Safety Study of Live Attenuated Mumps Vaccines in Junior High School Students Under 14 Years Old

NCT05145166 | Completed

• 1 other identifier: PRO-MUMPS-4007
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 3

Brief Summary

This study of live attenuated mumps vaccines is an observational study in which active monitoring and passive monitoring were combined to conduct safety observation.The live attenuated mumps vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The purpose of this study is to evaluate the safety of live attenuated mumps vaccines after large-scale application and accumulate safety data for the application of live attenuated mumps vaccines,and provide scientific basis for the formulation of vaccine immunization prevention strategies.

Conditions

Mumps

Outcome Measures

Primary Outcomes (2)

• Safety index-the incidence of local and systemic adverse reactions

  The incidence of local and systemic adverse reactions from 0 day to 14 days after vaccination.

  From 0 day to 14 days after vaccination

• Safety index-The incidence of local and systemic adverse reactions

  The incidence of local and systemic adverse reactions from 0 day to 30 days after vaccination.

  From 0 day to 30 days after vaccination.

Interventions

Safety group BIOLOGICAL

All of the participants(N=10000) received one dose of live attenuated mumps vaccine.Vaccine will given by single intramuscular injection(0.5 ml) on day 0.

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

In this study, only junior high school students under 14 years old who were judged by vaccination doctors to be eligible for vaccination and voluntarily received one dose of live attenuated mumps vaccine were enrolled.

You may qualify if:

• Junior high school students under 14 years old;
• The subjects and guardians of the subjects can understand and voluntarily sign the informed consent form ;
• Subjects and their legal guardians are able to attend follow-up visits and follow all study procedures (such as cooperating in completing safety observation notes)

Sponsors & Collaborators

• Sinovac (Dalian) Vaccine Technology Co., Ltd.: lead

Study Sites (3)

Baoji Center for Disease Prevention and Control

Baoji, Shanxi, 721006, China

Location

Xianyang Center for Disease Control and Prevention

Xianyang, Shanxi, 712000, China

Location

Yanan Center for Disease Prevention and Control

Yan’an, Shanxi, 716000, China

Location

Related Publications (1)

• Hu W, Jia N, Meng W, Zhou T, Wang R, Xiong Y, Luan C, Zhang S. Safety analysis of a live attenuated mumps vaccine in healthy adolescents in China: A phase 4, observational, open-label trial. PLoS One. 2023 Sep 21;18(9):e0291730. doi: 10.1371/journal.pone.0291730. eCollection 2023.

  PMID: 37733724 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

This study did not involve sample collection.Only adverse reactions/events at 30 minutes, 14 days and 30 days after vaccination of live attenuated mumps vaccine were collected by face-to-face or telephone follow-up.

MeSH Terms

Conditions

Mumps

Condition Hierarchy (Ancestors)

Rubulavirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Weijun Hu, Master

  Shaanxi Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 6, 2021
• Study Start: October 6, 2020
• Primary Completion: November 6, 2020
• Study Completion: March 25, 2021
• Last Updated: December 6, 2021

Record last verified: 2021-11

Locations

CN (3)