Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Group B Streptococcus Trivalent Vaccine
Group B Streptococcus Trivalent Vaccine- 20/20/20 μg · 2 trials · 4 indications
GMCs of anti-Group B Streptococcus (GBS) capsular polysaccharide (CPS) antibodies against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.
The Geometric mean transfer ratio of anti-GBS CPS antibodies 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 percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.
| Arm | Type | Description |
|---|---|---|
| Group B Streptococcus Trivalent Vaccine | EXPERIMENTAL | Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine. |
| Placebo | PLACEBO_COMPARATOR | Pregnant women who received one injection of saline solution. |
| 1: GBS Trivalent Vaccine with aluminium - 20/20/20 μg | EXPERIMENTAL | Non-pregnant women who received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum. |
| 2: Placebo - Sterile saline | PLACEBO_COMPARATOR | Non-Pregnant Women who received two injection of saline solution. |
| 3: GBS Trivalent Vaccine - 0.5/0.5/0.5 µg | EXPERIMENTAL | Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine. |
| 4: GBS Trivalent Vaccine - 2.5/2.5/2.5 µg | EXPERIMENTAL | Pregnant Women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine. |
| 5: GBS Trivalent Vaccine - 5/5/5 µg | EXPERIMENTAL | Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine. |
| 6: Placebo - Sterile saline | PLACEBO_COMPARATOR | Pregnant Women who received one injection of saline solution. |
| Name | Type | Description |
|---|---|---|
| Group B Streptococcus Trivalent Vaccine | BIOLOGICAL | Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine administered intramuscularly. |
| Placebo | BIOLOGICAL | Pregnant women who received one injection of saline solution administered intramuscularly. |
| Group B Streptococcus Trivalent Vaccine - 20/20/20 μg | BIOLOGICAL | Subjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum. |
| Saline solution | OTHER | Subjects received two injection of saline solution. |
| Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg | BIOLOGICAL | Subjects received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine. |
| Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg | BIOLOGICAL | Subjects received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine. |
| Group B Streptococcus Trivalent Vaccine - 5/5/5 μg | BIOLOGICAL | Subjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine. |
Inclusion Criteria: 1. Healthy pregnant women 18-40 years of age at 24-35 weeks of gestation at screening. 2. Individuals who have given a written consent after the nature of the study has been explained according to local regulatory requirements. 3. Individuals in good health as determined by the ...