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.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00537524
First received: September 28, 2007
Last updated: February 14, 2012
Last verified: February 2012
  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: H5N1 Influenza Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • safety profile of a H5N1 compared to a seasonal flu vaccinepersistence of specific antibodies [ Time Frame: 12 months after primary immunization ] [ Designated as safety issue: Yes ]

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).

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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 Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00537524     History of Changes
Other Study ID Numbers: V87P6, 2007-002480-27
Study First Received: September 28, 2007
Last Updated: February 14, 2012
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 April 15, 2014