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

NCT ID: NCT03160820

Last Updated: 2017-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

873 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-02-28

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Measles Mumps Rubella Adverse Event Following Immunisation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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one dose of MMR

Subjects are vaccinated with MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 months old.

Group Type OTHER

Measles, mumps and rubella Combined Vaccine, Live

Intervention Type BIOLOGICAL

Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.

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.

Group Type OTHER

Measles, mumps and rubella Combined Vaccine, Live

Intervention Type BIOLOGICAL

Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.

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.

Group Type OTHER

Measles, mumps and rubella Combined Vaccine, Live

Intervention Type BIOLOGICAL

Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.

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.

Group Type OTHER

Measles, mumps and rubella Combined Vaccine, Live

Intervention Type BIOLOGICAL

Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.

Interventions

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Measles, mumps and rubella Combined Vaccine, Live

Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.

Intervention Type BIOLOGICAL

Other Intervention Names

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Beijing Tiantan Biological Products Co., Ltd

Eligibility Criteria

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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;
Minimum Eligible Age

18 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Tiantan Biological Products Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Centers for Disease Control and Prevention, China

OTHER_GOV

Sponsor Role lead

Responsible Party

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Wu Jiang

Director of Department of Immunization and Prevention,Beijing Center for Disease Control and Prevention. Principal Investigator, Public Health Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiang Wu

Role: PRINCIPAL_INVESTIGATOR

Beijing Center for Diseases Control and Prevention

Locations

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Hebei Provincial Center for Disease Control and Prevention

Shijiazhuang, Hebei, China

Site Status

Inner Mongolia Center for Disease Control and Prevention

Hohhot, Inner Mongolia, China

Site Status

Shanxi Provincial Center for Disease Control and Prevention

Taiyuan, Shanxi, China

Site Status

Tianjin Center for Disease Control and Prevention

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Other Identifiers

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BJCDCWJ201601

Identifier Type: -

Identifier Source: org_study_id

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