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A Safety Study For Prevenar 13 Among Chinese Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03656939
Recruitment Status : Completed
First Posted : September 4, 2018
Results First Posted : August 27, 2021
Last Update Posted : August 27, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
This is an observational study based on a population-based EHR database.

Condition or disease
Seizures Urticaria and Angioedema Apnea Fever

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.
Study Design
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Layout table for study information
Study Type : Observational
Actual Enrollment : 21240 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: AN OBSERVATIONAL SAFETY STUDY FOR PREVENAR 13 AMONG CHINESE CHILDREN
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Prevenar 13 cohort
This is a non-interventional study. Children in the study receive Prevenar 13 per normal medical practice.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.

  2. Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 1 [ Time Frame: 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.

  3. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 1 [ Time Frame: 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.

  4. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 1 [ Time Frame: 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.

  5. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 1 [ Time Frame: 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.

  6. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 1 [ Time Frame: 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.

  7. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 [ Time Frame: 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.

  8. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 [ Time Frame: 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.

  9. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 [ Time Frame: 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.

  10. Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 1 [ Time Frame: 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.

  11. Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 1 [ Time Frame: 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.

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

  13. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 1 [ Time Frame: 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.

  14. Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 1 [ Time Frame: 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.

  15. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 1 [ Time Frame: 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.

  16. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 2 [ Time Frame: 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.

  17. Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 2 [ Time Frame: 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.

  18. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 2 [ Time Frame: 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.

  19. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 2 [ Time Frame: 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.

  20. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 2 [ Time Frame: 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.

  21. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 2 [ Time Frame: 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.

  22. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2 [ Time Frame: 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.

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

  24. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2 [ Time Frame: 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.

  25. Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 2 [ Time Frame: 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.

  26. Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 2 [ Time Frame: 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.

  27. Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 2 [ Time Frame: 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.

  28. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 2 [ Time Frame: 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.

  29. Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 2 [ Time Frame: 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.

  30. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 2 [ Time Frame: 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.

  31. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 3 [ Time Frame: 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.

  32. Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 3 [ Time Frame: 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.

  33. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 3 [ Time Frame: 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.

  34. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 3 [ Time Frame: 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.

  35. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 3 [ Time Frame: 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.

  36. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 3 [ Time Frame: 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.

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

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

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

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

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

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

  43. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 3 [ Time Frame: 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.

  44. Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 3 [ Time Frame: 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.

  45. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 3 [ Time Frame: 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.

  46. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 4 [ Time Frame: 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.

  47. Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 4 [ Time Frame: 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.

  48. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 4 [ Time Frame: 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.

  49. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 4 [ Time Frame: 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.

  50. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 4 [ Time Frame: 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.

  51. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 4 [ Time Frame: 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.

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

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

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

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

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

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

  58. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 4 [ Time Frame: 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.

  59. Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 4 [ Time Frame: 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.

  60. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 4 [ Time Frame: 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.

  61. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After All Doses [ Time Frame: 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.

  62. Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After All Doses [ Time Frame: 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.

  63. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After All Doses [ Time Frame: 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.

  64. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After All Doses [ Time Frame: 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.

  65. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After All Doses [ Time Frame: 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.

  66. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After All Doses [ Time Frame: 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.

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

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

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

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

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

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

  73. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After All Doses [ Time Frame: 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.

  74. Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After All Doses [ Time Frame: 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.

  75. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After All Doses [ Time Frame: 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.

  76. Incidence Rate (IR) (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 1 [ Time Frame: 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.

  77. Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 1 [ Time Frame: 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.

  78. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 1 [ Time Frame: 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.

  79. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 1 [ Time Frame: 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.

  80. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 1 [ Time Frame: 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.

  81. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 1 [ Time Frame: 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.

  82. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 [ Time Frame: 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.

  83. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 [ Time Frame: 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.

  84. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 [ Time Frame: 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.

  85. Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 1 [ Time Frame: 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.

  86. Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 1 [ Time Frame: 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.

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

  88. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 1 [ Time Frame: 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.

  89. Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 1 [ Time Frame: 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.

  90. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 1 [ Time Frame: 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.

  91. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 2 [ Time Frame: 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.

  92. Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 2 [ Time Frame: 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.

  93. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 2 [ Time Frame: 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.

  94. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 2 [ Time Frame: 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.

  95. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 2 [ Time Frame: 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.

  96. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 2 [ Time Frame: 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.

  97. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2 [ Time Frame: 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.

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

  99. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2 [ Time Frame: 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.

  100. Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 2 [ Time Frame: 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.

  101. Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 2 [ Time Frame: 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.

  102. Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 2 [ Time Frame: 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.

  103. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 2 [ Time Frame: 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.

  104. Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 2 [ Time Frame: 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.

  105. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 2 [ Time Frame: 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.

  106. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 3 [ Time Frame: 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.

  107. Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 3 [ Time Frame: 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.

  108. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 3 [ Time Frame: 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.

  109. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 3 [ Time Frame: 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.

  110. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 3 [ Time Frame: 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.

  111. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 3 [ Time Frame: 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.

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

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

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

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

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

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

  118. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 3 [ Time Frame: 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.

  119. Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 3 [ Time Frame: 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.

  120. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 3 [ Time Frame: 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.

  121. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 4 [ Time Frame: 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.

  122. Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 4 [ Time Frame: 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.

  123. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 4 [ Time Frame: 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.

  124. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 4 [ Time Frame: 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.

  125. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 4 [ Time Frame: 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.

  126. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 4 [ Time Frame: 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.

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

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

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

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

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

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

  133. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 4 [ Time Frame: 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.

  134. Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 4 [ Time Frame: 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.

  135. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 4 [ Time Frame: 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.

  136. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After All Doses [ Time Frame: 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.

  137. Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After All Doses [ Time Frame: 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.

  138. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After All Doses [ Time Frame: 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.

  139. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After All Doses [ Time Frame: 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.

  140. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After All Doses [ Time Frame: 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.

  141. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After All Doses [ Time Frame: 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.

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

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

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

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

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

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

  148. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After All Doses [ Time Frame: 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.

  149. Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After All Doses [ Time Frame: 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.

  150. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After All Doses [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656939


Locations
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China
School of Public Health at Fudan University
Shanghai, China, 200032
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] January 30, 2019
Statistical Analysis Plan  [PDF] January 7, 2021

More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03656939    
Other Study ID Numbers: B1851193
First Posted: September 4, 2018    Key Record Dates
Results First Posted: August 27, 2021
Last Update Posted: August 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Seizures
Angioedema
Urticaria
Neurologic Manifestations
Nervous System Diseases
Skin Diseases, Vascular
 Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases