Adverse Event Following Immunisation, Measles, Mumps, Rubella
Conditions
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.
Interventions
Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.
Sponsors
Beijing Tiantan Biological Products Co., Ltd.
Centers for Disease Control and Prevention, China
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Months to 6 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of the MMR vaccines in terms of antibody concentration | 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. |
Countries
China
Outcome results
None listed