TriangleNCT03546842 · OUTCOME
Percentage of Participants With a 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
- 95% Confidence Interval
- Time frame
- Up to 5 days after any vaccination
What was measured
An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study vaccine. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study vaccine or protocol-specified procedure was also an AE. The participant or the parent/guardian of the participant were to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.
Analysis population: All participants that received at least 1 vaccination with 9vHPV vaccine and provided safety data at any time during the study.
Groups in this outcome
9vHPV Vaccine
Participants received a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6
| Group | Source count |
|---|---|
| 9vHPV Vaccine | 200 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 9vHPV Vaccine | 45.0 | Not reported | 38.0 | 52.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 38.0
- upper Limit
- 52.2
- value
- 45.0
- denoms
- counts
- group Id
- OG000
- value
- 200
- units
- Participants
- description
- An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study vaccine. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study vaccine or protocol-specified procedure was also an AE. The participant or the parent/guardian of the participant were to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6
- id
- OG000
- title
- 9vHPV Vaccine
- param Type
- NUMBER
- population Description
- All participants that received at least 1 vaccination with 9vHPV vaccine and provided safety data at any time during the study.
- reporting Status
- POSTED
- time Frame
- Up to 5 days after any vaccination
- title
- Percentage of Participants With a 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