Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00491985
First received: June 26, 2007
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

This is an open, randomized, multicenter clinical trial.

Objectives:

  • To describe the safety profiles during the 21 days following each primary and booster injection.
  • To describe the immune response 21 days after each primary and booster injection of each formulation.
  • To describe the antibody persistence after the first vaccination

Condition Intervention Phase
Influenza
Orthomyxoviridae Infections
Influenza A Virus Infection
Biological: A/H5N1 Inactivated, split-virion pandemic influenza vaccine
Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To describe safety following administration of A/H5N1 inactivated split virion pandemic influenza vaccine. [ Time Frame: 21 Days post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: June 2007
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group 1
Subjects aged 9 to 17 years
Biological: A/H5N1 Inactivated, split-virion pandemic influenza vaccine
0.5 mL, Intramuscular
Experimental: Study Group 2
Subjects aged 3 to 8 years
Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine
0.5 mL, Intramuscular
Experimental: Study Group 3
Subjects aged 6 to 35 months
Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine
0.25 mL, Intramuscular

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

All subjects:

  • Able to attend all scheduled visits and to comply with all trial procedures.

Children/Adolescents aged ≥ 2 years to < 18 years:

  • Aged ≥ 2 years to < 18 years on the day of inclusion.
  • Informed Consent Form signed by one parent or another legal representative and by an independent witness if the parent/legal representative is illiterate.
  • For a female, inability to bear a child or negative urine pregnancy test (as applicable).
  • For a female of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination (as applicable).

Infants/toddlers aged ≥ 6 months to < 2 years:

  • Aged ≥ 6 months to < 2 years on the day of inclusion.
  • Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2 kg.
  • Informed Consent Form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate.
  • Subject who completed vaccination according to the national immunization schedule.

Exclusion Criteria :

All subjects:

  • Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
  • Systemic hypersensitivity to any of the vaccine components or history of life threatening reaction to the trial vaccine or a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
  • Chronic illness at a stage that could interfere with trial conduct or completion.
  • Blood or blood-derived products received in the past 3 months.
  • Any vaccination in the 4 weeks preceding the first trial vaccination.
  • Vaccination planned in the 4 weeks following any trial vaccination.
  • History of the H5N1 infection (confirmed either clinically, serologically or virologically).
  • Known HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity.
  • Previous vaccination with an avian flu vaccine.
  • Subject at high risk of the H5N1 infection during the trial.
  • Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
  • Febrile illness (rectal equivalent temperature ≥ 38.0°C) on the day of inclusion.

Children/Adolescents aged ≥ 2 years to < 18 years:

  • Breast-feeding mothers.
  • Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures (if applicable, depending on the subject's age).

Infants/toddlers aged ≥ 6 months to < 2 years:

  • History of seizures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491985

Locations
Thailand
Bangkok, Thailand
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00491985     History of Changes
Other Study ID Numbers: GPA04
Study First Received: June 26, 2007
Last Updated: January 10, 2014
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Sanofi:
Influenza A/H5N1 Virus
Influenza Pandemic
Orthomyxoviridae Infections

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Virus Diseases
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 14, 2014