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

Novartis

Status and phase: Completed; Phase 2

Conditions: Prophylaxis of Avian Influenza

Treatments: Biological: H5N1 Influenza Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00537524

2007-002480-27

V87P6

Details and patient eligibility

About

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

Enrollment: 471 patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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471 participants in 2 patient groups

Arm 1

Experimental group

Description:

0.5mL of H5N1 vaccine 7.5ug

Treatment:

Biological: H5N1 Influenza Vaccine

Biological: H5N1 Influenza Vaccine

Arm 2

Active Comparator group

Description:

0.25 or 0.5mL of H5N1 vaccine

Treatment:

Biological: H5N1 Influenza Vaccine

Biological: H5N1 Influenza Vaccine