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

Prophylaxis of Avian Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537524
• Other study ID #: V87P6
• Secondary ID: 2007-002480-27
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2007
• Last updated: February 14, 2012
• Start date: September 2007
• Est. completion date: May 2008

Study information

• Verified date: February 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 471
• Est. completion date: May 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza, Human
• Prophylaxis of Avian Influenza

Intervention

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).
• 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).

Locations

Country	Name	City	State
Finland	University of Tampere Medical School	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Vesikari T, Karvonen A, Tilman S, Borkowski A, Montomoli E, Banzhoff A, Clemens R. Immunogenicity and safety of MF59-adjuvanted H5N1 influenza vaccine from infancy to adolescence. Pediatrics. 2010 Oct;126(4):e762-70. doi: 10.1542/peds.2009-2628. Epub 2010 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and tolerability of, and magnitude of antibody responses to two 0.5mL intramuscular injections of an H5N1 influenza vaccineapart		administered 3 weeks apart	Yes
Secondary	safety and tolerability of, and magnitude of antibodies to one booster dose with a H5N1		12 months after primary immunization	Yes
Secondary	safety profile of a H5N1 compared to a seasonal flu vaccinepersistence of specific antibodies		12 months after primary immunization	Yes