Trials / Completed
CompletedNCT05145166
Safety Study of Live Attenuated Mumps Vaccines in Junior High School Students Under 14 Years Old
Safety Observation of Live Attenuated Mumps Vaccines in Junior High School Students Under 14 Years Old Vaccinated With Live Attenuated Mumps Vaccines in Shanxi Province
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 10,000 (actual)
- Sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 14 Years
- Healthy volunteers
- Accepted
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.
Detailed description
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.Bao'ji, Xian'yang, Yan 'an and Han'zhong of Shaanxi Province were selected as the research center.A total of 10000 junior high school students under 14 years old who voluntarily received a dose of live attenuated mumps vaccines were be enrolled.Adverse reactions/events at 30 minutes, 14 days and 30 days after vaccination of live attenuated mumps vaccine were were collected by face-to-face or telephone follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Safety group | 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. |
Timeline
- Start date
- 2020-10-06
- Primary completion
- 2020-11-06
- Completion
- 2021-03-25
- First posted
- 2021-12-06
- Last updated
- 2021-12-06
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05145166. Inclusion in this directory is not an endorsement.