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

Sponsor

Sanofi Pasteur, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00491985

Collaborator

(none)

240

Enrollment

Location

Arms

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	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 Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

To describe safety following administration of A/H5N1 inactivated split virion pandemic influenza vaccine. [21 Days post-vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 18 Years

Sexes Eligible for Study:

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).