Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
1 other identifier
interventional
85
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 17, 2010
CompletedFirst Posted
Study publicly available on registry
September 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
September 12, 2014
CompletedSeptember 23, 2016
July 1, 2016
2.9 years
September 17, 2010
July 24, 2014
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Rate of Seroconversion After 1 Dose of Vaccine
The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was \<10, or a 4-fold rise in HAI titer if the baseline ≥10.
at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose
Rate of Seroprotection After 1 Dose of Vaccine
The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.
at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose
Number of Participants Achieving Seroprotection After Second Dose of Vaccine
The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.
21 to 42 days after second dose
Secondary Outcomes (11)
Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD
From initial vaccine administration through up to 8 months
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD
at least 21 days after each dose of vaccine
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD
at least 21 days after each dose of vaccine
Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)
ALC at baseline and vaccine response at least 21 days after last dose of vaccine
Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)
ALC at baseline and vaccine response at least 21 days after last dose of vaccine
- +6 more secondary outcomes
Study Arms (6)
Leukemia-HD
ACTIVE COMPARATORSubjects with a diagnosis of leukemia will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses.
Leukemia-SD
ACTIVE COMPARATORSubjects with a diagnosis of leukemia will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses.
Solid Tumor-HD
ACTIVE COMPARATORSubjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses.
Solid Tumor-SD
ACTIVE COMPARATORSubjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses.
HIV-HD
ACTIVE COMPARATORSubjects with a diagnosis of human immunodeficiency virus (HIV) will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses.
HIV-SD
ACTIVE COMPARATORSubjects with a diagnosis of human immunodeficiency virus (HIV) will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses.
Interventions
Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.
Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jon McCullers, MD
- Organization
- St. Jude Children's Research Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan A McCullers, MD
St. Jude Children's Research Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2010
First Posted
September 20, 2010
Study Start
September 1, 2010
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
September 23, 2016
Results First Posted
September 12, 2014
Record last verified: 2016-07