CompletedPhase 1

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

Switzerland50 participantsStarted 2010-01

Plain-language summary

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.

Who can participate

Age range20 Years – 42 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 24- months post last injection from V98P1

Trial details

NCT IDNCT01052935

SponsorNovartis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-01

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