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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00491985
First Posted: June 27, 2007
Last Update Posted: January 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00491985     History of Changes
Other Study ID Numbers: GPA04
First Submitted: June 26, 2007
First Posted: June 27, 2007
Last Update Posted: January 14, 2014
Last Verified: January 2014

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Influenza A/H5N1 Virus
Influenza Pandemic
Orthomyxoviridae Infections

Additional relevant MeSH terms:
Infection
Communicable Diseases
Influenza, Human
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs