NCT05161845

Clinical Trial of Measles, Mumps and Rubella Combined Vaccine, Live

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,068 (actual)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 8 Months – 12 Months
• Healthy volunteers: Accepted

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.

Conditions

• Immunotoxicity
• Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Measles, Mumps and Rubella Combined Vaccine, Live	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.

Timeline

• Start date: 2021-12-23
• Primary completion: 2022-04-04
• Completion: 2022-10-01
• First posted: 2021-12-17
• Last updated: 2023-08-14

Locations

1 site across 1 country: China