Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China
NCT Number: NCT05161845
To evaluate the immunogenicity, lot-to-lot consistency and safety of three consecutive batches of Measles, Mumps and Rubella Combined Vaccine, Live.
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Notify Me8 month–12 month
All sexes
Interventional
Phase 4
Nanjing, Jiangsu, China
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, and the participants randomized to receive one injections of 0.5 mL Measles, Mumps and Rubella Combined Vaccine, Live at day 0.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Provide vaccination certificate and birth certificate for healthy children aged 8-12 months;
Exclusion criteria
0.5ml of reconstituted vaccine per container. 0.5 ml per single human dose containing not less than 3.0 lg CCID50 of both live measles virus and rubella virus and 4.3 lg CCID50 of live mumps virus.
Time frame: 42 days
GMC of measles, mumps and rubella antibodies should be compared 42 days after vaccination, and detected by enzyme-linked immunosorbent assay (ELISA).
Time frame: 42 days
Time frame: 42 days
The seroprevalence rate refers to the proportion of subjects whose serum antibodies are positive. The cut-off for seropositivity for the antibody titers is as follows:
Time frame: 14 days
The incidence of adverse events within 14 days after vaccination
Time frame: 42 days
All adverse events from day 0 to 42 after vaccination
Time frame: 180 days
Serious adverse events within 6 months after vaccination
Shanghai Institute Of Biological Products
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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