NCT03158220 · OUTCOME
Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type
Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) · Source last updated 2019-11-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- mMU/mL
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 4 weeks post vaccination 3 (Month 7)
What was measured
Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). Statistical comparisons between arms was performed for the HPV types considered oncogenic (HPV Types 16/18/31/33/45/52/58).
Analysis population: Received all 3 vaccinations of the correct dose and within acceptable day ranges, had evaluable serology results at Day 1 and Month 7, must have been seronegative to the appropriate HPV type at Day 1 and had no protocol deviations that could interfere with the evaluation of participant's immune response to the 9vHPV vaccine.
Groups in this outcome
Women 16-26 Years of Age
Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
Women 27-45 Years of Age
Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
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 |
|---|
| Women 16-26 Years of Age | 485 |
|---|
| Women 27-45 Years of Age | 533 |
|---|
Reported measurements
Anti-HPV 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Women 16-26 Years of Age | 421 |
|---|
| Women 27-45 Years of Age | 448 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Women 16-26 Years of Age | 787.8 | Not reported | 732.5 | 847.2 | Not reported |
|---|
| Women 27-45 Years of Age | 638.4 | Not reported | 594.9 | 685.0 | Not reported |
|---|
Anti-HPV 11
Analysis denominator · Participants
| Group | Source count |
|---|
| Women 16-26 Years of Age | 421 |
|---|
| Women 27-45 Years of Age | 448 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Women 16-26 Years of Age | 598.7 | Not reported | 558.7 | 641.6 | Not reported |
|---|
| Women 27-45 Years of Age | 453.5 | Not reported | 424.1 | 485.0 | Not reported |
|---|
Anti-HPV 16
Analysis denominator · Participants
| Group | Source count |
|---|
| Women 16-26 Years of Age | 436 |
|---|
| Women 27-45 Years of Age | 448 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Women 16-26 Years of Age | 3075.8 | Not reported | 2863.4 | 3303.9 | Not reported |
|---|
| Women 27-45 Years of Age | 2147.5 | Not reported | 2001.1 | 2304.5 | Not reported |
|---|
Anti-HPV 18
Analysis denominator · Participants
| Group | Source count |
|---|
| Women 16-26 Years of Age | 421 |
|---|
| Women 27-45 Years of Age | 471 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Women 16-26 Years of Age | 744.5 | Not reported | 685.0 | 809.1 | Not reported |
|---|
| Women 27-45 Years of Age | 532.1 | Not reported | 491.8 | 575.7 | Not reported |
|---|
Anti-HPV 31
Analysis denominator · Participants
| Group | Source count |
|---|
| Women 16-26 Years of Age | 447 |
|---|
| Women 27-45 Years of Age | 488 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Women 16-26 Years of Age | 596.1 | Not reported | 551.1 | 644.9 | Not reported |
|---|
| Women 27-45 Years of Age | 395.7 | Not reported | 367.0 | 426.6 | Not reported |
|---|
Anti-HPV 33
Analysis denominator · Participants
| Group | Source count |
|---|
| Women 16-26 Years of Age | 457 |
|---|
| Women 27-45 Years of Age | 493 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Women 16-26 Years of Age | 354.5 | Not reported | 331.7 | 378.9 | Not reported |
|---|
| Women 27-45 Years of Age | 259.0 | Not reported | 242.9 | 276.1 | Not reported |
|---|
Anti-HPV 45
Analysis denominator · Participants
| Group | Source count |
|---|
| Women 16-26 Years of Age | 470 |
|---|
| Women 27-45 Years of Age | 515 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Women 16-26 Years of Age | 214.9 | Not reported | 197.7 | 233.7 | Not reported |
|---|
| Women 27-45 Years of Age | 145.6 | Not reported | 134.4 | 157.7 | Not reported |
|---|
Anti-HPV 52
Analysis denominator · Participants
| Group | Source count |
|---|
| Women 16-26 Years of Age | 456 |
|---|
| Women 27-45 Years of Age | 496 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Women 16-26 Years of Age | 346.5 | Not reported | 324.0 | 370.5 | Not reported |
|---|
| Women 27-45 Years of Age | 244.7 | Not reported | 229.4 | 261.0 | Not reported |
|---|
Anti-HPV 58
Analysis denominator · Participants
| Group | Source count |
|---|
| Women 16-26 Years of Age | 451 |
|---|
| Women 27-45 Years of Age | 478 |
|---|
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Women 16-26 Years of Age | 428.0 | Not reported | 399.4 | 458.6 | Not reported |
|---|
| Women 27-45 Years of Age | 296.4 | Not reported | 277.1 | 317.0 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- 0.63
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.77
- estimate Comment
- Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds
- group Description
- Anti HPV 16
- non Inferiority Comment
- Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- < 0.001
- p Value Comment
- Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.
- param Type
- Fold Difference
- param Value
- 0.70
- statistical Method
- ANOVA
- ci Lower Limit
- 0.64
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.80
- estimate Comment
- Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds
- group Description
- Anti HPV 18
- non Inferiority Comment
- Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- < 0.001
- p Value Comment
- Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.
- param Type
- Fold Difference
- param Value
- 0.71
- statistical Method
- ANOVA
- ci Lower Limit
- 0.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.74
- estimate Comment
- Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds
- group Description
- Anti HPV 31
- non Inferiority Comment
- Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- < 0.001
- p Value Comment
- ANOVA model with response of log individual titers and a fixed effect for age groups.
- param Type
- Fold Difference
- param Value
- 0.66
- statistical Method
- ANOVA
- ci Lower Limit
- 0.67
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.80
- estimate Comment
- Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds
- group Description
- Anti HPV 33
- non Inferiority Comment
- Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- < 0.001
- p Value Comment
- ANOVA model with response of log individual titers and a fixed effect for age groups.
- param Type
- Fold Difference
- param Value
- 0.73
- statistical Method
- ANOVA
- ci Lower Limit
- 0.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.76
- estimate Comment
- Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds
- group Description
- Anti HPV 45
- non Inferiority Comment
- Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- < 0.001
- p Value Comment
- ANOVA model with response of log individual titers and a fixed effect for age groups.
- param Type
- Fold Difference
- param Value
- 0.68
- statistical Method
- ANOVA
- ci Lower Limit
- 0.64
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.78
- estimate Comment
- Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds
- group Description
- Anti HPV 52
- non Inferiority Comment
- Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- < 0.001
- p Value Comment
- ANOVA model with response of log individual titers and a fixed effect for age groups.
- param Type
- Fold Difference
- param Value
- 0.71
- statistical Method
- ANOVA
- ci Lower Limit
- 0.63
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.76
- estimate Comment
- Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds
- group Description
- Anti HPV 58
- non Inferiority Comment
- Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- < 0.001
- p Value Comment
- ANOVA model with response of log individual titers and a fixed effect for age groups.
- param Type
- Fold Difference
- param Value
- 0.69
- statistical Method
- ANOVA
Complete source fields
- analyses
- ci Lower Limit
- 0.63
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.77
- estimate Comment
- Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds
- group Description
- Anti HPV 16
- non Inferiority Comment
- Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- < 0.001
- p Value Comment
- Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.
- param Type
- Fold Difference
- param Value
- 0.70
- statistical Method
- ANOVA
- ci Lower Limit
- 0.64
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.80
- estimate Comment
- Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds
- group Description
- Anti HPV 18
- non Inferiority Comment
- Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- < 0.001
- p Value Comment
- Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.
- param Type
- Fold Difference
- param Value
- 0.71
- statistical Method
- ANOVA
- ci Lower Limit
- 0.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.74
- estimate Comment
- Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds
- group Description
- Anti HPV 31
- non Inferiority Comment
- Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- < 0.001
- p Value Comment
- ANOVA model with response of log individual titers and a fixed effect for age groups.
- param Type
- Fold Difference
- param Value
- 0.66
- statistical Method
- ANOVA
- ci Lower Limit
- 0.67
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.80
- estimate Comment
- Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds
- group Description
- Anti HPV 33
- non Inferiority Comment
- Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- < 0.001
- p Value Comment
- ANOVA model with response of log individual titers and a fixed effect for age groups.
- param Type
- Fold Difference
- param Value
- 0.73
- statistical Method
- ANOVA
- ci Lower Limit
- 0.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.76
- estimate Comment
- Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds
- group Description
- Anti HPV 45
- non Inferiority Comment
- Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- < 0.001
- p Value Comment
- ANOVA model with response of log individual titers and a fixed effect for age groups.
- param Type
- Fold Difference
- param Value
- 0.68
- statistical Method
- ANOVA
- ci Lower Limit
- 0.64
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.78
- estimate Comment
- Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds
- group Description
- Anti HPV 52
- non Inferiority Comment
- Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- < 0.001
- p Value Comment
- ANOVA model with response of log individual titers and a fixed effect for age groups.
- param Type
- Fold Difference
- param Value
- 0.71
- statistical Method
- ANOVA
- ci Lower Limit
- 0.63
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.76
- estimate Comment
- Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds
- group Description
- Anti HPV 58
- non Inferiority Comment
- Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- < 0.001
- p Value Comment
- ANOVA model with response of log individual titers and a fixed effect for age groups.
- param Type
- Fold Difference
- param Value
- 0.69
- statistical Method
- ANOVA
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 732.5
- upper Limit
- 847.2
- value
- 787.8
- group Id
- OG001
- lower Limit
- 594.9
- upper Limit
- 685.0
- value
- 638.4
- denoms
- counts
- group Id
- OG000
- value
- 421
- group Id
- OG001
- value
- 448
- units
- Participants
- title
- Anti-HPV 6
- categories
- measurements
- group Id
- OG000
- lower Limit
- 558.7
- upper Limit
- 641.6
- value
- 598.7
- group Id
- OG001
- lower Limit
- 424.1
- upper Limit
- 485.0
- value
- 453.5
- denoms
- counts
- group Id
- OG000
- value
- 421
- group Id
- OG001
- value
- 448
- units
- Participants
- title
- Anti-HPV 11
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2863.4
- upper Limit
- 3303.9
- value
- 3075.8
- group Id
- OG001
- lower Limit
- 2001.1
- upper Limit
- 2304.5
- value
- 2147.5
- denoms
- counts
- group Id
- OG000
- value
- 436
- group Id
- OG001
- value
- 448
- units
- Participants
- title
- Anti-HPV 16
- categories
- measurements
- group Id
- OG000
- lower Limit
- 685.0
- upper Limit
- 809.1
- value
- 744.5
- group Id
- OG001
- lower Limit
- 491.8
- upper Limit
- 575.7
- value
- 532.1
- denoms
- counts
- group Id
- OG000
- value
- 421
- group Id
- OG001
- value
- 471
- units
- Participants
- title
- Anti-HPV 18
- categories
- measurements
- group Id
- OG000
- lower Limit
- 551.1
- upper Limit
- 644.9
- value
- 596.1
- group Id
- OG001
- lower Limit
- 367.0
- upper Limit
- 426.6
- value
- 395.7
- denoms
- counts
- group Id
- OG000
- value
- 447
- group Id
- OG001
- value
- 488
- units
- Participants
- title
- Anti-HPV 31
- categories
- measurements
- group Id
- OG000
- lower Limit
- 331.7
- upper Limit
- 378.9
- value
- 354.5
- group Id
- OG001
- lower Limit
- 242.9
- upper Limit
- 276.1
- value
- 259.0
- denoms
- counts
- group Id
- OG000
- value
- 457
- group Id
- OG001
- value
- 493
- units
- Participants
- title
- Anti-HPV 33
- categories
- measurements
- group Id
- OG000
- lower Limit
- 197.7
- upper Limit
- 233.7
- value
- 214.9
- group Id
- OG001
- lower Limit
- 134.4
- upper Limit
- 157.7
- value
- 145.6
- denoms
- counts
- group Id
- OG000
- value
- 470
- group Id
- OG001
- value
- 515
- units
- Participants
- title
- Anti-HPV 45
- categories
- measurements
- group Id
- OG000
- lower Limit
- 324.0
- upper Limit
- 370.5
- value
- 346.5
- group Id
- OG001
- lower Limit
- 229.4
- upper Limit
- 261.0
- value
- 244.7
- denoms
- counts
- group Id
- OG000
- value
- 456
- group Id
- OG001
- value
- 496
- units
- Participants
- title
- Anti-HPV 52
- categories
- measurements
- group Id
- OG000
- lower Limit
- 399.4
- upper Limit
- 458.6
- value
- 428.0
- group Id
- OG001
- lower Limit
- 277.1
- upper Limit
- 317.0
- value
- 296.4
- denoms
- counts
- group Id
- OG000
- value
- 451
- group Id
- OG001
- value
- 478
- units
- Participants
- title
- Anti-HPV 58
- denoms
- counts
- group Id
- OG000
- value
- 485
- group Id
- OG001
- value
- 533
- units
- Participants
- description
- Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). Statistical comparisons between arms was performed for the HPV types considered oncogenic (HPV Types 16/18/31/33/45/52/58).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- id
- OG000
- title
- Women 16-26 Years of Age
- description
- Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- id
- OG001
- title
- Women 27-45 Years of Age
- param Type
- GEOMETRIC_MEAN
- population Description
- Received all 3 vaccinations of the correct dose and within acceptable day ranges, had evaluable serology results at Day 1 and Month 7, must have been seronegative to the appropriate HPV type at Day 1 and had no protocol deviations that could interfere with the evaluation of participant's immune response to the 9vHPV vaccine.
- reporting Status
- POSTED
- time Frame
- 4 weeks post vaccination 3 (Month 7)
- title
- Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type
- type
- PRIMARY
- unit Of Measure
- mMU/mL
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