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GBS Trivalent Vaccine

Phase 2

Bacterial Infection Due to Streptococcus, Group B | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Apr 4, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02690181Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.PHASE2 COMPLETED 80Mar 29, 2016Nov 2, 2016Apr 4, 20241 Belgium
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Study Endpoints
Primary Endpoints
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61
At Day 61

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 With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61
At Day 61

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 All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61
At Day 61

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.

Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Day 1 to Day 7

Threshold for Erythema, Swelling and Induration: None (0 mm), Any (\>= 1 mm).

Number of Subjects With Any Unsolicited Adverse Events (AEs)
Day 1 to Day 31

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.

Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal
Day 1 to Day 181

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.

Secondary Endpoints
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31
At Day 31
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31
At Day 31
Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31
At Day 31
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
GBS NoAdj/GBS NoAdjEXPERIMENTALSubjects 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 NoAdjEXPERIMENTALSubjects 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 NoAdjEXPERIMENTALSubjects 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 NoAdjEXPERIMENTALSubjects 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 NoAdjEXPERIMENTALSubjects 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 NoAdjEXPERIMENTALHealthy 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).
Interventions
NameTypeDescription
GBS Trivalent VaccineBIOLOGICALAdministration 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 .
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Eligibility Criteria
Age Range22 Years — 46 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

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....

Countries:Belgium
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