NCT03160820

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 873 (actual)
• Sponsor: Centers for Disease Control and Prevention, China · Other Government
• Sex: All
• Age: 18 Months – 6 Years
• Healthy volunteers: Accepted

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).

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

• Measles
• Mumps
• Rubella
• Adverse Event Following Immunisation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-12-01
• Completion: 2017-02-01
• First posted: 2017-05-19
• Last updated: 2017-05-19

Locations

4 sites across 1 country: China