CompletedPhase 1

Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women

Belgium678 participantsStarted 2010-05

Plain-language summary

This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.

Who can participate

Age range18 Years – 40 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: * Healthy females 18-40 years of age inclusive. Exclusion Criteria: * Individuals who are pregnant or nursing. * Individuals who have had a previous immunization with a vaccine containing streptococcus antigens or any vaccine within 30 days of enrollment through 30 days of study completion. * Individuals with a history of severe allergic reactions after previous vaccination * Individuals with designated blood tests that are not within normal range

What they're measuring

Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1

Timeframe: Day 1 and Day 61

Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61

Timeframe: Day 1 and Day 61

Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype

Timeframe: Day 61/Day 1

Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2

Timeframe: Day 1 and Day 361

Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361

Timeframe: Day 1 and Day 361

Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361

Timeframe: Day 1 and day 361

Trial details

NCT IDNCT01150123

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-11

Results submitted2014-04-03

View on ClinicalTrials.gov More Group B Streptococcus trials