TriangleNCT01047345 · OUTCOME
Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - Base Study
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 - Base Study
What was measured
An AE is 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 is also an AE. The percentage of participants who reported an AE that was associated with the injection site such as redness, swelling, and pain/tenderness/soreness was summarized.
Analysis population: All participants who received at least 1 vaccination and had available follow-up data.
Groups in this outcome
9vHPV Vaccine - Base Study
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
Placebo - Base Study
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
| Group | Source count |
|---|---|
| 9vHPV Vaccine - Base Study | 608 |
| Placebo - Base Study | 305 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 9vHPV Vaccine - Base Study | 91.1 | Not reported | Not reported | Not reported | Not reported |
| Placebo - Base Study | 43.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 91.1
- group Id
- OG001
- value
- 43.9
- denoms
- counts
- group Id
- OG000
- value
- 608
- group Id
- OG001
- value
- 305
- units
- Participants
- description
- An AE is 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 is also an AE. The percentage of participants who reported an AE that was associated with the injection site such as redness, swelling, and pain/tenderness/soreness was summarized.
- groups
- description
- Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
- id
- OG000
- title
- 9vHPV Vaccine - Base Study
- description
- Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
- id
- OG001
- title
- Placebo - Base Study
- param Type
- NUMBER
- population Description
- All participants who received at least 1 vaccination and had available follow-up data.
- reporting Status
- POSTED
- time Frame
- up to 5 days after any vaccination - Base Study
- title
- Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - Base Study
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice