Sanofi Pasteur, TIV + H1N1, Pediatric Population

Completed · Phase 2

Conditions studied: Influenza

In brief

The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study will help determine how and when the H1N1 flu shot should be given with the seasonal flu shot to make it most effective. The 650 participants will be divided into the following age groups: infants from 6 months-36 months old, children 36 months-9 years old, and adolescents 10-17 years old. Each age group will have 200 children. There are 4 treatment groups in each age level. Study procedures include: medical history, targeted physical exam based on history, maintaining a memory aid, and blood sample collection. Participants will be involved in the study for about 8 months.

Key facts

Study ID

NCT00943202

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

531

Starts

2009-08-01

Expected to finish

2010-05-01

Last updated by the study team

2013-04-22

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Are males or non-pregnant females aged 6 months to 17 years, inclusive.
• All subjects 6 months to 9 years must be "primed".
• Subjects of child-bearing potential must agree to practice adequate contraception that may include, but is not limited to, abstinence, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods during the study for at least 30 days following the last vaccination.
• The subject must be in good health, as determined by axillary (<10 years of age) or oral temperature (axillary temperature <100 degrees Fahrenheit or oral temperature <101 degrees Fahrenheit), medical history, and targeted physical examination based on medical history.
• Subject and/or parent(s)/legal guardian(s) must be willing and able to comply with planned study procedures and be available for all study visits.
• Subject and/or parent(s)/legal guardian(s) must provide written informed consent prior to initiation of any study procedures, and subject may provide written assent as appropriate.

You may not qualify if…

• Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, thimerosal and chicken protein).
• Have a positive urine or serum pregnancy test within 24 hours prior to vaccination or are breastfeeding.
• Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
• Have an active neoplastic disease or a history of any hematologic malignancy.
• Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.)
• Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis or major depression.
• Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others.
• Are receiving any psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate) or any drugs for treatment of depression.
• Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
• Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during the study period (prior to Day 180 after the last vaccination).
• Have received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following the last vaccination. This is inclusive of routine childhood immunizations provided outside the scope of this study. The initiation of this protocol does not take precedence over routine immunizations.
• Has received a licensed 2009-2010 seasonal influenza vaccine.
• Have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, or would interfere with the evaluation of responses.
• Have a history of severe reactions following previous immunization with influenza virus vaccines.
• Have an acute illness, including an axillary temperature greater than 100 degrees Fahrenheit or an oral temperature greater than or equal to 101 degrees Fahrenheit, within 3 days prior to vaccination.
• Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
• Participated in a novel influenza H1N1 2009 vaccine study in the past two years or have a history of novel influenza H1N1 2009 infection prior to enrollment.
• Have known active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection.
• Have a history of alcohol or drug abuse.
• Plan to travel outside of North America in the time between the first vaccination and 63 days following the first vaccination.
• Have a history of Guillain-Barré Syndrome.
• Have any condition that the investigator believes may interfere with successful completion of the study.

Where it is running

• Emory Children's Center - Pediatric Infectious Diseases — Atlanta, Georgia, United States
• Emory University School of Medicine - Emory Children's Center - Pediatric Infectious Diseases — Atlanta, Georgia, United States
• University of Iowa — Iowa City, Iowa, United States
• Saint Louis University Hospital - Internal Medicine - Infectious Diseases, Allergy & Immunology — St Louis, Missouri, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center — Nashville, Tennessee, United States
• The University of Texas Medical Branch — Galveston, Texas, United States
• Baylor College of Medicine — Houston, Texas, 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.