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NCT00943722 · OUTCOME

Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 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: GEOMETRIC_MEAN
Unit: milli Merck Units/mL
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 a competitive luminex immunoassay (cLIA). Titers were reported in milli Merck Units/mL.

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

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	2084.7	Not reported	1944.0	2235.7	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	900.8	Not reported	822.3	986.9	Not reported

Anti-HPV 11

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	1487.1	Not reported	1386.5	1595.0	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	706.6	Not reported	645.2	773.8	Not reported

Anti-HPV 16

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	8628.9	Not reported	8065.9	9231.3	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	3522.6	Not reported	3223.5	3849.5	Not reported

Anti-HPV 18

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	2822.8	Not reported	2602.8	3061.5	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	882.7	Not reported	795.4	979.5	Not reported

Anti-HPV 31

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	2221.2	Not reported	2056.1	2399.5	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	753.9	Not reported	682.5	832.7	Not reported

Anti-HPV 33

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	1198.7	Not reported	1117.1	1286.2	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	466.8	Not reported	426.9	510.3	Not reported

Anti-HPV 45

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	907.0	Not reported	830.2	991.0	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	272.2	Not reported	243.8	303.9	Not reported

Anti-HPV 52

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	1037.8	Not reported	964.4	1116.9	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	419.6	Not reported	381.4	461.5	Not reported

Anti-HPV 58

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Base Study: 9- to 15-Year-Old Males (Lot 1)	1567.7	Not reported	1460.2	1683.1	Not reported
Base Study: 16- to 26-Year-Old Females (Lot 1)	590.5	Not reported	538.2	647.9	Not reported

Source statistical analyses

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

ci Lower Limit
2.07
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.59
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 6
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
2.31
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA
ci Lower Limit
1.88
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.36
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 11
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
2.10
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA
ci Lower Limit
2.19
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.74
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 16
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
2.45
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA
ci Lower Limit
2.80
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.65
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 18
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
3.20
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA
ci Lower Limit
2.60
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.34
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 31
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
2.95
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA
ci Lower Limit
2.29
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.88
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 33
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
2.57
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA
ci Lower Limit
2.89
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.84
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 45
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
3.33
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA
ci Lower Limit
2.19
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.79
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 52
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
2.47
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA
ci Lower Limit
2.37
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.98
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 58
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
2.66
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA

Complete source fields

analyses

ci Lower Limit
2.07
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.59
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 6
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
2.31
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA
ci Lower Limit
1.88
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.36
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 11
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
2.10
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA
ci Lower Limit
2.19
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.74
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 16
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
2.45
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA
ci Lower Limit
2.80
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.65
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 18
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
3.20
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA
ci Lower Limit
2.60
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.34
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 31
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
2.95
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA
ci Lower Limit
2.29
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.88
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 33
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
2.57
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA
ci Lower Limit
2.89
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.84
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 45
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
3.33
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA
ci Lower Limit
2.19
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.79
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 52
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
2.47
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA
ci Lower Limit
2.37
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.98
estimate Comment
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
group Description
Anti-HPV 58
group Ids
OG000
OG001
non Inferiority Comment
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
non Inferiority Type
NON_INFERIORITY
p Value
< 0.001
p Value Comment
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
param Type
GMT ratio
param Value
2.66
statistical Comment
model with a response of log individual titers and a fixed effect for comparison group
statistical Method
ANOVA

classes

categories
measurements
group Id
OG000
lower Limit
1944.0
upper Limit
2235.7
value
2084.7
group Id
OG001
lower Limit
822.3
upper Limit
986.9
value
900.8
denoms
counts
group Id
OG000
value
559
group Id
OG001
value
328
units
Participants
title
Anti-HPV 6
categories
measurements
group Id
OG000
lower Limit
1386.5
upper Limit
1595.0
value
1487.1
group Id
OG001
lower Limit
645.2
upper Limit
773.8
value
706.6
denoms
counts
group Id
OG000
value
559
group Id
OG001
value
332
units
Participants
title
Anti-HPV 11
categories
measurements
group Id
OG000
lower Limit
8065.9
upper Limit
9231.3
value
8628.9
group Id
OG001
lower Limit
3223.5
upper Limit
3849.5
value
3522.6
denoms
counts
group Id
OG000
value
569
group Id
OG001
value
329
units
Participants
title
Anti-HPV 16
categories
measurements
group Id
OG000
lower Limit
2602.8
upper Limit
3061.5
value
2822.8
group Id
OG001
lower Limit
795.4
upper Limit
979.5
value
882.7
denoms
counts
group Id
OG000
value
567
group Id
OG001
value
345
units
Participants
title
Anti-HPV 18
categories
measurements
group Id
OG000
lower Limit
2056.1
upper Limit
2399.5
value
2221.2
group Id
OG001
lower Limit
682.5
upper Limit
832.7
value
753.9
denoms
counts
group Id
OG000
value
564
group Id
OG001
value
340
units
Participants
title
Anti-HPV 31
categories
measurements
group Id
OG000
lower Limit
1117.1
upper Limit
1286.2
value
1198.7
group Id
OG001
lower Limit
426.9
upper Limit
510.3
value
466.8
denoms
counts
group Id
OG000
value
567
group Id
OG001
value
354
units
Participants
title
Anti-HPV 33
categories
measurements
group Id
OG000
lower Limit
830.2
upper Limit
991.0
value
907.0
group Id
OG001
lower Limit
243.8
upper Limit
303.9
value
272.2
denoms
counts
group Id
OG000
value
570
group Id
OG001
value
368
units
Participants
title
Anti-HPV 45
categories
measurements
group Id
OG000
lower Limit
964.4
upper Limit
1116.9
value
1037.8
group Id
OG001
lower Limit
381.4
upper Limit
461.5
value
419.6
denoms
counts
group Id
OG000
value
568
group Id
OG001
value
337
units
Participants
title
Anti-HPV 52
categories
measurements
group Id
OG000
lower Limit
1460.2
upper Limit
1683.1
value
1567.7
group Id
OG001
lower Limit
538.2
upper Limit
647.9
value
590.5
denoms
counts
group Id
OG000
value
566
group Id
OG001
value
332
units
Participants
title
Anti-HPV 58

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 a competitive luminex immunoassay (cLIA). Titers were reported in milli Merck Units/mL.

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

GEOMETRIC_MEAN

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: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])

type

PRIMARY

unit Of Measure

milli Merck Units/mL

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