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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01205581
First received: September 17, 2010
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
HIV
Cancer
Biological: Fluzone High Dose Vaccine Vs Fluzone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Rate of sero-conversion [ Time Frame: 2 months after initial vaccine ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of participants reporting grade 3 and grade 4 adverse events [ Time Frame: 2 months after intial vaccine ] [ Designated as safety issue: Yes ]
    Number of participants reporting grade 3 and grade 4 adverse events possibly, probably, or definitely attributable to Fluzone or Fluzone HD.

  • Rate of sero-conversion for 1 dose vs. 2 doses of Fluzone HD [ Time Frame: 2 months after initial vaccine ] [ Designated as safety issue: No ]
    The rate of seroconversion to the 3 antigens contained in the vaccine will be determined by hemagglutination-inhibition test and will be compared by disease.

  • Relationship between absolute lymphocyte count (ALC) and vaccine response by seroconversion rate [ Time Frame: ALC at baseline and vaccine response at 2 years ] [ Designated as safety issue: No ]
    The relationship between baseline lymphocyte numbers/function and robustness/durability of the immune response will be described through descriptive analysis of relationships between pre-defined variables.

  • Number of participants reporting serious adverse events [ Time Frame: 8 months after initial vaccine ] [ Designated as safety issue: Yes ]
    Number of participants reporting a Serious Adverse Event definitely attributable to Fluzone or Fluzone HD.

  • Number of participants reporting local reactogenicity events [ Time Frame: 2 months after initial vaccine ] [ Designated as safety issue: Yes ]
    Number of participants reporting a moderate or greater local reactogenicity event associated with the administration of Fluzone or FluzoneHD.

  • Number of participants reporting systemic reactogenicity events [ Time Frame: 2 months after initial vaccine ] [ Designated as safety issue: Yes ]
    Number of participants reporting a moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD.


Estimated Enrollment: 280
Study Start Date: September 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cancer participants
Subjects will be vaccinated twice with one of the two vaccines (Fluzone High Dose Vaccine Vs Fluzone) and evaluated for development of immune responses.
Biological: Fluzone High Dose Vaccine Vs Fluzone
Two doses of either Fluzone HD or Fluzone will be administered to children with cancer or HIV.
HIV Participants
Subjects will be vaccinated twice with one of the two vaccines (Fluzone High Dose Vaccine Vs Fluzone) and evaluated for development of immune responses
Biological: Fluzone High Dose Vaccine Vs Fluzone
Two doses of either Fluzone HD or Fluzone will be administered to children with cancer or HIV.

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

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205581

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Jonathan A McCullers, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01205581     History of Changes
Other Study ID Numbers: FLUHD
Study First Received: September 17, 2010
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Fluzone
Trivalent Influenza Vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014