A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years

Completed · Phase 2 · Has a placebo group

Conditions studied: Influenza, Swine-origin A/H1N1 Influenza

In brief

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children. Primary Objectives: * To describe the immunogenicity of the candidate vaccines after each injection. * To describe the safety of the candidate vaccines after each injection.

Key facts

Study ID

NCT00952419

Run by

Sanofi Pasteur, a Sanofi Company

People needed

474

Starts

2009-08-01

Expected to finish

2010-06-01

Last updated by the study team

2016-04-14

Who can join

Age: 1 and older, up to 9. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All subjects:
• 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

You may not qualify if…

• 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 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

Where it is running

• Study site — Miami Beach, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Woodstock, Georgia, United States
• Study site — Crestview Hills, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Maddisonville, Kentucky, United States
• Study site — Metairie, Louisiana, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Rochester, New York, United States
• Study site — Hermitage, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Cranston, Rhode Island, United States
• Study site — Barnwell, South Carolina, United States
• Study site — Austin, Texas, United States
• Study site — Fort Worth, Texas, United States
• Study site — San Angelo, Texas, United States
• Study site — Orem, Utah, United States
• Study site — South Jordan, Utah, United States
• Study site — Springville, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.