Trial Outcomes & Findings for Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV (NCT NCT01205581)

NCT ID: NCT01205581

Last Updated: 2016-09-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 85 participants
• Primary outcome timeframe: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose
• Results posted on: 2016-09-23

Participant Flow

Participants were ≥3-21 yrs. at study entry with diagnosis of cancer or HIV. Those with cancer were receiving chemotherapy and/or radiotherapy or had received chemotherapy in the prior 12 weeks. One participant was enrolled but was lost to follow up prior to randomization. 84 participants were randomized between 9/2010 and 10/2011.

Participants excluded if they had: pre-vaccination titer of ≥1:2560, severe hypersensitivity to egg proteins or any component of Fluzone, life-threatening reaction after prior influenza vaccine, history of Guillain-Barre syndrome in subject/subject's family, or unwilling to agree to acceptable birth control for 3 months after each dose.

Participant milestones

Measure	Leukemia-HD Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD Patients with a diagnosis of HIV who received the standard dose Fluzone.
Overall Study STARTED	14	13	8	9	20	20
Overall Study COMPLETED	13	13	8	9	20	20
Overall Study NOT COMPLETED	1	0	0	0	0	0

Reasons for withdrawal

Measure	Leukemia-HD Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD Patients with a diagnosis of HIV who received the standard dose Fluzone.
Overall Study Withdrawal by Subject	1	0	0	0	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Leukemia-HD n=13 Participants Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD n=13 Participants Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD n=8 Participants Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD n=9 Participants Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD n=20 Participants Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD n=20 Participants Patients with a diagnosis of HIV who received the standard dose Fluzone.	Total n=83 Participants Total of all reporting groups
Age, Continuous	10.8 years STANDARD_DEVIATION 5.7 • n=5 Participants	11.8 years STANDARD_DEVIATION 5.1 • n=7 Participants	12.4 years STANDARD_DEVIATION 4.2 • n=5 Participants	11.7 years STANDARD_DEVIATION 4.5 • n=4 Participants	16.7 years STANDARD_DEVIATION 5.6 • n=21 Participants	19.9 years STANDARD_DEVIATION 1.8 • n=8 Participants	14.6 years STANDARD_DEVIATION 5.9 • n=8 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	7 Participants n=21 Participants	4 Participants n=8 Participants	28 Participants n=8 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	13 Participants n=21 Participants	16 Participants n=8 Participants	55 Participants n=8 Participants

PRIMARY outcome

Timeframe: 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. 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.

Outcome measures

Measure	Leukemia-HD n=13 Participants Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD n=13 Participants Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD n=8 Participants Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD n=9 Participants Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD n=18 Participants Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD n=20 Participants Patients with a diagnosis of HIV who received the standard dose Fluzone.
Rate of Seroconversion After 1 Dose of Vaccine H1 antigen	31 percentage of participants	0 percentage of participants	50 percentage of participants	22 percentage of participants	61 percentage of participants	65 percentage of participants
Rate of Seroconversion After 1 Dose of Vaccine H3 antigen	77 percentage of participants	85 percentage of participants	50 percentage of participants	89 percentage of participants	72 percentage of participants	65 percentage of participants
Rate of Seroconversion After 1 Dose of Vaccine B antigen	38 percentage of participants	46 percentage of participants	63 percentage of participants	44 percentage of participants	67 percentage of participants	35 percentage of participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Leukemia-HD n=13 Participants Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD n=13 Participants Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD n=8 Participants Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD n=9 Participants Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD n=18 Participants Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD n=20 Participants Patients with a diagnosis of HIV who received the standard dose Fluzone.
Rate of Seroprotection After 1 Dose of Vaccine H1 antigen	77 Percentage of participants	85 Percentage of participants	75 Percentage of participants	78 Percentage of participants	100 Percentage of participants	100 Percentage of participants
Rate of Seroprotection After 1 Dose of Vaccine H3 antigen	92 Percentage of participants	92 Percentage of participants	75 Percentage of participants	89 Percentage of participants	100 Percentage of participants	100 Percentage of participants
Rate of Seroprotection After 1 Dose of Vaccine B antigen	62 Percentage of participants	85 Percentage of participants	63 Percentage of participants	89 Percentage of participants	100 Percentage of participants	90 Percentage of participants

PRIMARY outcome

Timeframe: 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. Seroprotection was defined as a post-vaccine HAI titer ≥40.

Outcome measures

Measure	Leukemia-HD n=13 Participants Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD n=13 Participants Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD n=8 Participants Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD n=9 Participants Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD n=18 Participants Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD n=20 Participants Patients with a diagnosis of HIV who received the standard dose Fluzone.
Number of Participants Achieving Seroprotection After Second Dose of Vaccine H1 antigen	11 number of participants	12 number of participants	7 number of participants	9 number of participants	18 number of participants	19 number of participants
Number of Participants Achieving Seroprotection After Second Dose of Vaccine H3 antigen	8 number of participants	8 number of participants	7 number of participants	7 number of participants	18 number of participants	19 number of participants
Number of Participants Achieving Seroprotection After Second Dose of Vaccine B antigen	10 number of participants	10 number of participants	6 number of participants	8 number of participants	18 number of participants	19 number of participants

SECONDARY outcome

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

Outcome measures

Measure	Leukemia-HD n=41 Participants Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD n=42 Participants Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD Patients with a diagnosis of HIV who received the standard dose Fluzone.
Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD	1 participants	0 participants	—	—	—	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Leukemia-HD n=13 Participants Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD n=13 Participants Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD n=8 Participants Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD n=8 Participants Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD n=18 Participants Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD n=18 Participants Patients with a diagnosis of HIV who received the standard dose Fluzone.
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD H1 antigen	31 percentage of participants	54 percentage of participants	50 percentage of participants	88 percentage of participants	61 percentage of participants	72 percentage of participants
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD H3 antigen	77 percentage of participants	85 percentage of participants	50 percentage of participants	63 percentage of participants	72 percentage of participants	72 percentage of participants
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD B antigen	38 percentage of participants	85 percentage of participants	63 percentage of participants	75 percentage of participants	67 percentage of participants	78 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Leukemia-HD n=13 Participants Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD n=13 Participants Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD n=9 Participants Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD n=9 Participants Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD n=20 Participants Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD n=20 Participants Patients with a diagnosis of HIV who received the standard dose Fluzone.
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD H1 antigen	0 percentrage of participants	54 percentrage of participants	22 percentrage of participants	67 percentrage of participants	65 percentrage of participants	70 percentrage of participants
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD H3 antigen	85 percentrage of participants	92 percentrage of participants	89 percentrage of participants	89 percentrage of participants	65 percentrage of participants	70 percentrage of participants
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD B antigen	46 percentrage of participants	85 percentrage of participants	44 percentrage of participants	89 percentrage of participants	35 percentrage of participants	75 percentrage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Leukemia-HD n=26 Participants Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD n=28 Participants Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD Patients with a diagnosis of HIV who received the standard dose Fluzone.
Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)	62 percentagae of participants	68 percentagae of participants	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Leukemia-HD n=26 Participants Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD n=28 Participants Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD Patients with a diagnosis of HIV who received the standard dose Fluzone.
Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)	96 percentage of participants	100 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Leukemia-HD n=41 Participants Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD n=42 Participants Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD Patients with a diagnosis of HIV who received the standard dose Fluzone.
Number of Local Reactogenicity Events After First Dose	19 Events	16 Events	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Leukemia-HD n=39 Participants Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD n=40 Participants Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD Patients with a diagnosis of HIV who received the standard dose Fluzone.
Number of Local Reactogenicity Events After Second Dose	11 Events	7 Events	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Leukemia-HD n=41 Participants Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD n=42 Participants Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD Patients with a diagnosis of HIV who received the standard dose Fluzone.
Number of Systemic Reactogenicity Events After First Dose	10 Events	7 Events	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Leukemia-HD n=39 Participants Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD n=40 Participants Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD Patients with a diagnosis of HIV who received the standard dose Fluzone.
Number of Systemic Reactogenicity Events After Second Dose	8 Events	3 Events	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Leukemia-HD n=13 Participants Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD n=13 Participants Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD n=8 Participants Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD n=9 Participants Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD n=18 Participants Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD n=20 Participants Patients with a diagnosis of HIV who received the standard dose Fluzone.
Comparison of Geometric Mean Titer (GMT) by HAI H1 Antigen/Pre-vaccination	29 Titers Interval 17.0 to 49.0	50 Titers Interval 22.0 to 111.0	57 Titers Interval 16.0 to 203.0	40 Titers Interval 20.0 to 81.0	71 Titers Interval 37.0 to 137.0	67 Titers Interval 40.0 to 113.0
Comparison of Geometric Mean Titer (GMT) by HAI H1 Antigen/Post-vaccination	117 Titers Interval 62.0 to 221.0	161 Titers Interval 82.0 to 317.0	580 Titers Interval 157.0 to 2137.0	148 Titers Interval 84.0 to 260.0	373 Titers Interval 264.0 to 528.0	267 Titers Interval 188.0 to 378.0
Comparison of Geometric Mean Titer (GMT) by HAI H1 Antigen/9 Months Post-vaccination	30 Titers Interval 11.0 to 87.0	85 Titers Interval 14.0 to 533.0	403 Titers Interval 33.0 to 4940.0	80 Titers Interval 12.0 to 533.0	279 Titers Interval 145.0 to 535.0	174 Titers Interval 93.0 to 325.0
Comparison of Geometric Mean Titer (GMT) by HAI H3 Antigen/Pre-vaccination	26 Titers Interval 12.0 to 58.0	25 Titers Interval 10.0 to 61.0	20 Titers Interval 6.0 to 69.0	22 Titers Interval 9.0 to 53.0	42 Titers Interval 24.0 to 72.0	49 Titers Interval 31.0 to 78.0
Comparison of Geometric Mean Titer (GMT) by HAI H3 Antigen/Post-vaccination	139 Titers Interval 49.0 to 394.0	63 Titers Interval 21.0 to 188.0	215 Titers Interval 104.0 to 445.0	109 Titers Interval 31.0 to 381.0	154 Titers Interval 105.0 to 226.0	143 Titers Interval 97.0 to 212.0
Comparison of Geometric Mean Titer (GMT) by HAI H3 Antigen/9 Months Post-vaccination	49 Titers Interval 16.0 to 148.0	40 Titers Interval 13.0 to 123.0	101 Titers Interval 28.0 to 360.0	143 Titers Interval 49.0 to 416.0	70 Titers Interval 44.0 to 111.0	102 Titers Interval 52.0 to 199.0
Comparison of Geometric Mean Titer (GMT) by HAI B Antigen/Pre-vaccination	16 Titers Interval 8.0 to 31.0	29 Titers Interval 15.0 to 57.0	17 Titers Interval 8.0 to 35.0	23 Titers Interval 12.0 to 47.0	33 Titers Interval 23.0 to 48.0	34 Titers Interval 23.0 to 48.0
Comparison of Geometric Mean Titer (GMT) by HAI B Antigen/Post-vaccination	181 Titers Interval 89.0 to 371.0	113 Titers Interval 36.0 to 357.0	195 Titers Interval 33.0 to 1138.0	202 Titers Interval 83.0 to 488.0	160 Titers Interval 108.0 to 237.0	172 Titers Interval 100.0 to 297.0
Comparison of Geometric Mean Titer (GMT) by HAI B Antigen/9 Months Post-vaccination	9 Titers Interval 6.0 to 13.0	13 Titers Interval 6.0 to 28.0	16 Titers Interval 6.0 to 43.0	11 Titers Interval 5.0 to 23.0	13 Titers Interval 9.0 to 19.0	13 Titers Interval 9.0 to 19.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Leukemia-HD n=13 Participants Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD n=13 Participants Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD n=8 Participants Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD n=9 Participants Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD n=18 Participants Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD n=20 Participants Patients with a diagnosis of HIV who received the standard dose Fluzone.
Comparison of Geometric Mean Ratios (GMR) by HAI H1 post- over pre-vaccination	4.0 Ratio	3.2 Ratio	10.2 Ratio	3.7 Ratio	5.2 Ratio	4.0 Ratio
Comparison of Geometric Mean Ratios (GMR) by HAI H1 post-vaccination over 9 months	3.9 Ratio	1.9 Ratio	1.4 Ratio	1.9 Ratio	1.3 Ratio	1.5 Ratio
Comparison of Geometric Mean Ratios (GMR) by HAI H3 post- over pre-vaccination	5.3 Ratio	2.6 Ratio	10.8 Ratio	5.0 Ratio	3.7 Ratio	2.9 Ratio
Comparison of Geometric Mean Ratios (GMR) by HAI H3 post-vaccination over 9 months	2.8 Ratio	1.6 Ratio	2.1 Ratio	0.8 Ratio	2.2 Ratio	1.4 Ratio
Comparison of Geometric Mean Ratios (GMR) by HAI B post- over pre-vaccination	11.2 Ratio	3.9 Ratio	11.6 Ratio	8.6 Ratio	4.8 Ratio	5.1 Ratio
Comparison of Geometric Mean Ratios (GMR) by HAI B post-vaccination over 9 months	20.6 Ratio	8.8 Ratio	12.3 Ratio	18.0 Ratio	12.1 Ratio	12.9 Ratio

Adverse Events

Leukemia-HD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Leukemia-SD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Solid Tumor-HD

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Solid Tumor-SD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HIV-HD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HIV-SD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Leukemia-HD n=13 participants at risk Patients with a diagnosis of leukemia who received the high dose Fluzone HD.	Leukemia-SD n=13 participants at risk Patients with a diagnosis of leukemia who received the standard dose Fluzone.	Solid Tumor-HD n=8 participants at risk Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.	Solid Tumor-SD n=9 participants at risk Patients with a diagnosis of solid tumor who received the standard dose Fluzone.	HIV-HD n=20 participants at risk Patients with a diagnosis of HIV who received the high dose Fluzone HD.	HIV-SD n=20 participants at risk Patients with a diagnosis of HIV who received the standard dose Fluzone.
Nervous system disorders Somnolence	0.00% 0/13 • Adverse events were collected for 21 days after each dose of vaccine. No "other" adverse events were observed.	0.00% 0/13 • Adverse events were collected for 21 days after each dose of vaccine. No "other" adverse events were observed.	12.5% 1/8 • Number of events 1 • Adverse events were collected for 21 days after each dose of vaccine. No "other" adverse events were observed.	0.00% 0/9 • Adverse events were collected for 21 days after each dose of vaccine. No "other" adverse events were observed.	0.00% 0/20 • Adverse events were collected for 21 days after each dose of vaccine. No "other" adverse events were observed.	0.00% 0/20 • Adverse events were collected for 21 days after each dose of vaccine. No "other" adverse events were observed.

Other adverse events

Adverse event data not reported

Additional Information

Jon McCullers, MD

St. Jude Children's Research Hospital

Phone: 866-278-5833

Email: info@stjude.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place