Status:
COMPLETED
A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy Europeans Children Aged 6 to 35 Months
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza
Swine-origin A/H1N1 Influenza
Eligibility:
All Genders
6-35 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration. Primary objectives: * To describe the immune...
Detailed Description
All participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively. A subset of the participants eligible who received two half-doses of either formulation 1 o...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- All subjects
- Aged 6 to 35 months on the day of inclusion
- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
- Subject and parent/legal representative are able to attend all scheduled visits and to comply with all trial procedures
- Completion of vaccination according to the national immunization schedule.
- Subjects ≥ 6 to \< 24 months of age - Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
- At Month 8 for antibody persistence assessment:
- Having received two half-doses of either the formulation 1 or 2 of the vaccine
- Addendum 1 to Informed Consent Form has been signed and dated by the parents or other legally acceptable representative.
- At Visit 06, for subjects eligible for the Antibody persistence evaluation who will receive the Trivalent Influenza Vaccine (TIV):
- \- Addendum 2 to Informed Consent Form has been signed by the subject's parents/legal representative.
- Exclusion Criteria :
- All subjects
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- Planned receipt of any vaccine prior to the Day 42 blood sample
- Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
- 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 corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B antigen, or Hepatitis C as reported by parents/legal representative
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- Thrombocytopenia contraindicating intramuscular (IM) vaccination as reported by parents/legal representative
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
- Chronic illness that in the opinion of the Investigator is at a stage where it might interfere with trial conduct or completion
- Family members of the employees or the Investigator
- Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
- Confirmed infection with the swine-origin A/H1N1 influenza strain (different from the seasonal strain) in 2009
- Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
- Receipt of any allergy shots and/or seasonal allergy medication in the 7-day period prior to enrollment (vaccination), or scheduled to receive any allergy shots and/or seasonal allergy medication in the 7-day period after enrollment (vaccination)
- Subjects ≥ 6 to \< 24 months of age - History of seizures
- At Month 8, for antibody persistence assessment:
- \- Subjects who received, in the context of a pandemic immunization program, another A/H1N1 pandemic influenza vaccine than the Investigational Medicinal Products.
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT00956046
Start Date
September 1 2009
End Date
June 1 2011
Last Update
January 14 2014
Active Locations (15)
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1
Espoo, Finland, FIN-02100
2
Helsinki, Finland, FIN-00100
3
Helsinki, Finland, FIN-00930
4
Jarvenpaa, Finland, FIN-04400