Vaccination for Children of H&O and Their Parents

Children's Cancer Group, China

Status: Enrolling

Conditions: Hematologic Malignancy; Vaccination; Solid Tumor, Childhood

Treatments: Other: No Vaccination; Biological: Vaccination

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT03373656

CCGChina-CCSR-V

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

low antibody titers

Experimental group

Description:

Antibody titers lower than protection level

Treatment:

Biological: Vaccination

high antibody titers

Other group

Description:

Antibody titers higher than protection level

Treatment:

Other: No Vaccination