Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Children
Study Details
Study Description
Brief Summary
This study is part of an effort to develop an effective vaccination program in children in the event of a pandemic.
Study objectives:
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To describe the safety profiles in the periods following each vaccination in subjects receiving different vaccination schedule.
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To describe the immune response after each vaccination in subjects receiving study vaccine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Study participants will receive two administrations of the investigational vaccine at one of 3 vaccination schedules.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- To provide information concerning the safety of the Split Virion Pandemic Influenza vaccine. [21 days post-vaccination and entire study]
Secondary Outcome Measures
- To provide information concerning the immunogenicity of Split Virion Pandemic Influenza vaccine. [21 days post-vaccination]
Eligibility Criteria
Criteria
Inclusion Criteria :
All Subjects
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Subject and parent(s)/legal representative able to attend all scheduled visits and to comply with all trial procedures.
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Completion of vaccination according to the national immunization schedule
Subjects Aged ≥ 2 Years to < 18 Years:
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Aged ≥ 2 years to < 18 years on the day of inclusion.
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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.
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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:
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Aged ≥ 6 months to < 2 years on the day of inclusion.
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Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg.
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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
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Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding trial vaccination
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Planned participation in another clinical trial during the present trial period
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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
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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
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Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
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Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
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Receipt of Blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
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Receipt of any vaccine in the 4 weeks preceding trial vaccination
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Planned receipt of any vaccine in the 4 weeks following any trial vaccination
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(Known) Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen or Hepatitis C seropositivity
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Previous vaccination against avian influenza with either the trial vaccine or another vaccine
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Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
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Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
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Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
Subjects Aged ≥2 Years to <18 Years:
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For a female of child-bearing potential, known pregnancy or positive urine pregnancy test
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Breast-feeding female
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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:
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History of seizures
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Febrile illness (temperature ≥ 38 °C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Espoo | Finland | FIN-02100 | ||
| 2 | Helsinki | Finland | FIN-00100 | ||
| 3 | Helsinki | Finland | FIN-00930 | ||
| 4 | Järvenpää | Finland | FIN-04400 | ||
| 5 | Kuopio | Finland | FIN-70100 | ||
| 6 | Lahti | Finland | FIN-15140 | ||
| 7 | Oulu | Finland | FIN-90220 | ||
| 8 | Pori | Finland | FIN-28100 | ||
| 9 | Tampere | Finland | FIN-33014 | ||
| 10 | Tampere | Finland | FIN-33100 | ||
| 11 | Turku | Finland | FIN-20520 | ||
| 12 | Vantaa | Finland | FIN-01300 | ||
| 13 | Vantaa | Finland | FIN-01600 |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Monitor, Sanofi Pasteur Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- GPA12