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Trial record 24 of 597 for:    Fluzone® | Studies With Results

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01205581
Recruitment Status : Completed
First Posted : September 20, 2010
Results First Posted : September 12, 2014
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV
Cancer
Interventions Biological: Fluzone High Dose Vaccine
Biological: Fluzone Standard Dose Vaccine
Enrollment 85

Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Leukemia-HD Leukemia-SD Solid Tumor-HD Solid Tumor-SD HIV-HD HIV-SD
Hide Arm/Group Description Patients with a diagnosis of leukemia who received the high dose Fluzone HD. Patients with a diagnosis of leukemia who received the standard dose Fluzone. Patients with a diagnosis of solid tumor who received the high dose Fluzone HD. Patients with a diagnosis of solid tumor who received the standard dose Fluzone. Patients with a diagnosis of HIV who received the high dose Fluzone HD. Patients with a diagnosis of HIV who received the standard dose Fluzone.
Period Title: Overall Study
Started 14 13 8 9 20 20
Completed 13 13 8 9 20 20
Not Completed 1 0 0 0 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0             0             0
Arm/Group Title Leukemia-HD Leukemia-SD Solid Tumor-HD Solid Tumor-SD HIV-HD HIV-SD Total
Hide Arm/Group Description Patients with a diagnosis of leukemia who received the high dose Fluzone HD. Patients with a diagnosis of leukemia who received the standard dose Fluzone. Patients with a diagnosis of solid tumor who received the high dose Fluzone HD. Patients with a diagnosis of solid tumor who received the standard dose Fluzone. Patients with a diagnosis of HIV who received the high dose Fluzone HD. Patients with a diagnosis of HIV who received the standard dose Fluzone. Total of all reporting groups
Overall Number of Baseline Participants 13 13 8 9 20 20 83
Hide Baseline Analysis Population Description
This was an open-label study where participants were randomized at a 1:1 ratio into Fluzone high-dose (HD) and Fluzone standard dose (SD) groups by disease group with the use of a computer-generated randomization schedule.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 8 participants 9 participants 20 participants 20 participants 83 participants
10.8  (5.7) 11.8  (5.1) 12.4  (4.2) 11.7  (4.5) 16.7  (5.6) 19.9  (1.8) 14.6  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 8 participants 9 participants 20 participants 20 participants 83 participants
Female
4
  30.8%
5
  38.5%
4
  50.0%
4
  44.4%
7
  35.0%
4
  20.0%
28
  33.7%
Male
9
  69.2%
8
  61.5%
4
  50.0%
5
  55.6%
13
  65.0%
16
  80.0%
55
  66.3%
1.Primary Outcome
Title Rate of Seroconversion After 1 Dose of Vaccine
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leukemia-HD Leukemia-SD Solid Tumor-HD Solid Tumor-SD HIV-HD HIV-SD
Hide Arm/Group Description:
Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
Patients with a diagnosis of leukemia who received the standard dose Fluzone.
Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
Patients with a diagnosis of HIV who received the high dose Fluzone HD.
Patients with a diagnosis of HIV who received the standard dose Fluzone.
Overall Number of Participants Analyzed 13 13 8 9 18 20
Measure Type: Number
Unit of Measure: percentage of participants
H1 antigen 31 0 50 22 61 65
H3 antigen 77 85 50 89 72 65
B antigen 38 46 63 44 67 35
2.Primary Outcome
Title Rate of Seroprotection After 1 Dose of Vaccine
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leukemia-HD Leukemia-SD Solid Tumor-HD Solid Tumor-SD HIV-HD HIV-SD
Hide Arm/Group Description:
Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
Patients with a diagnosis of leukemia who received the standard dose Fluzone.
Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
Patients with a diagnosis of HIV who received the high dose Fluzone HD.
Patients with a diagnosis of HIV who received the standard dose Fluzone.
Overall Number of Participants Analyzed 13 13 8 9 18 20
Measure Type: Number
Unit of Measure: Percentage of participants
H1 antigen 77 85 75 78 100 100
H3 antigen 92 92 75 89 100 100
B antigen 62 85 63 89 100 90
3.Primary Outcome
Title Number of Participants Achieving Seroprotection After Second Dose of Vaccine
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leukemia-HD Leukemia-SD Solid Tumor-HD Solid Tumor-SD HIV-HD HIV-SD
Hide Arm/Group Description:
Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
Patients with a diagnosis of leukemia who received the standard dose Fluzone.
Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
Patients with a diagnosis of HIV who received the high dose Fluzone HD.
Patients with a diagnosis of HIV who received the standard dose Fluzone.
Overall Number of Participants Analyzed 13 13 8 9 18 20
Measure Type: Number
Unit of Measure: number of participants
H1 antigen 11 12 7 9 18 19
H3 antigen 8 8 7 7 18 19
B antigen 10 10 6 8 18 19
4.Secondary Outcome
Title Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title High-dose FluzoneHD Standard Dose Fluzone
Hide Arm/Group Description:
41 participants received 80 doses of high-dose FluzoneHD.
42 participants received 82 doses of standard-dose Fluzone.
Overall Number of Participants Analyzed 41 42
Measure Type: Number
Unit of Measure: participants
1 0
5.Secondary Outcome
Title Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leukemia-1 Dose Leukemia-2 Doses Solid Tumor-1 Dose Solid Tumor-2 Doses HIV-1 Dose HIV-2 Doses
Hide Arm/Group Description:
Patients with a diagnosis of leukemia who received one dose of high dose Fluzone HD.
Patients with a diagnosis of leukemia who received 2 doses of high dose Fluzone HD.
Patients with a diagnosis of solid tumor who received one dose of high dose Fluzone HD.
Patients with a diagnosis of solid tumor who received 2 doses of high dose Fluzone HD.
Patients with a diagnosis of HIV who received one dose of high dose Fluzone HD.
Patients with a diagnosis of HIV who received 2 doses of high dose Fluzone HD.
Overall Number of Participants Analyzed 13 13 8 8 18 18
Measure Type: Number
Unit of Measure: percentage of participants
H1 antigen 31 54 50 88 61 72
H3 antigen 77 85 50 63 72 72
B antigen 38 85 63 75 67 78
6.Secondary Outcome
Title Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leukemia-1 Dose Leukemia-2 Doses Solid Tumor-1 Dose Solid Tumor-2 Doses HIV-1 Dose HIV-2 Doses
Hide Arm/Group Description:
Patients with a diagnosis of leukemia who received one dose of high dose Fluzone SD.
Patients with a diagnosis of leukemia who received 2 doses of high dose Fluzone SD.
Patients with a diagnosis of solid tumor who received one dose of high dose Fluzone SD.
Patients with a diagnosis of solid tumor who received 2 doses of high dose Fluzone SD.
Patients with a diagnosis of HIV who received one dose of high dose Fluzone SD.
Patients with a diagnosis of HIV who received 2 doses of high dose Fluzone SD.
Overall Number of Participants Analyzed 13 13 9 9 20 20
Measure Type: Number
Unit of Measure: percentrage of participants
H1 antigen 0 54 22 67 65 70
H3 antigen 85 92 89 89 65 70
B antigen 46 85 44 89 35 75
7.Secondary Outcome
Title Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
30 participants did not have ALC data collected at baseline evaluation because they had complete blood count (CBC) ordered without differential count.
Arm/Group Title ALC <1000 Cells/mm³ ALC ≥1000 Cells/mm³
Hide Arm/Group Description:
Participants whose ALC was <1000 cells/mm³ were analyzed.
Participants whose ALC was ≥1000 cells/mm³ were analyzed.
Overall Number of Participants Analyzed 26 28
Measure Type: Number
Unit of Measure: percentagae of participants
62 68
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALC <1000 Cells/mm³, ALC ≥1000 Cells/mm³
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
30 participants did not have ALC data collected at baseline evaluation because they had complete blood count (CBC) ordered without differential count.
Arm/Group Title ALC <1000 Cells/mm³ ALC ≥1000 Cells/mm³
Hide Arm/Group Description:
Participants whose ALC was <1000 cells/mm³ were analyzed.
Participants whose ALC was ≥1000 cells/mm³ were analyzed.
Overall Number of Participants Analyzed 26 28
Measure Type: Number
Unit of Measure: percentage of participants
96 100
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALC <1000 Cells/mm³, ALC ≥1000 Cells/mm³
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Number of Local Reactogenicity Events After First Dose
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High-dose FluzoneHD Standard Dose Fluzone
Hide Arm/Group Description:
41 participants received 80 doses of high-dose FluzoneHD.
42 participants received 82 doses of standard-dose Fluzone.
Overall Number of Participants Analyzed 41 42
Measure Type: Number
Unit of Measure: Events
19 16
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High-dose FluzoneHD, Standard Dose Fluzone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
10.Secondary Outcome
Title Number of Local Reactogenicity Events After Second Dose
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High-dose FluzoneHD Standard Dose Fluzone
Hide Arm/Group Description:
41 participants received 80 doses of high-dose FluzoneHD.
42 participants received 82 doses of standard-dose Fluzone.
Overall Number of Participants Analyzed 39 40
Measure Type: Number
Unit of Measure: Events
11 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High-dose FluzoneHD, Standard Dose Fluzone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
11.Secondary Outcome
Title Number of Systemic Reactogenicity Events After First Dose
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High-dose FluzoneHD Standard Dose Fluzone
Hide Arm/Group Description:
41 participants received 80 doses of high-dose FluzoneHD.
42 participants received 82 doses of standard-dose Fluzone.
Overall Number of Participants Analyzed 41 42
Measure Type: Number
Unit of Measure: Events
10 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High-dose FluzoneHD, Standard Dose Fluzone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
12.Secondary Outcome
Title Number of Systemic Reactogenicity Events After Second Dose
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High-dose FluzoneHD Standard Dose Fluzone
Hide Arm/Group Description:
41 participants received 80 doses of high-dose FluzoneHD.
42 participants received 82 doses of standard-dose Fluzone.
Overall Number of Participants Analyzed 39 40
Measure Type: Number
Unit of Measure: Events
8 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High-dose FluzoneHD, Standard Dose Fluzone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
13.Secondary Outcome
Title Comparison of Geometric Mean Titer (GMT) by HAI
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leukemia-HD Leukemia-SD Solid Tumor-HD Solid Tumor-SD HIV-HD HIV-SD
Hide Arm/Group Description:
Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
Patients with a diagnosis of leukemia who received the standard dose Fluzone.
Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
Patients with a diagnosis of HIV who received the high dose Fluzone HD.
Patients with a diagnosis of HIV who received the standard dose Fluzone.
Overall Number of Participants Analyzed 13 13 8 9 18 20
Geometric Mean (Full Range)
Unit of Measure: Titers
H1 Antigen/Pre-vaccination
29
(17 to 49)
50
(22 to 111)
57
(16 to 203)
40
(20 to 81)
71
(37 to 137)
67
(40 to 113)
H1 Antigen/Post-vaccination
117
(62 to 221)
161
(82 to 317)
580
(157 to 2137)
148
(84 to 260)
373
(264 to 528)
267
(188 to 378)
H1 Antigen/9 Months Post-vaccination
30
(11 to 87)
85
(14 to 533)
403
(33 to 4940)
80
(12 to 533)
279
(145 to 535)
174
(93 to 325)
H3 Antigen/Pre-vaccination
26
(12 to 58)
25
(10 to 61)
20
(6 to 69)
22
(9 to 53)
42
(24 to 72)
49
(31 to 78)
H3 Antigen/Post-vaccination
139
(49 to 394)
63
(21 to 188)
215
(104 to 445)
109
(31 to 381)
154
(105 to 226)
143
(97 to 212)
H3 Antigen/9 Months Post-vaccination
49
(16 to 148)
40
(13 to 123)
101
(28 to 360)
143
(49 to 416)
70
(44 to 111)
102
(52 to 199)
B Antigen/Pre-vaccination
16
(8 to 31)
29
(15 to 57)
17
(8 to 35)
23
(12 to 47)
33
(23 to 48)
34
(23 to 48)
B Antigen/Post-vaccination
181
(89 to 371)
113
(36 to 357)
195
(33 to 1138)
202
(83 to 488)
160
(108 to 237)
172
(100 to 297)
B Antigen/9 Months Post-vaccination
9
(6 to 13)
13
(6 to 28)
16
(6 to 43)
11
(5 to 23)
13
(9 to 19)
13
(9 to 19)
14.Secondary Outcome
Title Comparison of Geometric Mean Ratios (GMR) by HAI
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leukemia-HD Leukemia-SD Solid Tumor-HD Solid Tumor-SD HIV-HD HIV-SD
Hide Arm/Group Description:
Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
Patients with a diagnosis of leukemia who received the standard dose Fluzone.
Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
Patients with a diagnosis of HIV who received the high dose Fluzone HD.
Patients with a diagnosis of HIV who received the standard dose Fluzone.
Overall Number of Participants Analyzed 13 13 8 9 18 20
Measure Type: Number
Unit of Measure: Ratio
H1 post- over pre-vaccination 4.0 3.2 10.2 3.7 5.2 4.0
H1 post-vaccination over 9 months 3.9 1.9 1.4 1.9 1.3 1.5
H3 post- over pre-vaccination 5.3 2.6 10.8 5.0 3.7 2.9
H3 post-vaccination over 9 months 2.8 1.6 2.1 0.8 2.2 1.4
B post- over pre-vaccination 11.2 3.9 11.6 8.6 4.8 5.1
B post-vaccination over 9 months 20.6 8.8 12.3 18.0 12.1 12.9
Time Frame Adverse events were collected for 21 days after each dose of vaccine. No "other" adverse events were observed.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Leukemia-HD Leukemia-SD Solid Tumor-HD Solid Tumor-SD HIV-HD HIV-SD
Hide Arm/Group Description Patients with a diagnosis of leukemia who received the high dose Fluzone HD. Patients with a diagnosis of leukemia who received the standard dose Fluzone. Patients with a diagnosis of solid tumor who received the high dose Fluzone HD. Patients with a diagnosis of solid tumor who received the standard dose Fluzone. Patients with a diagnosis of HIV who received the high dose Fluzone HD. Patients with a diagnosis of HIV who received the standard dose Fluzone.
All-Cause Mortality
Leukemia-HD Leukemia-SD Solid Tumor-HD Solid Tumor-SD HIV-HD HIV-SD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Leukemia-HD Leukemia-SD Solid Tumor-HD Solid Tumor-SD HIV-HD HIV-SD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/13 (0.00%)      1/8 (12.50%)      0/9 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Nervous system disorders             
Somnolence * 1 [1]  0/13 (0.00%)  0 0/13 (0.00%)  0 1/8 (12.50%)  1 0/9 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.02)
[1]
In 9-year-old with history of neurologic disorder who received FluzoneHD after recovery from sedation.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Leukemia-HD Leukemia-SD Solid Tumor-HD Solid Tumor-SD HIV-HD HIV-SD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/13 (0.00%)      0/8 (0.00%)      0/9 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jon McCullers, MD
Organization: St. Jude Children's Research Hospital
Phone: 866-278-5833
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01205581     History of Changes
Other Study ID Numbers: FLUHD
First Submitted: September 17, 2010
First Posted: September 20, 2010
Results First Submitted: July 24, 2014
Results First Posted: September 12, 2014
Last Update Posted: September 23, 2016