Vaccination for Children of H&O and Their Parents

NCT ID: NCT03373656

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2025-09-30

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.

Conditions

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Vaccination Hematologic Malignancy Solid Tumor, Childhood

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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low antibody titers

Antibody titers lower than protection level

Group Type EXPERIMENTAL

Vaccination

Intervention Type BIOLOGICAL

Patients with higher antibody titers will accept vaccination. There are two vaccines provided in this study:

hepatitis B vaccine measles-rubella combined vaccine

high antibody titers

Antibody titers higher than protection level

Group Type OTHER

No Vaccination

Intervention Type OTHER

Patients with higher antibody titers will NOT accept vaccination. But we will keep monitoring their antibody titers.

Interventions

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Vaccination

Patients with higher antibody titers will accept vaccination. There are two vaccines provided in this study:

hepatitis B vaccine measles-rubella combined vaccine

Intervention Type BIOLOGICAL

No Vaccination

Patients with higher antibody titers will NOT accept vaccination. But we will keep monitoring their antibody titers.

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Pudong District Center for Disease Control and Prevention

UNKNOWN

Sponsor Role collaborator

Children's Cancer Group, China

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yi-Jin Gao, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Children's Medical Center

Locations

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Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi-Jin Gao, MD

Role: CONTACT

86-21-38626161 ext. 82064

Xing-Wei Wang, MD

Role: CONTACT

86-21-38626161 ext. 82064

Facility Contacts

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Yi-Jin Gao, MD

Role: primary

0086-21-38626161

Xing-Wei Wang, MD

Role: backup

0086-21-38626161

Other Identifiers

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CCGChina-CCSR-V

Identifier Type: -

Identifier Source: org_study_id

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