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


Phase 2
3 Years
21 Years
Open (Enrolling)
Both
HIV, Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of sero-conversion

Outcome Description:

Compare the immune responses of Fluzone HD to Fluzone in children with cancer or HIV. This is an open label, randomized study in two groups of patients.

Outcome Time Frame:

2 months after initial vaccine

Safety Issue:

No

Principal Investigator

Jonathan A McCullers, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Food and Drug Administration

Study ID:

FLUHD

NCT ID:

NCT01205581

Start Date:

September 2010

Completion Date:

August 2013

Related Keywords:

  • HIV
  • Cancer
  • Fluzone
  • Trivalent Influenza Vaccine
  • Influenza, Human

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794