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

Influenza Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00491985
• Other study ID #: GPA04
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2007
• Last updated: January 10, 2014
• Start date: June 2007
• Est. completion date: June 2010

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Influenza
• Influenza A Virus Infection
• Influenza, Human
• Orthomyxoviridae Infections
• Virus Diseases

Intervention

Biological:
• A/H5N1 Inactivated, split-virion pandemic influenza vaccine
0.5 mL, Intramuscular
• A/H5N1 Inactivated, split virion pandemic influenza vaccine
0.5 mL, Intramuscular
• A/H5N1 Inactivated, split virion pandemic influenza vaccine
0.25 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe safety following administration of A/H5N1 inactivated split virion pandemic influenza vaccine.		21 Days post-vaccination	Yes

External Links

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