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Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children
This study is ongoing, but not recruiting participants.
Study NCT00491985   Information provided by Sanofi-Aventis
First Received: June 26, 2007   Last Updated: September 22, 2008   History of Changes

June 26, 2007
September 22, 2008
June 2007
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00491985 on ClinicalTrials.gov Archive Site
 
 
 
Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children
 

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
 
Phase II
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
  • 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
  • Experimental: Subjects aged 9 to 17 years
  • Experimental: Subjects aged 3 to 8 years
  • Experimental: Subjects aged 6 to 35 months
Chotpitayasunondh T, Thisyakorn U, Pancharoen C, Pepin S, Nougarede N. Safety, humoral and cell mediated immune responses to two formulations of an inactivated, split-virion influenza A/H5N1 vaccine in children. PLoS ONE. 2008;3(12):e4028. Epub 2008 Dec 29.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
240
March 2010
December 2009   (final data collection date for primary outcome measure)

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.
Both
6 Months to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00491985
Medical Monitor, Sanofi Pasteur Inc
GPA04
Sanofi-Aventis
 
Study Director: Medical Monitor Sanofi Pasteur Inc
Sanofi-Aventis
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP