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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01205581
First received: September 17, 2010
Last updated: September 5, 2014
Last verified: July 2014

September 17, 2010
September 5, 2014
September 2010
August 2013   (final data collection date for primary outcome measure)
  • Rate of Seroconversion After 1 Dose of Vaccine [ Time Frame: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose ] [ Designated as safety issue: No ]
    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.
  • Rate of Seroprotection After 1 Dose of Vaccine [ Time Frame: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose ] [ Designated as safety issue: No ]
    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.
  • Rate of Seroprotection After Last Dose of Vaccine [ Time Frame: 21 to 42 days after last dose ] [ Designated as safety issue: No ]
    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.
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 Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD [ Time Frame: From initial vaccine administration through up to 8 months ] [ 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: at least 21 days after each dose of vaccine ] [ Designated as safety issue: No ]

    The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease.

    The immune response of 1 dose vs. 2 doses of Fluzone HD 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.

  • Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD [ Time Frame: at least 21 days after each dose of vaccine ] [ Designated as safety issue: No ]

    The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease.

    The immune response of 1 dose vs. 2 doses of Fluzone SD 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.

  • Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC) [ Time Frame: ALC at baseline and vaccine response at least 21 days after last dose of vaccine ] [ Designated as safety issue: No ]
    The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables.
  • Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC) [ Time Frame: ALC at baseline and vaccine response at least 21 days after last dose of vaccine ] [ Designated as safety issue: No ]
    The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables.
  • Number of Local Reactogenicity Events After First Dose [ Time Frame: First 14 days after vaccination ] [ Designated as safety issue: Yes ]
    Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration.
  • Number of Local Reactogenicity Events After Second Dose [ Time Frame: First 14 days after vaccination ] [ Designated as safety issue: Yes ]
    Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration.
  • Number of Systemic Reactogenicity Events After First Dose [ Time Frame: First 14 days after vaccination ] [ Designated as safety issue: Yes ]
    Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever.
  • Number of Systemic Reactogenicity Events After Second Dose [ Time Frame: First 14 days after vaccination ] [ Designated as safety issue: Yes ]
    Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever.
  • Comparison of Geometric Mean Titer (GMT) by HAI [ Time Frame: Pre-vaccination, post-vaccination and 9 months after vaccination ] [ Designated as safety issue: No ]
    Serum antibody levels expressed as the reciprocal of the dilution needed to inhibit hemagglutination in vitro.
  • Comparison of Geometric Mean Ratios (GMR) by HAI [ Time Frame: Pre-vaccination, post-vaccination and 9 months after vaccination ] [ Designated as safety issue: No ]

    GMTs compared to each other as a ratio of the pre- and post-vaccine titers and as the ratio post-last dose to 9 months later.

    GMRs were compared pre- to post-vaccination and post- vaccination to 9 months later.

  • 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
    Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.
    Other Name: Fluzone-HD
  • Biological: Fluzone Standard Dose Vaccine
    Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.
    Other Name: Fluzone-SD
  • Active Comparator: Leukemia-HD
    Subjects with a diagnosis of leukemia will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses.
    Intervention: Biological: Fluzone High Dose Vaccine
  • Active Comparator: Leukemia-SD
    Subjects with a diagnosis of leukemia will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses.
    Intervention: Biological: Fluzone Standard Dose Vaccine
  • Active Comparator: Solid Tumor-HD
    Subjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses.
    Intervention: Biological: Fluzone High Dose Vaccine
  • Active Comparator: Solid Tumor-SD
    Subjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses.
    Intervention: Biological: Fluzone Standard Dose Vaccine
  • Active Comparator: HIV-HD
    Subjects with a diagnosis of human immunodeficiency virus (HIV) will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses.
    Intervention: Biological: Fluzone High Dose Vaccine
  • Active Comparator: HIV-SD
    Subjects with a diagnosis of human immunodeficiency virus (HIV) will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses.
    Intervention: Biological: Fluzone Standard Dose Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
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
July 2014

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