Trials / Completed
CompletedNCT02046148
Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GBS trivalent vaccine | 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 |
| BIOLOGICAL | Placebo | Intramuscular injection - Normal saline |
Timeline
- Start date
- 2014-03-18
- Primary completion
- 2015-12-30
- Completion
- 2016-03-26
- First posted
- 2014-01-27
- Last updated
- 2020-12-29
- Results posted
- 2017-05-30
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02046148. Inclusion in this directory is not an endorsement.