Pediatric Patients With Acute Lymphoblastic LeukemiaPhase 1NCT01216332

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

A Phase 1 study testing High-dose trivalent inactivated influenza vaccine and Standard dose trivalent inactivated influenza vaccine in people with Pediatric Patients With Acute Lymphoblastic Leukemia, run by Vanderbilt University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 3 to 17 years
Conditions the study is for: Pediatric Patients With Acute Lymphoblastic Leukemia
What is being tested?: High-dose trivalent inactivated influenza vaccine and Standard dose trivalent inactivated influenza vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Oct 2010to May 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Randomized, Double Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High Dose Trivalent Inactivated Influenza Vaccine in Pediatric Patients With Acute Lymphoblastic Leukemia

Conditions: Pediatric Patients With Acute Lymphoblastic Leukemia
Being tested: High-dose trivalent inactivated influenza vaccine, Standard dose trivalent inactivated influenza vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High-dose trivalent inactivated influenza vaccineDrug
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.
Standard dose trivalent inactivated influenza vaccineDrug
0.5 mL standard dose trivalent inactivated influenza vaccine

Study groups in NCT01216332
Study group	Role	What they receive
High-Dose trivalent inactivated influenza vaccine	Experimental	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. Receives: Drug: High-dose trivalent inactivated influenza vaccine
Standard dose trivalent inactivated influenza vaccine	Active comparator	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 Receives: Drug: Standard dose trivalent inactivated influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Local Reactions After Each Vaccination
Number of participants with local reactions after each vaccination
Measured: From baseline to 7 days after each vaccination
Systemic Reaction
Number of participants with systemic reactions after each vaccination
Measured: From baseline to 7 days after each vaccination

Secondary outcomes (5)

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)
Measured: About 6 months after last dose of vaccine.
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)
Measured: About 6 months after last dose of vaccine.
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)
Measured: About 6 months after last dose of vaccine.
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)
Measured: baseline
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)
Measured: About 6 months after last dose of vaccine.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010May 2013

First posted7 Oct 2010 (estimated)
Study startOct 2010
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pediatric Patients With Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01216332
Sponsor's protocol ID: VICC PED 1067
Status last verified: Apr 2019
First submitted: 5 Oct 2010
Last updated: 3 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
RecruitingPhase 2
Ruxolitinib With Tacrolimus and Methotrexate for the Prevention of Graft Versus Host Disease in Pediatric and Young Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Recruiting
Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
Melanoma Stage III, B-cell Non Hodgkin Lymphoma
RecruitingPhase 1
A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)
Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia, Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

All Pediatric Patients With Acute Lymphoblastic Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High Dose Trivalent Inactivated Influenza Vaccine in Pediatric Patients With Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT01216332
Acronym / sponsor ID: VICC PED 1067
Conditions: Pediatric Patients With Acute Lymphoblastic Leukemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Vanderbilt UniversityUniversity, hospital or other
Study start: Oct 2010
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 7 Oct 2010 (estimated)
Results: Posted 3 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
High-Dose trivalent inactivated influenza vaccine	Experimental	Drug: High-dose trivalent inactivated influenza vaccine0.5 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.
Standard dose trivalent inactivated influenza vaccine	Active comparator	Drug: Standard dose trivalent inactivated influenza vaccine0.5 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

Who may qualify

Ages: 3 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High-dose trivalent inactivated influenza vaccine0.5 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
Standard dose trivalent inactivated influenza vaccine0.5 mL standard dose trivalent inactivated influenza vaccine	Drug	Standard dose trivalent inactivated influenza vaccine

Primary outcome

Local Reactions After Each Vaccination
Time frame: From baseline to 7 days after each vaccination
Number of participants with local reactions after each vaccination
Systemic Reaction
Time frame: From baseline to 7 days after each vaccination
Number of participants with systemic reactions after each vaccination

5 secondary outcomes

Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise
Time frame: About 6 months after last dose of vaccine.
Immunogenicity:Number of Participants With a Pre-titer ≥1:40
Time frame: About 6 months after last dose of vaccine.
Immunogenicity: Number of Participants With a Post-titer ≥1:40
Time frame: About 6 months after last dose of vaccine.
Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants
Time frame: baseline
Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants
Time frame: About 6 months after last dose of vaccine.

Results and safety

Results posted to the registry on 3 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High-Dose Trivalent Inactivated Influenza Vaccine	34	30
Standard Dose Trivalent Inactivated Influenza Vaccine	16	16

Primary outcome: Local Reactions After Each Vaccination

Time frame: From baseline to 7 days after each vaccination. Count of participants. Unit: Participants

Measure	High-Dose Trivalent Inactivated Influenza Vaccine n = 30	Standard Dose Trivalent Inactivated Influenza Vaccine n = 16
Pain	12	7
Tenderness	14	9
Intense Swelling	3	3
Redness	4	2

Primary outcome: Systemic Reaction

Time frame: From baseline to 7 days after each vaccination. Count of participants. Unit: Participants

Measure	High-Dose Trivalent Inactivated Influenza Vaccine n = 30	Standard Dose Trivalent Inactivated Influenza Vaccine n = 16
Fatigue	14	14
Decrease in Activity	13	7
Fever	4	3
Headache	6	9
Nausea	7	6
Body aches	6	3
Vomiting	2	7

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High-Dose Trivalent Inactivated Influenza Vaccine	9 of 34 (26.5%)	21 of 34 (61.8%)	0 of 34
Standard Dose Trivalent Inactivated Influenza Vaccine	6 of 16 (37.5%)	14 of 16 (87.5%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pediatric Patients With Acute Lymphoblastic Leukemia

RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
RecruitingPhase 2
Ruxolitinib With Tacrolimus and Methotrexate for the Prevention of Graft Versus Host Disease in Pediatric and Young Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Recruiting
Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
Melanoma Stage III, B-cell Non Hodgkin Lymphoma
RecruitingPhase 1
A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)
Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia, Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Natasha Halasa, M.D. principal investigator

Vanderbilt Universtiy Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local Reactions After Each Vaccination (time frame: From baseline to 7 days after each vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01216332.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.