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

Novartis Vaccines95 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

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 V98P2 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 V98P2 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 V98P2.

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 V98P2 GMCs, GMRs and associated 95% confidence intervals will also be determined.

Time frame: 24- months post last injection from V98P2

Data from ClinicalTrials.gov

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