TriangleNCT01245764 · OUTCOME
Number of Participants With Serious Adverse Experiences
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From the time of informed consent is signed through the last study visit (up to 19 months)
What was measured
A serious adverse experience is any adverse experience that results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention
Analysis population: The analysis included all participants receiving at least 1 vaccination in study Phase A or B and who had postvaccination follow-up
Groups in this outcome
GARDASIL 9 to 12 Years Old
GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
Placebo 13 to 15 Years Old
GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
GARDASIL 16 to 26 Years Old
GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation will continue to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
Placebo 9 to 12 Years Old
Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
| Group | Source count |
|---|---|
| GARDASIL 9 to 12 Years Old | 79 |
| Placebo 13 to 15 Years Old | 29 |
| GARDASIL 16 to 26 Years Old | 119 |
| Placebo 9 to 12 Years Old | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GARDASIL 9 to 12 Years Old | 0 | Not reported | Not reported | Not reported | Not reported |
| Placebo 13 to 15 Years Old | 0 | Not reported | Not reported | Not reported | Not reported |
| GARDASIL 16 to 26 Years Old | 1 | Not reported | Not reported | Not reported | Not reported |
| Placebo 9 to 12 Years Old | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 79
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 119
- group Id
- OG003
- value
- 19
- units
- Participants
- description
- A serious adverse experience is any adverse experience that results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention
- groups
- description
- GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
- id
- OG000
- title
- GARDASIL 9 to 12 Years Old
- description
- GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
- id
- OG001
- title
- Placebo 13 to 15 Years Old
- description
- GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation will continue to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
- id
- OG002
- title
- GARDASIL 16 to 26 Years Old
- description
- Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
- id
- OG003
- title
- Placebo 9 to 12 Years Old
- param Type
- NUMBER
- population Description
- The analysis included all participants receiving at least 1 vaccination in study Phase A or B and who had postvaccination follow-up
- reporting Status
- POSTED
- time Frame
- From the time of informed consent is signed through the last study visit (up to 19 months)
- title
- Number of Participants With Serious Adverse Experiences
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice