TriangleNCT00543543 · OUTCOME
Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (Test of Hypothesis)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Cases per 10,000 person-years follow-up
- Interval / dispersion
- Not reported
- Time frame
- From Day 1 until >=30 cases accumulate, up to Month 54 in the base study
What was measured
HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports data based on the protocol-specified plan of conducting hypothesis testing when at least 30 cases had accumulated. The cutoff date for this analysis was 10 April 2013. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.
Analysis population: The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.
Groups in this outcome
Mid-dose V503
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
Gardasil
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
| Group | Source count |
|---|---|
| Mid-dose V503 | 6016 |
| Gardasil | 6017 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Mid-dose V503 | 0.5 | Not reported | Not reported | Not reported | Not reported |
| Gardasil | 15.8 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 80.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 99.8
- estimate Comment
- Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Vaccine efficacy
- param Value
- 96.7
- statistical Method
- Exact test, 1-sided
Complete source fields
- analyses
- ci Lower Limit
- 80.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 99.8
- estimate Comment
- Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Vaccine efficacy
- param Value
- 96.7
- statistical Method
- Exact test, 1-sided
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.5
- group Id
- OG001
- value
- 15.8
- denoms
- counts
- group Id
- OG000
- value
- 6016
- group Id
- OG001
- value
- 6017
- units
- Participants
- description
- HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports data based on the protocol-specified plan of conducting hypothesis testing when at least 30 cases had accumulated. The cutoff date for this analysis was 10 April 2013. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.
- groups
- description
- V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
- id
- OG000
- title
- Mid-dose V503
- description
- Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
- id
- OG001
- title
- Gardasil
- param Type
- NUMBER
- population Description
- The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.
- reporting Status
- POSTED
- time Frame
- From Day 1 until >=30 cases accumulate, up to Month 54 in the base study
- title
- Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (Test of Hypothesis)
- type
- PRIMARY
- unit Of Measure
- Cases per 10,000 person-years follow-up
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice