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

NCT00537524 | Completed Phase 2 DMC

• 2 other identifiers: V87P62007-002480-27
• Study Type: interventional
• Target: 471
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prophylaxis of Avian Influenza

Keywords

Bird flu; seasonal influenza vaccine; influenza vaccine; prepandemic vaccine; virus strain with the potential to cause pandemic; toddlers; children; adolescents

Outcome Measures

Primary Outcomes (1)

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

  administered 3 weeks apart

Secondary Outcomes (2)

• 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

Study Arms (2)

Arm 1

EXPERIMENTAL

0.5mL of H5N1 vaccine 7.5ug

Biological: H5N1 Influenza Vaccine

Arm 2

ACTIVE COMPARATOR

0.25 or 0.5mL of H5N1 vaccine

Biological: H5N1 Influenza Vaccine

Interventions

H5N1 Influenza Vaccine BIOLOGICAL

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).

Arm 1

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy subjects

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

University of Tampere Medical School

Tampere, 33014, Finland

Location

Related Publications (2)

• 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 Sep 6.

  PMID: 20819892 RESULT

• Vesikari T, Forsten A, Borkowski A, Gaitatzis N, Banzhoff A, Clemens R. Homologous and heterologous antibody responses to a one-year booster dose of an MF59((R)) adjuvanted A/H5N1 pre-pandemic influenza vaccine in pediatric subjects. Hum Vaccin Immunother. 2012 Jul;8(7):921-8. doi: 10.4161/hv.20248. Epub 2012 Jul 1.

  PMID: 22777094 DERIVED

MeSH Terms

Conditions

Influenza in Birds; Influenza, Human

Condition Hierarchy (Ancestors)

Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Bird Diseases; Animal Diseases; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2007
• First Posted: October 1, 2007
• Study Start: September 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: May 1, 2008
• Last Updated: February 16, 2012

Record last verified: 2012-02

Locations

FI (1)