TriangleNCT01209325 · OUTCOME
Incidence of Persistent Anogenital Infection With HPV 16 DNA
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- events per 100 person years
- Interval / dispersion
- Not reported
- Time frame
- Post Month 7 through Month 24
What was measured
Incident events are defined as having positive PCR results with HPV 16 at 2 or more consecutive visits in those who were DNA negative for HPV 16 at baseline. Persistence was defined based on being persistent in the same anatomical site.
Analysis population: All eligible participants who were HPV 16 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.
Groups in this outcome
Naive to HPV 16
HPV 16 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
Prior Exposure to HPV 16
HPV 16 positive based on serum at visit 0 from any anatomical site.
| Group | Source count |
|---|---|
| Naive to HPV 16 | 54 |
| Prior Exposure to HPV 16 | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Naive to HPV 16 | 2.9 | Not reported | Not reported | Not reported | Not reported |
| Prior Exposure to HPV 16 | 0.0 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.386
- p Value Comment
- Two-sided p-value.
- statistical Method
- Exact Poisson calculation
- group Description
- This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 2.9 events per 100 person years (PY) versus 4.9 events per 100 PY, respectively.
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.305
- p Value Comment
- One-sided test
- statistical Method
- Exact Poisson calculation
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.386
- p Value Comment
- Two-sided p-value.
- statistical Method
- Exact Poisson calculation
- group Description
- This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 2.9 events per 100 person years (PY) versus 4.9 events per 100 PY, respectively.
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.305
- p Value Comment
- One-sided test
- statistical Method
- Exact Poisson calculation
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2.9
- group Id
- OG001
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 23
- units
- Participants
- description
- Incident events are defined as having positive PCR results with HPV 16 at 2 or more consecutive visits in those who were DNA negative for HPV 16 at baseline. Persistence was defined based on being persistent in the same anatomical site.
- groups
- description
- HPV 16 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
- id
- OG000
- title
- Naive to HPV 16
- description
- HPV 16 positive based on serum at visit 0 from any anatomical site.
- id
- OG001
- title
- Prior Exposure to HPV 16
- param Type
- NUMBER
- population Description
- All eligible participants who were HPV 16 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.
- reporting Status
- POSTED
- time Frame
- Post Month 7 through Month 24
- title
- Incidence of Persistent Anogenital Infection With HPV 16 DNA
- type
- PRIMARY
- unit Of Measure
- events per 100 person years
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice