A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years
NCT ID: NCT00952419
Last Updated: 2016-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
474 participants
INTERVENTIONAL
2009-08-31
2010-06-30
Brief Summary
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Primary Objectives:
* To describe the immunogenicity of the candidate vaccines after each injection.
* To describe the safety of the candidate vaccines after each injection.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1
Monovalent Subvirion A/H1N1 Influenza vaccine
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)
A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2
Monovalent Subvirion A/H1N1 Influenza vaccine
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
Placebo Group
Participants will receive a placebo vaccine
Normal saline solution (placebo)
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
Interventions
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Monovalent Subvirion A/H1N1 Influenza vaccine
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)
Monovalent Subvirion A/H1N1 Influenza vaccine
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
Normal saline solution (placebo)
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
Eligibility Criteria
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Inclusion Criteria
* Provision of Informed Consent Form signed by the subject's parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 7 to 9 years
* Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
Subjects aged 3 to 9 years:
* Healthy children aged 3 to 9 years on the day of inclusion
Subjects aged 6 to 35 months:
* Healthy infants and toddlers aged 6 to 35 months on the day of inclusion
* Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
Exclusion Criteria
* Planned participation in another clinical trial during the present trial period
* Receipt of any vaccine in the 4 weeks preceding the 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)
* Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C
* 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
* Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination
* Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Chronic illness that in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
* Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
* Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
* Personal or family history of Guillain-Barré syndrome
* Active neoplastic disease or a history of any hematologic malignancy
* Known seizure/epilepsy history and/or taking anti-seizure medication
* Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study
* Febrile illness (temperature ≥ 100.4°F \[≥ 38.0°C\]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
6 Months
9 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Miami Beach, Florida, United States
Marietta, Georgia, United States
Woodstock, Georgia, United States
Crestview Hills, Kentucky, United States
Louisville, Kentucky, United States
Maddisonville, Kentucky, United States
Metairie, Louisiana, United States
Las Vegas, Nevada, United States
Rochester, New York, United States
Hermitage, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Cranston, Rhode Island, United States
Barnwell, South Carolina, United States
Austin, Texas, United States
Fort Worth, Texas, United States
San Angelo, Texas, United States
Orem, Utah, United States
South Jordan, Utah, United States
Springville, Utah, United States
Countries
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References
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Plennevaux E, Blatter M, Cornish MJ, Go K, Kirby D, Wali M, Reeves-Hoche MK, Denis M. Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial. Vaccine. 2011 Feb 11;29(8):1569-75. doi: 10.1016/j.vaccine.2010.12.116. Epub 2011 Jan 8.
Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche MK, Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet. 2010 Jan 2;375(9708):41-8. doi: 10.1016/S0140-6736(09)62026-2. Epub 2009 Dec 15.
Related Links
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Related Info
Other Identifiers
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UTN: U1111-1111-4713
Identifier Type: -
Identifier Source: secondary_id
FUF15
Identifier Type: -
Identifier Source: org_study_id
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