CompletedNCT03160820Updated May 19, 2017

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

A Phase 4 interventional study of Measles, mumps and rubella Combined Vaccine, Live in Measles, Mumps and Rubella, sponsored by Centers for Disease Control and Prevention, China. Completed at 4 sites in China. Open to participants aged 18 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-19.

Sponsored by Centers for Disease Control and Prevention, China · Phase 4, Interventional, and Prevention

Phase: Phase 4
Study type: Interventional
Enrollment: 873
Allocation: Non-randomized
Ages: 18 Months to 6 Years
Sex: All

Study summary

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).

Read the 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.

Conditions studied

Measles
Mumps
Rubella
Adverse Event Following Immunisation

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In context

Measles

120 studies on the registry are indexed under Measles; 17 are open to participants now.

This study's enrollment of 873 is above the median of 540 across 93 interventional studies indexed under Measles.

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Lead sponsor

Centers for Disease Control and Prevention, China is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

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

Who can participate

Ages eligible: 18 Months to 6 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 873 participants (actual)

Study arms

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
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
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
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

Interventions

BiologicalMeasles, mumps and rubella Combined Vaccine, Live
Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.
Also known as: Beijing Tiantan Biological Products Co., Ltd

What researchers measure

Primary outcomes

Immunogenicity of the MMR vaccines in terms of antibody concentration
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.
Time frame: through study completion, an average of 1 year

Study locations

4 sites

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03160820
Lead sponsor: Centers for Disease Control and Prevention, China
Collaborators: Beijing Tiantan Biological Products Co., Ltd.
Responsible party: Wu Jiang (Director of Department of Immunization and Prevention,Beijing Center for Disease Control and Prevention. Principal Investigator, Public Health Chief Physician, Centers for Disease Control and Prevention, China) — Principal investigator
First posted: May 19, 2017
Start date: Mar 2016
Primary completion: Dec 2016
Completion: Feb 2017
Last update: May 19, 2017

Study contacts

Jiang Wu

principal investigator · Beijing Center for Diseases Control and Prevention

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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