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
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: 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 July 23, 2014