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Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Notable

    Results first posted: Jul 29, 2026

    Primary endpoint revised; Enrollment target: 76 to 75; Secondary endpoint revised

    Show what changed: Primary endpoints
    To prospectively determine the response rate and durationPercentage of protectiveParticipants titersWith followingProtective revaccinationAntibody withTiters routineAfter childhood immunizations in pediatric survivors of childhood cancer.Vaccination
    Show what changed: Secondary endpoints
    ToMedian determineAbsolute whetherLymphocyte inCount vitro(ALC), parametersthe ofAbsolute lymphoidCD4+ reconstitutionT correlateCell with responseCount, and durationthe ofAbsolute response.CD8+ T Cell Count at Baseline

    Study Status, Study Design, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv31

  2. Minor

    Trial status: Active, Not Recruiting to Completed

    Enrollment target: estimated 75 to confirmed 76; Primary and study completion dates changed from estimate of Jul 2025 to Jun 11, 2025; Start date: Jul 2007 to Jul 10, 2007; and 1 more

    Show all 5 changes in this update
    • Minor Trial status: Active, Not Recruiting to Completed
    • Minor Enrollment target: estimated 75 to confirmed 76
    • Minor Primary and study completion dates changed from estimate of Jul 2025 to Jun 11, 2025
    • Minor Start date: Jul 2007 to Jul 10, 2007
    • Minor Study site revised
      Show what changed
      Memorial Sloan-Kettering Cancer Center 1275 York Avenue

    Study Status, Study Design, Contacts/Locationsv30

  3. Notable

    Primary and study completion dates: Jul 2024 to Jul 2025

    Study Statusv29

  4. Notable

    Primary and study completion dates: Jul 2023 to Jul 2024

    Study Statusv28

  5. Minor

    Study Status

    Re-verified, no change to tracked fields

    v27

Show 25 earlier versions

  1. Notable

    Primary and study completion dates: Jul 2022 to Jul 2023

    Study Statusv26

  2. Notable

    Primary and study completion dates: Jul 2021 to Jul 2022

    Study Statusv25

  3. Notable

    Primary and study completion dates: Jul 2020 to Jul 2021

    Study Statusv24

  4. Notable

    Primary and study completion dates: Jul 2019 to Jul 2020

    Study Statusv23

  5. Notable

    Primary and study completion dates: Jul 2018 to Jul 2019

    Study Statusv22

  6. Notable

    Primary and study completion dates: Jul 2017 to Jul 2018

    Study Statusv21

  7. Minor

    Study Status, Contacts/Locations

    Re-verified, no change to tracked fields

    v20

  8. Notable

    Primary and study completion dates: Jul 2016 to Jul 2017

    Study Statusv19

  9. Notable

    Primary and study completion dates: Jul 2015 to Jul 2016

    Study Statusv18

  10. Notable

    Primary and study completion dates: Jul 2014 to Jul 2015

    Study Statusv17

  11. Minor

    Study Status, Contacts/Locations

    Re-verified, no change to tracked fields

    v16

  12. Notable

    Primary and study completion dates: Jul 2012 to Jul 2014

    Study Statusv15

  13. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised

    Study Status, Contacts/Locationsv14

  14. Minor

    Eligibility criteria expanded, about 3 words

    Show what changed: Eligibility criteria
    Inclusion Criteria: Patient must be < or less 18 years of age at cancer diagnosis Patient must be 3 to 24m [...]

    Study Status, Sponsor/Collaborators, Eligibilityv13

  15. Notable

    Primary and study completion dates: Jul 2011 to Jul 2012

    Study Status, Conditionsv12

  16. Minor

    2 amendments

    2 re-verifications since 2010-07-15, no change to tracked fields

    v10-v11

  17. Notable

    Primary and study completion dates: Jul 2010 to Jul 2011

    Site contact updated

    Study Status, Contacts/Locationsv9

  18. Minor

    Study Status

    Re-verified, no change to tracked fields

    v8

  19. Minor

    Study description shortened, about 56 words

    Show what changed: Study description
    To prospectively determine the response rate and duration of protective titers following revaccination with routine childhood immunizations in pediatric survivors of childhood cancer. To develop standardized recommendations for the revaccination of children following cancer treatment which can be pr [...]

    Study Status, Study Descriptionv7

  20. Minor

    Study Status

    Re-verified, no change to tracked fields

    v6

  21. Minor

    Interventions: Immunizations (Biological), Immunizations (Biological) to Immunization Schedule patients > or = to 11 years of age (Biological), Immunization Schedule patients > or = to 7 years and <11 years of…

    Study arms: 2 to 3

    Study Status, Arms and Interventions, Contacts/Locationsv5

  22. Minor

    Eligibility criteria expanded, about 28 words

    Show what changed: Eligibility criteria
    Inclusion Criteria: Patient must be <18 years of age at cancer diagnosis Patient must be 3 to 12 months24months following completion of chemotherapy for malignant disease. For withpatients <12 months following completion of therapy, CR must be documented CR within 3 months of startingenrollment. For re-vaccinationpatients >12 months, CR must be documented at approximately 12 months and then only as clinically indicated i. For patients with leukemia: bone marrow aspirate defined a [...] plicable) and no evidence of CSF involvement (if applicable) ii. For patients with solid tumors remission will be de [...] [...]

    Study Status, Eligibilityv4

  23. Minor

    Primary completion date: Jul 2010

    Eligibility criteria expanded, about 7 words

    Show what changed: Eligibility criteria
    Inclusion Criteria: Patient must be <18 years of age at cancer diagnosis Patient must be in remission 63 to 912 months following completion of chemotherapy for malignant disease with documented CR within 3 months of starting re-vaccination. For patients with leukemia: bone marrow aspirate defined a [...]

    Study Status, Eligibilityv3

  24. Notable

    Primary endpoint revised

    Completion date: Jul 2010; Interventions: Pediarix, Diphtheria/tetanus +/- Acellular pertussis vaccine, IPOL®: , IPV,.Haemophilus influenza b conjugate vaccine,Recombinant Hepatitis… to Immunizations (Biological), Immunizations (Biological); Secondary endpoint revised; and 1 more

    Show all 5 changes in this update
    • Notable Primary endpoint revised
      Show what changed
      IsTo toprospectively derivedetermine precisethe estimatesresponse rate and duration of responseprotective fortiters vaccinesfollowing revaccination with routine childhood immunizations in pediatric survivors of childhood cancer.
    • Minor Completion date: Jul 2010
    • Minor Interventions: Pediarix, Diphtheria/tetanus +/- Acellular pertussis vaccine, IPOL®: , IPV,.Haemophilus influenza b conjugate vaccine,Recombinant Hepatitis… to Immunizations (Biological), Immunizations (Biological)
    • Minor Secondary endpoint revised
      Show what changed
      IsTo todetermine assesswhether thein associationvitro betweenparameters vaccineof lymphoid reconstitution correlate with response and immunologicduration reconstitutionof factorsresponse.
    • Minor Study arms: 0 to 2

    Study Status, Sponsor/Collaborators, Arms and Interventions, Outcome Measuresv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will look at your body's response to the new immunizations. We want to see how well they will protect you. Immunization is the same as vaccination. Our goal is to protect you as much as we can. We do not want you to have the measles, mumps, or whooping cough. We are doing the study because there is no standard way to re-immunize people after cancer treatments.
Trial Details
NCT Number NCT00505063
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions Childhood Cancer, Multiple Diseases
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov