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CompletedNCT01205581Updated Sep 23, 2016Results posted

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

A Phase 2 interventional study of Fluzone High Dose Vaccine and Fluzone Standard Dose Vaccine in HIV and Cancer, sponsored by St. Jude Children's Research Hospital. Completed at 1 site in United States. Open to participants aged 3 Years to 21 Years. Per ClinicalTrials.gov, last updated 2016-09-23.

Sponsored by St. Jude Children's Research Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
85
Allocation
Randomized
Ages
3 Years to 21 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.
02

Conditions studied

  • HIV
  • Cancer

Browse trials for

Keywords

  • Fluzone
  • Trivalent Influenza Vaccine
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 85 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
85 participants (actual)

Study arms

  • 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.

    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.

    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.

    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.

    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.

    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.

    Biological: Fluzone Standard Dose Vaccine

Interventions

  • BiologicalFluzone High Dose Vaccine

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

    Also known as: Fluzone-HD

  • BiologicalFluzone Standard Dose Vaccine

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

    Also known as: Fluzone-SD

06

What researchers measure

Primary outcomes

  1. Rate of Seroconversion After 1 Dose of Vaccine

    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

  2. Rate of Seroprotection After 1 Dose of Vaccine

    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

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

    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

Secondary outcomes

  1. Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD

    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

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

    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

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

    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

  4. Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)

    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

  5. Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)

    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

  6. Number of Local Reactogenicity Events After First Dose

    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

  7. Number of Local Reactogenicity Events After Second Dose

    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

  8. Number of Systemic Reactogenicity Events After First Dose

    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

  9. Number of Systemic Reactogenicity Events After Second Dose

    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

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

    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

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

    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

07

Results

Posted Sep 12, 2014

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.

Participant flow — Overall Study
MilestoneLeukemia-HDLeukemia-SDSolid Tumor-HDSolid Tumor-SDHIV-HDHIV-SD
Started1413892020
Completed1313892020
Not completed100000
Withdrew: Withdrawal by subject100000

Outcome measures

PrimaryRate of Seroconversion After 1 Dose of Vaccine

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
Reported as:
Number · percentage of participants
Rate of Seroconversion After 1 Dose of Vaccine
percentage of participantsLeukemia-HDLeukemia-SDSolid Tumor-HDSolid Tumor-SDHIV-HDHIV-SD
H1 antigen31050226165
H3 antigen778550897265
B antigen384663446735
SecondaryNumber of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD

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
Reported as:
Number · participants
Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD
participantsHigh-dose FluzoneHDStandard Dose Fluzone
Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD10
SecondaryRate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD

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
Reported as:
Number · percentage of participants
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD
percentage of participantsLeukemia-1 DoseLeukemia-2 DosesSolid Tumor-1 DoseSolid Tumor-2 DosesHIV-1 DoseHIV-2 Doses
H1 antigen315450886172
H3 antigen778550637272
B antigen388563756778
SecondaryRate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD

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
Reported as:
Number · percentrage of participants
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD
percentrage of participantsLeukemia-1 DoseLeukemia-2 DosesSolid Tumor-1 DoseSolid Tumor-2 DosesHIV-1 DoseHIV-2 Doses
H1 antigen05422676570
H3 antigen859289896570
B antigen468544893575
SecondaryRate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)

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
Reported as:
Number · percentagae of participants
Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)
percentagae of participantsALC <1000 Cells/mm³ALC ≥1000 Cells/mm³
Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)6268
Statistical analysis
  • ALC <1000 Cells/mm³ vs ALC ≥1000 Cells/mm³ · Fisher Exact · p = 0.78
PrimaryRate of Seroprotection After 1 Dose of Vaccine

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
Reported as:
Number · Percentage of participants
Rate of Seroprotection After 1 Dose of Vaccine
Percentage of participantsLeukemia-HDLeukemia-SDSolid Tumor-HDSolid Tumor-SDHIV-HDHIV-SD
H1 antigen77857578100100
H3 antigen92927589100100
B antigen6285638910090
PrimaryNumber of Participants Achieving Seroprotection After Second Dose of Vaccine

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
Reported as:
Number · number of participants
Number of Participants Achieving Seroprotection After Second Dose of Vaccine
number of participantsLeukemia-HDLeukemia-SDSolid Tumor-HDSolid Tumor-SDHIV-HDHIV-SD
H1 antigen1112791819
H3 antigen88771819
B antigen1010681819
SecondaryRate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)

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
Reported as:
Number · percentage of participants
Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)
percentage of participantsALC <1000 Cells/mm³ALC ≥1000 Cells/mm³
Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)96100
Statistical analysis
  • ALC <1000 Cells/mm³ vs ALC ≥1000 Cells/mm³ · Fisher Exact · p = 0.48
SecondaryNumber of Local Reactogenicity Events After First Dose

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
Reported as:
Number · Events
Number of Local Reactogenicity Events After First Dose
EventsHigh-dose FluzoneHDStandard Dose Fluzone
Number of Local Reactogenicity Events After First Dose1916
Statistical analysis
  • High-dose FluzoneHD vs Standard Dose Fluzone · Fisher Exact · p = 0.51
SecondaryNumber of Local Reactogenicity Events After Second Dose

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
Reported as:
Number · Events
Number of Local Reactogenicity Events After Second Dose
EventsHigh-dose FluzoneHDStandard Dose Fluzone
Number of Local Reactogenicity Events After Second Dose117
Statistical analysis
  • High-dose FluzoneHD vs Standard Dose Fluzone · Fisher Exact · p = 0.29
SecondaryNumber of Systemic Reactogenicity Events After First Dose

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
Reported as:
Number · Events
Number of Systemic Reactogenicity Events After First Dose
EventsHigh-dose FluzoneHDStandard Dose Fluzone
Number of Systemic Reactogenicity Events After First Dose107
Statistical analysis
  • High-dose FluzoneHD vs Standard Dose Fluzone · Fisher Exact · p = 0.43
SecondaryNumber of Systemic Reactogenicity Events After Second Dose

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
Reported as:
Number · Events
Number of Systemic Reactogenicity Events After Second Dose
EventsHigh-dose FluzoneHDStandard Dose Fluzone
Number of Systemic Reactogenicity Events After Second Dose83
Statistical analysis
  • High-dose FluzoneHD vs Standard Dose Fluzone · Fisher Exact · p = 0.11
SecondaryComparison of Geometric Mean Titer (GMT) by HAI

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
Reported as:
Geometric mean · Titers
Comparison of Geometric Mean Titer (GMT) by HAI
TitersLeukemia-HDLeukemia-SDSolid Tumor-HDSolid Tumor-SDHIV-HDHIV-SD
H1 Antigen/Pre-vaccination29 (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-vaccination117 (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-vaccination30 (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-vaccination26 (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-vaccination139 (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-vaccination49 (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-vaccination16 (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-vaccination181 (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-vaccination9 (6 to 13)13 (6 to 28)16 (6 to 43)11 (5 to 23)13 (9 to 19)13 (9 to 19)
SecondaryComparison of Geometric Mean Ratios (GMR) by HAI

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
Reported as:
Number · Ratio
Comparison of Geometric Mean Ratios (GMR) by HAI
RatioLeukemia-HDLeukemia-SDSolid Tumor-HDSolid Tumor-SDHIV-HDHIV-SD
H1 post- over pre-vaccination4.03.210.23.75.24.0
H1 post-vaccination over 9 months3.91.91.41.91.31.5
H3 post- over pre-vaccination5.32.610.85.03.72.9
H3 post-vaccination over 9 months2.81.62.10.82.21.4
B post- over pre-vaccination11.23.911.68.64.85.1
B post-vaccination over 9 months20.68.812.318.012.112.9

Adverse events

Collected over Adverse events were collected for 21 days after each dose of vaccine. No "other" adverse events were observed.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Leukemia-HD—0/13 (0%)0/13 (0%)
Leukemia-SD—0/13 (0%)0/13 (0%)
Solid Tumor-HD—1/8 (12.5%)0/8 (0%)
Solid Tumor-SD—0/9 (0%)0/9 (0%)
HIV-HD—0/20 (0%)0/20 (0%)
HIV-SD—0/20 (0%)0/20 (0%)
Most frequent serious events
Most frequent serious events
EventLeukemia-HDLeukemia-SDSolid Tumor-HDSolid Tumor-SDHIV-HDHIV-SD
SomnolenceNervous system disorders0/130/131/80/90/200/20

Baseline characteristics

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
Age, Continuous(years)Leukemia-HDLeukemia-SDSolid Tumor-HDSolid Tumor-SDHIV-HDHIV-SDTotal
Mean10.8 ± 5.711.8 ± 5.112.4 ± 4.211.7 ± 4.516.7 ± 5.619.9 ± 1.814.6 ± 5.9
Sex: Female, Male
Sex: Female, Male(Participants)Leukemia-HDLeukemia-SDSolid Tumor-HDSolid Tumor-SDHIV-HDHIV-SDTotal
Female45447428
Male9845131655
08

Study locations

1 site
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01205581
Lead sponsor
St. Jude Children's Research Hospital
Responsible party
Sponsor
First posted
Sep 20, 2010
Start date
Sep 2010
Primary completion
Aug 2013
Completion
Aug 2013
Results posted
Sep 12, 2014
Last update
Sep 23, 2016

Study contacts

Jonathan A McCullers, MD
principal investigator · St. Jude Children's Research Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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