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

This study has been completed.

First Received on September 28, 2007. Last Updated on March 21, 2011 History of Changes

Sponsor:	Novartis
Collaborator:	Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00537524

Purpose

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

Condition	Intervention	Phase
Prophylaxis of Avian Influenza	Biological: avian influenza vaccine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention
Official Title:	A Phase II, Randomized, Controlled, Observer-blind, Single-center Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of an H5N1 Influenza Vaccine in Subjects Aged 6 Months to 17 Years

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

safety and tolerability of, and magnitude of antibody responses to two 0.5mL intramuscular injections of an H5N1 influenza vaccine, administered 3 weeks apart

Secondary Outcome Measures:

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

Estimated Enrollment:	469
Study Start Date:	September 2007

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537524

Locations

Finland
University of Tampere Medical School
Tampere, Finland, 33014

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines

More Information

Publications:

ClinicalTrials.gov Identifier:	NCT00537524 History of Changes
Other Study ID Numbers:	V87P6, 2007-002480-27
Study First Received:	September 28, 2007
Last Updated:	March 21, 2011
Health Authority:	Finland: Finnish Medicines Agency

Keywords provided by Novartis:

Bird flu
seasonal influenza vaccine
influenza vaccine
prepandemic vaccine

virus strain with the potential to cause pandemic
toddlers
children
adolescents

Additional relevant MeSH terms:

Influenza in Birds
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012