Study on Immunization Schedule of Beijing Tiantan Biological's Measles-mumps-rubella(MMR) Vaccine
Comparison of Immunization Schedules of Beijing Tiantan Biological's MMR Vaccine in 18-72 Month-Old Children
1 other identifier
interventional
873
1 country
4
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2016
Shorter than P25 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 10, 2017
CompletedFirst Posted
Study publicly available on registry
May 19, 2017
CompletedMay 19, 2017
May 1, 2017
9 months
May 10, 2017
May 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
through study completion, an average of 1 year
Study Arms (4)
one dose of MMR
OTHERSubjects are vaccinated with MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 months old.
30 months after two doses of MMR
OTHERSubjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 4 years old, sequentially.
42 months after two doses of MMR
OTHERSubjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 5 years old, sequentially.
54 months after two doses of MMR
OTHERSubjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 6 years old, sequentially.
Interventions
Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
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 Municipality, 300011, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiang Wu
Beijing Center for Diseases Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Immunization and Prevention,Beijing Center for Disease Control and Prevention. Principal Investigator, Public Health Chief Physician
Study Record Dates
First Submitted
May 10, 2017
First Posted
May 19, 2017
Study Start
March 1, 2016
Primary Completion
December 1, 2016
Study Completion
February 1, 2017
Last Updated
May 19, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share