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

September 17, 2010
June 13, 2013
September 2010
August 2013   (final data collection date for primary outcome measure)
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.
This study will measure Fluzone HD, a high-dose, trivalent influenza vaccine (TIV), to Fluzone, a standard-dose TIV [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Two doses of either Fluzone HD or Fluzone will be administered to children with cancer or HIV.
Complete list of historical versions of study NCT01205581 on ClinicalTrials.gov Archive Site
  • 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.
  • Reactogenicity will be assessed using a pre-specified set of criteria to include both local and systemic reactions to the vaccine. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The immunogenicity of 1 vs. 2 doses will be assessed by determining the rate of sero-conversion using the hemagglutinin-inhibition assay. [ Time Frame: 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • Cancer
Biological: Fluzone High Dose Vaccine Vs Fluzone
Two doses of either Fluzone HD or Fluzone will be administered to children with cancer or HIV.
  • 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.
    Intervention: Biological: Fluzone High Dose Vaccine Vs Fluzone
  • 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
    Intervention: Biological: Fluzone High Dose Vaccine Vs Fluzone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
280
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
3 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01205581
FLUHD
No
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
Not Provided
Principal Investigator: Jonathan A McCullers, MD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP