Childhood CancerPhase 2NCT00505063
Prospective Trial of Vaccine Responses in Childhood Cancer Survivors
A Phase 2 study testing Immunization Schedule patients <7 years., Immunization Schedule patients > or = to 7 years and <11 years of age and Immunization Schedule patients > or = to 11 years of age in people with Childhood Cancer and Multiple Diseases, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Childhood Cancer, Multiple Diseases
- What is being tested?
- Immunization Schedule patients <7 years., Immunization Schedule patients > or = to 7 years and <11 years of age and Immunization Schedule patients > or = to 11 years of age
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2007to 11 Jun 2025
- Phase
- Phase 2
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient must be < or less 18 years of age at cancer diagnosis
- Patient must be 3 to 24months following completion of chemotherapy for malignant disease.
- For patients <12 months following completion of therapy, CR must be documented within 3 months of enrollment.
- For patients >12 months, CR must be documented at approximately 12 months and then only as clinically indicated
- For patients with leukemia: bone marrow aspirate defined as <5% blasts, absence of cytogenetic abnormality by FISH or karyotype (if applicable) and no evidence of CSF involvement (if applicable) ii. For patients with solid tumors remission will be determined by appropriate radiologic scans, and other tests, including bone marrow aspirate and biopsies demonstrating absence of extrinsic cells and absence of specific FISH or cytogenetic abnormality (if applicable), iii. For patients with lymphoma, remission will be determined by bone marrow aspirate and biopsy, radiologic scans and other tests. Bone marrow will show <5% blasts, absence of cytogenetic abnormality by FISH or karyotype (if applicable), and flow cytometry (if lymphoma specific marker present) and absence of CNS disease by spinal fluid (if applicable)
- Patient may be of either gender and of any ethnic background
- Patients or their guardians must be able to understand the nature and risk of the proposed study and be able to sign consent.
Who cannot join
- Karnofsky score <70%.
- Female patients who are pregnant or lactating.
- Patients who have received an autologous or allogeneic HCT.
- Active uncontrolled bacterial or fungal infection.
- Patients who have a history of previous allergic reaction to vaccinations currently recommended by the ACIP.
- Patients on any immunosuppressive drugs.
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- HIV-1,2 sero-positive patients.
- Patients or guardians not signing informed consent.
- Patients with prior allergic reaction to any vaccine component or to latex.
- Patients who have received Rituximab.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Phase II Prospective Trial of Vaccine Responses in Childhood Cancer Survivors
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.
- Conditions
- Childhood Cancer, Multiple Diseases
- Being tested
- Immunization Schedule patients <7 years., Immunization Schedule patients > or = to 7 years and <11 years of age, Immunization Schedule patients > or = to 11 years of age
- Keywords
- vaccine, childhood, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunization Schedule patients <7 years.Biological
Also called vaccine, Prevnar 13, vaccine, Menactra II, Measles, mumps, rubella, MMR, Live, attenuated varicella vaccine, Varivax
- Time 0 months: Prevnar 13 #1, Hib #1
- Time 1 months: Pediarix #1
- Time 2 months: Prevnar 13 #2, Hib #2
- Time 3-4 months: Pediarix #2
- Time 4-6 months: Draw post vaccine titers
- Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.
Immunization Schedule patients > or = to 7 years and <11 years of ageBiological
Also called vaccine, Prevnar 13, vaccine, Menactra II, Measles, mumps, rubella, MMR, Live, attenuated varicella vaccine, Varivax
- Time 0 months: Hib #1, Prevnar 13 #1, Hepatitis B #1
- Time 1 month: Td#1, IPV #1(inactivated polio virus vaccine), Hepatitis B #2
- Time 2-3 months: Prevnar 13 #2, Hib #2
- Time 3-6 months: Td #2, Draw post vaccine titers Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.
Immunization Schedule patients > or = to 11 years of ageBiological
- Time 0 month: Hib#1, Prevnar 13#1, Hepatitis B #1
- Time 1 month: Tdap(BOOSTRIX), Hepatitis B #2
- Time 2-3 months: Hib #2, Prevnar 13#2, Menactra
- Time 3-6 months: IPV, Draw post vaccine titers
- Time 6-12 months: Gardasil (dose #2 given 2 months after first dose, and dose #3 given 6 months after first dose)
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Immunization Schedule patients <7 years. Receives: Biological: Immunization Schedule patients <7 years. |
| B | Other | Immunization Schedule patients > or = to 7 years and <11 years of age Receives: Biological: Immunization Schedule patients > or = to 7 years and <11 years of age |
| C | Other | Immunization Schedule patients > or = to 11 years of age Receives: Biological: Immunization Schedule patients > or = to 11 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Protective Antibody Titers After Vaccination
To prospectively determine the response rate and duration of protective titers following revaccination with routine childhood immunizations in pediatric survivors of childhood cancer.
Measured: Up to 2 years
Secondary outcomes (1)
Median Absolute Lymphocyte Count (ALC), the Absolute CD4+ T Cell Count, and the Absolute CD8+ T Cell Count at Baseline
The Absolute Lymphocyte Count (ALC), the absolute CD4+ T cell count, and the absolute CD8+ T cell count at baseline were the in-vitro parameters of lymphoid reconstitution.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study start10 Jul 2007
- Primary completion11 Jun 2025
- Study completion11 Jun 2025
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 Childhood CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Kernan, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505063
- Sponsor's protocol ID
- 07-088
- Status last verified
- Jun 2024
- First submitted
- 18 Jul 2007
- Last updated
- 29 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Prospective Trial of Vaccine Responses in Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT00505063
- Acronym / sponsor ID
- 07-088
- Conditions
- Childhood Cancer, Multiple Diseases
- Keywords
- vaccine, childhood, cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 10 Jul 2007 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 20 Jul 2007 (estimated)
- Results
- Posted 29 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Other | Biological: Immunization Schedule patients <7 years.Immunization Schedule patients <7 years. |
| B | Other | Biological: Immunization Schedule patients > or = to 7 years and <11 years of ageImmunization Schedule patients > or = to 7 years and <11 years of age |
| C | Other | Biological: Immunization Schedule patients > or = to 11 years of ageImmunization Schedule patients > or = to 11 years of age |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patient must be < or less 18 years of age at cancer diagnosis
- Patient must be 3 to 24months following completion of chemotherapy for malignant disease.
- Patient may be of either gender and of any ethnic background
- Patients or their guardians must be able to understand the nature and risk of the proposed study and be able to sign consent.
Key exclusion criteria (10 listed)
- Karnofsky score <70%.
- Female patients who are pregnant or lactating.
- Patients who have received an autologous or allogeneic HCT.
- Active uncontrolled bacterial or fungal infection.
- Patients who have a history of previous allergic reaction to vaccinations currently recommended by the ACIP.
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 |
|---|---|---|
| Immunization Schedule patients <7 years.Also: vaccine, Prevnar 13, vaccine, Menactra II, Measles, mumps, rubella, MMR, Live, attenuated varicella vaccine, Varivax* Time 0 months: Prevnar 13 #1, Hib #1 * Time 1 months: Pediarix #1 * Time 2 months: Prevnar 13 #2, Hib #2 * Time 3-4 months: Pediarix #2 * Time 4-6 months: Draw post vaccine titers * Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations. | Biological | A |
| Immunization Schedule patients > or = to 7 years and <11 years of ageAlso: vaccine, Prevnar 13, vaccine, Menactra II, Measles, mumps, rubella, MMR, Live, attenuated varicella vaccine, Varivax* Time 0 months: Hib #1, Prevnar 13 #1, Hepatitis B #1 * Time 1 month: Td#1, IPV #1(inactivated polio virus vaccine), Hepatitis B #2 * Time 2-3 months: Prevnar 13 #2, Hib #2 * Time 3-6 months: Td #2, Draw post vaccine titers Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations. | Biological | B |
| Immunization Schedule patients > or = to 11 years of age* Time 0 month: Hib#1, Prevnar 13#1, Hepatitis B #1 * Time 1 month: Tdap(BOOSTRIX), Hepatitis B #2 * Time 2-3 months: Hib #2, Prevnar 13#2, Menactra * Time 3-6 months: IPV, Draw post vaccine titers * Time 6-12 months: Gardasil (dose #2 given 2 months after first dose, and dose #3 given 6 months after first dose) | Biological | C |
Primary outcome
Percentage of Participants With Protective Antibody Titers After Vaccination
Time frame: Up to 2 years
To prospectively determine the response rate and duration of protective titers following revaccination with routine childhood immunizations in pediatric survivors of childhood cancer.
1 secondary outcome
Median Absolute Lymphocyte Count (ALC), the Absolute CD4+ T Cell Count, and the Absolute CD8+ T Cell Count at Baseline
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Nancy Kernan, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immunization Schedule patients <7 years., Immunization Schedule patients > or = to 7 years and <11 years of age and Immunization Schedule patients > or = to 11 years of age in people with Childhood Cancer and Multiple Diseases, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 7 inclusion and 10 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 29 Jul 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 29 Jul 2026). 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?
Percentage of Participants With Protective Antibody Titers After Vaccination (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2026.