Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Children
January 10, 2014 updated by: Sanofi Pasteur, a Sanofi Company
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 Overview
Status
Completed
Intervention / Treatment
Detailed Description
Study participants will receive two administrations of the investigational vaccine at one of 3 vaccination schedules.
Study Type
Interventional
Enrollment (Actual)
350
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Espoo, Finland, FIN-02100
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Helsinki, Finland, FIN-00100
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Helsinki, Finland, FIN-00930
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Järvenpää, Finland, FIN-04400
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Kuopio, Finland, FIN-70100
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Lahti, Finland, FIN-15140
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Oulu, Finland, FIN-90220
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Pori, Finland, FIN-28100
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Tampere, Finland, FIN-33014
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Tampere, Finland, FIN-33100
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Turku, Finland, FIN-20520
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Vantaa, Finland, FIN-01300
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Vantaa, Finland, FIN-01600
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group 1
Participants on vaccination schedule 1 (Day 0 and Day 21)
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0.5 mL, Intramuscular
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Experimental: Group 2
Participants on vaccination schedule 2 (Day 0 and Day 14)
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0.5 mL, Intramuscular
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Experimental: Group 3
Participants on vaccination schedule 3 (Day 0 and Day 42)
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0.5 mL, Intramuscular
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To provide information concerning the safety of the Split Virion Pandemic Influenza vaccine.
Time Frame: 21 days post-vaccination and entire study
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21 days post-vaccination and entire study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To provide information concerning the immunogenicity of Split Virion Pandemic Influenza vaccine.
Time Frame: 21 days post-vaccination
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21 days post-vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
April 16, 2009
First Submitted That Met QC Criteria
April 17, 2009
First Posted (Estimate)
April 20, 2009
Study Record Updates
Last Update Posted (Estimate)
January 14, 2014
Last Update Submitted That Met QC Criteria
January 10, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GPA12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.