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

Novartis Vaccines471 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

471

Conditions

Prophylaxis of Avian Influenza

Interventions

H5N1 Influenza VaccineBIOLOGICAL

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).

H5N1 Influenza VaccineBIOLOGICAL

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).

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Tampere Medical School

Tampere, Finland

Outcomes

Primary Outcomes

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

Time frame: administered 3 weeks apart

Secondary Outcomes

safety and tolerability of, and magnitude of antibodies to one booster dose with a H5N1

Time frame: 12 months after primary immunization

safety profile of a H5N1 compared to a seasonal flu vaccinepersistence of specific antibodies

Time frame: 12 months after primary immunization

Data from ClinicalTrials.gov

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