CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 75 enrolled
Drug / intervention
GBS trivalent vaccine +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02046148
NCT02046148Phase 2Completed
CompareCT.gov

A Phase II, Multicenter, Randomized, Observer-Blind, Controlled Study to Evaluate Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women

GlaxoSmithKline·interventional·Posted Jan 27, 2014·Updated Dec 29, 2020

In Brief

A Phase 2 clinical trial evaluating GBS trivalent vaccine and Placebo for GBS Disease and Streptococcus Agalactiae. Completed, enrolled 75 participants across 6 sites.

Detailed Summary

Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific antibodies in infants, placental transfer from the pregnant women to the infant and levels of antibodies in the breast milk.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGBS Disease, Streptococcus Agalactiae
CountriesUnited States
CollaboratorsNovartis Vaccines

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 27, 2014
Enrollment StartMar 18, 2014
Primary CompletionDec 30, 2015
Study CompletionMar 26, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.4 years ago

Interventions

GBS trivalent vaccinebiological

Intramuscular injection - Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus and conjugated to the Corynebacterium diphtheriae CRM197 carrier protein

Placebobiological

Intramuscular injection - Normal saline