NCT04364399

Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine

Randomized, Double-blind, Controlled Phase Ⅳ Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine in Healthy Infants Aged 8 ~12 Months.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 920 (actual)
• Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd. · Industry
• Sex: All
• Age: 8 Months – 12 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of mumps vaccine in healthy infants aged 8-12months, compared with measles, mumps and rubella combined vaccine, live (MMRV).

Detailed description

The study is a randomized, double-blind, controlled phase Ⅳ clinical trial. And 920 infants will be assigned to investigational group and controlled group in a 1:1 ratio. The investigational vaccine is manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The controlled vaccine is manufactured by Shanghai institute of biological products Co., Ltd.

Conditions

• Mumps

Interventions

Type	Name	Description
BIOLOGICAL	Mumps vaccine	One dose of mumps vaccine: 0.5 ml per dose, mumps live virus not less than 3.7 lg CCID50
BIOLOGICAL	measles, mumps and rubella combined vaccine, live	One dose of measles, mumps and rubella combined vaccine, live: 0.5 ml per dose, mumps live virus not less than 4.3 lg CCID50

Timeline

• Start date: 2020-11-18
• Primary completion: 2020-11-18
• Completion: 2021-04-07
• First posted: 2020-04-28
• Last updated: 2021-08-18

Locations

1 site across 1 country: China