Vaccination for Children of H&O and Their Parents

Not Applicable

Recruiting

• Conditions: Hematologic Malignancy; Solid Tumor, Childhood; Vaccination
• Interventions: Other: No Vaccination; Biological: Vaccination

• Registration Number: NCT03373656
• Lead Sponsor: Children's Cancer Group, China

Brief 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.

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 Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-12-13
• Study First Posted: 2017-12-14
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-23
• Last Update Posted: 2022-07-26
• Primary Completion: 2025-07
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high antibody titers	No Vaccination	Antibody titers higher than protection level
low antibody titers	Vaccination	Antibody titers lower than protection level

Primary Outcome Measures

Name	Time	Method
Number of participants with vaccination-related adverse events	2 years
The level of serum antibody increased after vaccination	2 years
Number of parents of children willing to be vaccinated after receiving relevant knowledge propagation	2 years

Trial Locations

Locations (1)

Shanghai Children's Medical Center; 🇨🇳 Shanghai, Shanghai, China