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

PHASE2CompletedINTERVENTIONAL
Enrollment

471

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

October 31, 2007

Study Completion Date

May 31, 2008

Conditions
Prophylaxis of Avian Influenza
Interventions
BIOLOGICAL

H5N1 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).

BIOLOGICAL

H5N1 Influenza Vaccine

Two 0.25mL or 0.5mL injections of H5N1 influenza vaccine, administered 3 weeks apart, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).

Trial Locations (1)

33014

University of Tampere Medical School, Tampere

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY