Study on Immunization Schedule of Beijing Tiantan Biological's Measles-mumps-rubella(MMR) Vaccine

May 17, 2017 updated by: Wu Jiang, Centers for Disease Control and Prevention, China

Comparison of Immunization Schedules of Beijing Tiantan Biological's MMR Vaccine in 18-72 Month-Old Children

This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in subjects 18 months of age and older. The MMR vaccine may be administered as a second dose to 4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18 month-old subjects with one dose immunization with measles-rubella(MR).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in subjects 18 months of age and older.

The MMR vaccine may be administered as a second dose to 4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18 month-old subjects with one dose immunization with MR.

Immune efficacy and safety will be compared among different immunization schedules,including inoculation doses,enhanced immunity age,vaccination interval time.

Antibody persistence of 1 dose of MMR vaccine will be evaluated in this study.

Study Type

Interventional

Enrollment (Actual)

873

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050021
        • Hebei Provincial Center for Disease Control and Prevention
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010031
        • Inner Mongolia Center for Disease Control and Prevention
    • Shanxi
      • Taiyuan, Shanxi, China, 030012
        • Shanxi Provincial Center for Disease Control and Prevention
    • Tianjin
      • Tianjin, Tianjin, China, 300011
        • Tianjin Center for Disease Control and Prevention

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

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy children; 150 subjects 18 months old; 150 subjects 4 years old;300 subjects 5 years old; 150 subjects 6 years old; their guardians signed informed consent;
  • undiagnosed as measles, mumps and rubella;
  • in good health as determined by the outcome of medical history, physical examination and clinical judgment; suitable to MMR immunization;
  • guardians would comply with the requirements of the protocol;
  • immunized with MR or measles vaccine(MV) at 8 months old;immunized with MMR at 18 months old(not applicable to subjects 18 months old); unvaccinated by biological products within one month;
  • Axillary temperature ≤37℃;
  • the local household population or permanent population;

Exclusion Criteria:

  • history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(any previous vaccination history of allergies and egg allergy history);
  • Current confirmed as acute disease, severe chronic diseases or acute development of chronic diseases;
  • Participating in another clinical trial at the same time;

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: one dose of MMR
Subjects are vaccinated with MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 months old.
Biological: Measles, mumps and rubella Combined Vaccine, Live
Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.
Other Names:
  • Beijing Tiantan Biological Products Co., Ltd
Other: 30 months after two doses of MMR
Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 4 years old, sequentially.
Biological: Measles, mumps and rubella Combined Vaccine, Live
Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.
Other Names:
  • Beijing Tiantan Biological Products Co., Ltd
Other: 42 months after two doses of MMR
Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 5 years old, sequentially.
Biological: Measles, mumps and rubella Combined Vaccine, Live
Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.
Other Names:
  • Beijing Tiantan Biological Products Co., Ltd
Other: 54 months after two doses of MMR
Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 6 years old, sequentially.
Biological: Measles, mumps and rubella Combined Vaccine, Live
Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.
Other Names:
  • Beijing Tiantan Biological Products Co., Ltd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity of the MMR vaccines in terms of antibody concentration
Time Frame: through study completion, an average of 1 year

For measles virus, seroresponse is defined as post-vaccination anti-measles virus antibody concentration (Ab conc) >200 mIU/mL.

For mumps virus, seroresponse is defined as post-vaccination anti-mumps virus Ab conc >100 IU/mL.

For rubella virus, seroresponse is defined as post-vaccination anti-rubella virus Ab conc >20 IU/mL.
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Centers for Disease Control and Prevention, China

Collaborators

Beijing Tiantan Biological Products Co., Ltd.

Investigators

  • Principal Investigator: Jiang Wu, Beijing Center for Diseases 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

March 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

May 10, 2017

First Submitted That Met QC Criteria

May 17, 2017

First Posted (Actual)

May 19, 2017

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 17, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJCDCWJ201601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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