A Phase IV Randomized, Blinded Clinical Trial to Assess Measles Mumps and Rubella Combined Vaccine, Live, (MMR) Lot-to-lot Consistency in Healthy Chinese Children at the Age of 8-12 Months
Status: Completed
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
To evaluate the immunogenicity, lot-to-lot consistency and safety of three consecutive batches of Measles, Mumps and Rubella Combined Vaccine, Live.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 8 months
Maximum Age: 1
Healthy Volunteers: t
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⁃ Provide vaccination certificate and birth certificate for healthy children aged 8-12 months;
• Volunteers' legal guardian informed consent, volunteered to participate and signed an informed consent form；
• The volunteer's legal guardian has the ability to understand the research procedures, use the thermometer, scale and fill in the diary card as required, and can complete the clinical study in accordance with the requirements of the clinical trial protocol.
Locations
Other Locations
China
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing
Time Frame
Start Date: 2021-12-23
Completion Date: 2022-10-01
Participants
Target number of participants: 1068
Treatments
Experimental: Experimental group
Participants randomized to receive one injections of 0.5 mL Measles, Mumps and Rubella Combined Vaccine, Live at Day 0.
Authors
Related Therapeutic Areas
Sponsors
Leads: Shanghai Institute Of Biological Products