NCT02692599

Safety and Immunogenicity Study of Live Attenuated Mumps Vaccines in Healthy Infants

A Blind, Randomized and Controlled Clinical Trial With Live Attenuated Mumps Vaccines in Healthy Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,150 (actual)
• Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd. · Industry
• Sex: All
• Age: 8 Months – 18 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated mumps vaccine in healthy infants between 8 - 18 months old with a commercialized live attenuated mumps vaccine as the control vaccine.

Detailed description

This study is a randomized, blind, single-center, controlled phase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated mumps vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control vaccine is a commercialized live attenuated mumps vaccine manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd. All participants are healthy infants between 8 - 18 months old, and will be randomly assigned into experimental group or control group in the ratio 1:1.

Conditions

• Mumps

Interventions

Type	Name	Description
BIOLOGICAL	investigational live attenuated mumps vaccine	The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
BIOLOGICAL	control live attenuated mumps vaccine	The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-03-01
• Completion: 2016-07-15
• First posted: 2016-02-26
• Last updated: 2017-10-26

Locations

1 site across 1 country: China