Apnea, Fever, Seizures, Urticaria and Angioedema
Conditions
Brief summary
This is an observational study based on a population-based EHR database.
Detailed description
This observational study based on a population-based EHR database in Yinzhou district of Ningbo city in China is to estimate incidence rates of seizures (including febrile seizures), urticaria and angioedema, apnea, and fever among Chinese children after receiving Prevenar 13. In addition, a validation study including validation of International classification of diseases, tenth revision (ICD-10) codes or ICD-10 code based algorithm for identifying all safety outcomes of interest and a prospective cohort study in a sub-population of the main study will be conducted in order to offset the potential biased results from the main study because of potential misclassification of the safety outcomes of interest due to miscoding and/or undercoding of ICD-10 codes used to identify these safety outcomes in the EHR database.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
1 Months to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 1 | 0 to 3 days after Dose 1 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 1 | 4 to 7 days after Dose 1 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 1 | 0 to 7 days after Dose 1 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 1 | 0 to 3 days after Dose 1 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 1 | 4 to 7 days after Dose 1 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 1 | 0 to 7 days after Dose 1 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 | 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. |
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 | 4 to 7 days after Dose 1 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. |
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 | 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. |
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 1 | 0 to 3 days after Dose 1 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. |
| Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 1 | 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. |
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 1 | 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. |
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 1 | 0 to 3 days after Dose 1 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 1 | 4 to 7 days after Dose 1 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 1 | 0 to 7 days after Dose 1 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 2 | 0 to 3 days after Dose 2 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 2 | 4 to 7 days after Dose 2 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 2 | 0 to 7 days after Dose 2 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 2 | 0 to 3 days after Dose 2 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 2 | 4 to 7 days after Dose 2 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 2 | 0 to 7 days after Dose 2 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2 | 0 to 3 days after Dose 2 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. |
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2 | 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. |
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2 | 0 to 7 days after Dose 2 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. |
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 2 | 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. |
| Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 2 | 4 to 7 days after Dose 2 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. |
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 2 | 0 to 7 days after Dose 2 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing. |
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 2 | 0 to 3 days after Dose 2 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 2 | 4 to 7 days after Dose 2 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 2 | 0 to 7 days after Dose 2 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 3 | 0 to 3 days after Dose 3 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 3 | 4 to 7 days after Dose 3 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 3 | 0 to 7 days after Dose 3 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 3 | 0 to 3 days after Dose 3 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 3 | 4 to 7 days after Dose 3 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 3 | 0 to 7 days after Dose 3 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3 | 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. |
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3 | 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. |
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3 | 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. |
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 3 | 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. |
| Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 3 | 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. |
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 3 | 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. |
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 3 | 0 to 3 days after Dose 3 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 3 | 4 to 7 days after Dose 3 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 3 | 0 to 7 days after Dose 3 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 4 | 0 to 3 days after Dose 4 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 4 | 4 to 7 days after Dose 4 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 4 | 0 to 7 days after Dose 4 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 4 | 0 to 3 days after Dose 4 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 4 | 4 to 7 days after Dose 4 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 4 | 0 to 7 days after Dose 4 | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4 | 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. |
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4 | 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. |
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4 | 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. |
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 4 | 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. |
| Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 4 | 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. |
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 4 | 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. |
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 4 | 0 to 3 days after Dose 4 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After All Doses | 0 to 3 Days after all Doses | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 4 | 4 to 7 days after Dose 4 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 4 | 0 to 7 days after Dose 4 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After All Doses | 4 to 7 Days after all Doses | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After All Doses | 0 to 7 Days after all Doses | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After All Doses | 0 to 3 Days after all Doses | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After All Doses | 4 to 7 Days after all Doses | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After All Doses | 0 to 7 Days after all Doses | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After All Doses | 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. |
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After All Doses | 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. |
| Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After All Doses | 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. |
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After All Doses | 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. |
| Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After All Doses | 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. |
| Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After All Doses | 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. |
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After All Doses | 0 to 3 days after all doses | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After All Doses | 4 to 7 days after all doses | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After All Doses | 0 to 7 days after all doses | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. |
| Incidence Rate (IR) (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 1 | 0 to 3 days after Dose 1 | IR was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 1 | 4 to 7 days after Dose 1 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 1 | 0 to 7 days after Dose 1 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 1 | 0 to 3 days after Dose 1 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 1 | 4 to 7 days after Dose 1 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 1 | 0 to 7 days after Dose 1 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 | 0 to 3 days after Dose 1 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. |
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 | 4 to 7 days after Dose 1 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. |
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 | 0 to 7 days after Dose 1 | Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes. |
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 1 | 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. |
| Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 1 | 4 to 7 days after Dose 1 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. |
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 1 | 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. |
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 1 | 0 to 3 days after Dose 1 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 1 | 4 to 7 days after Dose 1 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 1 | 0 to 7 days after Dose 1 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 2 | 0 to 3 days after Dose 2 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 2 | 4 to 7 days after Dose 2 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 2 | 0 to 7 days after Dose 2 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 2 | 0 to 3 days after Dose 2 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 2 | 4 to 7 days after Dose 2 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 2 | 0 to 7 days after Dose 2 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2 | 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. |
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2 | 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. |
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2 | 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. |
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 2 | 0 to 3 days after Dose 2 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. |
| Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 2 | 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. |
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 2 | 0 to 7 days after Dose 2 | Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing. |
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 2 | 0 to 3 days after Dose 2 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 2 | 4 to 7 days after Dose 2 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 2 | 0 to 7 days after Dose 2 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 3 | 0 to 3 days after Dose 3 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 3 | 4 to 7 days after Dose 3 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 3 | 0 to 7 days after Dose 3 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 3 | 0 to 3 days after Dose 3 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 3 | 4 to 7 days after Dose 3 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 3 | 0 to 7 days after Dose 3 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3 | 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. |
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3 | 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. |
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3 | 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. |
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 3 | 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. |
| Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 3 | 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. |
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 3 | 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. |
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 3 | 0 to 3 days after Dose 3 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 3 | 4 to 7 days after Dose 3 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 3 | 0 to 7 days after Dose 3 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 4 | 0 to 3 days after Dose 4 | Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 4 | 4 to 7 days after Dose 4 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 4 | 0 to 7 days after Dose 4 | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 4 | 0 to 3 days after Dose 4 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 4 | 4 to 7 days after Dose 4 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 4 | 0 to 7 days after Dose 4 | Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4 | 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. |
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4 | 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. |
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4 | 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. |
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 4 | 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. |
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After All Doses | 0 to 3 days after all doses | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After All Doses | 4 to 7 days after all doses | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 4 | 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. |
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 4 | 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. |
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 4 | 0 to 3 days after Dose 4 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 4 | 4 to 7 days after Dose 4 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 4 | 0 to 7 days after Dose 4 | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After All Doses | 0 to 7 days after all doses | Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After All Doses | 0 to 3 days after all doses | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After All Doses | 4 to 7 days after all doses | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After All Doses | 0 to 7 days after all doses | Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After All Doses | 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. |
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After All Doses | 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. |
| Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After All Doses | 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. |
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After All Doses | 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. |
| Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After All Doses | 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. |
| Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After All Doses | 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. |
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After All Doses | 0 to 3 days after all doses | Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After All Doses | 4 to 7 days after all doses | Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. |
| Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After All Doses | 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. |
Countries
China
Participant flow
Recruitment details
This observational study had main study and prospective cohort study. Data for main study and prospective cohort study were observed during 2 years of this observational study.
Pre-assignment details
The main study utilized population-based Yinzhou electronic health record (EHR) database. As part of validation study, prospective cohort study was conducted in sub-population of main study. Main study included eligible children aged 1-24 months who received at least 1 dose of Prevenar 13 recorded in Yinzhou EHR database between 1 May 2017 and 24 July 2020. Prospective cohort study had eligible children for main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020.
Participants by arm
| Arm | Count |
|---|---|
| Prevenar 13 Main study cohort included participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Prospective study cohort included eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13. | 21,240 |
| Total | 21,240 |
Baseline characteristics
| Characteristic | Prevenar 13 | — |
|---|---|---|
| Age, Continuous | 3.15 Months STANDARD_DEVIATION 1.62 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 9944 Participants | — |
| Sex: Female, Male Male | 11296 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 0 to 3 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (IR) (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 1 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (IR) (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 1 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after all doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After All Doses | 0.042 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After All Doses | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 2 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 2 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 3 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 3 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 4 | 0.232 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 4 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after all doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After All Doses | 0.099 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After All Doses | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 1 | 0.098 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 1 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 2 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 2 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 3 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 3 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 4 | 0.386 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 4 | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after all doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After All Doses | 0.056 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After All Doses | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 1 | 0.098 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 1 | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 2 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 2 | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 3 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 3 | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 4 | 0.155 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 4 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after all Doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After All Doses | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After All Doses | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 1 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 1 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 2 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 2 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 3 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 3 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 4 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 4 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after all Doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After All Doses | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After All Doses | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 1 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 1 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 2 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 2 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 3 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 3 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 4 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 4 | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after all Doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After All Doses | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After All Doses | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 1 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 1 | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 2 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 2 | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 3 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 3 | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 4 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 4 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after all doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After All Doses | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After All Doses | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 1 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 1 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 2 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 2 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 3 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 3 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 4 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 4 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after all doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After All Doses | 0.028 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After All Doses | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 1 | 0.049 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 1 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 2 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 2 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 3 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 3 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 4 | 0.077 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 4 | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after all doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After All Doses | 0.028 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After All Doses | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 1 | 0.049 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 1 | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 2 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 2 | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 3 | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 3 | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 4 | 0.077 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 4 | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after all doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After All Doses | 2.505 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After All Doses | 29.588 Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 1 | 2.215 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 1 | 41.304 Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 2 | 2.063 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 2 | 16.341 Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 3 | 1.466 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 3 | 11.236 Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 4 | 5.099 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 4 | 60.418 Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after all doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After All Doses | 3.659 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After All Doses | 33.159 Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 1 | 2.362 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 1 | 43.478 Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 2 | 2.476 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 2 | 18.611 Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 3 | 2.226 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 3 | 12.702 Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 4 | 9.503 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 4 | 72.037 Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after all doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After All Doses | 1.323 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After All Doses | 3.826 Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 1 | 0.197 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 1 | 2.174 Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 2 | 0.464 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 2 | 2.270 Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 3 | 0.760 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 3 | 1.954 Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 4 | 5.176 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 4 | 12.394 Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after all Doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After All Doses | Urticaria | 0.352 Events per 1000 doses |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After All Doses | Angioedema | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After All Doses | Urticaria | 0.893 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After All Doses | Angioedema | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 | Urticaria | 0.049 Events per 1000 doses |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 | Angioedema | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 | Urticaria | 1.304 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 | Angioedema | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2 | Urticaria | 0.258 Events per 1000 doses |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2 | Angioedema | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2 | Urticaria | 0.908 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2 | Angioedema | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3 | Urticaria | 0.217 Events per 1000 doses |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3 | Angioedema | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3 | Urticaria | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3 | Angioedema | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4 | Urticaria | 1.159 Events per 1000 doses |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4 | Angioedema | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4 | Urticaria | 1.549 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4 | Angioedema | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after all Doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After All Doses | Urticaria | 1.013 Events per 1000 doses |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After All Doses | Angioedema | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After All Doses | Urticaria | 0.893 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After All Doses | Angioedema | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 | Urticaria | 0.148 Events per 1000 doses |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 | Angioedema | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 | Urticaria | 1.304 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 | Angioedema | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2 | Urticaria | 0.774 Events per 1000 doses |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2 | Angioedema | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2 | Urticaria | 0.908 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2 | Angioedema | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3 | Urticaria | 0.760 Events per 1000 doses |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3 | Angioedema | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3 | Urticaria | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3 | Angioedema | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4 | Urticaria | 3.090 Events per 1000 doses |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4 | Angioedema | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4 | Urticaria | 1.549 Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4 | Angioedema | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after all Doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After All Doses | Urticaria | 0.661 Events per 1000 doses |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After All Doses | Angioedema | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After All Doses | Urticaria | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After All Doses | Angioedema | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 | Urticaria | 0.098 Events per 1000 doses |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 | Angioedema | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 | Urticaria | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 | Angioedema | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2 | Urticaria | 0.516 Events per 1000 doses |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2 | Angioedema | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2 | Urticaria | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2 | Angioedema | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3 | Urticaria | 0.543 Events per 1000 doses |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3 | Angioedema | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3 | Urticaria | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3 | Angioedema | NA Events per 1000 doses |
Primary
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.
Time frame: 4 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4 | Urticaria | 1.931 Events per 1000 doses |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4 | Angioedema | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4 | Urticaria | NA Events per 1000 doses |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4 | Angioedema | NA Events per 1000 doses |
Primary
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.
Time frame: 0 to 3 Days after all Doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After All Doses | 0.011 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After All Doses | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 1 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 1 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 2 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 2 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 3 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 3 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 4 | 0.058 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 4 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 Days after all Doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After All Doses | 0.012 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After All Doses | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 1 | 0.012 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 1 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 2 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 2 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 3 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 3 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 4 | 0.048 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 4 | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 Days after all Doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After All Doses | 0.014 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After All Doses | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 1 | 0.025 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 1 | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 2 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 2 | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 3 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 3 | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 4 | 0.039 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 4 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after all doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After All Doses | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After All Doses | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 1 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 1 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 2 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 2 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 3 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 3 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 4 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 4 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after all doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After All Doses | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After All Doses | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 1 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 1 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 2 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 2 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 3 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 3 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 4 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 4 | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after all doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After All Doses | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After All Doses | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 1 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 1 | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 2 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 2 | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 3 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 3 | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 4 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 4 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 Days after all Doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After All Doses | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After All Doses | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 1 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 1 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 2 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 2 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 3 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 3 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 4 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 4 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 Days after all Doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After All Doses | 0.004 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After All Doses | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 1 | 0.006 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 1 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 2 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 2 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 3 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 3 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 4 | 0.010 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 4 | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 Days after all Doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After All Doses | 0.007 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After All Doses | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 1 | 0.012 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 1 | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 2 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 2 | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 3 | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 3 | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 4 | 0.019 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 4 | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after all doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After All Doses | 0.627 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After All Doses | 7.575 Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 1 | 0.555 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 1 | 10.689 Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 2 | 0.517 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 2 | 4.14 Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 3 | 0.367 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 3 | 2.834 Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 4 | 1.278 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 4 | 15.822 Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after all doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After All Doses | 0.458 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After All Doses | 4.261 Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 1 | 0.296 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 1 | 5.649 Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 2 | 0.310 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 2 | 2.362 Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 3 | 0.279 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 3 | 1.604 Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 4 | 1.194 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 4 | 9.54 Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after all doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After All Doses | 0.331 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After All Doses | 0.958 Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 1 | 0.049 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 1 | 0.544 Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 2 | 0.116 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 2 | 0.568 Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 3 | 0.190 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 3 | 0.489 Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 4 | 1.298 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 4 | 3.124 Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after all Doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After All Doses | Urticaria | 0.088 Events per 1000 person-days |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After All Doses | Angioedema | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After All Doses | Urticaria | 0.223 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After All Doses | Angioedema | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 | Urticaria | 0.012 Events per 1000 person-days |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 | Angioedema | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 | Urticaria | 0.326 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 | Angioedema | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2 | Urticaria | 0.065 Events per 1000 person-days |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2 | Angioedema | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2 | Urticaria | 0.227 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2 | Angioedema | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3 | Urticaria | 0.054 Events per 1000 person-days |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3 | Angioedema | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3 | Urticaria | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3 | Angioedema | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 3 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4 | Urticaria | 0.29 Events per 1000 person-days |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4 | Angioedema | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4 | Urticaria | 0.388 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4 | Angioedema | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after all Doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After All Doses | Urticaria | 0.127 Events per 1000 person-days |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After All Doses | Angioedema | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After All Doses | Urticaria | 0.112 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After All Doses | Angioedema | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 | Urticaria | 0.019 Events per 1000 person-days |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 | Angioedema | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 | Urticaria | 0.163 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 | Angioedema | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2 | Urticaria | 0.097 Events per 1000 person-days |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2 | Angioedema | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2 | Urticaria | 0.114 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2 | Angioedema | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3 | Angioedema | NA Events per 1000 person-days |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3 | Urticaria | 0.095 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3 | Urticaria | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3 | Angioedema | NA Events per 1000 person-days |
Primary
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.
Time frame: 0 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4 | Urticaria | 0.387 Events per 1000 person-days |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4 | Angioedema | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4 | Urticaria | 0.194 Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4 | Angioedema | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after all Doses
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After All Doses | Urticaria | 0.165 Events per 1000 person-days |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After All Doses | Angioedema | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After All Doses | Urticaria | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After All Doses | Angioedema | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 1
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 | Urticaria | 0.025 Events per 1000 person-days |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 | Angioedema | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 | Urticaria | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 | Angioedema | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 2
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2 | Urticaria | 0.129 Events per 1000 person-days |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2 | Angioedema | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2 | Urticaria | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2 | Angioedema | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 3
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3 | Urticaria | 0.136 Events per 1000 person-days |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3 | Angioedema | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3 | Urticaria | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3 | Angioedema | NA Events per 1000 person-days |
Primary
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.
Time frame: 4 to 7 days after Dose 4
Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4 | Urticaria | 0.483 Events per 1000 person-days |
| Prevenar 13: Main Study Cohort | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4 | Angioedema | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4 | Urticaria | NA Events per 1000 person-days |
| Prevenar 13 Cohort: Prospective Cohort Study | Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4 | Angioedema | NA Events per 1000 person-days |