Status:
COMPLETED
Sanofi Pasteur, TIV + H1N1, Pediatric Population
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
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 deter...
Detailed Description
Recently, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause of febrile respiratory illnesses in Mexico and the United States. It rapidly spread to many countries around...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
531 Patients enrolled
Trial Details
Trial ID
NCT00943202
Start Date
August 1 2009
End Date
May 1 2010
Last Update
April 22 2013
Active Locations (8)
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1
Emory Children's Center - Pediatric Infectious Diseases
Atlanta, Georgia, United States, 30322
2
Emory University School of Medicine - Emory Children's Center - Pediatric Infectious Diseases
Atlanta, Georgia, United States, 30322
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
Saint Louis University Hospital - Internal Medicine - Infectious Diseases, Allergy & Immunology
St Louis, Missouri, United States, 63110