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Clinical Trial Summary

This study is a randomized, controlled, open-label phase Ⅳ clinical trial of a live attenuated mumps vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the booster doses of a mumps vaccine administrated alone and concomitantly with a quadrivalent inactivated influenza vaccine in healthy junior high school students. And the cross-neutralization of mumps vaccine immune serum and mumps virus strains


Clinical Trial Description

This study is an open-lable, randomised, controlled phase Ⅳ clinical trial in healthy junior high school students to the immunogenicity and safety of the booster doses of a mumps vaccine (MV) administrated alone and concomitantly with a quadrivalent influenza vaccine (QIV) in healthy junior high school students. The experimental vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. A total of 400 healthy students will be enrolled, including 300 students who have received one dose of mumps-containing vaccine (MCV) before vaccination, and 100 students who have received two doses of mumps-containing vaccine before vaccination. 300 students with a history of 1 dose of MCV will be randomly divided into 3 groups in a ratio of 1:1:1, and will receive 1 dose of MV alone, 1 dose of QIV alone, or 1 dose of MV and 1 dose of QIV simultaneously. Students with a history of 2 doses of MCV received 1 dose of MV alone. Blood samples were collected before and 30 days after vaccination. Pre-vaccination blood samples were used to detect antibody levels of measles, mumps, influenza and varicella, and post-vaccination blood samples were used to detect mumps antibodies and/or influenza antibodies corresponding to the vaccination. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06208683
Study type Interventional
Source Sinovac Biotech Co., Ltd
Contact
Status Active, not recruiting
Phase Phase 4
Start date November 4, 2023
Completion date December 1, 2024

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