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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Weijun Hu, Master | Shaanxi Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baoji Center for Disease Prevention and Control | Baoji | Shanxi | 721006 | China | ||
| Xianyang Center for Disease Control and Prevention |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37733724 | Derived | 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. |
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| ID | Term |
|---|---|
| D009107 | Mumps |
| ID | Term |
|---|---|
| D019351 | Rubulavirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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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.
| Xianyang |
| Shanxi |
| 712000 |
| China |
| Yanan Center for Disease Prevention and Control | Yan’an | Shanxi | 716000 | China |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |