AzTrials
AzTrials

SeizuresNCT03656939

A Safety Study For Prevenar 13 Among Chinese Children

An observational study of Seizures and Urticaria and Angioedema, run by Pfizer at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an observational study based on a population-based EHR database. Read more about this study

Who is it for?
Ages 1 month to 24 months
Conditions the study is for
Seizures, Urticaria and Angioedema, Apnea
How many people
21,240 participants
Where
1 siteChina
Study dates
1 Aug 2018to 31 Jul 2020
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 24 months
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

  • 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.

Who cannot join

  • There are no exclusion criteria for this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • School of Public Health at Fudan University

    Shanghai, 200032

Other trials in China

About this study

Official title: AN OBSERVATIONAL SAFETY STUDY FOR PREVENAR 13 AMONG CHINESE CHILDREN

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

Read the 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.

Medical subject headings
Seizures, Urticaria, Angioedema, Apnea, Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03656939
Study groupRoleWhat they receive
Prevenar 13 cohortThis is a non-interventional study. Children in the study receive Prevenar 13 per normal medical practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence Rate (Per 1000 Person Days) of All Seizures Through 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.

    Measured: 0 to 3 days after Dose 1

  2. Incidence Rate (Per 1000 Person Days) of All Seizures Through 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.

    Measured: 4 to 7 days after Dose 1

  3. Incidence Rate (Per 1000 Person Days) of All Seizures Through 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.

    Measured: 0 to 7 days after Dose 1

  4. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 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.

    Measured: 0 to 3 days after Dose 1

  5. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 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.

    Measured: 4 to 7 days after Dose 1

  6. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 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.

    Measured: 0 to 7 days after Dose 1

  7. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 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 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.

    Measured: 0 to 3 days after Dose 1

  8. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 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.

    Measured: 4 to 7 days after Dose 1

  9. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 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 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.

    Measured: 0 to 7 days after Dose 1

  10. Incidence Rate (Per 1000 Person Days) of Apnea Through 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.

    Measured: 0 to 3 days after Dose 1

  11. Incidence Rate (Per 1000 Person Days) of Apnea Through 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 observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    Measured: 4 to 7 days after Dose 1

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

    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.

    Measured: 0 to 7 days after Dose 1

  13. Incidence Rate (Per 1000 Person Days) of Fever Through 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.

    Measured: 0 to 3 days after Dose 1

  14. Incidence Rate (Per 1000 Person Days) of Fever Through 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.

    Measured: 4 to 7 days after Dose 1

  15. Incidence Rate (Per 1000 Person Days) of Fever Through 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.

    Measured: 0 to 7 days after Dose 1

  16. Incidence Rate (Per 1000 Person Days) of All Seizures Through 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.

    Measured: 0 to 3 days after Dose 2

  17. Incidence Rate (Per 1000 Person Days) of All Seizures Through 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.

    Measured: 4 to 7 days after Dose 2

  18. Incidence Rate (Per 1000 Person Days) of All Seizures Through 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.

    Measured: 0 to 7 days after Dose 2

  19. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 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.

    Measured: 0 to 3 days after Dose 2

  20. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 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.

    Measured: 4 to 7 days after Dose 2

  21. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 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.

    Measured: 0 to 7 days after Dose 2

  22. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 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.

    Measured: 0 to 3 days after Dose 2

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

    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.

    Measured: 4 to 7 days after Dose 2

  24. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 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.

    Measured: 0 to 7 days after Dose 2

  25. Incidence Rate (Per 1000 Person Days) of Apnea Through 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 observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    Measured: 0 to 3 days after Dose 2

  26. Incidence Rate (Per 1000 Person Days) of Apnea Through 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.

    Measured: 4 to 7 days after Dose 2

  27. Incidence Rate (Per 1000 Person Days) of Apnea Through 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.

    Measured: 0 to 7 days after Dose 2

  28. Incidence Rate (Per 1000 Person Days) of Fever Through 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.

    Measured: 0 to 3 days after Dose 2

  29. Incidence Rate (Per 1000 Person Days) of Fever Through 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.

    Measured: 4 to 7 days after Dose 2

  30. Incidence Rate (Per 1000 Person Days) of Fever Through 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.

    Measured: 0 to 7 days after Dose 2

  31. Incidence Rate (Per 1000 Person Days) of All Seizures Through 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.

    Measured: 0 to 3 days after Dose 3

  32. Incidence Rate (Per 1000 Person Days) of All Seizures Through 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.

    Measured: 4 to 7 days after Dose 3

  33. Incidence Rate (Per 1000 Person Days) of All Seizures Through 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.

    Measured: 0 to 7 days after Dose 3

  34. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 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.

    Measured: 0 to 3 days after Dose 3

  35. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 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.

    Measured: 4 to 7 days after Dose 3

  36. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 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.

    Measured: 0 to 7 days after Dose 3

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

    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.

    Measured: 0 to 3 days after Dose 3

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

    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.

    Measured: 4 to 7 days after Dose 3

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

    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.

    Measured: 0 to 7 days after Dose 3

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

    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.

    Measured: 0 to 3 days after Dose 3

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

    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.

    Measured: 4 to 7 days after Dose 3

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

    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.

    Measured: 0 to 7 days after Dose 3

  43. Incidence Rate (Per 1000 Person Days) of Fever Through 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.

    Measured: 0 to 3 days after Dose 3

  44. Incidence Rate (Per 1000 Person Days) of Fever Through 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.

    Measured: 4 to 7 days after Dose 3

  45. Incidence Rate (Per 1000 Person Days) of Fever Through 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.

    Measured: 0 to 7 days after Dose 3

  46. Incidence Rate (Per 1000 Person Days) of All Seizures Through 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.

    Measured: 0 to 3 days after Dose 4

  47. Incidence Rate (Per 1000 Person Days) of All Seizures Through 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.

    Measured: 4 to 7 days after Dose 4

  48. Incidence Rate (Per 1000 Person Days) of All Seizures Through 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.

    Measured: 0 to 7 days after Dose 4

  49. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 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.

    Measured: 0 to 3 days after Dose 4

  50. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 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.

    Measured: 4 to 7 days after Dose 4

  51. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 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.

    Measured: 0 to 7 days after Dose 4

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

    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.

    Measured: 0 to 3 days after Dose 4

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

    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.

    Measured: 4 to 7 days after Dose 4

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

    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.

    Measured: 0 to 7 days after Dose 4

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

    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.

    Measured: 0 to 3 days after Dose 4

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

    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.

    Measured: 4 to 7 days after Dose 4

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

    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.

    Measured: 0 to 7 days after Dose 4

  58. Incidence Rate (Per 1000 Person Days) of Fever Through 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.

    Measured: 0 to 3 days after Dose 4

  59. Incidence Rate (Per 1000 Person Days) of Fever Through 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.

    Measured: 4 to 7 days after Dose 4

  60. Incidence Rate (Per 1000 Person Days) of Fever Through 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.

    Measured: 0 to 7 days after Dose 4

  61. Incidence Rate (Per 1000 Person Days) of All Seizures Through 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.

    Measured: 0 to 3 Days after all Doses

  62. Incidence Rate (Per 1000 Person Days) of All Seizures Through 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.

    Measured: 4 to 7 Days after all Doses

  63. Incidence Rate (Per 1000 Person Days) of All Seizures Through 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.

    Measured: 0 to 7 Days after all Doses

  64. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 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.

    Measured: 0 to 3 Days after all Doses

  65. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 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.

    Measured: 4 to 7 Days after all Doses

  66. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 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.

    Measured: 0 to 7 Days after all Doses

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

    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.

    Measured: 0 to 3 days after all Doses

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

    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.

    Measured: 4 to 7 days after all Doses

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

    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.

    Measured: 0 to 7 days after all Doses

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

    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.

    Measured: 0 to 3 days after all doses

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

    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.

    Measured: 4 to 7 days after all doses

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

    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.

    Measured: 0 to 7 days after all doses

  73. Incidence Rate (Per 1000 Person Days) of Fever Through 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.

    Measured: 0 to 3 days after all doses

  74. Incidence Rate (Per 1000 Person Days) of Fever Through 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.

    Measured: 4 to 7 days after all doses

  75. Incidence Rate (Per 1000 Person Days) of Fever Through 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.

    Measured: 0 to 7 days after all doses

  76. Incidence Rate (IR) (Per 1000 Doses) of All Seizures Through 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.

    Measured: 0 to 3 days after Dose 1

  77. Incidence Rate (Per 1000 Doses) of All Seizures Through 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.

    Measured: 4 to 7 days after Dose 1

  78. Incidence Rate (Per 1000 Doses) of All Seizures Through 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.

    Measured: 0 to 7 days after Dose 1

  79. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 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.

    Measured: 0 to 3 days after Dose 1

  80. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 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.

    Measured: 4 to 7 days after Dose 1

  81. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 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.

    Measured: 0 to 7 days after Dose 1

  82. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 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.

    Measured: 0 to 3 days after Dose 1

  83. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 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.

    Measured: 4 to 7 days after Dose 1

  84. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 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.

    Measured: 0 to 7 days after Dose 1

  85. Incidence Rate (Per 1000 Doses) of Apnea Through 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 number of doses, multiply by 1000. Apnea is the cessation of breathing.

    Measured: 0 to 3 days after Dose 1

  86. Incidence Rate (Per 1000 Doses) of Apnea Through 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.

    Measured: 4 to 7 days after Dose 1

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

    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.

    Measured: 0 to 7 days after Dose 1

  88. Incidence Rate (Per 1000 Doses) of Fever Through 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.

    Measured: 0 to 3 days after Dose 1

  89. Incidence Rate (Per 1000 Doses) of Fever Through 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.

    Measured: 4 to 7 days after Dose 1

  90. Incidence Rate (Per 1000 Doses) of Fever Through 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.

    Measured: 0 to 7 days after Dose 1

  91. Incidence Rate (Per 1000 Doses) of All Seizures Through 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.

    Measured: 0 to 3 days after Dose 2

  92. Incidence Rate (Per 1000 Doses) of All Seizures Through 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.

    Measured: 4 to 7 days after Dose 2

  93. Incidence Rate (Per 1000 Doses) of All Seizures Through 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.

    Measured: 0 to 7 days after Dose 2

  94. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 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.

    Measured: 0 to 3 days after Dose 2

  95. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 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.

    Measured: 4 to 7 days after Dose 2

  96. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 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.

    Measured: 0 to 7 days after Dose 2

  97. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 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 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.

    Measured: 0 to 3 days after Dose 2

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

    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.

    Measured: 4 to 7 days after Dose 2

  99. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 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 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.

    Measured: 0 to 7 days after Dose 2

  100. Incidence Rate (Per 1000 Doses) of Apnea Through 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.

    Measured: 0 to 3 days after Dose 2

  101. Incidence Rate (Per 1000 Doses) of Apnea Through 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 number of doses, multiply by 1000. Apnea is the cessation of breathing.

    Measured: 4 to 7 days after Dose 2

  102. Incidence Rate (Per 1000 Doses) of Apnea Through 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.

    Measured: 0 to 7 days after Dose 2

  103. Incidence Rate (Per 1000 Doses) of Fever Through 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.

    Measured: 0 to 3 days after Dose 2

  104. Incidence Rate (Per 1000 Doses) of Fever Through 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.

    Measured: 4 to 7 days after Dose 2

  105. Incidence Rate (Per 1000 Doses) of Fever Through 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.

    Measured: 0 to 7 days after Dose 2

  106. Incidence Rate (Per 1000 Doses) of All Seizures Through 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.

    Measured: 0 to 3 days after Dose 3

  107. Incidence Rate (Per 1000 Doses) of All Seizures Through 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.

    Measured: 4 to 7 days after Dose 3

  108. Incidence Rate (Per 1000 Doses) of All Seizures Through 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.

    Measured: 0 to 7 days after Dose 3

  109. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 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.

    Measured: 0 to 3 days after Dose 3

  110. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 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.

    Measured: 4 to 7 days after Dose 3

  111. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 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.

    Measured: 0 to 7 days after Dose 3

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

    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.

    Measured: 0 to 3 days after Dose 3

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

    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.

    Measured: 4 to 7 days after Dose 3

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

    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.

    Measured: 0 to 7 days after Dose 3

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

    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.

    Measured: 0 to 3 days after Dose 3

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

    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.

    Measured: 4 to 7 days after Dose 3

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

    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.

    Measured: 0 to 7 days after Dose 3

  118. Incidence Rate (Per 1000 Doses) of Fever Through 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.

    Measured: 0 to 3 days after Dose 3

  119. Incidence Rate (Per 1000 Doses) of Fever Through 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.

    Measured: 4 to 7 days after Dose 3

  120. Incidence Rate (Per 1000 Doses) of Fever Through 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.

    Measured: 0 to 7 days after Dose 3

  121. Incidence Rate (Per 1000 Doses) of All Seizures Through 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.

    Measured: 0 to 3 days after Dose 4

  122. Incidence Rate (Per 1000 Doses) of All Seizures Through 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.

    Measured: 4 to 7 days after Dose 4

  123. Incidence Rate (Per 1000 Doses) of All Seizures Through 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.

    Measured: 0 to 7 days after Dose 4

  124. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 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.

    Measured: 0 to 3 days after Dose 4

  125. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 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.

    Measured: 4 to 7 days after Dose 4

  126. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 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.

    Measured: 0 to 7 days after Dose 4

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

    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.

    Measured: 0 to 3 days after Dose 4

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

    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.

    Measured: 4 to 7 days after Dose 4

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

    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.

    Measured: 0 to 7 days after Dose 4

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

    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.

    Measured: 0 to 3 days after Dose 4

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

    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.

    Measured: 4 to 7 days after Dose 4

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

    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.

    Measured: 0 to 7 days after Dose 4

  133. Incidence Rate (Per 1000 Doses) of Fever Through 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.

    Measured: 0 to 3 days after Dose 4

  134. Incidence Rate (Per 1000 Doses) of Fever Through 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.

    Measured: 4 to 7 days after Dose 4

  135. Incidence Rate (Per 1000 Doses) of Fever Through 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.

    Measured: 0 to 7 days after Dose 4

  136. Incidence Rate (Per 1000 Doses) of All Seizures Through 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.

    Measured: 0 to 3 days after all doses

  137. Incidence Rate (Per 1000 Doses) of All Seizures Through 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.

    Measured: 4 to 7 days after all doses

  138. Incidence Rate (Per 1000 Doses) of All Seizures Through 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.

    Measured: 0 to 7 days after all doses

  139. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 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.

    Measured: 0 to 3 days after all doses

  140. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 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.

    Measured: 4 to 7 days after all doses

  141. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 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.

    Measured: 0 to 7 days after all doses

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

    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.

    Measured: 0 to 3 days after all Doses

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

    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.

    Measured: 4 to 7 days after all Doses

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

    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.

    Measured: 0 to 7 days after all Doses

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

    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.

    Measured: 0 to 3 days after all Doses

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

    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.

    Measured: 4 to 7 days after all Doses

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

    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.

    Measured: 0 to 7 days after all Doses

  148. Incidence Rate (Per 1000 Doses) of Fever Through 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.

    Measured: 0 to 3 days after all doses

  149. Incidence Rate (Per 1000 Doses) of Fever Through 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.

    Measured: 4 to 7 days after all doses

  150. Incidence Rate (Per 1000 Doses) of Fever Through 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.

    Measured: 0 to 7 days after all doses

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2018
  2. Study start1 Aug 2018
  3. Primary completion31 Jul 2020
  4. Study completion31 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
21,240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03656939
Sponsor's protocol ID
B1851193
Status last verified
Jul 2021
First submitted
20 Jul 2018
Last updated
27 Aug 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

An observational study of Seizures and Urticaria and Angioedema, run by Pfizer at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 1 (time frame: 0 to 3 days after Dose 1). The study lists 150 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03656939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.

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