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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Influenza Orthomyxoviridae Infections Influenza A Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study Group 1

Subjects aged 9 to 17 years

Group Type EXPERIMENTAL

A/H5N1 Inactivated, split-virion pandemic influenza vaccine

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Study Group 2

Subjects aged 3 to 8 years

Group Type EXPERIMENTAL

A/H5N1 Inactivated, split virion pandemic influenza vaccine

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Study Group 3

Subjects aged 6 to 35 months

Group Type EXPERIMENTAL

A/H5N1 Inactivated, split virion pandemic influenza vaccine

Intervention Type BIOLOGICAL

0.25 mL, Intramuscular

Interventions

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A/H5N1 Inactivated, split-virion pandemic influenza vaccine

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

A/H5N1 Inactivated, split virion pandemic influenza vaccine

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

A/H5N1 Inactivated, split virion pandemic influenza vaccine

0.25 mL, Intramuscular

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes