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

NCT00491985 | Completed Phase 2

• 1 other identifier: GPA04
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Conditions

Influenza; Orthomyxoviridae Infections; Influenza A Virus Infection

Keywords

Influenza A/H5N1 Virus; Influenza Pandemic; Orthomyxoviridae Infections

Outcome Measures

Primary Outcomes (1)

• To describe safety following administration of A/H5N1 inactivated split virion pandemic influenza vaccine.

  21 Days post-vaccination

Study Arms (3)

Study Group 1

EXPERIMENTAL

Subjects aged 9 to 17 years

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

Study Group 2

EXPERIMENTAL

Subjects aged 3 to 8 years

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

Study Group 3

EXPERIMENTAL

Subjects aged 6 to 35 months

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

Interventions

A/H5N1 Inactivated, split-virion pandemic influenza vaccine BIOLOGICAL

0.5 mL, Intramuscular

Study Group 1

A/H5N1 Inactivated, split virion pandemic influenza vaccine BIOLOGICAL

0.5 mL, Intramuscular

Study Group 2

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All subjects:
• Able to attend all scheduled visits and to comply with all trial procedures.
• Children/Adolescents aged ≥ 2 years to \< 18 years:
• 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:
• 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.

You may not qualify if:

• 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.
• Children/Adolescents aged ≥ 2 years to \< 18 years:

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Bangkok, Thailand

Location

Related Publications (1)

• 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.

  PMID: 19112513 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human; Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Medical Monitor

  Sanofi Pasteur Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 27, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2010
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

TH (1)