-2 Inj- MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 11 percentage of subjects |
| 20 µg-2 Inj- MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 31 percentage of subjects |
| 20 µg-2 Inj- MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 92 percentage of subjects |
| 20 µg-2 Inj- MF59_F | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 8 percentage of subjects |
| Placebo - Group 2 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ia) | 20 percentage of subjects |
| Placebo - Group 2 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ia) | 20 percentage of subjects |
| Placebo - Group 2 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup III) | 0 percentage of subjects |
| Placebo - Group 2 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup III) | 6 percentage of subjects |
| Placebo - Group 2 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 361 (Serogroup Ib) | 22 percentage of subjects |
| Placebo - Group 2 | Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | Day 1 (Serogroup Ib) | 24 percentage of subjects |
Secondary
Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1
GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across all cohorts 1 and 2.
Time frame: Day 1 and Day 721
Population: Analysis was done on secondary persistence PPS
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 5µg-1 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/Day 1(Serotype Ia) | 7.5 Ratios |
| 5µg-1 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype III) | 23 Ratios |
| 5µg-1 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype Ib) | 19 Ratios |
| 5µg-2 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype III) | 19 Ratios |
| 5µg-2 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype Ib) | 26 Ratios |
| 5µg-2 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/Day 1(Serotype Ia) | 7.67 Ratios |
| 20 µg-1 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype Ib) | 18 Ratios |
| 20 µg-1 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/Day 1(Serotype Ia) | 7.89 Ratios |
| 20 µg-1 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype III) | 18 Ratios |
| 20 µg-2 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype III) | 27 Ratios |
| 20 µg-2 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/Day 1(Serotype Ia) | 9.24 Ratios |
| 20 µg-2 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype Ib) | 24 Ratios |
| 5µg-1 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype Ib) | 13 Ratios |
| 5µg-1 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/Day 1(Serotype Ia) | 9.25 Ratios |
| 5µg-1 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype III) | 11 Ratios |
| 5µg-2 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype Ib) | 23 Ratios |
| 5µg-2 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/Day 1(Serotype Ia) | 6.15 Ratios |
| 5µg-2 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype III) | 24 Ratios |
| 20 µg-1 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype III) | 15 Ratios |
| 20 µg-1 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/Day 1(Serotype Ia) | 6.64 Ratios |
| 20 µg-1 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype Ib) | 18 Ratios |
| 20 µg-2 Inj- Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype Ib) | 17 Ratios |
| 20 µg-2 Inj- Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype III) | 22 Ratios |
| 20 µg-2 Inj- Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/Day 1(Serotype Ia) | 6.35 Ratios |
| Placebo - Group 1 | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype Ib) | 1.17 Ratios |
| Placebo - Group 1 | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/ Day 1 (Serotype III) | 0.76 Ratios |
| Placebo - Group 1 | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | Day 721/Day 1(Serotype Ia) | 0.82 Ratios |
Secondary
Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2
GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across cohorts 3 and 4.
Time frame: Day 1 and Day 721
Population: Analysis was done on secondary persistence PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 5µg-1 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ia) | 3.98 Ratios |
| 5µg-1 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype III) | 16 Ratios |
| 5µg-1 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ib) | 13 Ratios |
| 5µg-2 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype III) | 19 Ratios |
| 5µg-2 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ib) | 19 Ratios |
| 5µg-2 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ia) | 4.14 Ratios |
| 20 µg-1 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ib) | 16 Ratios |
| 20 µg-1 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ia) | 6.12 Ratios |
| 20 µg-1 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype III) | 21 Ratios |
| 20 µg-2 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype III) | 35 Ratios |
| 20 µg-2 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ia) | 11 Ratios |
| 20 µg-2 Inj - No Adj | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ib) | 29 Ratios |
| 5µg-1 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ib) | 17 Ratios |
| 5µg-1 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ia) | 3.61 Ratios |
| 5µg-1 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype III) | 23 Ratios |
| 5µg-2 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ib) | 29 Ratios |
| 5µg-2 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ia) | 9.61 Ratios |
| 5µg-2 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype III) | 27 Ratios |
| 20 µg-1 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype III) | 23 Ratios |
| 20 µg-1 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ia) | 4.7 Ratios |
| 20 µg-1 Inj - Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ib) | 31 Ratios |
| 20 µg-2 Inj- Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ib) | 20 Ratios |
| 20 µg-2 Inj- Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype III) | 21 Ratios |
| 20 µg-2 Inj- Alum | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ia) | 6.8 Ratios |
| Placebo - Group 1 | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ib) | 1.31 Ratios |
| Placebo - Group 1 | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype III) | 1.22 Ratios |
| Placebo - Group 1 | Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | Day 721/Day 1 (Serotype Ia) | 0.89 Ratios |
Secondary
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving trivalent GBS vaccine from day 1 to day 7 for subjects across cohorts 1 and 2.
Time frame: Day 1 to Day 7
Population: Analysis was done on Solicited Safety Set - All subjects in the Exposed Set who provided data on post vaccination local or systemic AEs or other signs of reactogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Malaise | 7 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Rash | 1 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site swelling | 5 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Headache | 16 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Nausea | 6 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Chills | 3 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fever (≥ 38C) | 2 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Systemic | 25 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Pain | 28 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Local | 30 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Warmth | 10 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Arthralgia | 2 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Myalgia | 6 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Redness | 8 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fatigue | 18 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Ecchymosis | 5 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Induration | 9 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Rash | 0 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Myalgia | 1 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Arthralgia | 1 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Induration | 13 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site swelling | 5 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fatigue | 9 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Redness | 8 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Ecchymosis | 3 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Warmth | 11 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Pain | 28 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Local | 32 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Systemic | 21 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fever (≥ 38C) | 0 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Chills | 2 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Nausea | 5 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Headache | 15 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Malaise | 6 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Headache | 13 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Warmth | 9 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site swelling | 5 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Pain | 31 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Ecchymosis | 7 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Rash | 0 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Nausea | 8 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Arthralgia | 3 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Myalgia | 7 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Redness | 9 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fatigue | 18 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Chills | 5 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Malaise | 11 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Local | 31 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Systemic | 22 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fever (≥ 38C) | 1 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Induration | 6 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Rash | 1 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Ecchymosis | 2 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Redness | 8 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Arthralgia | 2 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Warmth | 13 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Pain | 34 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fever (≥ 38C) | 1 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Systemic | 28 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Myalgia | 8 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Malaise | 11 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Chills | 2 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Local | 35 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Headache | 18 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Induration | 9 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Nausea | 5 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site swelling | 5 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fatigue | 21 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Local | 39 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Induration | 12 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Systemic | 27 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Myalgia | 3 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Ecchymosis | 5 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Redness | 9 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fatigue | 19 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Chills | 3 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Headache | 19 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site swelling | 7 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Malaise | 7 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Rash | 1 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Arthralgia | 3 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fever (≥ 38C) | 1 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Warmth | 11 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Pain | 39 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Nausea | 7 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Malaise | 9 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Local | 37 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Headache | 17 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Nausea | 6 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Arthralgia | 3 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Systemic | 20 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fatigue | 13 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Redness | 12 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Rash | 1 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site swelling | 8 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Induration | 16 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Myalgia | 5 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fever (≥ 38C) | 2 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Pain | 37 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Chills | 1 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Ecchymosis | 4 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Warmth | 14 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fever (≥ 38C) | 0 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Headache | 19 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Local | 38 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Induration | 16 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site swelling | 16 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Ecchymosis | 0 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Redness | 15 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Warmth | 11 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Pain | 38 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Systemic | 29 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Chills | 4 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Nausea | 5 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Malaise | 12 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Myalgia | 8 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Arthralgia | 3 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fatigue | 17 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Rash | 0 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Redness | 14 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Headache | 11 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Systemic | 21 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Ecchymosis | 2 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Nausea | 4 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Rash | 0 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fatigue | 13 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Pain | 39 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site swelling | 8 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Malaise | 9 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Induration | 15 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Warmth | 16 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Local | 39 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Chills | 4 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fever (≥ 38C) | 3 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Myalgia | 6 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Arthralgia | 6 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Malaise | 2 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Arthralgia | 0 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Nausea | 1 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Chills | 3 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Systemic | 11 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Pain | 7 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Warmth | 1 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Redness | 3 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fever (≥ 38C) | 0 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Ecchymosis | 0 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site swelling | 2 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Fatigue | 6 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Inj site Induration | 3 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Any Local | 8 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Headache | 7 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Myalgia | 2 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Rash | 0 participants |
Secondary
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving GBS vaccine from day 1 to day 7 for subjects in cohorts 3 and 4.
Time frame: Day 1 to Day 7
Population: Analysis was done on Solicited Safety Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Arthralgia | 1 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Rash | 0 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Induration | 5 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Chills | 2 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Systemic | 23 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Pain | 32 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Myalgia | 6 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fever (≥ 38C) | 0 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Warmth | 6 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Nausea | 8 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Malaise | 11 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Headache | 13 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Redness | 3 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Ecchymosis | 2 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fatigue | 17 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site swelling | 2 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Local | 33 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Nausea | 8 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Chills | 5 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Local | 37 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Rash | 1 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Induration | 12 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site swelling | 9 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fatigue | 18 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Ecchymosis | 4 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Redness | 11 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fever (≥ 38C) | 1 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Headache | 19 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Warmth | 17 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Myalgia | 11 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Pain | 35 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Malaise | 17 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Systemic | 28 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Arthralgia | 3 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Headache | 14 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Pain | 35 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site swelling | 7 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Redness | 8 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Systemic | 23 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Warmth | 14 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Malaise | 13 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Local | 36 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Arthralgia | 5 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Myalgia | 8 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Nausea | 6 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Ecchymosis | 4 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Induration | 7 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Rash | 2 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fever (≥ 38C) | 2 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Chills | 7 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fatigue | 18 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fatigue | 21 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Pain | 40 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site swelling | 11 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fever (≥ 38C) | 1 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Nausea | 10 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Ecchymosis | 2 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Headache | 23 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Arthralgia | 3 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Malaise | 13 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Redness | 8 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Systemic | 31 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Warmth | 21 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Chills | 9 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Myalgia | 10 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Rash | 1 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Local | 40 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Induration | 12 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Induration | 8 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Malaise | 17 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Headache | 14 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Local | 37 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Myalgia | 14 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site swelling | 8 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Ecchymosis | 5 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Arthralgia | 3 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fatigue | 25 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Pain | 37 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fever (≥ 38C) | 5 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Nausea | 5 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Redness | 6 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Rash | 2 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Warmth | 12 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Chills | 7 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Systemic | 28 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Redness | 8 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Myalgia | 10 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Arthralgia | 4 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Local | 38 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Induration | 9 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site swelling | 10 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Ecchymosis | 4 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Chills | 7 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Warmth | 14 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Pain | 37 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Systemic | 31 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Nausea | 10 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Malaise | 15 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Headache | 23 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fatigue | 20 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Rash | 1 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fever (≥ 38C) | 1 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Induration | 14 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Chills | 5 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Ecchymosis | 5 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fatigue | 20 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Headache | 22 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Malaise | 17 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fever (≥ 38C) | 4 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site swelling | 7 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Nausea | 8 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Rash | 3 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Systemic | 30 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Warmth | 17 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Arthralgia | 4 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Pain | 39 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Local | 39 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Myalgia | 7 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Redness | 7 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Nausea | 13 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Pain | 39 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Malaise | 20 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Warmth | 21 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Arthralgia | 7 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Redness | 17 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Ecchymosis | 5 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Headache | 30 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site swelling | 13 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Induration | 14 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fatigue | 22 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Local | 39 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fever (≥ 38C) | 6 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Rash | 1 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Myalgia | 17 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Systemic | 34 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Chills | 16 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Local | 8 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Chills | 5 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Arthralgia | 1 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Redness | 4 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Any Systemic | 13 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Malaise | 6 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Pain | 5 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Rash | 0 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Myalgia | 2 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site swelling | 2 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Inj site Induration | 3 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Nausea | 5 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Headache | 10 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fever (≥ 38C) | 0 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Warmth | 6 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Fatigue | 9 participants |
| Placebo - Group 1 | Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Ecchymosis | 2 participants |
Secondary
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1
Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 1 and 2.
Time frame: Day 1 through Day 721
Population: Analysis was done on unsolicited safety set - All subjects in the Exposed Set who provided information about postvaccination unsolicited AEs.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5µg-1 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | At least possibly related AEs | 8 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Any AEs | 32 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Serious AEs | 1 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Medically attended AEs | 25 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Any AEs | 33 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | At least possibly related AEs | 11 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Medically attended AEs | 24 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Serious AEs | 1 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | At least possibly related AEs | 11 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Medically attended AEs | 23 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Any AEs | 31 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Serious AEs | 0 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Serious AEs | 2 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Medically attended AEs | 18 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | At least possibly related AEs | 11 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Any AEs | 27 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Medically attended AEs | 26 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Serious AEs | 6 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | At least possibly related AEs | 4 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Any AEs | 32 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Medically attended AEs | 24 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | At least possibly related AEs | 6 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Any AEs | 30 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Serious AEs | 2 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Medically attended AEs | 28 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | At least possibly related AEs | 7 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Serious AEs | 2 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Any AEs | 33 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | At least possibly related AEs | 5 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Any AEs | 32 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Serious AEs | 0 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Medically attended AEs | 27 participants |
| Placebo - Group 1 | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | At least possibly related AEs | 0 participants |
| Placebo - Group 1 | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Any AEs | 16 participants |
| Placebo - Group 1 | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Medically attended AEs | 11 participants |
| Placebo - Group 1 | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Serious AEs | 2 participants |
Secondary
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2
Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 3 and 4.
Time frame: Day 1 through Day 721
Population: Analysis was done on Unsolicited Safety Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5µg-1 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Any AEs | 30 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | At least possibly related AEs | 0 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Serious AEs | 2 participants |
| 5µg-1 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Medically attended AEs | 27 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Medically attended AEs | 26 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Any AEs | 34 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | At least possibly related AEs | 6 participants |
| 5µg-2 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Serious AEs | 2 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | At least possibly related AEs | 5 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Medically attended AEs | 26 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Serious AEs | 0 participants |
| 20 µg-1 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Any AEs | 36 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Any AEs | 38 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | At least possibly related AEs | 6 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Serious AEs | 3 participants |
| 20 µg-2 Inj - No Adj | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Medically attended AEs | 27 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Serious AEs | 3 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | At least possibly related AEs | 4 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Any AEs | 29 participants |
| 5µg-1 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Medically attended AEs | 22 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Medically attended AEs | 28 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Any AEs | 35 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Serious AEs | 2 participants |
| 5µg-2 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | At least possibly related AEs | 2 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Serious AEs | 6 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | At least possibly related AEs | 9 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Medically attended AEs | 27 participants |
| 20 µg-1 Inj - Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Any AEs | 34 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | At least possibly related AEs | 13 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Medically attended AEs | 26 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Serious AEs | 2 participants |
| 20 µg-2 Inj- Alum | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Any AEs | 32 participants |
| Placebo - Group 1 | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Any AEs | 16 participants |
| Placebo - Group 1 | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Medically attended AEs | 10 participants |
| Placebo - Group 1 | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Serious AEs | 1 participants |
| Placebo - Group 1 | Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | At least possibly related AEs | 1 participants |
Secondary
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1
The persistence of Serotype-specific (Ia, Ib & III) GBS IgG antibody response was assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohorts 1 and 2.
Time frame: Day 1 and Day 721
Population: Analysis was done on secondary persistence PPS - All the subjects who provided all serum sample results from Baseline (prior to vaccination) through Day 721 within protocol required windows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 5µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype III;N=34,33,28,34,30,30,34,31,6) | 3.19 µg/mL |
| 5µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 2.92 µg/mL |
| 5µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype III;N=34,33,28,34,30,30,34,31,6) | 0.14 µg/mL |
| 5µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1 (serotype Ia) | 0.63 µg/mL |
| 5µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 0.16 µg/mL |
| 5µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721 (Serotype Ia) | 4.69 µg/mL |
| 5µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype III;N=34,33,28,34,30,30,34,31,6) | 0.097 µg/mL |
| 5µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721 (Serotype Ia) | 3.48 µg/mL |
| 5µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1 (serotype Ia) | 0.45 µg/mL |
| 5µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 0.11 µg/mL |
| 5µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype III;N=34,33,28,34,30,30,34,31,6) | 1.89 µg/mL |
| 5µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 2.81 µg/mL |
| 20 µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 0.094 µg/mL |
| 20 µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1 (serotype Ia) | 0.39 µg/mL |
| 20 µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype III;N=34,33,28,34,30,30,34,31,6) | 0.094 µg/mL |
| 20 µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721 (Serotype Ia) | 3.11 µg/mL |
| 20 µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype III;N=34,33,28,34,30,30,34,31,6) | 1.7 µg/mL |
| 20 µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 1.71 µg/mL |
| 20 µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype III;N=34,33,28,34,30,30,34,31,6) | 0.079 µg/mL |
| 20 µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype III;N=34,33,28,34,30,30,34,31,6) | 2.16 µg/mL |
| 20 µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 2.64 µg/mL |
| 20 µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 0.11 µg/mL |
| 20 µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721 (Serotype Ia) | 3.18 µg/mL |
| 20 µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1 (serotype Ia) | 0.34 µg/mL |
| 5µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype III;N=34,33,28,34,30,30,34,31,6) | 0.12 µg/mL |
| 5µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1 (serotype Ia) | 0.55 µg/mL |
| 5µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721 (Serotype Ia) | 5.1 µg/mL |
| 5µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 0.18 µg/mL |
| 5µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 2.32 µg/mL |
| 5µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype III;N=34,33,28,34,30,30,34,31,6) | 1.26 µg/mL |
| 5µg-2 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 0.13 µg/mL |
| 5µg-2 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 2.96 µg/mL |
| 5µg-2 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721 (Serotype Ia) | 3.01 µg/mL |
| 5µg-2 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype III;N=34,33,28,34,30,30,34,31,6) | 0.16 µg/mL |
| 5µg-2 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1 (serotype Ia) | 0.49 µg/mL |
| 5µg-2 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype III;N=34,33,28,34,30,30,34,31,6) | 3.87 µg/mL |
| 20 µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 0.14 µg/mL |
| 20 µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1 (serotype Ia) | 0.56 µg/mL |
| 20 µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 2.55 µg/mL |
| 20 µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype III;N=34,33,28,34,30,30,34,31,6) | 1.44 µg/mL |
| 20 µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype III;N=34,33,28,34,30,30,34,31,6) | 0.095 µg/mL |
| 20 µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721 (Serotype Ia) | 3.69 µg/mL |
| 20 µg-2 Inj- Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 0.085 µg/mL |
| 20 µg-2 Inj- Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721 (Serotype Ia) | 2.17 µg/mL |
| 20 µg-2 Inj- Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype III;N=34,33,28,34,30,30,34,31,6) | 2.68 µg/mL |
| 20 µg-2 Inj- Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1 (serotype Ia) | 0.34 µg/mL |
| 20 µg-2 Inj- Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype III;N=34,33,28,34,30,30,34,31,6) | 0.12 µg/mL |
| 20 µg-2 Inj- Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 1.45 µg/mL |
| Placebo - Group 1 | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype III;N=34,33,28,34,30,30,34,31,6) | 0.071 µg/mL |
| Placebo - Group 1 | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721 (Serotype Ia) | 0.3 µg/mL |
| Placebo - Group 1 | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1 (serotype Ia) | 0.37 µg/mL |
| Placebo - Group 1 | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 1.02 µg/mL |
| Placebo - Group 1 | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 1(Serotype Ib;N=32,30,28,32,29,28,28,27,6) | 0.88 µg/mL |
| Placebo - Group 1 | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | Day 721(Serotype III;N=34,33,28,34,30,30,34,31,6) | 0.054 µg/mL |
Secondary
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2
The persistence of Serotype-specific (Ia, Ib & III) GBS IgG antibody response assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohort 3 and 4.
Time frame: Day 1 and Day 721
Population: Analysis was done on secondary persistence PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 5µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721 (Serotype Ia) | 1.86 µg/mL |
| 5µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype III;N=34,32,34,32,33,31,36,33,14) | 0.11 µg/mL |
| 5µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1 (serotype Ia) | 0.47 µg/mL |
| 5µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 0.13 µg/mL |
| 5µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day721(Serotype III;N=34,32,34,32,33,31,36,33,14) | 1.72 µg/mL |
| 5µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 1.7 µg/mL |
| 5µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype III;N=34,32,34,32,33,31,36,33,14) | 0.082 µg/mL |
| 5µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 1.72 µg/mL |
| 5µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 0.092 µg/mL |
| 5µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1 (serotype Ia) | 0.48 µg/mL |
| 5µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day721(Serotype III;N=34,32,34,32,33,31,36,33,14) | 1.59 µg/mL |
| 5µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721 (Serotype Ia) | 1.97 µg/mL |
| 20 µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721 (Serotype Ia) | 1.73 µg/mL |
| 20 µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day721(Serotype III;N=34,32,34,32,33,31,36,33,14) | 1.29 µg/mL |
| 20 µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 0.072 µg/mL |
| 20 µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype III;N=34,32,34,32,33,31,36,33,14) | 0.061 µg/mL |
| 20 µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 1.16 µg/mL |
| 20 µg-1 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1 (serotype Ia) | 0.28 µg/mL |
| 20 µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day721(Serotype III;N=34,32,34,32,33,31,36,33,14) | 2.48 µg/mL |
| 20 µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype III;N=34,32,34,32,33,31,36,33,14) | 0.071 µg/mL |
| 20 µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721 (Serotype Ia) | 3.09 µg/mL |
| 20 µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1 (serotype Ia) | 0.29 µg/mL |
| 20 µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 0.1 µg/mL |
| 20 µg-2 Inj - No Adj | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 2.99 µg/mL |
| 5µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1 (serotype Ia) | 0.46 µg/mL |
| 5µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 0.15 µg/mL |
| 5µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 2.5 µg/mL |
| 5µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721 (Serotype Ia) | 1.66 µg/mL |
| 5µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype III;N=34,32,34,32,33,31,36,33,14) | 0.09 µg/mL |
| 5µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day721(Serotype III;N=34,32,34,32,33,31,36,33,14) | 2.04 µg/mL |
| 5µg-2 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1 (serotype Ia) | 0.53 µg/mL |
| 5µg-2 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 4.23 µg/mL |
| 5µg-2 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype III;N=34,32,34,32,33,31,36,33,14) | 0.12 µg/mL |
| 5µg-2 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721 (Serotype Ia) | 5.06 µg/mL |
| 5µg-2 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day721(Serotype III;N=34,32,34,32,33,31,36,33,14) | 3.18 µg/mL |
| 5µg-2 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 0.15 µg/mL |
| 20 µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1 (serotype Ia) | 0.37 µg/mL |
| 20 µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721 (Serotype Ia) | 1.72 µg/mL |
| 20 µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 2.47 µg/mL |
| 20 µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype III;N=34,32,34,32,33,31,36,33,14) | 0.077 µg/mL |
| 20 µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 0.08 µg/mL |
| 20 µg-1 Inj - Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day721(Serotype III;N=34,32,34,32,33,31,36,33,14) | 1.78 µg/mL |
| 20 µg-2 Inj- Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721 (Serotype Ia) | 3.32 µg/mL |
| 20 µg-2 Inj- Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype III;N=34,32,34,32,33,31,36,33,14) | 0.1 µg/mL |
| 20 µg-2 Inj- Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 1.93 µg/mL |
| 20 µg-2 Inj- Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 0.094 µg/mL |
| 20 µg-2 Inj- Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day721(Serotype III;N=34,32,34,32,33,31,36,33,14) | 2.05 µg/mL |
| 20 µg-2 Inj- Alum | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1 (serotype Ia) | 0.49 µg/mL |
| Placebo - Group 1 | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 0.16 µg/mL |
| Placebo - Group 1 | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1(Serotype III;N=34,32,34,32,33,31,36,33,14) | 0.061 µg/mL |
| Placebo - Group 1 | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721(Serotype Ib;N=32,28,29,29,28,24,30,33,9) | 0.21 µg/mL |
| Placebo - Group 1 | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 721 (Serotype Ia) | 0.33 µg/mL |
| Placebo - Group 1 | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day721(Serotype III;N=34,32,34,32,33,31,36,33,14) | 0.075 µg/mL |
| Placebo - Group 1 | Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | Day 1 (serotype Ia) | 0.37 µg/mL |