Clinical trial NCT03656939: A Safety Study For Prevenar 13 Among Chinese Children
Official title: AN OBSERVATIONAL SAFETY STUDY FOR PREVENAR 13 AMONG CHINESE CHILDREN
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seizures
Urticaria and Angioedema
Apnea
Fever
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-09-04
Enrollment: 21240
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The main study population consists of eligible children aged 1-24 months receiving at least one dose of 13vPnC recorded in Yinzhou EHR database between May 1st, 2017 and July 24th, 2020 (ie, one week prior to the end of the study).

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. It should be noted that the actual start date for the prospective cohort study is pending on the approval of Human Genetic Resources Administration of China (HGRAC) application.

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

Detailed description: 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.

Eligibility criteria: 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 August 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.

Primary outcomes:
measure: Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 1
timeFrame: 0 to 3 days after Dose 1
measure: Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 1
timeFrame: 4 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 1
timeFrame: 0 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 1
timeFrame: 0 to 3 days after Dose 1
measure: Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 1
timeFrame: 4 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 1
timeFrame: 0 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1
timeFrame: 0 to 3 days after Dose 1
measure: Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1
timeFrame: 4 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1
timeFrame: 0 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 1
timeFrame: 0 to 3 days after Dose 1
measure: Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 1
timeFrame: 4 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 1
timeFrame: 0 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 1
timeFrame: 0 to 3 days after Dose 1
measure: Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 1
timeFrame: 4 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 1
timeFrame: 0 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 2
timeFrame: 0 to 3 days after Dose 2
measure: Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 2
timeFrame: 4 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 2
timeFrame: 0 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 2
timeFrame: 0 to 3 days after Dose 2
measure: Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 2
timeFrame: 4 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 2
timeFrame: 0 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2
timeFrame: 0 to 3 days after Dose 2
measure: Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2
timeFrame: 4 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2
timeFrame: 0 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 2
timeFrame: 0 to 3 days after Dose 2
measure: Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 2
timeFrame: 4 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 2
timeFrame: 0 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 2
timeFrame: 0 to 3 days after Dose 2
measure: Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 2
timeFrame: 4 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 2
timeFrame: 0 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 3
timeFrame: 0 to 3 days after Dose 3
measure: Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 3
timeFrame: 4 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 3
timeFrame: 0 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 3
timeFrame: 0 to 3 days after Dose 3
measure: Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 3
timeFrame: 4 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 3
timeFrame: 0 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3
timeFrame: 0 to 3 days after Dose 3
measure: Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3
timeFrame: 4 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3
timeFrame: 0 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 3
timeFrame: 0 to 3 days after Dose 3
measure: Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 3
timeFrame: 4 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 3
timeFrame: 0 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 3
timeFrame: 0 to 3 days after Dose 3
measure: Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 3
timeFrame: 4 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 3
timeFrame: 0 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 4
timeFrame: 0 to 3 days after Dose 4
measure: Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 4
timeFrame: 4 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 4
timeFrame: 0 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 4
timeFrame: 0 to 3 days after Dose 4
measure: Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 4
timeFrame: 4 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 4
timeFrame: 0 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4
timeFrame: 0 to 3 days after Dose 4
measure: Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4
timeFrame: 4 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4
timeFrame: 0 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 4
timeFrame: 0 to 3 days after Dose 4
measure: Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 4
timeFrame: 4 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 4
timeFrame: 0 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 4
timeFrame: 0 to 3 days after Dose 4
measure: Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 4
timeFrame: 4 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 4
timeFrame: 0 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After All Doses
timeFrame: 0 to 3 Days after all Doses
measure: Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After All Doses
timeFrame: 4 to 7 Days after all Doses
measure: Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After All Doses
timeFrame: 0 to 7 Days after all Doses
measure: Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After All Doses
timeFrame: 0 to 3 Days after all Doses
measure: Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After All Doses
timeFrame: 4 to 7 Days after all Doses
measure: Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After All Doses
timeFrame: 0 to 7 Days after all Doses
measure: Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After All Doses
timeFrame: 0 to 3 days after all Doses
measure: Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After All Doses
timeFrame: 4 to 7 days after all Doses
measure: Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After All Doses
timeFrame: 0 to 7 days after all Doses
measure: Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After All Doses
timeFrame: 0 to 3 days after all doses
measure: Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After All Doses
timeFrame: 4 to 7 days after all doses
measure: Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After All Doses
timeFrame: 0 to 7 days after all doses
measure: Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After All Doses
timeFrame: 0 to 3 days after all doses
measure: Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After All Doses
timeFrame: 4 to 7 days after all doses
measure: Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After All Doses
timeFrame: 0 to 7 days after all doses
measure: Incidence Rate (IR) (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 1
timeFrame: 0 to 3 days after Dose 1
measure: Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 1
timeFrame: 4 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 1
timeFrame: 0 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 1
timeFrame: 0 to 3 days after Dose 1
measure: Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 1
timeFrame: 4 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 1
timeFrame: 0 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1
timeFrame: 0 to 3 days after Dose 1
measure: Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1
timeFrame: 4 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1
timeFrame: 0 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 1
timeFrame: 0 to 3 days after Dose 1
measure: Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 1
timeFrame: 4 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 1
timeFrame: 0 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 1
timeFrame: 0 to 3 days after Dose 1
measure: Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 1
timeFrame: 4 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 1
timeFrame: 0 to 7 days after Dose 1
measure: Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 2
timeFrame: 0 to 3 days after Dose 2
measure: Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 2
timeFrame: 4 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 2
timeFrame: 0 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 2
timeFrame: 0 to 3 days after Dose 2
measure: Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 2
timeFrame: 4 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 2
timeFrame: 0 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2
timeFrame: 0 to 3 days after Dose 2
measure: Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2
timeFrame: 4 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2
timeFrame: 0 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 2
timeFrame: 0 to 3 days after Dose 2
measure: Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 2
timeFrame: 4 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 2
timeFrame: 0 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 2
timeFrame: 0 to 3 days after Dose 2
measure: Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 2
timeFrame: 4 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 2
timeFrame: 0 to 7 days after Dose 2
measure: Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 3
timeFrame: 0 to 3 days after Dose 3
measure: Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 3
timeFrame: 4 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 3
timeFrame: 0 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 3
timeFrame: 0 to 3 days after Dose 3
measure: Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 3
timeFrame: 4 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 3
timeFrame: 0 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3
timeFrame: 0 to 3 days after Dose 3
measure: Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3
timeFrame: 4 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3
timeFrame: 0 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 3
timeFrame: 0 to 3 days after Dose 3
measure: Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 3
timeFrame: 4 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 3
timeFrame: 0 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 3
timeFrame: 0 to 3 days after Dose 3
measure: Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 3
timeFrame: 4 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 3
timeFrame: 0 to 7 days after Dose 3
measure: Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 4
timeFrame: 0 to 3 days after Dose 4
measure: Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 4
timeFrame: 4 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 4
timeFrame: 0 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 4
timeFrame: 0 to 3 days after Dose 4
measure: Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 4
timeFrame: 4 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 4
timeFrame: 0 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4
timeFrame: 0 to 3 days after Dose 4
measure: Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4
timeFrame: 4 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4
timeFrame: 0 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 4
timeFrame: 0 to 3 days after Dose 4
measure: Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 4
timeFrame: 4 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 4
timeFrame: 0 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 4
timeFrame: 0 to 3 days after Dose 4
measure: Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 4
timeFrame: 4 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 4
timeFrame: 0 to 7 days after Dose 4
measure: Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After All Doses
timeFrame: 0 to 3 days after all doses
measure: Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After All Doses
timeFrame: 4 to 7 days after all doses
measure: Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After All Doses
timeFrame: 0 to 7 days after all doses
measure: Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After All Doses
timeFrame: 0 to 3 days after all doses
measure: Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After All Doses
timeFrame: 4 to 7 days after all doses
measure: Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After All Doses
timeFrame: 0 to 7 days after all doses
measure: Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After All Doses
timeFrame: 0 to 3 days after all Doses
measure: Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After All Doses
timeFrame: 4 to 7 days after all Doses
measure: Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After All Doses
timeFrame: 0 to 7 days after all Doses
measure: Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After All Doses
timeFrame: 0 to 3 days after all Doses
measure: Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After All Doses
timeFrame: 4 to 7 days after all Doses
measure: Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After All Doses
timeFrame: 0 to 7 days after all Doses
measure: Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After All Doses
timeFrame: 0 to 3 days after all doses
measure: Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After All Doses
timeFrame: 4 to 7 days after all doses
measure: Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After All Doses
timeFrame: 0 to 7 days after all doses
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: School of Public Health at Fudan University
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: