TriangleNCT03158220 · OUTCOME
Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 5 days post any vaccination
What was measured
Participants were asked to record any injection-site reactions prompted in the Vaccination Report Card, i.e., injection-site tenderness, swelling, or redness, occurring after each study vaccination (solicited injection-site reactions). The percentage of participants with 1 or more solicited injection-site AE was assessed.
Analysis population: All participants that received at least 1 vaccination and had available data for endpoint.
Groups in this outcome
Women 16-26 Years of Age
Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
Women 27-45 Years of Age
Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
| Group | Source count |
|---|---|
| Women 16-26 Years of Age | 570 |
| Women 27-45 Years of Age | 640 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Women 16-26 Years of Age | 87.2 | Not reported | Not reported | Not reported | Not reported |
| Women 27-45 Years of Age | 84.7 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -6.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.4
- estimate Comment
- Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.212
- param Type
- Difference in Percentages
- param Value
- -2.5
- statistical Method
- Miettinen & Nurminen
Complete source fields
- analyses
- ci Lower Limit
- -6.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.4
- estimate Comment
- Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.212
- param Type
- Difference in Percentages
- param Value
- -2.5
- statistical Method
- Miettinen & Nurminen
- classes
- categories
- measurements
- group Id
- OG000
- value
- 87.2
- group Id
- OG001
- value
- 84.7
- denoms
- counts
- group Id
- OG000
- value
- 570
- group Id
- OG001
- value
- 640
- units
- Participants
- description
- Participants were asked to record any injection-site reactions prompted in the Vaccination Report Card, i.e., injection-site tenderness, swelling, or redness, occurring after each study vaccination (solicited injection-site reactions). The percentage of participants with 1 or more solicited injection-site AE was assessed.
- groups
- description
- Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- id
- OG000
- title
- Women 16-26 Years of Age
- description
- Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- id
- OG001
- title
- Women 27-45 Years of Age
- param Type
- NUMBER
- population Description
- All participants that received at least 1 vaccination and had available data for endpoint.
- reporting Status
- POSTED
- time Frame
- Up to 5 days post any vaccination
- title
- Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice