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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00491985
• Date of registration: 26/06/2007
• Primary sponsor: Sanofi-Aventis
• Public title: Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children
• Date of first enrolment: June 2007
• Target sample size: 240
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00491985
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

Thailand

Contacts

• Name: Medical Monitor
• Affiliation: Sanofi Pasteur Inc

Key inclusion & 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.



Age minimum: 6 Months
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza

Influenza A Virus Infection

Orthomyxoviridae Infections

Intervention(s)

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

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

Primary Outcome(s)

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

Secondary ID(s)

GPA04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors