Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV

Completed · Phase 2

Conditions studied: HIV, Cancer

In brief

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 twice with one of the two vaccines and evaluated for development of immune responses.

Key facts

Study ID

NCT01205581

Run by

St. Jude Children's Research Hospital

People needed

85

Starts

2010-09-01

Expected to finish

2013-08-01

Last updated by the study team

2016-09-23

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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