CompletedPhase 2

Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents

United States524 participantsStarted 2004-10

Plain-language summary

The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.

Who can participate

Age range11 Years – 17 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 11-17 years of age, who provide written informed consent Exclusion Criteria: * Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease

What they're measuring

Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine

Timeframe: 1 month after vaccination

Trial details

NCT IDNCT00262041

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-03

Results submitted2013-09-09

View on ClinicalTrials.gov More Prevention of Meningococcal Disease trials