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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Infection
Communicable Diseases
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014