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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03373656
Other study ID # CCGChina-CCSR-V
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date September 2025

Study information

Verified date July 2022
Source Children's Cancer Group, China
Contact Yi-Jin Gao, MD
Phone 86-21-38626161
Email gaoyijin@scmc.com.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date September 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: 1. Children patients(=18 years) who accepted chemotherapy, hematopoietic stem cell transplantation or splenectomy since our study started. 2. No history of hepatitis B and measles, do not suffer from other diseases that affect immune function and allergic diseases. Exclusion Criteria: 1. Children patients who did not reach clinical remission after treatment, critically ill or eventually died. 2. Patients who used monoclonal antibodies, especially anti-tumor necrosis factors. 3. Intermittent or low-dose chemotherapy or other immunosuppressive drugs users.

Study Design


Intervention

Biological:
Vaccination
Patients with higher antibody titers will accept vaccination. There are two vaccines provided in this study: hepatitis B vaccine measles-rubella combined vaccine
Other:
No Vaccination
Patients with higher antibody titers will NOT accept vaccination. But we will keep monitoring their antibody titers.

Locations

Country Name City State
China Shanghai Children's Medical Center Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Children's Cancer Group, China Shanghai Pudong District Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of parents of children willing to be vaccinated after receiving relevant knowledge propagation 2 years
Primary Number of participants with vaccination-related adverse events 2 years
Primary The level of serum antibody increased after vaccination 2 years
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