Vaccination for Children of H&O and Their Parents

Hematologic Malignancy Clinical Trial

Official title:

Study on Compliance, Safety and Effectivity of Vaccination for Children With Hematologic Malignancies or Solid Tumors and Their Parents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03373656
• Other study ID #: CCGChina-CCSR-V
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms
• Solid Tumor, Childhood
• Vaccination

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