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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Influenza A Virus Infection; Influenza; Orthomyxoviridae Infections

Treatments: Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine; Biological: A/H5N1 Inactivated, split-virion pandemic influenza vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00491985

GPA04

Details and patient eligibility

About

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

Enrollment: 240 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

Study Group 1

Experimental group

Description:

Subjects aged 9 to 17 years

Treatment:

Biological: A/H5N1 Inactivated, split-virion pandemic influenza vaccine

Study Group 2

Experimental group

Description:

Subjects aged 3 to 8 years

Treatment:

Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine

Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine

Study Group 3

Experimental group

Description:

Subjects aged 6 to 35 months

Treatment:

Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine

Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine