NCT02270944

Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine

A Phase II, Randomized, Comparative, Observer-Blind, Multi-Center Study Evaluating the Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine in Healthy Non-Pregnant Women Aged 18 to 40 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,053 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to 40 years of age the safety and immunogenicity of a liquid formulation of Group B Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration), and of the lyophilized formulation of GBS Trivalent Vaccine, administered in non-pregnant and pregnant women in the clinical development program to date.

Conditions

• Infections, Streptococcal
• Streptococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	GBS Vaccine	Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus
BIOLOGICAL	GBS Vaccine	Lyophilized formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus

Timeline

• Start date: 2014-11-20
• Primary completion: 2015-04-23
• Completion: 2015-09-22
• First posted: 2014-10-22
• Last updated: 2019-12-05
• Results posted: 2017-07-28

Locations

9 sites across 3 countries: United States, Belgium, Czechia