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Completed

NCT Number: NCT03160820

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

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).

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Key information

Age range

18 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hebei Provincial Center for Disease Control and Prevention, Shijiazhuang, Hebei, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Measles, mumps and rubella Combined Vaccine, Live

Biological

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention, China

Other Gov

Collaborators

  • Beijing Tiantan Biological Products Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 19, 2017
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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