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

Centers for Disease Control and Prevention, China

Status and phase: Completed; Phase 4

Conditions: Rubella; Mumps; Measles; Adverse Event Following Immunisation

Treatments: Biological: Measles, mumps and rubella Combined Vaccine, Live

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03160820

BJCDCWJ201601

Details and patient eligibility

About

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).

Full 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.

Enrollment: 873 patients

Sex: All

Ages: 18 months to 6 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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873 participants in 4 patient groups

one dose of MMR

Other group

Description:

Subjects are vaccinated with MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 months old.

Treatment:

Biological: Measles, mumps and rubella Combined Vaccine, Live

30 months after two doses of MMR

Other group

Description:

Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 4 years old, sequentially.

Treatment:

Biological: Measles, mumps and rubella Combined Vaccine, Live

42 months after two doses of MMR

Other group

Description:

Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 5 years old, sequentially.

Treatment:

Biological: Measles, mumps and rubella Combined Vaccine, Live

54 months after two doses of MMR

Other group

Description:

Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 6 years old, sequentially.

Treatment:

Biological: Measles, mumps and rubella Combined Vaccine, Live