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

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.

Time frame: 21 to 42 days after second dose

Population: Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.

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.

Time frame: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose

Population: Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.

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.

Time frame: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose

Population: Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.

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.

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

Population: Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.

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

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

Population: Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.

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.

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.

Time frame: First 14 days after vaccination

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

Population: Adverse events of Fluzone HD and Fluzone are provided as combined data from cancer and HIV patients, since there is no reason to believe one group is more susceptible to adverse events than the other.

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.

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.

Time frame: First 14 days after vaccination

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.

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

Population: Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.

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.

Time frame: at least 21 days after each 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.

Time frame: ALC at baseline and vaccine response at least 21 days after last dose of vaccine

Population: 30 participants did not have ALC data collected at baseline evaluation because they had complete blood count (CBC) ordered without differential count.

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.

Time frame: ALC at baseline and vaccine response at least 21 days after last dose of vaccine

Population: 30 participants did not have ALC data collected at baseline evaluation because they had complete blood count (CBC) ordered without differential count.