NCT01047345 · OUTCOME
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study
A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006) · 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
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 4 weeks post-vaccination 3 (Month 7; End of Base Study)
What was measured
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Analysis population: Participants who received all 3 vaccinations within an acceptable day range, had Month 7 serology sample collected within an acceptable range and had no other protocol violations that could interfere with immunes response to the vaccine. Statistical testing performed only within the 9vHPV arm and only for HPV types 31, 33, 45, 52, and 58.
Groups in this outcome
9vHPV Vaccine - Base Study
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
Placebo - Base Study
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of 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 |
|---|
| 9vHPV Vaccine - Base Study | 515 |
|---|
| Placebo - Base Study | 261 |
|---|
Reported measurements
Anti-HPV 6 (n=511; n=251)
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 9vHPV Vaccine - Base Study | 100.0 | Not reported | 99.3 | 100.0 | Not reported |
|---|
| Placebo - Base Study | 100.0 | Not reported | 98.5 | 100.0 | Not reported |
|---|
Anti-HPV 11 (n=515; n=261)
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 9vHPV Vaccine - Base Study | 100.0 | Not reported | 99.3 | 100.0 | Not reported |
|---|
| Placebo - Base Study | 99.6 | Not reported | 97.9 | 100.0 | Not reported |
|---|
Anti-HPV 16 (n=515; n=261)
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 9vHPV Vaccine - Base Study | 100.0 | Not reported | 99.3 | 100.0 | Not reported |
|---|
| Placebo - Base Study | 100.0 | Not reported | 98.6 | 100.0 | Not reported |
|---|
Anti-HPV 18 (n=515; n=261)
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 9vHPV Vaccine - Base Study | 100.0 | Not reported | 99.3 | 100.0 | Not reported |
|---|
| Placebo - Base Study | 85.4 | Not reported | 80.6 | 89.5 | Not reported |
|---|
Anti-HPV 31 (n=515; n=261)
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 9vHPV Vaccine - Base Study | 99.8 | Not reported | 98.9 | 100.0 | Not reported |
|---|
| Placebo - Base Study | 23.8 | Not reported | 18.7 | 29.4 | Not reported |
|---|
Anti-HPV 33 (n=515; n=261)
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 9vHPV Vaccine - Base Study | 99.8 | Not reported | 98.9 | 100.0 | Not reported |
|---|
| Placebo - Base Study | 8.0 | Not reported | 5.0 | 12.0 | Not reported |
|---|
Anti-HPV 45 (n=515; n=261)
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 9vHPV Vaccine - Base Study | 98.3 | Not reported | 96.7 | 99.2 | Not reported |
|---|
| Placebo - Base Study | 3.4 | Not reported | 1.6 | 6.4 | Not reported |
|---|
Anti-HPV 52 (n=515; n=261)
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 9vHPV Vaccine - Base Study | 99.6 | Not reported | 98.6 | 100.0 | Not reported |
|---|
| Placebo - Base Study | 3.8 | Not reported | 1.9 | 6.9 | Not reported |
|---|
Anti-HPV 58 (n=515; n=261)
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 9vHPV Vaccine - Base Study | 99.8 | Not reported | 98.9 | 100.0 | Not reported |
|---|
| Placebo - Base Study | 9.2 | Not reported | 6.0 | 13.4 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- 98.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 100.0
- group Description
- Anti-HPV 31
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- statistical criterion of acceptability required that the lower bound of the 95% confidence interval (CI) for the proportion of participants seroconverting be greater than 90%
- param Type
- Seroconversion rate
- param Value
- 99.8
- statistical Method
- Clopper-Pearson
- ci Lower Limit
- 98.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 100.0
- group Description
- Anti-HPV 33
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%
- param Type
- Seroconversion Rate
- param Value
- 99.8
- statistical Method
- Clopper-Pearson
- ci Lower Limit
- 96.7
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 99.2
- group Description
- Anti-HPV 45
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%
- param Type
- Seroconversion Rate
- param Value
- 98.3
- statistical Method
- Clopper-Pearson
- ci Lower Limit
- 98.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 100.0
- group Description
- Anti-HPV 52
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%
- param Type
- Seroconversion Rate
- param Value
- 99.6
- statistical Method
- Clopper-Pearson
- ci Lower Limit
- 98.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 100.0
- group Description
- Anti-HPV 58
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%
- param Type
- Seroconversion Rate
- param Value
- 99.8
- statistical Method
- Clopper-Pearson
Complete source fields
- analyses
- ci Lower Limit
- 98.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 100.0
- group Description
- Anti-HPV 31
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- statistical criterion of acceptability required that the lower bound of the 95% confidence interval (CI) for the proportion of participants seroconverting be greater than 90%
- param Type
- Seroconversion rate
- param Value
- 99.8
- statistical Method
- Clopper-Pearson
- ci Lower Limit
- 98.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 100.0
- group Description
- Anti-HPV 33
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%
- param Type
- Seroconversion Rate
- param Value
- 99.8
- statistical Method
- Clopper-Pearson
- ci Lower Limit
- 96.7
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 99.2
- group Description
- Anti-HPV 45
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%
- param Type
- Seroconversion Rate
- param Value
- 98.3
- statistical Method
- Clopper-Pearson
- ci Lower Limit
- 98.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 100.0
- group Description
- Anti-HPV 52
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%
- param Type
- Seroconversion Rate
- param Value
- 99.6
- statistical Method
- Clopper-Pearson
- ci Lower Limit
- 98.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 100.0
- group Description
- Anti-HPV 58
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%
- param Type
- Seroconversion Rate
- param Value
- 99.8
- statistical Method
- Clopper-Pearson
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 99.3
- upper Limit
- 100.0
- value
- 100.0
- group Id
- OG001
- lower Limit
- 98.5
- upper Limit
- 100.0
- value
- 100.0
- title
- Anti-HPV 6 (n=511; n=251)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 99.3
- upper Limit
- 100.0
- value
- 100.0
- group Id
- OG001
- lower Limit
- 97.9
- upper Limit
- 100.0
- value
- 99.6
- title
- Anti-HPV 11 (n=515; n=261)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 99.3
- upper Limit
- 100.0
- value
- 100.0
- group Id
- OG001
- lower Limit
- 98.6
- upper Limit
- 100.0
- value
- 100.0
- title
- Anti-HPV 16 (n=515; n=261)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 99.3
- upper Limit
- 100.0
- value
- 100.0
- group Id
- OG001
- lower Limit
- 80.6
- upper Limit
- 89.5
- value
- 85.4
- title
- Anti-HPV 18 (n=515; n=261)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 98.9
- upper Limit
- 100.0
- value
- 99.8
- group Id
- OG001
- lower Limit
- 18.7
- upper Limit
- 29.4
- value
- 23.8
- title
- Anti-HPV 31 (n=515; n=261)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 98.9
- upper Limit
- 100.0
- value
- 99.8
- group Id
- OG001
- lower Limit
- 5.0
- upper Limit
- 12.0
- value
- 8.0
- title
- Anti-HPV 33 (n=515; n=261)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 96.7
- upper Limit
- 99.2
- value
- 98.3
- group Id
- OG001
- lower Limit
- 1.6
- upper Limit
- 6.4
- value
- 3.4
- title
- Anti-HPV 45 (n=515; n=261)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 98.6
- upper Limit
- 100.0
- value
- 99.6
- group Id
- OG001
- lower Limit
- 1.9
- upper Limit
- 6.9
- value
- 3.8
- title
- Anti-HPV 52 (n=515; n=261)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 98.9
- upper Limit
- 100.0
- value
- 99.8
- group Id
- OG001
- lower Limit
- 6.0
- upper Limit
- 13.4
- value
- 9.2
- title
- Anti-HPV 58 (n=515; n=261)
- denoms
- counts
- group Id
- OG000
- value
- 515
- group Id
- OG001
- value
- 261
- units
- Participants
- description
- Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
- id
- OG000
- title
- 9vHPV Vaccine - Base Study
- description
- Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
- id
- OG001
- title
- Placebo - Base Study
- param Type
- NUMBER
- population Description
- Participants who received all 3 vaccinations within an acceptable day range, had Month 7 serology sample collected within an acceptable range and had no other protocol violations that could interfere with immunes response to the vaccine. Statistical testing performed only within the 9vHPV arm and only for HPV types 31, 33, 45, 52, and 58.
- reporting Status
- POSTED
- time Frame
- 4 weeks post-vaccination 3 (Month 7; End of Base Study)
- title
- Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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