NCT01053767

A Study to Assess the Persistence of Two GBS Antibodies in Women Previously Immunized With a GBS Vaccine

A Phase I Extension Study to Assess the Long-Term Persistence of GBS Serotypes Ib and III Antibodies in Women Previously Immunized With a GBS Ib and III Crm-Glycoconjugate Vaccine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: Female
• Age: 20 Years – 42 Years
• Healthy volunteers: Accepted

Summary

This study looks at the body's immune response to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P2 study. Blood will be drawn and evaluated for GBS antibody levels.

Conditions

• Group B Streptococcus (GBS) Disease

Interventions

Type	Name	Description
BIOLOGICAL	Group B streptococcus (GBS) vaccine	No vaccine will be administered in this study. Only one study visit is required. Subjects will return to the clinic for a single visit at 24 months (± 3 months) after the last injection administered in the V98P2 study.

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-08-01
• Completion: 2010-12-01
• First posted: 2010-01-21
• Last updated: 2020-02-11

Locations

1 site across 1 country: Switzerland