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

NCT01205581 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2016-09-23

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

Conditions

Interventions

BIOLOGICAL

Fluzone High Dose Vaccine

Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.

BIOLOGICAL

Fluzone Standard Dose Vaccine

Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.

Sponsors & Collaborators

Principal Investigators

  • Jonathan A McCullers, MD · St. Jude Children's Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01205581 on ClinicalTrials.gov