NCT00543543 · OUTCOME
Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) · Source last updated 2018-11-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- milli Merck U/mL
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 4 weeks postdose 3 in the base study
What was measured
Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. Statistical analysis was performed only for HPV types contained in both vaccines.
Analysis population: The Per-protocol Immunogenicity population included all participants who were not protocol violators, received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable ranges, were seronegative at Day 1 and PCR negative from Day 1- Month 7 for the relevant HPV types, and had a Month 7 serum sample collected within an acceptable range
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Mid-dose V503 | 6792 |
|---|
| Gardasil | 6795 |
|---|
Reported measurements
Anti-HPV Type 6 (n=3993, 3975)
Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mid-dose V503 | 893.1 | Not reported | 871.7 | 915.1 | Not reported |
|---|
| Gardasil | 875.2 | Not reported | 854.2 | 896.8 | Not reported |
|---|
Anti-HPV Type 11 (n=3995, 3982)
Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mid-dose V503 | 666.3 | Not reported | 649.6 | 683.4 | Not reported |
|---|
| Gardasil | 830.0 | Not reported | 809.2 | 851.4 | Not reported |
|---|
Anti-HPV Type 16 (n=4032, 4062)
Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mid-dose V503 | 3131.1 | Not reported | 3057.1 | 3206.9 | Not reported |
|---|
| Gardasil | 3156.6 | Not reported | 3082.3 | 3232.7 | Not reported |
|---|
Anti-HPV Type 18 (n=4539, 4541)
Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mid-dose V503 | 804.6 | Not reported | 782.7 | 827.1 | Not reported |
|---|
| Gardasil | 678.7 | Not reported | 660.2 | 697.7 | Not reported |
|---|
Anti-HPV Type 31 (n=4466, 4377)
Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mid-dose V503 | 658.4 | Not reported | 636.7 | 680.9 | Not reported |
|---|
| Gardasil | 9.7 | Not reported | 9.4 | 10.1 | Not reported |
|---|
Anti-HPV Type 33 (n=4702, 4691)
Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mid-dose V503 | 415.9 | Not reported | 405.6 | 426.4 | Not reported |
|---|
| Gardasil | NA | Not reported | NA | NA | The GMT value was \<4 milli Merck U/mL |
|---|
Anti-HPV Type 45 (n=4792, 4750)
Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mid-dose V503 | 252.8 | Not reported | 246.2 | 259.6 | Not reported |
|---|
| Gardasil | NA | Not reported | NA | NA | The GMT value was \<3 milli Merck U/mL |
|---|
Anti-HPV Type 52 (n=4455, 4335)
Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mid-dose V503 | 379.7 | Not reported | 371.6 | 388.0 | Not reported |
|---|
| Gardasil | NA | Not reported | NA | NA | The GMT value was \<3 milli Merck U/mL |
|---|
Anti-HPV Type 58 (n=4486, 4446)
Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Mid-dose V503 | 482.5 | Not reported | 469.9 | 495.3 | Not reported |
|---|
| Gardasil | NA | Not reported | NA | NA | The GMT value was \<4 milli Merck U/mL |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- 0.99
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.06
- estimate Comment
- GMT ratio = GMT (V503) / GMT (Gardasil)
- group Description
- Anti-HPV Type 6
- non Inferiority Comment
- Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- <0.001
- param Type
- GMT ratio
- param Value
- 1.02
- statistical Method
- ANOVA
- ci Lower Limit
- 0.77
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.83
- estimate Comment
- GMT ratio = GMT (V503) / GMT (Gardasil)
- group Description
- Anti-HPV Type 11
- non Inferiority Comment
- Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- <0.001
- param Type
- GMT ratio
- param Value
- 0.80
- statistical Method
- ANOVA
- ci Lower Limit
- 0.96
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.03
- estimate Comment
- GMT ratio = GMT (V503) / GMT (Gardasil)
- group Description
- Anti-HPV Type 16
- non Inferiority Comment
- Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- <0.001
- param Type
- GMT ratio
- param Value
- 0.99
- statistical Method
- ANOVA
- ci Lower Limit
- 1.14
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.23
- estimate Comment
- GMT ratio = GMT (V503) / GMT (Gardasil)
- group Description
- Anti-HPV Type 18
- non Inferiority Comment
- Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- <0.001
- param Type
- GMT ratio
- param Value
- 1.19
- statistical Method
- ANOVA
Complete source fields
- analyses
- ci Lower Limit
- 0.99
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.06
- estimate Comment
- GMT ratio = GMT (V503) / GMT (Gardasil)
- group Description
- Anti-HPV Type 6
- non Inferiority Comment
- Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- <0.001
- param Type
- GMT ratio
- param Value
- 1.02
- statistical Method
- ANOVA
- ci Lower Limit
- 0.77
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.83
- estimate Comment
- GMT ratio = GMT (V503) / GMT (Gardasil)
- group Description
- Anti-HPV Type 11
- non Inferiority Comment
- Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- <0.001
- param Type
- GMT ratio
- param Value
- 0.80
- statistical Method
- ANOVA
- ci Lower Limit
- 0.96
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.03
- estimate Comment
- GMT ratio = GMT (V503) / GMT (Gardasil)
- group Description
- Anti-HPV Type 16
- non Inferiority Comment
- Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- <0.001
- param Type
- GMT ratio
- param Value
- 0.99
- statistical Method
- ANOVA
- ci Lower Limit
- 1.14
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.23
- estimate Comment
- GMT ratio = GMT (V503) / GMT (Gardasil)
- group Description
- Anti-HPV Type 18
- non Inferiority Comment
- Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- <0.001
- param Type
- GMT ratio
- param Value
- 1.19
- statistical Method
- ANOVA
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 871.7
- upper Limit
- 915.1
- value
- 893.1
- group Id
- OG001
- lower Limit
- 854.2
- upper Limit
- 896.8
- value
- 875.2
- title
- Anti-HPV Type 6 (n=3993, 3975)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 649.6
- upper Limit
- 683.4
- value
- 666.3
- group Id
- OG001
- lower Limit
- 809.2
- upper Limit
- 851.4
- value
- 830.0
- title
- Anti-HPV Type 11 (n=3995, 3982)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3057.1
- upper Limit
- 3206.9
- value
- 3131.1
- group Id
- OG001
- lower Limit
- 3082.3
- upper Limit
- 3232.7
- value
- 3156.6
- title
- Anti-HPV Type 16 (n=4032, 4062)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 782.7
- upper Limit
- 827.1
- value
- 804.6
- group Id
- OG001
- lower Limit
- 660.2
- upper Limit
- 697.7
- value
- 678.7
- title
- Anti-HPV Type 18 (n=4539, 4541)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 636.7
- upper Limit
- 680.9
- value
- 658.4
- group Id
- OG001
- lower Limit
- 9.4
- upper Limit
- 10.1
- value
- 9.7
- title
- Anti-HPV Type 31 (n=4466, 4377)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 405.6
- upper Limit
- 426.4
- value
- 415.9
- comment
- The GMT value was \<4 milli Merck U/mL
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Anti-HPV Type 33 (n=4702, 4691)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 246.2
- upper Limit
- 259.6
- value
- 252.8
- comment
- The GMT value was \<3 milli Merck U/mL
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Anti-HPV Type 45 (n=4792, 4750)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 371.6
- upper Limit
- 388.0
- value
- 379.7
- comment
- The GMT value was \<3 milli Merck U/mL
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Anti-HPV Type 52 (n=4455, 4335)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 469.9
- upper Limit
- 495.3
- value
- 482.5
- comment
- The GMT value was \<4 milli Merck U/mL
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Anti-HPV Type 58 (n=4486, 4446)
- denoms
- counts
- group Id
- OG000
- value
- 6792
- group Id
- OG001
- value
- 6795
- units
- Participants
- description
- Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. Statistical analysis was performed only for HPV types contained in both vaccines.
- dispersion Type
- 95% Confidence Interval
- 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
- GEOMETRIC_MEAN
- population Description
- The Per-protocol Immunogenicity population included all participants who were not protocol violators, received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable ranges, were seronegative at Day 1 and PCR negative from Day 1- Month 7 for the relevant HPV types, and had a Month 7 serum sample collected within an acceptable range
- reporting Status
- POSTED
- time Frame
- 4 weeks postdose 3 in the base study
- title
- Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58
- type
- PRIMARY
- unit Of Measure
- milli Merck U/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle