NCT01205581

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 21 Years
• Healthy volunteers: Not accepted

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.

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 children with HIV. The secondary objectives of this study are to: * Describe the safety and reactogenicity of high-dose and standard-dose TIV. * Compare the immunogenicity induced by 1 dose, compared to 2 doses, of high-dose and standard-dose TIV. * Describe the relationship between baseline lymphocyte numbers/function and robustness/durability of the immune response.

Conditions

• HIV
• Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2010-09-20
• Last updated: 2016-09-23
• Results posted: 2014-09-12

Locations

1 site across 1 country: United States