Vaccination for Children of H&O and Their Parents

NCT03373656 | Unknown DMC

• 1 other identifier: CCGChina-CCSR-V
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccination; Hematologic Malignancy; Solid Tumor, Childhood

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

low antibody titers

EXPERIMENTAL

Antibody titers lower than protection level

Biological: Vaccination

high antibody titers

OTHER

Antibody titers higher than protection level

Other: No Vaccination

Interventions

Vaccination BIOLOGICAL

Patients with higher antibody titers will accept vaccination. There are two vaccines provided in this study: hepatitis B vaccine measles-rubella combined vaccine

low antibody titers

No Vaccination OTHER

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

high antibody titers

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Cancer Group, China: lead
• Shanghai Pudong District Center for Disease Control and Prevention: collaborator

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Immunologic Deficiency Syndromes

Interventions

Vaccination

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Yi-Jin Gao, MD

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Jin Gao, MD

CONTACT

86-21-38626161; gaoyijin@scmc.com.cn

Xing-Wei Wang, MD

CONTACT

86-21-38626161; wangxingwei@scmc.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: December 14, 2017
• Study Start: May 1, 2017
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

CN (1)