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NCT00943722 · OUTCOME

Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])

A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002) · Source last updated 2022-10-03

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)

What was measured

Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using 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: 9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range

Groups in this outcome

Base Study: 9- to 15-Year-Old Males (Lot 1)

9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.

Base Study: 16- to 26-Year-Old Females (Lot 1)

9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.

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
Base Study: 9- to 15-Year-Old Males (Lot 1)	570
Base Study: 16- to 26-Year-Old Females (Lot 1)	378

Reported measurements

Anti-HPV 6 cLIA ≥30 mMU/mL

Analysis denominator · Participants

Group	Source count
Base Study: 9- to 15-Year-Old Males (Lot 1)	559
Base Study: 16- to 26-Year-Old Females (Lot 1)	328

Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	99.8	Not reported	99.0	100.0	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	99.7	Not reported	98.3	100.0	Not reported

Anti-HPV 11 cLIA ≥16 mMU/mL

Analysis denominator · Participants

Group	Source count
Base Study: 9- to 15-Year-Old Males (Lot 1)	559
Base Study: 16- to 26-Year-Old Females (Lot 1)	332

Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	100.0	Not reported	99.3	100.0	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	100.0	Not reported	98.9	100.0	Not reported

Anti-HPV 16 cLIA ≥20 mMU/mL

Analysis denominator · Participants

Group	Source count
Base Study: 9- to 15-Year-Old Males (Lot 1)	569
Base Study: 16- to 26-Year-Old Females (Lot 1)	329

Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	100.0	Not reported	99.4	100.0	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	100.0	Not reported	98.9	100.0	Not reported

Anti-HPV 18 cLIA ≥24 mMU/mL

Analysis denominator · Participants

Group	Source count
Base Study: 9- to 15-Year-Old Males (Lot 1)	567
Base Study: 16- to 26-Year-Old Females (Lot 1)	345

Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	100.0	Not reported	99.4	100.0	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	99.7	Not reported	98.4	100.0	Not reported

Anti-HPV 31 cLIA ≥10 mMU/mL

Analysis denominator · Participants

Group	Source count
Base Study: 9- to 15-Year-Old Males (Lot 1)	564
Base Study: 16- to 26-Year-Old Females (Lot 1)	340

Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	100.0	Not reported	99.3	100.0	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	99.7	Not reported	98.4	100.0	Not reported

Anti-HPV 33 cLIA ≥8 mMU/mL

Analysis denominator · Participants

Group	Source count
Base Study: 9- to 15-Year-Old Males (Lot 1)	567
Base Study: 16- to 26-Year-Old Females (Lot 1)	354

Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	100.0	Not reported	99.4	100.0	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	99.7	Not reported	98.4	100.0	Not reported

Anti-HPV 45 cLIA ≥8 mMU/mL

Analysis denominator · Participants

Group	Source count
Base Study: 9- to 15-Year-Old Males (Lot 1)	570
Base Study: 16- to 26-Year-Old Females (Lot 1)	368

Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	100.0	Not reported	99.4	100.0	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	99.5	Not reported	98.1	99.9	Not reported

Anti-HPV 52 cLIA ≥8 mMU/mL

Analysis denominator · Participants

Group	Source count
Base Study: 9- to 15-Year-Old Males (Lot 1)	568
Base Study: 16- to 26-Year-Old Females (Lot 1)	337

Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	100.0	Not reported	99.4	100.0	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	99.7	Not reported	98.4	100.0	Not reported

Anti-HPV 58 cLIA ≥8 mMU/mL

Analysis denominator · Participants

Group	Source count
Base Study: 9- to 15-Year-Old Males (Lot 1)	566
Base Study: 16- to 26-Year-Old Females (Lot 1)	332

Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	100.0	Not reported	99.4	100.0	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	100.0	Not reported	98.9	100.0	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
-0.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.5
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 6
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.1
statistical Method
Miettinen and Nurminen
ci Lower Limit
-0.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.2
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 11
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.0
statistical Method
Miettinen and Nurminen
ci Lower Limit
-0.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.2
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 16
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.0
statistical Method
Miettinen and Nurminen
ci Lower Limit
-0.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.6
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 18
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.3
statistical Method
Miettinen and Nurminen
ci Lower Limit
-0.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.7
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 31
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.3
statistical Method
Miettinen and Nurminen
ci Lower Limit
-0.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.6
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 33
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.3
statistical Method
Miettinen and Nurminen
ci Lower Limit
-0.1
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.0
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 45
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.5
statistical Method
Miettinen and Nurminen
ci Lower Limit
-0.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.7
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 52
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.3
statistical Method
Miettinen and Nurminen
ci Lower Limit
-0.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.2
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 58
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.0
statistical Method
Miettinen and Nurminen

Complete source fields

analyses

ci Lower Limit
-0.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.5
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 6
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.1
statistical Method
Miettinen and Nurminen
ci Lower Limit
-0.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.2
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 11
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.0
statistical Method
Miettinen and Nurminen
ci Lower Limit
-0.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.2
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 16
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.0
statistical Method
Miettinen and Nurminen
ci Lower Limit
-0.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.6
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 18
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.3
statistical Method
Miettinen and Nurminen
ci Lower Limit
-0.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.7
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 31
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.3
statistical Method
Miettinen and Nurminen
ci Lower Limit
-0.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.6
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 33
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.3
statistical Method
Miettinen and Nurminen
ci Lower Limit
-0.1
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.0
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 45
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.5
statistical Method
Miettinen and Nurminen
ci Lower Limit
-0.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.7
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 52
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.3
statistical Method
Miettinen and Nurminen
ci Lower Limit
-0.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.2
estimate Comment
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 58
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
param Type
Percentage Point Difference
param Value
0.0
statistical Method
Miettinen and Nurminen

classes

categories
measurements
group Id
OG000
lower Limit
99.0
upper Limit
100.0
value
99.8
group Id
OG001
lower Limit
98.3
upper Limit
100.0
value
99.7
denoms
counts
group Id
OG000
value
559
group Id
OG001
value
328
units
Participants
title
Anti-HPV 6 cLIA ≥30 mMU/mL
categories
measurements
group Id
OG000
lower Limit
99.3
upper Limit
100.0
value
100.0
group Id
OG001
lower Limit
98.9
upper Limit
100.0
value
100.0
denoms
counts
group Id
OG000
value
559
group Id
OG001
value
332
units
Participants
title
Anti-HPV 11 cLIA ≥16 mMU/mL
categories
measurements
group Id
OG000
lower Limit
99.4
upper Limit
100.0
value
100.0
group Id
OG001
lower Limit
98.9
upper Limit
100.0
value
100.0
denoms
counts
group Id
OG000
value
569
group Id
OG001
value
329
units
Participants
title
Anti-HPV 16 cLIA ≥20 mMU/mL
categories
measurements
group Id
OG000
lower Limit
99.4
upper Limit
100.0
value
100.0
group Id
OG001
lower Limit
98.4
upper Limit
100.0
value
99.7
denoms
counts
group Id
OG000
value
567
group Id
OG001
value
345
units
Participants
title
Anti-HPV 18 cLIA ≥24 mMU/mL
categories
measurements
group Id
OG000
lower Limit
99.3
upper Limit
100.0
value
100.0
group Id
OG001
lower Limit
98.4
upper Limit
100.0
value
99.7
denoms
counts
group Id
OG000
value
564
group Id
OG001
value
340
units
Participants
title
Anti-HPV 31 cLIA ≥10 mMU/mL
categories
measurements
group Id
OG000
lower Limit
99.4
upper Limit
100.0
value
100.0
group Id
OG001
lower Limit
98.4
upper Limit
100.0
value
99.7
denoms
counts
group Id
OG000
value
567
group Id
OG001
value
354
units
Participants
title
Anti-HPV 33 cLIA ≥8 mMU/mL
categories
measurements
group Id
OG000
lower Limit
99.4
upper Limit
100.0
value
100.0
group Id
OG001
lower Limit
98.1
upper Limit
99.9
value
99.5
denoms
counts
group Id
OG000
value
570
group Id
OG001
value
368
units
Participants
title
Anti-HPV 45 cLIA ≥8 mMU/mL
categories
measurements
group Id
OG000
lower Limit
99.4
upper Limit
100.0
value
100.0
group Id
OG001
lower Limit
98.4
upper Limit
100.0
value
99.7
denoms
counts
group Id
OG000
value
568
group Id
OG001
value
337
units
Participants
title
Anti-HPV 52 cLIA ≥8 mMU/mL
categories
measurements
group Id
OG000
lower Limit
99.4
upper Limit
100.0
value
100.0
group Id
OG001
lower Limit
98.9
upper Limit
100.0
value
100.0
denoms
counts
group Id
OG000
value
566
group Id
OG001
value
332
units
Participants
title
Anti-HPV 58 cLIA ≥8 mMU/mL

denoms

counts
group Id
OG000
value
570
group Id
OG001
value
378
units
Participants

description

Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using 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
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
id
OG000
title
Base Study: 9- to 15-Year-Old Males (Lot 1)
description
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
id
OG001
title
Base Study: 16- to 26-Year-Old Females (Lot 1)

param Type

NUMBER

population Description

9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range

reporting Status

POSTED

time Frame

4 weeks post-vaccination 3 (Month 7)

title

Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])

type

SECONDARY

unit Of Measure

Percentage of Participants

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Preserved source evidence · Not medical advice