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

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ClinicalTrials.gov Identifier: NCT03160820
Recruitment Status : Completed
First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
Collaborator:
Beijing Tiantan Biological Products Co., Ltd
Information provided by (Responsible Party):
Wu Jiang, Centers for Disease Control and Prevention, China

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).

Condition or disease Intervention/treatment Phase
Measles Mumps Rubella Adverse Event Following Immunisation Biological: Measles, mumps and rubella Combined Vaccine, Live Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 873 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Immunization Schedules of Beijing Tiantan Biological's MMR Vaccine in 18-72 Month-Old Children
Study Start Date : March 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Measles Mumps Rubella

Arm Intervention/treatment
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 Name: Beijing Tiantan Biological Products Co., Ltd

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 Name: Beijing Tiantan Biological Products Co., Ltd

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 Name: Beijing Tiantan Biological Products Co., Ltd

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 Name: Beijing Tiantan Biological Products Co., Ltd




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160820


Locations
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China, Hebei
Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, China, 050021
China, Inner Mongolia
Inner Mongolia Center for Disease Control and Prevention
Hohhot, Inner Mongolia, China, 010031
China, Shanxi
Shanxi Provincial Center for Disease Control and Prevention
Taiyuan, Shanxi, China, 030012
China, Tianjin
Tianjin Center for Disease Control and Prevention
Tianjin, Tianjin, China, 300011
Sponsors and Collaborators
Centers for Disease Control and Prevention, China
Beijing Tiantan Biological Products Co., Ltd
Investigators
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Principal Investigator: Jiang Wu Beijing Center for Diseases Control and Prevention

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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
ClinicalTrials.gov Identifier: NCT03160820     History of Changes
Other Study ID Numbers: BJCDCWJ201601
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Measles
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubivirus Infections
Togaviridae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs