Status:
COMPLETED
Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
HIV
Cancer
Eligibility:
All Genders
3-21 years
Phase:
PHASE2
Brief Summary
This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or HIV will be vaccinated ...
Detailed Description
The primary objectives of this study are to compare the immune response of Fluzone HD, a high-dose, trivalent influenza vaccine (TIV), to Fluzone, a standard-dose TIV, in children with cancer and in c...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age 3 years (on or past their 3rd birthday) through 21 years of age (not yet reached their 22nd birthday) at the time of entry into the study.
- Written informed consent (and assent, if applicable) obtained.
- Participant has a diagnosis of cancer or HIV.
- If subject has cancer, currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or has received chemotherapy in the past 12 weeks
- Exclusion Criteria
- Severe hypersensitivity to egg proteins or any component of Fluzone, or life-threatening reactions after any previous administration of any influenza vaccine;
- History of Guillain-Barre´ syndrome in the subject or subject's family (parents, siblings, half siblings, or children);
- Not willing to agree to acceptable birth control for three months after study immunization
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01205581
Start Date
September 1 2010
End Date
August 1 2013
Last Update
September 23 2016
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105