Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00884182
First received: April 16, 2009
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

This study is part of an effort to develop an effective vaccination program in children in the event of a pandemic.

Study objectives:

  • To describe the safety profiles in the periods following each vaccination in subjects receiving different vaccination schedule.
  • To describe the immune response after each vaccination in subjects receiving study vaccine.

Condition Intervention Phase
Influenza
Orthomyxoviridae Infections
Orthomyxovirus Infections
Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in European Children

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the safety of the Split Virion Pandemic Influenza vaccine. [ Time Frame: 21 days post-vaccination and entire study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To provide information concerning the immunogenicity of Split Virion Pandemic Influenza vaccine. [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 350
Study Start Date: April 2009
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Participants on vaccination schedule 1 (Day 0 and Day 21)
Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine
0.5 mL, Intramuscular
Experimental: Group 2
Participants on vaccination schedule 2 (Day 0 and Day 14)
Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine
0.5 mL, Intramuscular
Experimental: Group 3
Participants on vaccination schedule 3 (Day 0 and Day 42)
Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine
0.5 mL, Intramuscular

Detailed Description:

Study participants will receive two administrations of the investigational vaccine at one of 3 vaccination schedules.

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

All Subjects

  • Subject and parent(s)/legal representative able to attend all scheduled visits and to comply with all trial procedures.
  • Completion of vaccination according to the national immunization schedule

Subjects Aged ≥ 2 Years to < 18 Years:

  • Aged ≥ 2 years to < 18 years on the day of inclusion.
  • Provision of Informed Consent Form signed by the subject's the parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 8 to 11 years, and of Informed Consent Form signed by subjects ≥ 12 years.
  • For a female of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination.

Subjects 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 ≥ 2.5 kg.
  • Provision of Informed Consent Form signed by the parent(s) or other legal representative (and by an independent witness if required by local regulations).

Exclusion Criteria :

All subjects

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
  • Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
  • Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
  • Receipt of Blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
  • Receipt of any vaccine in the 4 weeks preceding trial vaccination
  • Planned receipt of any vaccine in the 4 weeks following any trial vaccination
  • (Known) Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen or Hepatitis C seropositivity
  • Previous vaccination against avian influenza with either the trial vaccine or another vaccine
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
  • Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  • Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw

Subjects Aged ≥2 Years to <18 Years:

  • For a female of child-bearing potential, known pregnancy or positive urine pregnancy test
  • Breast-feeding female
  • Febrile illness (temperature ≥ 37.5 °C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment

Subjects Aged ≥ 6 Months to < 2 Years:

  • History of seizures
  • Febrile illness (temperature ≥ 38 °C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884182

Locations
Finland
Espoo, Finland, FIN-02100
Helsinki, Finland, FIN-00100
Helsinki, Finland, FIN-00930
Järvenpää, Finland, FIN-04400
Kuopio, Finland, FIN-70100
Lahti, Finland, FIN-15140
Oulu, Finland, FIN-90220
Pori, Finland, FIN-28100
Tampere, Finland, FIN-33014
Tampere, Finland, FIN-33100
Turku, Finland, FIN-20520
Vantaa, Finland, FIN-01600
Vantaa, Finland, FIN-01300
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00884182     History of Changes
Other Study ID Numbers: GPA12
Study First Received: April 16, 2009
Last Updated: January 10, 2014
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Sanofi:
Influenza
Orthomyxoviruses
Split Virion Pandemic Influenza Vaccine
A/H5N1

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014