NCT00543543 · OUTCOME

Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 28 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 61: 28 days 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)	2585.0	Not reported	2239.5	2983.8	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)	2548.7	Not reported	2191.4	2964.3	Not reported

Anti-HPV Type 16 (n=123)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	10904.3	Not reported	9605.6	12378.7	Not reported

Anti-HPV Type 18 (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)	2907.9	Not reported	2531.1	3340.7	Not reported

Anti-HPV Type 31 (n=130)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	1745.4	Not reported	1538.8	1979.8	Not reported

Anti-HPV Type 33 (n=136)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	2094.9	Not reported	1848.7	2373.9	Not reported

Anti-HPV Type 45 (n=143)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	440.0	Not reported	386.9	500.4	Not reported

Anti-HPV Type 52 (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)	1131.5	Not reported	991.6	1291.1	Not reported

Anti-HPV Type 58 (n=127)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	2024.6	Not reported	1803.1	2273.2	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
2239.5
upper Limit
2983.8
value
2585.0
title
Anti-HPV Type 6 (n=109)
categories
measurements
group Id
OG000
lower Limit
2191.4
upper Limit
2964.3
value
2548.7
title
Anti-HPV Type 11 (n=109)
categories
measurements
group Id
OG000
lower Limit
9605.6
upper Limit
12378.7
value
10904.3
title
Anti-HPV Type 16 (n=123)
categories
measurements
group Id
OG000
lower Limit
2531.1
upper Limit
3340.7
value
2907.9
title
Anti-HPV Type 18 (n=137)
categories
measurements
group Id
OG000
lower Limit
1538.8
upper Limit
1979.8
value
1745.4
title
Anti-HPV Type 31 (n=130)
categories
measurements
group Id
OG000
lower Limit
1848.7
upper Limit
2373.9
value
2094.9
title
Anti-HPV Type 33 (n=136)
categories
measurements
group Id
OG000
lower Limit
386.9
upper Limit
500.4
value
440.0
title
Anti-HPV Type 45 (n=143)
categories
measurements
group Id
OG000
lower Limit
991.6
upper Limit
1291.1
value
1131.5
title
Anti-HPV Type 52 (n=129)
categories
measurements
group Id
OG000
lower Limit
1803.1
upper Limit
2273.2
value
2024.6
title
Anti-HPV Type 58 (n=127)

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 61: 28 days 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 28 Postdose 4

type

OTHER_PRE_SPECIFIED

unit Of Measure

milli Merck U/mL

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Preserved source evidence · Not medical advice