VaccinationNCT03373656
Vaccination for Children of H&O and Their Parents
A study testing Vaccination and No Vaccination in people with Vaccination and Hematologic Malignancy, run by Children's Cancer Group, China at 1 site in China.
Trial summary
The purpose of this study is to study on compliance, safety and effectivity of vaccination for children with hematologic malignancies or solid tumors and their parents. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Vaccination, Hematologic Malignancy, Solid Tumor, Childhood
- What is being tested?
- Vaccination and No Vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children patients(≤18 years) who accepted chemotherapy, hematopoietic stem cell transplantation or splenectomy since our study started.
- No history of hepatitis B and measles, do not suffer from other diseases that affect immune function and allergic diseases.
Who cannot join
- Children patients who did not reach clinical remission after treatment, critically ill or eventually died.
- Patients who used monoclonal antibodies, especially anti-tumor necrosis factors.
- Intermittent or low-dose chemotherapy or other immunosuppressive drugs users.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, 200127
Yi-Jin Gao, MD, 0086-21-38626161, gaoyijin@scmc.com.cn
Xing-Wei Wang, MD, 0086-21-38626161, wangxingwei@scmc.com.cn
About this study
Official title: Study on Compliance, Safety and Effectivity of Vaccination for Children With Hematologic Malignancies or Solid Tumors and Their Parents
The purpose of this study is to study on compliance, safety and effectivity of vaccination for children with hematologic malignancies or solid tumors and their parents.
Read the detailed description
Children with hematologic malignancies or solid tumors are all facing with immune deficiency due to the disease, the chemotherapy, the hematopoietic stem cell transplantation or the splenectomy, which greatly increases their chance to get infectious diseases. In this study, we will assess the compliance of children with hematologic malignancies or solid tumors and their parents to accept vaccination after finishing treatments, follow up with untoward effect questionnaires to assess the safety, obtain the serum of children patients to test antibody titers and assess the effectivity, provide clues for the study of vaccination in children with hematologic malignancies or solid tumors and provide a scientific basis for the formulation and reunification of vaccination programs.
- Conditions
- Vaccination, Hematologic Malignancy, Solid Tumor, Childhood
- Being tested
- Vaccination, No Vaccination
- Keywords
- Vaccination, Childhood, Hematologic Malignancy, Solid Tumor, Immune Deficiency
- Medical subject headings
- Hematologic Neoplasms, Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccinationBiological
Patients with higher antibody titers will accept vaccination. There are two vaccines provided in this study:
hepatitis B vaccine measles-rubella combined vaccine
No VaccinationOther
Patients with higher antibody titers will NOT accept vaccination. But we will keep monitoring their antibody titers.
| Study group | Role | What they receive |
|---|---|---|
| low antibody titers | Experimental | Antibody titers lower than protection level Receives: Biological: Vaccination |
| high antibody titers | Other | Antibody titers higher than protection level Receives: Other: No Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of parents of children willing to be vaccinated after receiving relevant knowledge propagation
Measured: 2 years
Number of participants with vaccination-related adverse events
Measured: 2 years
The level of serum antibody increased after vaccination
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start1 May 2017
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccinationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Group, China
- Sponsor type
- Research network
- Collaborators
- Shanghai Pudong District Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Yi-Jin Gao, MD, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373656
- Sponsor's protocol ID
- CCGChina-CCSR-V
- Status last verified
- Jul 2022
- First submitted
- 18 Oct 2017
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Compliance, Safety and Effectivity of Vaccination for Children With Hematologic Malignancies or Solid Tumors and Their Parents
- ClinicalTrials.gov ID
- NCT03373656
- Acronym / sponsor ID
- CCGChina-CCSR-V
- Conditions
- Vaccination, Hematologic Malignancy, Solid Tumor, Childhood
- Keywords
- Vaccination, Childhood, Hematologic Malignancy, Solid Tumor, Immune Deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Children's Cancer Group, ChinaResearch network
- Collaborators
- Shanghai Pudong District Center for Disease Control and Prevention
- Study start
- 1 May 2017 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study on compliance, safety and effectivity of vaccination for children with hematologic malignancies or solid tumors and their parents.
Detailed description
Children with hematologic malignancies or solid tumors are all facing with immune deficiency due to the disease, the chemotherapy, the hematopoietic stem cell transplantation or the splenectomy, which greatly increases their chance to get infectious diseases. In this study, we will assess the compliance of children with hematologic malignancies or solid tumors and their parents to accept vaccination after finishing treatments, follow up with untoward effect questionnaires to assess the safety, obtain the serum of children patients to test antibody titers and assess the effectivity, provide clues for the study of vaccination in children with hematologic malignancies or solid tumors and provide a scientific basis for the formulation and reunification of vaccination programs.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low antibody titers | Experimental | Biological: VaccinationAntibody titers lower than protection level |
| high antibody titers | Other | Other: No VaccinationAntibody titers higher than protection level |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children patients(≤18 years) who accepted chemotherapy, hematopoietic stem cell transplantation or splenectomy since our study started.
- No history of hepatitis B and measles, do not suffer from other diseases that affect immune function and allergic diseases.
Key exclusion criteria (3 listed)
- Children patients who did not reach clinical remission after treatment, critically ill or eventually died.
- Patients who used monoclonal antibodies, especially anti-tumor necrosis factors.
- Intermittent or low-dose chemotherapy or other immunosuppressive drugs users.
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 |
|---|---|---|
| VaccinationPatients with higher antibody titers will accept vaccination. There are two vaccines provided in this study: hepatitis B vaccine measles-rubella combined vaccine | Biological | low antibody titers |
| No VaccinationPatients with higher antibody titers will NOT accept vaccination. But we will keep monitoring their antibody titers. | Other | high antibody titers |
Primary outcome
Number of parents of children willing to be vaccinated after receiving relevant knowledge propagation
Time frame: 2 years
Number of participants with vaccination-related adverse events
Time frame: 2 years
The level of serum antibody increased after vaccination
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
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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.
Yi-Jin Gao, MD principal investigator
Shanghai Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccination and No Vaccination in people with Vaccination and Hematologic Malignancy, run by Children's Cancer Group, China at 1 site in China.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Jul 2022. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Jin Gao, MD (86-21-38626161 ext. 82064, gaoyijin@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of parents of children willing to be vaccinated after receiving relevant knowledge propagation (time frame: 2 years). The study lists 3 primary outcomes in all. 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 26 Jul 2022.