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Vaccination for Children of H&O and Their Parents

Primary Purpose

Vaccination, Hematologic Malignancy, Solid Tumor, Childhood

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Vaccination

No Vaccination

About this trial

This is an interventional prevention trial for Vaccination focused on measuring Vaccination, Childhood, Hematologic Malignancy, Solid Tumor, Immune Deficiency

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shanghai Children's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

low antibody titers

high antibody titers

Arm Description

Antibody titers lower than protection level

Antibody titers higher than protection level

Outcomes

Primary Outcome Measures

Number of parents of children willing to be vaccinated after receiving relevant knowledge propagation

Number of participants with vaccination-related adverse events

The level of serum antibody increased after vaccination

Secondary Outcome Measures

Full Information

NCT ID

NCT03373656

First Posted

October 18, 2017

Last Updated

July 23, 2022

Sponsor

Children's Cancer Group, China

Collaborators

Shanghai Pudong District Center for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT03373656

Brief Title

Vaccination for Children of H&O and Their Parents

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2017 (Actual)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Cancer Group, China

Collaborators

Shanghai Pudong District Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vaccination, Hematologic Malignancy, Solid Tumor, Childhood

Keywords

Vaccination, Childhood, Hematologic Malignancy, Solid Tumor, Immune Deficiency

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

low antibody titers

Arm Type

Experimental

Arm Description

Antibody titers lower than protection level

Arm Title

high antibody titers

Arm Type

Other

Arm Description

Antibody titers higher than protection level

Intervention Type

Biological

Intervention Name(s)

Vaccination

Intervention Description

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

Other

Intervention Name(s)

No Vaccination

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of parents of children willing to be vaccinated after receiving relevant knowledge propagation

Time Frame

2 years

Title

Number of participants with vaccination-related adverse events

Time Frame

2 years

Title

The level of serum antibody increased after vaccination

Time Frame

2 years

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yi-Jin Gao, MD

Phone

86-21-38626161

Ext

82064

gaoyijin@scmc.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Xing-Wei Wang, MD

Phone

86-21-38626161

Ext

82064

wangxingwei@scmc.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi-Jin Gao, MD

Organizational Affiliation

Shanghai Children's Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Children's Medical Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200127

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi-Jin Gao, MD

Phone

0086-21-38626161

gaoyijin@scmc.com.cn

First Name & Middle Initial & Last Name & Degree

Xing-Wei Wang, MD

Phone

0086-21-38626161

wangxingwei@scmc.com.cn

12. IPD Sharing Statement

Learn more about this trial

Vaccination for Children of H&O and Their Parents

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