Immunogenicity, Safety and Tolerability of Two Doses of a Pre-pandemic Influenza Vaccine in Participants Aged 6 Months to 17 Years
Phase 2
Completed
- Conditions
- Prophylaxis of Avian Influenza
- Interventions
- Biological: H5N1 Influenza Vaccine
- Registration Number
- NCT00537524
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months to 17 years compared to seasonal flu vaccination
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 471
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 H5N1 Influenza Vaccine 0.5mL of H5N1 vaccine 7.5ug Arm 2 H5N1 Influenza Vaccine 0.25 or 0.5mL of H5N1 vaccine
- Primary Outcome Measures
Name Time Method safety and tolerability of, and magnitude of antibody responses to two 0.5mL intramuscular injections of an H5N1 influenza vaccineapart administered 3 weeks apart
- Secondary Outcome Measures
Name Time Method safety and tolerability of, and magnitude of antibodies to one booster dose with a H5N1 12 months after primary immunization safety profile of a H5N1 compared to a seasonal flu vaccinepersistence of specific antibodies 12 months after primary immunization
Trial Locations
- Locations (1)
University of Tampere Medical School
🇫🇮Tampere, Finland