Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women

PHASE2CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

March 18, 2014

Primary Completion Date

December 30, 2015

Study Completion Date

March 26, 2016

Conditions
GBS DiseaseStreptococcus Agalactiae
Interventions
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

Trial Locations (6)

15213

GSK Investigational Site, Pittsburgh

21201

GSK Investigational Site, Baltimore

27705

GSK Investigational Site, Durham

29425

GSK Investigational Site, Charleston

37232

GSK Investigational Site, Nashville

80045

GSK Investigational Site, Aurora

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Vaccines

INDUSTRY

lead

GlaxoSmithKline

INDUSTRY

NCT02046148 - Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women | Biotech Hunter | Biotech Hunter