Vaccination for Children of H&O and Their Parents

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vaccination, Hematologic Malignancy, Solid Tumor, Childhood

Intervention / Treatment
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* Biological: Vaccination
* Other: No Vaccination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low antibody titers<br>Antibody titers lower than protection level | Biological: Vaccination<br>* Patients with higher antibody titers will accept vaccination. There are two vaccines provided in this study: hepatitis B vaccine measles-rubella combined vaccine<br>|
| Other: high antibody titers<br>Antibody titers higher than protection level | Other: No Vaccination<br>* Patients with higher antibody titers will NOT accept vaccination. But we will keep monitoring their antibody titers.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccination, Childhood, Hematologic Malignancy, Solid Tumor, Immune Deficiency