NCT06208683

The Immunogenicity and Safety of the Booster Doses of a Live-attenuated Mumps Vaccine in Junior High School Students

The Immunogenicity and Safety of the Booster Doses of a Live-attenuated Mumps Vaccine Administrated Alone and Concomitantly With a Quadrivalent Inactivated Influenza Vaccine in Junior High School Students

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Mumps
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Mumps vaccine, Live (MV)	0.5mL per dose,containing ≥3.7 lg CCID50 live mumps virus
BIOLOGICAL	Influenza Vaccine, inactivated, quadrivlent(QIV)	0.5mL per dose, containing 4 strains of influenza virus recommended by the WHO, 15ug of each strain.

Timeline

• Start date: 2023-11-04
• Primary completion: 2024-02-02
• Completion: 2024-12-01
• First posted: 2024-01-17
• Last updated: 2024-01-17

Locations

3 sites across 1 country: China