CompletedPhase 2

Immunogenicity, Safety and Tolerability of Two Doses of a Pre-pandemic Influenza Vaccine in Participants Aged 6 Months to 17 Years

Finland471 participantsStarted 2007-09

Plain-language summary

Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months to 17 years compared to seasonal flu vaccination

Who can participate

Age range6 Months – 17 Years

SexALL

See this in plain English?

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

Inclusion Criteria: * Healthy subjects Exclusion Criteria: * Receipt of Seasonal Influenza Vaccine for season 2007/2008 * Receipt of another vaccine within 3 weeks before and after each vaccination * Previous vaccination with a pandemic candidate vaccine and/or vaccine containing the adjuvant MF59 or a similar adjuvant * Children who are in the local recommendation for influenza vaccination due to underlying diseases

What they're measuring

safety and tolerability of, and magnitude of antibody responses to two 0.5mL intramuscular injections of an H5N1 influenza vaccineapart

Timeframe: administered 3 weeks apart

Trial details

NCT IDNCT00537524

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-10

View on ClinicalTrials.gov More Prophylaxis of Avian Influenza trials