Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Group B streptococcus (GBS) vaccine, Group B streptococcus (GBS) vaccine- low dose, Group B streptococcus vaccine- low dose
Group B streptococcus vaccine · 4 trials · 5 indications
GMCs of Group B Streptococcus (GBS)-specific Abs against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.
The Geometric mean transfer ratio of GBS-specific Ab against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.
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.
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 (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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| HIVneg | EXPERIMENTAL | HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of Group B streptococcus vaccine. |
| HIVposCD4HIGH | EXPERIMENTAL | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count \>350 cells/µL received one dose of Group B streptococcus vaccine. |
| HIVposCD4LOW | EXPERIMENTAL | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but \> 50 cells/µL received one dose of Group B streptococcus vaccine |
| 5 µg_No Adj | EXPERIMENTAL | Subjects received either 1 or 2 doses of active vaccine (5 µg) without any adjuvant |
| 20 µg_No Adj | EXPERIMENTAL | Subjects received either 1 or 2 doses of active vaccine (20 µg) without any adjuvant. |
| 5 µg_Alum | EXPERIMENTAL | Subjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant. |
| 20 µg_Alum | EXPERIMENTAL | Subjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant. |
| 5 µg_MF59-H | EXPERIMENTAL | Subjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 4.87 mg of MF59 |
| 20 µg_MF59-H | EXPERIMENTAL | Subjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 4.87 mg of MF59 |
| 5 µg_MF59-F | EXPERIMENTAL | Subjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 9.75 mg of MF59 |
| 20 µg_MF59-F | EXPERIMENTAL | Subjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 9.75 mg of MF59 |
| Placebo | PLACEBO_COMPARATOR | Subjects received 2 injections of placebo administered 1 month apart |
| Arm 1 | NO_INTERVENTION | This is a phlebotomy study. |
| Name | Type | Description |
|---|---|---|
| Group B streptococcus vaccine | BIOLOGICAL | Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine. |
| Group B streptococcus (GBS) vaccine- low dose | BIOLOGICAL | - |
| Group B streptococcus (GBS) vaccine- High dose | BIOLOGICAL | - |
| Placebo- Saline | BIOLOGICAL | - |
| Group B streptococcus (GBS) vaccine | BIOLOGICAL | No vaccine will be administered in this study. Only one study visit is required. Subjects will return to the clinic for a single visit at 24 months (± 3 months) after the last injection administered in the V98P1 study. |
Inclusion Criteria: * Pregnant women 18-40 years of age between 24-35 weeks gestation * Women who were HIVneg or HIVpos with WHO stage I or II disease and with CD4+ counts \> 50 cells/µL Exclusion Criteria: * Women who had CD4+ count ≤ 50 cells/µL * Women who were HIVpos with WHO stage III or IV ...