Clinical trial NCT01205581: Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
Official title: Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Cancer
Keywords: Fluzone
Trivalent Influenza Vaccine
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2010-09-20
Enrollment: 85
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Rate of Seroconversion After 1 Dose of Vaccine
timeFrame: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose
measure: Rate of Seroprotection After 1 Dose of Vaccine
timeFrame: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose
measure: Number of Participants Achieving Seroprotection After Second Dose of Vaccine
timeFrame: 21 to 42 days after second dose
Secondary outcomes:
measure: Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD
timeFrame: From initial vaccine administration through up to 8 months
measure: Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD
timeFrame: at least 21 days after each dose of vaccine
measure: Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD
timeFrame: at least 21 days after each dose of vaccine
measure: Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)
timeFrame: ALC at baseline and vaccine response at least 21 days after last dose of vaccine
measure: Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)
timeFrame: ALC at baseline and vaccine response at least 21 days after last dose of vaccine
measure: Number of Local Reactogenicity Events After First Dose
timeFrame: First 14 days after vaccination
measure: Number of Local Reactogenicity Events After Second Dose
timeFrame: First 14 days after vaccination
measure: Number of Systemic Reactogenicity Events After First Dose
timeFrame: First 14 days after vaccination
measure: Number of Systemic Reactogenicity Events After Second Dose
timeFrame: First 14 days after vaccination
measure: Comparison of Geometric Mean Titer (GMT) by HAI
timeFrame: Pre-vaccination, post-vaccination and 9 months after vaccination
measure: Comparison of Geometric Mean Ratios (GMR) by HAI
timeFrame: Pre-vaccination, post-vaccination and 9 months after vaccination
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Jonathan A McCullers, MD
role: PRINCIPAL_INVESTIGATOR
References: