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

NCT01052935 Phase 1 COMPLETED

This study looks at the body's immune responses to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P1 study. Blood will be drawn and evaluated for GBS antibody levels.

Details

Lead sponsor	Novartis
Phase	Phase 1
Status	COMPLETED
Enrolment	50
Start date	2010-01
Completion	2010-10

Conditions

• Group B Streptococcus (GBS) Disease

Interventions

• Group B streptococcus (GBS) vaccine

Primary outcomes

• Antibody (Ab) response data at 24-months after the last injection given in study V98P1 GMCs, GMRs and associated 95% confidence intervals will also be determined — 24- months post last injection from V98P1

Countries

Switzerland