Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
Information source: St. Jude Children's Research Hospital
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV; Cancer
Intervention: Fluzone High Dose Vaccine Vs Fluzone (Biological)
Phase: Phase 2
Status: Recruiting
Sponsored by: St. Jude Children's Research Hospital Official(s) and/or principal investigator(s):
Jonathan A McCullers, MD, Principal Investigator, Affiliation: St. Jude Children's Research Hospital
Overall contact:
Jonathan A McCullers, MD, Phone: 1-866-278-5833, Email: info@stjude.org
Summary
This is a 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.
Clinical Details
Official title: Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Rate of sero-conversion
Secondary outcome: Number of participants reporting grade 3 and grade 4 adverse eventsRate of sero-conversion for 1 dose vs. 2 doses of Fluzone HD Relationship between absolute lymphocyte count (ALC) and vaccine response by seroconversion rate Number of participants reporting serious adverse events Number of participants reporting local reactogenicity events Number of participants reporting systemic reactogenicity events
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.
Eligibility
Minimum age: 3 Years.
Maximum age: 21 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Jonathan A McCullers, MD, Phone: 1-866-278-5833, Email: info@stjude.org
St. Jude Children's Research Hospital, Memphis, Tennessee 38105, United States; Recruiting
Jonathan A McCullers, MD, Phone: 866-278-5833, Email: info@stjude.org
Jonathan A McCullers, MD, Principal Investigator
Additional Information
St. Jude Children's Research Hospital
Starting date: September 2010
Last updated: October 4, 2011
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