Prophylaxis of Avian Influenza
Conditions
Keywords
Bird flu, seasonal influenza vaccine, influenza vaccine, prepandemic vaccine, virus strain with the potential to cause pandemic, toddlers, children, adolescents
Brief summary
Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months to 17 years compared to seasonal flu vaccination
Interventions
BIOLOGICALH5N1 Influenza Vaccine
Two 0.5mL injections of H5N1 influenza vaccine containing 7.5μg of H5N1 antigen (A/Vietnam/1194/2004), administered 3 weeks apart, and one 0.5mL injection of H5N1 vaccine 12 months after the second dose, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Finland
Outcome results
None listed