NCT02690181

Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.

A Phase 2, Non-Randomized, Controlled, Open-Label, Parallel-Group, Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-pregnant Subjects.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 22 Years – 46 Years
• Healthy volunteers: Accepted

Summary

The objective of this extension study is the initial assessment of safety and immunogenicity of the second dose of GBS Trivalent Vaccine following the time interval that is close to the inter-pregnancy interval observed in the general population.

Conditions

• Bacterial Infection Due to Streptococcus, Group B
• Streptococcus Agalactiae

Interventions

Type	Name	Description
BIOLOGICAL	GBS Trivalent Vaccine	Administration 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 .

Timeline

• Start date: 2016-03-29
• Primary completion: 2016-11-02
• Completion: 2016-11-02
• First posted: 2016-02-24
• Last updated: 2024-04-04
• Results posted: 2018-07-16

Locations

1 site across 1 country: Belgium