A Safety Study For Prevenar 13 Among Chinese Children
关键词
抽象
描述
This observational study based on a population-based EHR database in Yinzhou district of Ningbo city in China is to estimate incidence rates of seizures (including febrile seizures), urticaria and angioedema, apnea, and fever among Chinese children after receiving Prevenar 13. In addition, a validation study including validation of International classification of diseases, tenth revision (ICD-10) codes or ICD-10 code based algorithm for identifying all safety outcomes of interest and a prospective cohort study in a sub-population of the main study will be conducted in order to offset the potential biased results from the main study because of potential misclassification of the safety outcomes of interest due to miscoding and/or undercoding of ICD-10 codes used to identify these safety outcomes in the EHR database.
日期
| 最后验证: | 05/31/2019 |
| 首次提交: | 07/19/2018 |
| 提交的预估入学人数: | 08/29/2018 |
| 首次发布: | 09/03/2018 |
| 上次提交的更新: | 06/10/2019 |
| 最近更新发布: | 06/12/2019 |
| 实际学习开始日期: | 07/31/2018 |
| 预计主要完成日期: | 09/29/2020 |
| 预计完成日期: | 09/29/2020 |
状况或疾病
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Prevenar 13 cohort This is a non-interventional study. Children in the study receive Prevenar 13 per normal medical practice. |
资格标准
| 有资格学习的年龄 | 1 Month 至 1 Month |
| 有资格学习的性别 | All |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: To be eligible for the main study, children in Yinzhou population-based EHR database must be aged 1 to 24 months and receive at least one dose of 13vPnC between May 1st, 2017 and July 24th, 2020 where the first dose is received before or on July 24th, 2020 since a 7-day post-vaccination follow-up for each dose in each child receiving 13vPnC is needed. For the prospective cohort in a sub-population of the main study, eligible children for the main study must receive the first dose of 13vPnC between July 1st, 2018 and July 24th, 2020 and an informed consent must be obtained from parents/legal guardians. Exclusion Criteria: There are no exclusion criteria for this study. |
结果
主要结果指标
1. Estimate the Rate of Seizures [0 through 7 days (with 0 indicating the day of vaccination) after the 13vPnC vaccination]
2. Estimate the Rate of Urticaria [0 through 7 days (with 0 indicating the day of vaccination) after the 13vPnC vaccination]
3. Estimate the Rate of Angioedema [0 through 7 days (with 0 indicating the day of vaccination) after the 13vPnC vaccination]
4. Estimate the Rate of Apnea [0 through 7 days (with 0 indicating the day of vaccination) after the 13vPnC vaccination]
5. Estimate the Rate of Fever [0 through 7 days (with 0 indicating the day of vaccination) after the 13vPnC vaccination]
