CompletedPhase 2

Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents

United States203 participantsStarted 2006-02

Plain-language summary

The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11 to 18 years.

Who can participate

Age range11 Years – 18 Years

SexALL

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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 Adolescents between and including 11-18 years of age, who provide written informed consent. Exclusion Criteria: * Previous or suspected disease caused by N. meningitidis; or previous immunization with a serogroup B meningococcal vaccine; Any acute, chronic or progressive disease.

What they're measuring

Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents

Timeframe: 1 month after completion of immunization schedule

Trial details

NCT IDNCT00297817

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-04

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