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

• ClinicalTrials.gov Identifier: NCT00491985
• Recruitment Status: Completed
• First Posted: June 27, 2007
• Last Update Posted: January 14, 2014
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

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	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Study Start Date: June 2007
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: June 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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Thailand

Bangkok, Thailand

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Monitor; Sanofi Pasteur Inc

More Information

Additional Information:

Related Info 

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chotpitayasunondh T, Thisyakorn U, Pancharoen C, Pepin S, Nougarede N. Safety, humoral and cell mediated immune responses to two formulations of an inactivated, split-virion influenza A/H5N1 vaccine in children. PLoS One. 2008;3(12):e4028. doi: 10.1371/journal.pone.0004028. Epub 2008 Dec 29.

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT00491985
• Other Study ID Numbers: GPA04
• First Posted: June 27, 2007
• Last Update Posted: January 14, 2014
• Last Verified: January 2014

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Influenza A/H5N1 Virus; Influenza Pandemic; Orthomyxoviridae Infections

Additional relevant MeSH terms:

Infection; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs