TriangleNCT00943722 · OUTCOME
Base Study: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC)
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
Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded. The percentage of participants who had at least 1 oral body temperature reading that was ≥100.0°F (≥37.8ºC) was summarized.
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)
Multivalent HPV 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) | 1908 |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 660 |
| Base Study: 16- to 26-Year-Old Females (Lot 1) | 463 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 9- to 15-Year-Old Females (Lots 1, 2, or 3) | 8.4 | Not reported | Not reported | Not reported | Not reported |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 10.0 | Not reported | Not reported | Not reported | Not reported |
| Base Study: 16- to 26-Year-Old Females (Lot 1) | 8.4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8.4
- group Id
- OG001
- value
- 10.0
- group Id
- OG002
- value
- 8.4
- denoms
- counts
- group Id
- OG000
- value
- 1908
- group Id
- OG001
- value
- 660
- group Id
- OG002
- value
- 463
- units
- Participants
- description
- Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded. The percentage of participants who had at least 1 oral body temperature reading that was ≥100.0°F (≥37.8ºC) was summarized.
- groups
- description
- Multivalent HPV 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 Body Temperature ≥100.0°F (≥37.8ºC)
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice