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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014