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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.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines ) Identifier:
First received: September 28, 2007
Last updated: February 14, 2012
Last verified: February 2012
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: H5N1 Influenza Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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:

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 vaccineapart [ Time Frame: administered 3 weeks apart ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 471
Study Start Date: September 2007
Study Completion Date: May 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
0.5mL of H5N1 vaccine 7.5ug
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).
Active Comparator: Arm 2
0.25 or 0.5mL of H5N1 vaccine
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).


Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00537524

University of Tampere Medical School
Tampere, Finland, 33014
Sponsors and Collaborators
Novartis Vaccines
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Vaccines Identifier: NCT00537524     History of Changes
Other Study ID Numbers: V87P6
Study First Received: September 28, 2007
Last Updated: February 14, 2012

Keywords provided by Novartis:
Bird flu
seasonal influenza vaccine
influenza vaccine
prepandemic vaccine
virus strain with the potential to cause pandemic

Additional relevant MeSH terms:
Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017