NCT00491985CompletedPhase 2
Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children
Sanofi Pasteur, a Sanofi Company1 site in 1 country240 target enrollmentStarted: June 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- To describe safety following administration of A/H5N1 inactivated split virion pandemic influenza vaccine.
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Study Group 1
Experimental
Subjects aged 9 to 17 years
Intervention: A/H5N1 Inactivated, split-virion pandemic influenza vaccine (Biological)
Study Group 2
Experimental
Subjects aged 3 to 8 years
Intervention: A/H5N1 Inactivated, split virion pandemic influenza vaccine (Biological)
Study Group 3
Experimental
Subjects aged 6 to 35 months
Intervention: A/H5N1 Inactivated, split virion pandemic influenza vaccine (Biological)
Outcomes
Primary Outcomes
To describe safety following administration of A/H5N1 inactivated split virion pandemic influenza vaccine.
Time Frame: 21 Days post-vaccination
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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