NCT00543543 · OUTCOME

Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 7 Postdose 4

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: Month 60 + 1 week: Day 7 postdose 4 in the Extension Study (Cohort 1)

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. This outcome measure applied to Cohort 1 participants only.

Analysis population: All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.

Groups in this outcome

Extension Study: Mid-dose V503 (Cohort 1)

V503 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.

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
Extension Study: Mid-dose V503 (Cohort 1)	150

Reported measurements

Anti-HPV Type 6 (n=109)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	2180.5	Not reported	1826.2	2603.7	Not reported

Anti-HPV Type 11 (n=109)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	2228.7	Not reported	1852.5	2681.3	Not reported

Anti-HPV Type 16 (n=126)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	7986.3	Not reported	6795.7	9385.6	Not reported

Anti-HPV Type 18 (n=138)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	2399.0	Not reported	2049.4	2808.1	Not reported

Anti-HPV Type 31 (n=131)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	1462.2	Not reported	1263.9	1691.5	Not reported

Anti-HPV Type 33 (n=137)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	1709.0	Not reported	1466.7	1991.2	Not reported

Anti-HPV Type 45 (n=144)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	323.0	Not reported	277.2	376.5	Not reported

Anti-HPV Type 52 (n=131)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	1078.1	Not reported	907.2	1281.2	Not reported

Anti-HPV Type 58 (n=129)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	1801.8	Not reported	1530.5	2121.2	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
1826.2
upper Limit
2603.7
value
2180.5
title
Anti-HPV Type 6 (n=109)
categories
measurements
group Id
OG000
lower Limit
1852.5
upper Limit
2681.3
value
2228.7
title
Anti-HPV Type 11 (n=109)
categories
measurements
group Id
OG000
lower Limit
6795.7
upper Limit
9385.6
value
7986.3
title
Anti-HPV Type 16 (n=126)
categories
measurements
group Id
OG000
lower Limit
2049.4
upper Limit
2808.1
value
2399.0
title
Anti-HPV Type 18 (n=138)
categories
measurements
group Id
OG000
lower Limit
1263.9
upper Limit
1691.5
value
1462.2
title
Anti-HPV Type 31 (n=131)
categories
measurements
group Id
OG000
lower Limit
1466.7
upper Limit
1991.2
value
1709.0
title
Anti-HPV Type 33 (n=137)
categories
measurements
group Id
OG000
lower Limit
277.2
upper Limit
376.5
value
323.0
title
Anti-HPV Type 45 (n=144)
categories
measurements
group Id
OG000
lower Limit
907.2
upper Limit
1281.2
value
1078.1
title
Anti-HPV Type 52 (n=131)
categories
measurements
group Id
OG000
lower Limit
1530.5
upper Limit
2121.2
value
1801.8
title
Anti-HPV Type 58 (n=129)

denoms

counts
group Id
OG000
value
150
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
V503 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
Extension Study: Mid-dose V503 (Cohort 1)

param Type

GEOMETRIC_MEAN

population Description

All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.

reporting Status

POSTED

time Frame

Month 60 + 1 week: Day 7 postdose 4 in the Extension Study (Cohort 1)

title

Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 7 Postdose 4

type

OTHER_PRE_SPECIFIED

unit Of Measure

milli Merck U/mL

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Preserved source evidence · Not medical advice