NCT05161845
Completed
Phase 4
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
Shanghai Institute Of Biological Products1 site in 1 country1,068 target enrollmentDecember 23, 2021
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Immunotoxicity
- Sponsor
- Shanghai Institute Of Biological Products
- Enrollment
- 1068
- Locations
- 1
- Primary Endpoint
- The geometric mean concentrations (GMC)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
To evaluate the immunogenicity, lot-to-lot consistency and safety of three consecutive batches of Measles, Mumps and Rubella Combined Vaccine, Live.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •The axillary body temperature on the day of enrollment was more than 37.0 ℃;
- •Have suffered from measles, mumps and rubella in the past or are suffering from measles, mumps and rubella;
- •Any previous vaccination containing measles, mumps and rubella;
- •Persons known to be allergic to any ingredient in the investigational vaccine;
- •Any previous history of vaccine or drug allergy;
- •Premature (delivered before the 37th week of pregnancy) and low weight (birth weight \< 2500g);
- •History of dystocia, asphyxia rescue and nervous system damage;
- •Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
- •Acute disease, serious chronic disease or acute attack of chronic disease on the day of vaccination;
- •Have a history of live attenuated vaccine within 28 days before vaccination and other vaccines within 7 days;
Outcomes
Primary Outcomes
The geometric mean concentrations (GMC)
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).
Secondary Outcomes
- The positive conversion rate of antibodies(42 days)
- Serious adverse events(180 days)
- The incidence of adverse events within 14 days(14 days)
- All adverse events(42 days)
- The Seropositivity rate(42 days)
Study Sites (1)
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