TriangleNCT00943722 · OUTCOME
Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs)
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 after any vaccination
What was measured
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine was also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
Analysis population: All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Per protocol, this outcome measure included data from 9- to 15-year-old females regardless of lot administered.
Groups in this outcome
9- to 15-Year-Old Females (Lots 1, 2 or 3)
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
Base Study: 16- to 26-Year-Old Females (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
| Group | Source count |
|---|---|
| 9- to 15-Year-Old Females (Lots 1, 2 or 3) | 1923 |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 662 |
| Base Study: 16- to 26-Year-Old Females (Lot 1) | 466 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 9- to 15-Year-Old Females (Lots 1, 2 or 3) | 81.9 | Not reported | Not reported | Not reported | Not reported |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 72.8 | Not reported | Not reported | Not reported | Not reported |
| Base Study: 16- to 26-Year-Old Females (Lot 1) | 85.4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 81.9
- group Id
- OG001
- value
- 72.8
- group Id
- OG002
- value
- 85.4
- denoms
- counts
- group Id
- OG000
- value
- 1923
- group Id
- OG001
- value
- 662
- group Id
- OG002
- value
- 466
- units
- Participants
- description
- An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine was also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
- groups
- description
- 9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.
- id
- OG000
- title
- 9- to 15-Year-Old Females (Lots 1, 2 or 3)
- description
- 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
- id
- OG001
- title
- Base Study: 9- to 15-Year-Old Males (Lot 1)
- description
- 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
- id
- OG002
- title
- Base Study: 16- to 26-Year-Old Females (Lot 1)
- param Type
- NUMBER
- population Description
- All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Per protocol, this outcome measure included data from 9- to 15-year-old females regardless of lot administered.
- reporting Status
- POSTED
- time Frame
- Up to 5 days after any vaccination
- title
- Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs)
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice