Clinical trial NCT03160820: Study on Immunization Schedule of Beijing Tiantan Biological's Measles-mumps-rubella(MMR) Vaccine
Official title: Comparison of Immunization Schedules of Beijing Tiantan Biological's MMR Vaccine in 18-72 Month-Old Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Measles
Mumps
Rubella
Adverse Event Following Immunisation
Lead sponsor: Centers for Disease Control and Prevention, China
Sponsor class: OTHER_GOV
Collaborators: name: Beijing Tiantan Biological Products Co., Ltd.
First posted: 2017-05-19
Enrollment: 873
Sex: ALL
Minimum age (years): 18
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Eligibility 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;

Primary outcomes:
measure: Immunogenicity of the MMR vaccines in terms of antibody concentration
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei Provincial Center for Disease Control and Prevention
state: Hebei
city: Hohhot
country: China
facility: Inner Mongolia Center for Disease Control and Prevention
state: Inner Mongolia
city: Taiyuan
country: China
facility: Shanxi Provincial Center for Disease Control and Prevention
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Center for Disease Control and Prevention
state: Tianjin
Study officials:
affiliation: Beijing Center for Diseases Control and Prevention
name: Jiang Wu
role: PRINCIPAL_INVESTIGATOR
References: