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

Measles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160820
• Other study ID #: BJCDCWJ201601
• Status: Completed
• Phase: Phase 4
• First received: May 10, 2017
• Last updated: May 17, 2017
• Start date: March 2016
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: Centers for Disease Control and Prevention, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 873
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 6 Years

Eligibility

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;

Related Conditions & MeSH terms

• Adverse Event Following Immunisation
• Measles
• Mumps
• Rubella

Intervention

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.

Locations

Country	Name	City	State
China	Inner Mongolia Center for Disease Control and Prevention	Hohhot	Inner Mongolia
China	Hebei Provincial Center for Disease Control and Prevention	Shijiazhuang	Hebei
China	Shanxi Provincial Center for Disease Control and Prevention	Taiyuan	Shanxi
China	Tianjin Center for Disease Control and Prevention	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention, China	Beijing Tiantan Biological Products Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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