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CompletedNCT01216332Updated May 3, 2019Results posted

Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia Patients

A Phase 1 interventional study of High-dose trivalent inactivated influenza vaccine and Standard dose trivalent inactivated influenza vaccine in Pediatric Patients With Acute Lymphoblastic Leukemia, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-05-03.

Sponsored by Vanderbilt University · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
3 Years to 17 Years
Sex
All
01

Study summary

This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with Acute Lymphoblastic Leukemia.

02

Conditions studied

  • Pediatric Patients With Acute Lymphoblastic Leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 50 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

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

04

Who can participate

Ages eligible
3 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Pediatric patients with standard or high risk Acute Lymphoblastic Leukemia.
  • Must be in 1st complete remission.
  • Must be 4 weeks into maintenance therapy.
  • 17 years of age, inclusive.
  • Available for duration of study.

Exclusion criteria

Exclusion Criteria:

  • History of hypersensitivity to previous influenza vaccination or hypersensitivity to eggs/egg protein.
  • History of Guillain-Barre syndrome.
  • Evidence of relapsed disease.
  • Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
  • Have any condition that the investigator believes may interfere with successful completion of the study.
  • History of receiving 2010 - 2011 influenza vaccine.
  • Pregnant female.
  • History of proven influenza disease after September 1, 2010.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    High-Dose trivalent inactivated influenza vaccine

    0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.

    Drug: High-dose trivalent inactivated influenza vaccine

  • Active comparator
    Standard dose trivalent inactivated influenza vaccine

    0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine

    Drug: Standard dose trivalent inactivated influenza vaccine

Interventions

  • DrugHigh-dose trivalent inactivated influenza vaccine

    0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.

  • DrugStandard dose trivalent inactivated influenza vaccine

    0.5 mL standard dose trivalent inactivated influenza vaccine

06

What researchers measure

Primary outcomes

  1. Local Reactions After Each Vaccination

    Number of participants with local reactions after each vaccination

    Time frame: From baseline to 7 days after each vaccination

  2. Systemic Reaction

    Number of participants with systemic reactions after each vaccination

    Time frame: From baseline to 7 days after each vaccination

Secondary outcomes

  1. Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise

    Greater than or equal to a Fourfold titer rise three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

    Time frame: About 6 months after last dose of vaccine.

  2. Immunogenicity:Number of Participants With a Pre-titer ≥1:40

    Pre-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

    Time frame: About 6 months after last dose of vaccine.

  3. Immunogenicity: Number of Participants With a Post-titer ≥1:40

    Post-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

    Time frame: About 6 months after last dose of vaccine.

  4. Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants

    Geometric mean titers pre-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

    Time frame: baseline

  5. Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants

    Geometric mean titers post-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

    Time frame: About 6 months after last dose of vaccine.

07

Results

Posted May 3, 2019

Participant flow

Participant flow — Overall Study
MilestoneHigh-Dose Trivalent Inactivated Influenza VaccineStandard Dose Trivalent Inactivated Influenza Vaccine
Started3416
Completed3016
Not completed40
Withdrew: Withdrawal by subject40

Outcome measures

PrimaryLocal Reactions After Each Vaccination

Number of participants with local reactions after each vaccination

Time frame:
From baseline to 7 days after each vaccination
Reported as:
Count of participants · Participants
Local Reactions After Each Vaccination
ParticipantsHigh-Dose Trivalent Inactivated Influenza VaccineStandard Dose Trivalent Inactivated Influenza Vaccine
Pain127
Tenderness149
Intense Swelling33
Redness42
PrimarySystemic Reaction

Number of participants with systemic reactions after each vaccination

Time frame:
From baseline to 7 days after each vaccination
Reported as:
Count of participants · Participants
Systemic Reaction
ParticipantsHigh-Dose Trivalent Inactivated Influenza VaccineStandard Dose Trivalent Inactivated Influenza Vaccine
Fatigue1414
Decrease in Activity137
Fever43
Headache69
Nausea76
Body aches63
Vomiting27
SecondaryImmunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise

Greater than or equal to a Fourfold titer rise three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

Time frame:
About 6 months after last dose of vaccine.
Reported as:
Count of participants · Participants
Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise
ParticipantsHigh-Dose Trivalent Inactivated Influenza VaccineStandard Dose Trivalent Inactivated Influenza Vaccine
A/California/7/09 H1N166
A/Perth/16/2009 H3N285
B/Brisbane/60/200820
SecondaryImmunogenicity:Number of Participants With a Pre-titer ≥1:40

Pre-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

Time frame:
About 6 months after last dose of vaccine.
Reported as:
Count of participants · Participants
Immunogenicity:Number of Participants With a Pre-titer ≥1:40
ParticipantsHigh-Dose Trivalent Inactivated Influenza VaccineStandard Dose Trivalent Inactivated Influenza Vaccine
A/California/7/09 H1N1179
A/Perth/16/2009 H3N297
B/Brisbane/60/20082111
SecondaryImmunogenicity: Number of Participants With a Post-titer ≥1:40

Post-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

Time frame:
About 6 months after last dose of vaccine.
Reported as:
Count of participants · Participants
Immunogenicity: Number of Participants With a Post-titer ≥1:40
ParticipantsHigh-Dose Trivalent Inactivated Influenza VaccineStandard Dose Trivalent Inactivated Influenza Vaccine
A/California/7/09 H1N12011
A/Perth/16/2009 H3N2138
B/Brisbane/60/2008199
SecondaryImmunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants

Geometric mean titers pre-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

Time frame:
baseline
Reported as:
Geometric mean · Titers
Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants
TitersHigh-Dose Trivalent Inactivated Influenza VaccineStandard Dose Trivalent Inactivated Influenza Vaccine
A/California/7/09 H1N146.2 (27.4 to 75.7)87.4 (37.9 to 209.1)
A/Perth/16/2009 H3N228.3 (18.7 to 43.3)28.8 (18.1 to 46.5)
B/Brisbane/60/200866.5 (51.8 to 82.2)56.1 (43.9 to 69.4)
SecondaryImmunogenicity: Geometric Mean Titers Post-vaccine in Study Participants

Geometric mean titers post-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

Time frame:
About 6 months after last dose of vaccine.
Reported as:
Geometric mean · Titers
Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants
TitersHigh-Dose Trivalent Inactivated Influenza VaccineStandard Dose Trivalent Inactivated Influenza Vaccine
A/California/7/09 H1N197.9 (61.1 to 166.3)322.9 (141.3 to 792.1)
A/Perth/16/2009 H3N262.9 (34.6 to 122.2)76.5 (36 to 176.5)
B/Brisbane/60/200874.4 (49.9 to 111.6)50.6 (35.3 to 67.3)

Adverse events

Collected over AEs were collected for 28 days after last vaccination, and SAEs were collected through 180 days after their final vaccination via phone call and medical chart review.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
High-Dose Trivalent Inactivated Influenza Vaccine0/34 (0%)9/34 (26.5%)21/34 (61.8%)
Standard Dose Trivalent Inactivated Influenza Vaccine0/16 (0%)6/16 (37.5%)14/16 (87.5%)
Most frequent serious events
Most frequent serious events
EventHigh-Dose Trivalent Inactivated Influenza VaccineStandard Dose Trivalent Inactivated Influenza Vaccine
Influenza BInfections and infestations0/342/16
Viral IllnessInfections and infestations2/342/16
FeverGeneral disorders4/340/16
Acute Otitis MediaEar and labyrinth disorders0/341/16
PneumoniaInfections and infestations1/341/16
CoronavirusInfections and infestations1/340/16
New Onset SeizuresNervous system disorders1/340/16
Most frequent other events
Showing 10 of 11
Most frequent other events
EventHigh-Dose Trivalent Inactivated Influenza VaccineStandard Dose Trivalent Inactivated Influenza Vaccine
FatigueGeneral disorders14/3414/16
TendernessGeneral disorders14/349/16
HeadacheGeneral disorders6/349/16
Decrease in ActivityGeneral disorders13/347/16
VomitingGeneral disorders2/347/16
NauseaGeneral disorders7/346/16
Pain at Injection SiteGeneral disorders12/343/16
Intense SwellingGeneral disorders3/343/16
FeverGeneral disorders4/343/16
Body AchesGeneral disorders6/343/16

Baseline characteristics

Four subjects were excluded from the data analysis (from the high dose group), because they were given the second dose of TIV outside the study window period

Age, Customized
Age, Customized(Participants)High-Dose Trivalent Inactivated Influenza VaccineStandard Dose Trivalent Inactivated Influenza VaccineTotal
<=18 years301646
Between 18 and 65 years000
>=65 years000
Sex/Gender, Customized
Sex/Gender, Customized(Participants)High-Dose Trivalent Inactivated Influenza VaccineStandard Dose Trivalent Inactivated Influenza VaccineTotal
Female12517
Male181129
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)High-Dose Trivalent Inactivated Influenza VaccineStandard Dose Trivalent Inactivated Influenza VaccineTotal
Hispanic or Latino246
Not Hispanic or Latino281240
Unknown or Not Reported000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)High-Dose Trivalent Inactivated Influenza VaccineStandard Dose Trivalent Inactivated Influenza VaccineTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American347
White271239
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)High-Dose Trivalent Inactivated Influenza VaccineStandard Dose Trivalent Inactivated Influenza VaccineTotal
United States301646
08

Study locations

1 site
  • Monroe Carell Jr. Children's Hospital at Vanderbilt
    Nashville, Tennessee 37232, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01216332
Lead sponsor
Vanderbilt University
Responsible party
Natasha Halasa (Assistant Professor, Vanderbilt University) — Principal investigator
First posted
Oct 7, 2010
Start date
Oct 2010
Primary completion
May 2013
Completion
May 2013
Results posted
May 3, 2019
Last update
May 3, 2019

Study contacts

Natasha Halasa, M.D.
principal investigator · Vanderbilt Universtiy Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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