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

April 16, 2009
January 10, 2014
April 2009
March 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00884182 on ClinicalTrials.gov Archive Site
To provide information concerning the immunogenicity of Split Virion Pandemic Influenza vaccine. [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Children
Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in European Children

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Influenza
  • Orthomyxoviridae Infections
  • Orthomyxovirus Infections
Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine
0.5 mL, Intramuscular
  • Experimental: Group 1
    Participants on vaccination schedule 1 (Day 0 and Day 21)
    Intervention: Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine
  • Experimental: Group 2
    Participants on vaccination schedule 2 (Day 0 and Day 14)
    Intervention: Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine
  • Experimental: Group 3
    Participants on vaccination schedule 3 (Day 0 and Day 42)
    Intervention: Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
June 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
6 Months to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00884182
GPA12
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Monitor Sanofi Pasteur Inc.
Sanofi
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP