Vaccination for Children of H&O and Their Parents

July 23, 2022 updated by: Children's Cancer Group, China

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Shanghai Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: low antibody titers
Antibody titers lower than protection level
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: high antibody titers
Antibody titers higher than protection level
Other: No Vaccination
Patients with higher antibody titers will NOT accept vaccination. But we will keep monitoring their antibody titers.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Cancer Group, China

Collaborators

Shanghai Pudong District Center for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2017

Primary Completion (ANTICIPATED)

July 1, 2025

Study Completion (ANTICIPATED)

September 1, 2025

Study Registration Dates

First Submitted

October 18, 2017

First Submitted That Met QC Criteria

December 13, 2017

First Posted (ACTUAL)

December 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 23, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCGChina-CCSR-V

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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