ClinicalTrials.gg
RecruitingNCT03373656Updated Jul 26, 2022

Vaccination for Children of H&O and Their Parents

An interventional study of Vaccination and No Vaccination in Vaccination, Hematologic Malignancy and Solid Tumor, Childhood, sponsored by Children's Cancer Group, China. Recruiting at 1 site in China. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2022-07-26.

Sponsored by Children's Cancer Group, China · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled May 2017, registered Oct 2017).
  • Started May 2017; still recruiting 9 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
Up to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Vaccination
  • Hematologic Malignancy
  • Solid Tumor, Childhood

Keywords

  • Vaccination
  • Childhood
  • Hematologic Malignancy
  • Solid Tumor
  • Immune Deficiency
03

In context

Hematologic Neoplasms

1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.

This study's planned enrollment of 300 is above the median of 46 across 1,044 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

Children's Cancer Group, China is the lead sponsor of 11 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Children patients(≤18 years) who accepted chemotherapy, hematopoietic stem cell transplantation or splenectomy since our study started.
  2. No history of and measles, do not suffer from other diseases that affect immune function and allergic diseases.

Exclusion criteria

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 drugs users.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    low antibody titers

    Antibody titers lower than protection level

    Biological: Vaccination

  • Other
    high antibody titers

    Antibody titers higher than protection level

    Other: No Vaccination

Interventions

  • BiologicalVaccination

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

  • OtherNo Vaccination

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

06

What researchers measure

Primary outcomes

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

    Time frame: 2 years

  2. Number of participants with vaccination-related adverse events

    Time frame: 2 years

  3. The level of serum antibody increased after vaccination

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03373656
Lead sponsor
Children's Cancer Group, China
Collaborators
Shanghai Pudong District Center for Disease Control and Prevention
Responsible party
Sponsor
First posted
Dec 14, 2017
Start date
May 1, 2017
Primary completion
Jul 2025 (estimated)
Completion
Sep 2025 (estimated)
Last update
Jul 26, 2022

Study contacts

Yi-Jin Gao, MD
Contact
gaoyijin@scmc.com.cn
86-21-38626161 ext. 82064
Xing-Wei Wang, MD
Contact
wangxingwei@scmc.com.cn
86-21-38626161 ext. 82064
Yi-Jin Gao, MD
principal investigator · Shanghai Children's Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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