Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Group B Streptococcus Trivalent Vaccine · 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 ...
Group B Streptococcus Trivalent Vaccine- 20/20/20 μg is an investigational vaccine designed to protect against Group B Streptococcus (streptococcal) infection. It is a trivalent vaccine, meaning it combines three components at 20 μg each, and it is being developed by Novartis AG for use in women, including pregnant women and their offspring.
Group B Streptococcus Trivalent Vaccine- 20/20/20 μg is being studied for the prevention of streptococcal infection caused by Group B Streptococcus. Clinical trials have enrolled non-pregnant and pregnant women aged 18 and older, with the goal of evaluating immune response and safety in mothers and their offspring.
Group B Streptococcus Trivalent Vaccine- 20/20/20 μg is developed by Novartis AG, which trades under the ticker NVS. Novartis conducted the Phase 1/Phase 2 and Phase 2 trials of the vaccine in pregnant and non-pregnant women.
Group B Streptococcus Trivalent Vaccine- 20/20/20 μg is in Phase 2 development. It is an investigational vaccine and is not approved; both of its recorded clinical trials have been completed, and no trials are currently active.
Group B Streptococcus Trivalent Vaccine- 20/20/20 μg has been studied in two completed trials: NCT01446289, a Phase 2 trial in Belgium and Canada with 86 pregnant women, and NCT01193920, a Phase 1/Phase 2 trial in South Africa with 380 non-pregnant and pregnant women. Both were randomized, double-blind, and placebo-controlled.
Yes. Group B Streptococcus Trivalent Vaccine- 20/20/20 μg is the same product as Group B Streptococcus Trivalent Vaccine; the longer name specifies the 20/20/20 μg dose formulation. Both names refer to the Novartis investigational vaccine against Group B Streptococcus.