Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GBS trivalent vaccine · 2 trials · 3 indications
Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ia at Day 61 post-vaccination, as measured by Enzyme-linked immunosorbent Assay (ELISA).
Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ib at day 61 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype III at day 61 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Threshold for Erythema, Swelling and Induration: None (0 mm), Any (\>= 1 mm).
The number of subjects with any unsolicited AEs from the day of vaccination in study V98\_06E1 to Day 31. An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject. Possibly Related AE definition: the administration of the investigational vaccine and AE are considered reasonably related in time and the AE could be explained by exposure to the investigational vaccine or by other causes. Probably Related AE definition: exposure to the investigational vaccine and AE are reasonably related in time and no alternative explanation has been identified.
An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: Death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. "Medically attended adverse event" is defined as an adverse event that leads to a visit to a healthcare provider and "AEs leading to withdrawal" are defined as adverse events leading to study or vaccine withdrawal.
To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).
To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay
To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
To evaluate serotype-specific (Ia) GBS serum IgG antibody levels (anti-Ia) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).
To evaluate serotype-specific (Ib) GBS serum IgG antibody levels (anti-Ib) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
To evaluate serotype-specific (III) GBS serum IgG antibody levels (anti-III) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ia) GBS serum IgG antibody concentrations (anti-Ia) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).
Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ib) GBS serum IgG antibody concentrations (anti-Ib) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (III) GBS serum IgG antibody concentrations (anti-III) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
| Arm | Type | Description |
|---|---|---|
| GBS NoAdj/GBS NoAdj | EXPERIMENTAL | Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181). |
| GBS Alum/GBS NoAdj | EXPERIMENTAL | Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181). |
| GBS MF59 Full/GBS NoAdj | EXPERIMENTAL | Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181). |
| GBS MF59 Half/GBS NoAdj | EXPERIMENTAL | Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181). |
| Placebo/GBS NoAdj | EXPERIMENTAL | Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181). |
| Naive/GBS NoAdj | EXPERIMENTAL | Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181). |
| GBS Group | EXPERIMENTAL | Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum). |
| Placebo Group | ACTIVE_COMPARATOR | Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum). |
| Name | Type | Description |
|---|---|---|
| GBS Trivalent Vaccine | BIOLOGICAL | Administration of lyophilized formulation of a GBS trivalent vaccine containing 5 µg of each polysaccharide capsules from serotypes Ia, Ib, and III of Group B Streptococcus conjugated to CRM-197 . |
| Placebo | BIOLOGICAL | Intramuscular injection - Normal saline |
Inclusion Criteria: 1. Healthy, non-pregnant subjects who have received a single 5 µg dose of GBS Trivalent Vaccine or placebo in the V98\_06 study and healthy non-pregnant female subjects aged 22-46 years inclusive on the day of informed consent who have not received any GBS vaccine in the past 2....
The GBS trivalent vaccine is an investigational vaccine developed by GSK plc (ticker: GSK) for bacterial infection due to Streptococcus, group B, also known as GBS disease. It is designed to protect against group B Streptococcus and is being studied in Phase 2 clinical development.
The GBS trivalent vaccine is being developed for the prevention of GBS disease and bacterial infection due to Streptococcus, group B. GBS disease is caused by Streptococcus agalactiae. The vaccine is intended for use in healthy non-pregnant subjects and in pregnant women, according to the studied trial populations.
GSK plc, which trades under the ticker GSK, is the developer of the GBS trivalent vaccine. GSK is conducting the clinical development program for this investigational vaccine candidate.
The GBS trivalent vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA. Two Phase 2 trials have been completed, and no active trials are currently listed.
The GBS trivalent vaccine has been studied in two completed Phase 2 trials. NCT02690181 evaluated the immunogenicity and safety of a second dose in healthy non-pregnant subjects in Belgium. NCT02046148 evaluated safety and immunogenicity in healthy pregnant women in the United States.