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

Novartis50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Group B Streptococcus (GBS) Disease

Interventions

Group B streptococcus (GBS) vaccineBIOLOGICAL

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 V98P1 study.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 42 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals who have given written consent. * Individuals who participated in V98P1 and received the complete schedule of vaccinations. Exclusion Criteria: * Individuals who have not given written consent. * Subjects who did not receive the complete schedule of vaccination in V98P1.

Locations (1)

Institute for Pharmacokinetic and Analytical Studies

Via Mastri, 36, CH - 6853 Ligornetto, Switzerland

Outcomes

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

Time frame: 24- months post last injection from V98P1

Data from ClinicalTrials.gov

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