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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.

Current Primary Outcome: The seroconversion rates (SCRs) of susceptible subjects in each group [ Time Frame: 28 days ]

Subjects whose pre-immune HI antibody level < 1:2 are considered susceptible; among these subjects, those with post-immune HI antibody level ≥ 1:2 are considered seroconverted.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The incidences of adverse events (AEs) of each group [ Time Frame: 28 days ]
    AEs occurred within 28 days after injection will be collected.
  • The incidences of serious adverse events (SAEs) of each group [ Time Frame: 28 days ]
    SAEs occurred within 28 days after injection will be collected.
  • The post-immune geometric mean titers (GMTs) of susceptible subjects in each group [ Time Frame: 28 days ]
    Subjects whose pre-immune HI antibody level < 1:2 are considered susceptible.
  • The overall SCRs of each group [ Time Frame: 28 days ]
    Subjects whose pre-immune HI antibody level < 1:2 and post-immune antibody level ≥ 1:2, or those whose pre-immune antibody level ≥ 1:2 and the increase of post-immune HI antibody level ≥ 4 folds are considered seroconverted.
  • The overall post-immune GMTs of each group [ Time Frame: 28 days ]
    The GMTs of all the subjects in each group.


Original Secondary Outcome: Same as current

Information By: Sinovac (Dalian) Vaccine Technology Co., Ltd.

Dates:
Date Received: February 23, 2016
Date Started: January 2016
Date Completion: May 2016
Last Updated: May 3, 2016
Last Verified: April 2016