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OpenTrials
Completed

NCT Number: NCT01205581

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.

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Key information

Conditions

HIV Cancer Infections Influenza, Human Neoplasms Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

3 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluzone High Dose Vaccine

Biological

Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.

Other names: Fluzone-HD

Fluzone Standard Dose Vaccine

Biological

Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.

Other names: Fluzone-SD

Primary outcomes

  1. 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

    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.

  2. 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

    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.

  3. Number of Participants Achieving Seroprotection After Second Dose of Vaccine

    Time frame: 21 to 42 days after second dose

    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.

Secondary outcomes

  1. 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

    Number of participants reporting grade 3 and grade 4 adverse events possibly, probably, or definitely attributable to Fluzone or Fluzone HD.

  2. Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD

    Time frame: at least 21 days after each dose of vaccine

    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.

  3. Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD

    Time frame: at least 21 days after each dose of vaccine

    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.

  4. 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

    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.

  5. 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

    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.

  6. Number of Local Reactogenicity Events After First Dose

    Time frame: First 14 days after vaccination

    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.

  7. Number of Local Reactogenicity Events After Second Dose

    Time frame: First 14 days after vaccination

    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.

  8. Number of Systemic Reactogenicity Events After First Dose

    Time frame: First 14 days after vaccination

    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.

  9. Number of Systemic Reactogenicity Events After Second Dose

    Time frame: First 14 days after vaccination

    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.

  10. Comparison of Geometric Mean Titer (GMT) by HAI

    Time frame: Pre-vaccination, post-vaccination and 9 months after vaccination

    Serum antibody levels expressed as the reciprocal of the dilution needed to inhibit hemagglutination in vitro.

  11. Comparison of Geometric Mean Ratios (GMR) by HAI

    Time frame: Pre-vaccination, post-vaccination and 9 months after vaccination

    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.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 20, 2010
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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