临床试验/NCT03656939

NCT03656939已完成不适用

AN OBSERVATIONAL SAFETY STUDY FOR PREVENAR 13 AMONG CHINESE CHILDREN

Pfizer1 个研究点分布在 1 个国家目标入组 21,240 人开始时间: 2018年8月1日最近更新: 2021年8月27日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Pfizer
入组人数: 21,240
试验地点: 1
主要终点: Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After All Doses

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an observational study based on a population-based EHR database.

详细描述

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.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Other

入排标准

年龄范围: 1 Month 至 24 Months（Child）
性别: All
接受健康志愿者: 否

入选标准

•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 August 1st, 2018 and July 24th, 2020 and an informed consent must be obtained from parents/legal guardians.

排除标准

•There are no exclusion criteria for this study.

结局指标

主要结局

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After All Doses

时间窗: 0 to 7 Days after all Doses

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 1

时间窗: 0 to 3 days after Dose 1

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1

时间窗: 4 to 7 days after Dose 1

Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 2

时间窗: 0 to 3 days after Dose 2

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2

时间窗: 0 to 3 days after Dose 2

Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2

时间窗: 0 to 7 days after Dose 2

Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 3

时间窗: 4 to 7 days after Dose 3

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 3

时间窗: 0 to 7 days after Dose 3

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 1

时间窗: 0 to 3 days after Dose 1

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 1

时间窗: 4 to 7 days after Dose 1

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 1

时间窗: 0 to 7 days after Dose 1

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 1

时间窗: 0 to 7 days after Dose 1

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 2

时间窗: 0 to 7 days after Dose 2

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 2

时间窗: 4 to 7 days after Dose 2

Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 2

时间窗: 0 to 7 days after Dose 2

Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 2

时间窗: 4 to 7 days after Dose 2

Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3

时间窗: 0 to 3 days after Dose 3

Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 3

时间窗: 0 to 7 days after Dose 3

Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 3

时间窗: 4 to 7 days after Dose 3

Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 1

时间窗: 4 to 7 days after Dose 1

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1

时间窗: 0 to 3 days after Dose 1

Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 1

时间窗: 0 to 7 days after Dose 1

Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 1

时间窗: 0 to 7 days after Dose 1

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 2

时间窗: 0 to 7 days after Dose 2

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 1

时间窗: 0 to 3 days after Dose 1

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1

时间窗: 0 to 7 days after Dose 1

Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 1

时间窗: 0 to 3 days after Dose 1

Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 1

时间窗: 4 to 7 days after Dose 1

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 2

时间窗: 4 to 7 days after Dose 2

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2

时间窗: 4 to 7 days after Dose 2

Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 2

时间窗: 0 to 3 days after Dose 2

Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 2

时间窗: 0 to 3 days after Dose 2

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 2

时间窗: 0 to 7 days after Dose 2

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 3

时间窗: 0 to 3 days after Dose 3

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 1

时间窗: 4 to 7 days after Dose 1

Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 2

时间窗: 4 to 7 days after Dose 2

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 2

时间窗: 0 to 3 days after Dose 2

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 3

时间窗: 0 to 3 days after Dose 3

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 4

时间窗: 0 to 3 days after Dose 4

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 4

时间窗: 4 to 7 days after Dose 4

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 4

时间窗: 0 to 7 days after Dose 4

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4

时间窗: 0 to 3 days after Dose 4

Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 4

时间窗: 0 to 7 days after Dose 4

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 3

时间窗: 4 to 7 days after Dose 3

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 3

时间窗: 0 to 3 days after Dose 3

Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 3

时间窗: 4 to 7 days after Dose 3

Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 4

时间窗: 4 to 7 days after Dose 4

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 4

时间窗: 0 to 3 days after Dose 4

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 4

时间窗: 0 to 3 days after Dose 4

Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 4

时间窗: 0 to 3 days after Dose 4

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After All Doses

时间窗: 0 to 3 days after all doses

Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After All Doses

时间窗: 4 to 7 days after all doses

Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 3

时间窗: 0 to 7 days after Dose 3

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3

时间窗: 4 to 7 days after Dose 3

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3

时间窗: 0 to 7 days after Dose 3

Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 3

时间窗: 0 to 3 days after Dose 3

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 3

时间窗: 0 to 7 days after Dose 3

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4

时间窗: 4 to 7 days after Dose 4

Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 4

时间窗: 4 to 7 days after Dose 4

Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After All Doses

时间窗: 0 to 3 Days after all Doses

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After All Doses

时间窗: 4 to 7 Days after all Doses

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After All Doses

时间窗: 0 to 3 Days after all Doses

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 4

时间窗: 0 to 7 days after Dose 4

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4

时间窗: 0 to 7 days after Dose 4

Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 4

时间窗: 0 to 7 days after Dose 4

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After All Doses

时间窗: 0 to 7 Days after all Doses

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After All Doses

时间窗: 4 to 7 Days after all Doses

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After All Doses

时间窗: 0 to 3 days after all Doses

Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After All Doses

时间窗: 0 to 7 days after all doses

Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After All Doses

时间窗: 0 to 3 days after all doses

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After All Doses

时间窗: 0 to 7 days after all doses

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 1

时间窗: 4 to 7 days after Dose 1

Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 1

时间窗: 0 to 7 days after Dose 1

Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 2

时间窗: 4 to 7 days after Dose 2

Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 4

时间窗: 4 to 7 days after Dose 4

Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 1

时间窗: 0 to 7 days after Dose 1

Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1

时间窗: 0 to 3 days after Dose 1

Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1

时间窗: 4 to 7 days after Dose 1

Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1

时间窗: 0 to 7 days after Dose 1

Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 1

时间窗: 0 to 7 days after Dose 1

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 2

时间窗: 0 to 3 days after Dose 2

Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 2

时间窗: 0 to 7 days after Dose 2

Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 3

时间窗: 0 to 7 days after Dose 3

Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After All Doses

时间窗: 4 to 7 days after all Doses

Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 1

时间窗: 0 to 3 days after Dose 1

Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 1

时间窗: 4 to 7 days after Dose 1

Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 1

时间窗: 0 to 3 days after Dose 1

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 2

时间窗: 0 to 7 days after Dose 2

Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 2

时间窗: 0 to 7 days after Dose 2

Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2

时间窗: 0 to 7 days after Dose 2

Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 2

时间窗: 4 to 7 days after Dose 2

Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 2

时间窗: 0 to 3 days after Dose 2

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After All Doses

时间窗: 0 to 7 days after all Doses

Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After All Doses

时间窗: 4 to 7 days after all doses

Incidence Rate (IR) (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 1

时间窗: 0 to 3 days after Dose 1

IR was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 1

时间窗: 0 to 7 days after Dose 1

Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 1

时间窗: 4 to 7 days after Dose 1

Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 2

时间窗: 0 to 3 days after Dose 2

Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2

时间窗: 0 to 3 days after Dose 2

Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 2

时间窗: 0 to 3 days after Dose 2

Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 2

时间窗: 4 to 7 days after Dose 2

Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 3

时间窗: 0 to 7 days after Dose 3

Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3

时间窗: 4 to 7 days after Dose 3

Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3

时间窗: 0 to 7 days after Dose 3

Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 3

时间窗: 0 to 3 days after Dose 3

Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 1

时间窗: 4 to 7 days after Dose 1

Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 1

时间窗: 0 to 3 days after Dose 1

Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 3

时间窗: 0 to 3 days after Dose 3

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 4

时间窗: 0 to 3 days after Dose 4

Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 4

时间窗: 0 to 7 days after Dose 4

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 3

时间窗: 4 to 7 days after Dose 3

Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4

时间窗: 0 to 3 days after Dose 4

Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 4

时间窗: 0 to 3 days after Dose 4

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 2

时间窗: 4 to 7 days after Dose 2

Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2

时间窗: 4 to 7 days after Dose 2

Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 2

时间窗: 0 to 7 days after Dose 2

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 3

时间窗: 0 to 3 days after Dose 3

Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 3

时间窗: 4 to 7 days after Dose 3

Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 3

时间窗: 0 to 3 days after Dose 3

Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3

时间窗: 0 to 3 days after Dose 3

Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 3

时间窗: 0 to 7 days after Dose 3

Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 4

时间窗: 0 to 3 days after Dose 4

Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After All Doses

时间窗: 0 to 7 days after all doses

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After All Doses

时间窗: 4 to 7 days after all doses

Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 4

时间窗: 0 to 7 days after Dose 4

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After All Doses

时间窗: 4 to 7 days after all Doses

Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 3

时间窗: 4 to 7 days after Dose 3

Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 3

时间窗: 0 to 7 days after Dose 3

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 4

时间窗: 4 to 7 days after Dose 4

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4

时间窗: 0 to 7 days after Dose 4

Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 4

时间窗: 0 to 3 days after Dose 4

Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 4

时间窗: 4 to 7 days after Dose 4

Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After All Doses

时间窗: 0 to 3 days after all doses

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After All Doses

时间窗: 4 to 7 days after all doses

Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After All Doses

时间窗: 4 to 7 days after all doses

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 3

时间窗: 4 to 7 days after Dose 3

Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 4

时间窗: 4 to 7 days after Dose 4

Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 4

时间窗: 0 to 7 days after Dose 4

Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4

时间窗: 4 to 7 days after Dose 4

Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 4

时间窗: 4 to 7 days after Dose 4

Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 4

时间窗: 0 to 7 days after Dose 4

Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After All Doses

时间窗: 0 to 3 days after all doses

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After All Doses

时间窗: 0 to 7 days after all doses

Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After All Doses

时间窗: 4 to 7 days after all Doses

Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After All Doses

时间窗: 0 to 7 days after all Doses

Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After All Doses

时间窗: 0 to 3 days after all Doses

Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After All Doses

时间窗: 0 to 3 days after all doses

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After All Doses

时间窗: 0 to 3 days after all Doses

Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After All Doses

时间窗: 0 to 7 days after all Doses

Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After All Doses

时间窗: 0 to 7 days after all doses

Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

次要结局

未报告次要终点

研究者

发起方

Pfizer

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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