Trial Outcomes & Findings for Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016) (NCT NCT00092495)
NCT ID: NCT00092495
Last Updated: 2015-01-13
Results Overview
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3055 participants
Primary outcome timeframe
Week 4 Postdose 3 (Month 7)
Results posted on
2015-01-13
Participant Flow
Participant milestones
| Measure |
20% Formulation qHPV Vaccine
Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
|
40% Formulation qHPV Vaccine
Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
60% Formulation qHPV Vaccine
Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
|
100% Formulation qHPV Vaccine
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
Extension Study
Extension Study: This group includes 12 subjects who participated in the base study and received either a partial dose formulation of the quadrivalent HPV vaccine in the base study and did not meet the protocol specified criteria for seroconversion, or subjects who, due to pregnancy, received 1 or 2 doses of the quadrivalent HPV vaccine in the base study and remained in the study through Month 7. The Extension Period began after all patients had completed the Month 7 follow-up period. Subjects designated as "Completed Period" are those who at the end of the study had received three injections of quadrivalent HPV vaccine and completed all follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.
|
|---|---|---|---|---|---|
|
Base Study Vaccination Period
STARTED
|
504
|
514
|
508
|
1529
|
0
|
|
Base Study Vaccination Period
With Long-term Follow-up *
|
2
|
2
|
6
|
10
|
0
|
|
Base Study Vaccination Period
Without Long-term Follow-up
|
34
|
20
|
28
|
73
|
0
|
|
Base Study Vaccination Period
COMPLETED
|
467
|
492
|
474
|
1441
|
0
|
|
Base Study Vaccination Period
NOT COMPLETED
|
37
|
22
|
34
|
88
|
0
|
|
Base Study Follow-up Period
STARTED
|
115
|
125
|
130
|
460
|
0
|
|
Base Study Follow-up Period
COMPLETED
|
112
|
122
|
126
|
446
|
0
|
|
Base Study Follow-up Period
NOT COMPLETED
|
3
|
3
|
4
|
14
|
0
|
|
Extension Study
STARTED
|
0
|
0
|
0
|
0
|
12
|
|
Extension Study
COMPLETED
|
0
|
0
|
0
|
0
|
12
|
|
Extension Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
20% Formulation qHPV Vaccine
Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
|
40% Formulation qHPV Vaccine
Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
60% Formulation qHPV Vaccine
Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
|
100% Formulation qHPV Vaccine
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
Extension Study
Extension Study: This group includes 12 subjects who participated in the base study and received either a partial dose formulation of the quadrivalent HPV vaccine in the base study and did not meet the protocol specified criteria for seroconversion, or subjects who, due to pregnancy, received 1 or 2 doses of the quadrivalent HPV vaccine in the base study and remained in the study through Month 7. The Extension Period began after all patients had completed the Month 7 follow-up period. Subjects designated as "Completed Period" are those who at the end of the study had received three injections of quadrivalent HPV vaccine and completed all follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.
|
|---|---|---|---|---|---|
|
Base Study Vaccination Period
Randomized Not Vaccinated
|
1
|
1
|
0
|
4
|
0
|
|
Base Study Vaccination Period
Extended
|
0
|
0
|
0
|
1
|
0
|
|
Base Study Vaccination Period
*Clinical AE
|
1
|
0
|
1
|
2
|
0
|
|
Base Study Vaccination Period
*Other reasons
|
1
|
0
|
0
|
1
|
0
|
|
Base Study Vaccination Period
*Pregnancy
|
0
|
2
|
5
|
7
|
0
|
|
Base Study Vaccination Period
Adverse Event
|
1
|
0
|
0
|
3
|
0
|
|
Base Study Vaccination Period
Lost to Follow-up
|
16
|
6
|
11
|
36
|
0
|
|
Base Study Vaccination Period
Moved
|
3
|
1
|
2
|
2
|
0
|
|
Base Study Vaccination Period
Other
|
1
|
1
|
0
|
2
|
0
|
|
Base Study Vaccination Period
Pregnancy
|
2
|
0
|
0
|
0
|
0
|
|
Base Study Vaccination Period
Parent Withdrew Consent
|
1
|
1
|
1
|
5
|
0
|
|
Base Study Vaccination Period
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
|
Base Study Vaccination Period
Withdrawal by Subject
|
9
|
10
|
14
|
25
|
0
|
|
Base Study Follow-up Period
Extended
|
0
|
0
|
1
|
2
|
0
|
|
Base Study Follow-up Period
Lost to Follow-up
|
1
|
3
|
3
|
12
|
0
|
|
Base Study Follow-up Period
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)
Baseline characteristics by cohort
| Measure |
20% Formulation qHPV Vaccine
n=504 Participants
Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
|
40% Formulation qHPV Vaccine
n=514 Participants
Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
60% Formulation qHPV Vaccine
n=508 Participants
Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
|
100% Formulation qHPV Vaccine
n=1529 Participants
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
Total
n=3055 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
16.2 years
n=5 Participants
|
16.5 years
n=7 Participants
|
16.2 years
n=5 Participants
|
15.1 years
n=4 Participants
|
15.7 years
FULL_RANGE 10 • n=21 Participants
|
|
Age, Customized
10 to 11 Years of Age
|
75 participants
n=5 Participants
|
77 participants
n=7 Participants
|
74 participants
n=5 Participants
|
302 participants
n=4 Participants
|
528 participants
n=21 Participants
|
|
Age, Customized
12 to 13 Years of Age
|
110 participants
n=5 Participants
|
95 participants
n=7 Participants
|
101 participants
n=5 Participants
|
370 participants
n=4 Participants
|
676 participants
n=21 Participants
|
|
Age, Customized
14 to 15 Years of Age
|
67 participants
n=5 Participants
|
83 participants
n=7 Participants
|
77 participants
n=5 Participants
|
344 participants
n=4 Participants
|
571 participants
n=21 Participants
|
|
Age, Customized
16 to 17 Years of Age
|
40 participants
n=5 Participants
|
24 participants
n=7 Participants
|
35 participants
n=5 Participants
|
77 participants
n=4 Participants
|
176 participants
n=21 Participants
|
|
Age, Customized
18 to 19 Years of Age
|
58 participants
n=5 Participants
|
62 participants
n=7 Participants
|
71 participants
n=5 Participants
|
125 participants
n=4 Participants
|
316 participants
n=21 Participants
|
|
Age, Customized
20 to 21 Years of Age
|
90 participants
n=5 Participants
|
86 participants
n=7 Participants
|
93 participants
n=5 Participants
|
165 participants
n=4 Participants
|
434 participants
n=21 Participants
|
|
Age, Customized
22 to 23 Years of Age
|
64 participants
n=5 Participants
|
86 participants
n=7 Participants
|
57 participants
n=5 Participants
|
146 participants
n=4 Participants
|
353 participants
n=21 Participants
|
|
Age, Customized
Over 23 Years of Age
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
504 Participants
n=5 Participants
|
514 Participants
n=7 Participants
|
508 Participants
n=5 Participants
|
1019 Participants
n=4 Participants
|
2545 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
510 Participants
n=4 Participants
|
510 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 4 Postdose 3 (Month 7)Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
Outcome measures
| Measure |
Girls 10-15 Years
n=423 Participants
|
Boys 10-15 Years
n=428 Participants
|
Women 16-23 Years
n=320 Participants
|
100% Formulation qHPV Vaccine
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3
HPV 6 ≥ 20 mMU/mL
|
423 Subjects
|
428 Subjects
|
320 Subjects
|
—
|
|
Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3
HPV 6 < 20 mMU/mL
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
PRIMARY outcome
Timeframe: Week 4 Postdose 3 (Month 7)Population: : Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.
Outcome measures
| Measure |
Girls 10-15 Years
n=423 Participants
|
Boys 10-15 Years
n=428 Participants
|
Women 16-23 Years
n=320 Participants
|
100% Formulation qHPV Vaccine
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3
|
987.3 mMU/mL
Interval 905.0 to 1077.0
|
1116.1 mMU/mL
Interval 1022.7 to 1218.1
|
603.0 mMU/mL
Interval 548.5 to 662.9
|
—
|
PRIMARY outcome
Timeframe: Week 4 Postdose 3 (Month 7)Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
Outcome measures
| Measure |
Girls 10-15 Years
n=372 Participants
|
Boys 10-15 Years
n=391 Participants
|
Women 16-23 Years
n=364 Participants
|
100% Formulation qHPV Vaccine
n=743 Participants
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3
HPV 6 ≥ 20 mMU/mL
|
372 Subjects
|
391 Subjects
|
363 Subjects
|
743 Subjects
|
|
Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3
HPV 6 < 20 mMU/mL
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
PRIMARY outcome
Timeframe: Week 4 Postdose 3 (Month 7)Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.
Outcome measures
| Measure |
Girls 10-15 Years
n=372 Participants
|
Boys 10-15 Years
n=391 Participants
|
Women 16-23 Years
n=364 Participants
|
100% Formulation qHPV Vaccine
n=743 Participants
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3
|
584.2 mMU/mL
Interval 526.7 to 647.9
|
704.5 mMU/mL
Interval 636.6 to 779.7
|
707.5 mMU/mL
Interval 632.5 to 791.2
|
798.4 mMU/mL
Interval 747.1 to 853.2
|
PRIMARY outcome
Timeframe: Week 4 Postdose 3 (Month 7)Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL).
Outcome measures
| Measure |
Girls 10-15 Years
n=423 Participants
|
Boys 10-15 Years
n=428 Participants
|
Women 16-23 Years
n=320 Participants
|
100% Formulation qHPV Vaccine
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3
HPV 11 ≥ 16 mMU/mL
|
423 Subjects
|
428 Subjects
|
320 Subjects
|
—
|
|
Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3
HPV 11 < 16 mMU/mL
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
PRIMARY outcome
Timeframe: Week 4 Postdose 3 (Month 7)Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.
Outcome measures
| Measure |
Girls 10-15 Years
n=423 Participants
|
Boys 10-15 Years
n=428 Participants
|
Women 16-23 Years
n=320 Participants
|
100% Formulation qHPV Vaccine
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3
|
1264.0 mMU/mL
Interval 1153.2 to 1385.4
|
1396.5 mMU/mL
Interval 1271.4 to 1534.0
|
739.2 mMU/mL
Interval 665.6 to 821.0
|
—
|
PRIMARY outcome
Timeframe: Week 4 Postdose 3 (Month 7)Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL).
Outcome measures
| Measure |
Girls 10-15 Years
n=373 Participants
|
Boys 10-15 Years
n=391 Participants
|
Women 16-23 Years
n=365 Participants
|
100% Formulation qHPV Vaccine
n=743 Participants
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3
HPV 11 ≥ 16 mMU/mL
|
373 Subjects
|
391 Subjects
|
364 Subjects
|
743 Subjects
|
|
Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3
HPV 11 < 16 mMU/mL
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
PRIMARY outcome
Timeframe: Week 4 Postdose 3 (Month 7)Population: : Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.
Outcome measures
| Measure |
Girls 10-15 Years
n=373 Participants
|
Boys 10-15 Years
n=391 Participants
|
Women 16-23 Years
n=365 Participants
|
100% Formulation qHPV Vaccine
n=743 Participants
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3
|
632.1 mMU/mL
Interval 565.2 to 706.8
|
804.7 mMU/mL
Interval 723.9 to 894.4
|
836.2 mMU/mL
Interval 743.7 to 940.2
|
1003.2 mMU/mL
Interval 934.0 to 1077.6
|
PRIMARY outcome
Timeframe: Week 4 Postdose 3 (Month 7)Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.
Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive.
Outcome measures
| Measure |
Girls 10-15 Years
n=424 Participants
|
Boys 10-15 Years
n=427 Participants
|
Women 16-23 Years
n=306 Participants
|
100% Formulation qHPV Vaccine
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
HPV 16 ≥ 20 mMU/mL
|
424 mMU/mL
|
427 mMU/mL
|
306 mMU/mL
|
—
|
|
Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
HPV 16 < 20 mMU/mL
|
0 mMU/mL
|
0 mMU/mL
|
0 mMU/mL
|
—
|
PRIMARY outcome
Timeframe: Week 4 Postdose 3 (Month 7)Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.
Outcome measures
| Measure |
Girls 10-15 Years
n=424 Participants
|
Boys 10-15 Years
n=427 Participants
|
Women 16-23 Years
n=306 Participants
|
100% Formulation qHPV Vaccine
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3
|
4848.8 mMU/mL
Interval 4350.2 to 5404.5
|
5923.0 mMU/mL
Interval 5325.2 to 6587.9
|
2753.0 mMU/mL
Interval 2400.5 to 3157.3
|
—
|
PRIMARY outcome
Timeframe: Week 4 Postdose 3 (Month 7)Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
Outcome measures
| Measure |
Girls 10-15 Years
n=365 Participants
|
Boys 10-15 Years
n=375 Participants
|
Women 16-23 Years
n=365 Participants
|
100% Formulation qHPV Vaccine
n=730 Participants
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
HPV 16 ≥ 20 mMU/mL
|
365 Subjects
|
375 Subjects
|
364 Subjects
|
730 Subjects
|
|
Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
HPV 16 < 20 mMU/mL
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
PRIMARY outcome
Timeframe: Week 4 Postdose 3 (Month 7)Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.
Outcome measures
| Measure |
Girls 10-15 Years
n=365 Participants
|
Boys 10-15 Years
n=375 Participants
|
Women 16-23 Years
n=365 Participants
|
100% Formulation qHPV Vaccine
n=730 Participants
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3
|
2401.1 mMU/mL
Interval 2084.0 to 2766.6
|
2963.3 mMU/mL
Interval 2593.3 to 3386.0
|
3105.3 mMU/mL
Interval 2692.8 to 3581.1
|
3824.6 mMU/mL
Interval 3504.4 to 4174.2
|
PRIMARY outcome
Timeframe: Week 4 Postdose 3 (Month 7)Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL).
Outcome measures
| Measure |
Girls 10-15 Years
n=426 Participants
|
Boys 10-15 Years
n=429 Participants
|
Women 16-23 Years
n=340 Participants
|
100% Formulation qHPV Vaccine
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3
HPV 18 ≥ 24 mMU/mL
|
426 Subjects
|
428 Subjects
|
337 Subjects
|
—
|
|
Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3
HPV 18 < 24 mMU/mL
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
—
|
PRIMARY outcome
Timeframe: Week 4 Postdose 3 (Month 7)Population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.
Outcome measures
| Measure |
Girls 10-15 Years
n=426 Participants
|
Boys 10-15 Years
n=429 Participants
|
Women 16-23 Years
n=340 Participants
|
100% Formulation qHPV Vaccine
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3
|
953.6 mMU/mL
Interval 857.3 to 1060.7
|
1232.9 mMU/mL
Interval 1105.6 to 1375.0
|
470.5 mMU/mL
Interval 418.5 to 528.9
|
—
|
PRIMARY outcome
Timeframe: Week 4 Postdose 3 (Month 7)Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL).
Outcome measures
| Measure |
Girls 10-15 Years
n=382 Participants
|
Boys 10-15 Years
n=406 Participants
|
Women 16-23 Years
n=379 Participants
|
100% Formulation qHPV Vaccine
n=766 Participants
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3
HPV 18 ≥ 24 mMU/mL
|
381 Subjects
|
403 Subjects
|
375 Subjects
|
763 Subjects
|
|
Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3
HPV 18 < 24 mMU/mL
|
1 Subjects
|
3 Subjects
|
4 Subjects
|
3 Subjects
|
PRIMARY outcome
Timeframe: Week 4 Postdose 3 (Month 7)Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.
Outcome measures
| Measure |
Girls 10-15 Years
n=382 Participants
|
Boys 10-15 Years
n=406 Participants
|
Women 16-23 Years
n=379 Participants
|
100% Formulation qHPV Vaccine
n=766 Participants
Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3
|
544.0 mMU/mL
Interval 480.9 to 615.3
|
640.4 mMU/mL
Interval 570.5 to 718.9
|
647.5 mMU/mL
Interval 571.6 to 733.5
|
696.9 mMU/mL
Interval 641.7 to 756.8
|
Adverse Events
20% Formulation
Serious events: 5 serious events
Other events: 434 other events
Deaths: 0 deaths
40% Formulation
Serious events: 2 serious events
Other events: 426 other events
Deaths: 0 deaths
60% Formulation
Serious events: 1 serious events
Other events: 431 other events
Deaths: 0 deaths
100% Formulation
Serious events: 4 serious events
Other events: 1276 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
20% Formulation
n=496 participants at risk
Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
|
40% Formulation
n=509 participants at risk
Subjects in this group received a 40% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
|
60% Formulation
n=500 participants at risk
Subjects in this group received a 60% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
|
100% Formulation
n=1498 participants at risk
Subjects in this group received a 100% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/496
Adverse events were collected from subjects with follow-up.
|
0.00%
0/509
Adverse events were collected from subjects with follow-up.
|
0.00%
0/500
Adverse events were collected from subjects with follow-up.
|
0.07%
1/1498 • Number of events 2
Adverse events were collected from subjects with follow-up.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/496
Adverse events were collected from subjects with follow-up.
|
0.00%
0/509
Adverse events were collected from subjects with follow-up.
|
0.00%
0/500
Adverse events were collected from subjects with follow-up.
|
0.07%
1/1498 • Number of events 1
Adverse events were collected from subjects with follow-up.
|
|
Cardiac disorders
Tachycardia foetal
|
0.00%
0/496
Adverse events were collected from subjects with follow-up.
|
0.20%
1/509 • Number of events 1
Adverse events were collected from subjects with follow-up.
|
0.00%
0/500
Adverse events were collected from subjects with follow-up.
|
0.00%
0/1498
Adverse events were collected from subjects with follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/496
Adverse events were collected from subjects with follow-up.
|
0.00%
0/509
Adverse events were collected from subjects with follow-up.
|
0.00%
0/500
Adverse events were collected from subjects with follow-up.
|
0.07%
1/1498 • Number of events 1
Adverse events were collected from subjects with follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/496
Adverse events were collected from subjects with follow-up.
|
0.00%
0/509
Adverse events were collected from subjects with follow-up.
|
0.00%
0/500
Adverse events were collected from subjects with follow-up.
|
0.07%
1/1498 • Number of events 1
Adverse events were collected from subjects with follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/496
Adverse events were collected from subjects with follow-up.
|
0.00%
0/509
Adverse events were collected from subjects with follow-up.
|
0.00%
0/500
Adverse events were collected from subjects with follow-up.
|
0.07%
1/1498 • Number of events 1
Adverse events were collected from subjects with follow-up.
|
|
General disorders
Adverse drug reaction
|
0.20%
1/496 • Number of events 1
Adverse events were collected from subjects with follow-up.
|
0.00%
0/509
Adverse events were collected from subjects with follow-up.
|
0.00%
0/500
Adverse events were collected from subjects with follow-up.
|
0.00%
0/1498
Adverse events were collected from subjects with follow-up.
|
|
General disorders
Pyrexia
|
0.00%
0/496
Adverse events were collected from subjects with follow-up.
|
0.20%
1/509 • Number of events 1
Adverse events were collected from subjects with follow-up.
|
0.00%
0/500
Adverse events were collected from subjects with follow-up.
|
0.00%
0/1498
Adverse events were collected from subjects with follow-up.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/496
Adverse events were collected from subjects with follow-up.
|
0.00%
0/509
Adverse events were collected from subjects with follow-up.
|
0.00%
0/500
Adverse events were collected from subjects with follow-up.
|
0.07%
1/1498 • Number of events 1
Adverse events were collected from subjects with follow-up.
|
|
Nervous system disorders
Convulsion
|
0.20%
1/496 • Number of events 1
Adverse events were collected from subjects with follow-up.
|
0.00%
0/509
Adverse events were collected from subjects with follow-up.
|
0.20%
1/500 • Number of events 1
Adverse events were collected from subjects with follow-up.
|
0.00%
0/1498
Adverse events were collected from subjects with follow-up.
|
|
Pregnancy, puerperium and perinatal conditions
Cephalo-pelvic disproportion
|
0.00%
0/496
Adverse events were collected from subjects with follow-up.
|
0.20%
1/509 • Number of events 1
Adverse events were collected from subjects with follow-up.
|
0.00%
0/500
Adverse events were collected from subjects with follow-up.
|
0.00%
0/1498
Adverse events were collected from subjects with follow-up.
|
|
Pregnancy, puerperium and perinatal conditions
Failed trial of labour
|
0.20%
1/496 • Number of events 1
Adverse events were collected from subjects with follow-up.
|
0.00%
0/509
Adverse events were collected from subjects with follow-up.
|
0.00%
0/500
Adverse events were collected from subjects with follow-up.
|
0.00%
0/1498
Adverse events were collected from subjects with follow-up.
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.20%
1/496 • Number of events 1
Adverse events were collected from subjects with follow-up.
|
0.00%
0/509
Adverse events were collected from subjects with follow-up.
|
0.00%
0/500
Adverse events were collected from subjects with follow-up.
|
0.00%
0/1498
Adverse events were collected from subjects with follow-up.
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.00%
0/496
Adverse events were collected from subjects with follow-up.
|
0.20%
1/509 • Number of events 1
Adverse events were collected from subjects with follow-up.
|
0.00%
0/500
Adverse events were collected from subjects with follow-up.
|
0.00%
0/1498
Adverse events were collected from subjects with follow-up.
|
|
Psychiatric disorders
Anorexia nervosa
|
0.20%
1/496 • Number of events 1
Adverse events were collected from subjects with follow-up.
|
0.00%
0/509
Adverse events were collected from subjects with follow-up.
|
0.00%
0/500
Adverse events were collected from subjects with follow-up.
|
0.00%
0/1498
Adverse events were collected from subjects with follow-up.
|
Other adverse events
| Measure |
20% Formulation
n=496 participants at risk
Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
|
40% Formulation
n=509 participants at risk
Subjects in this group received a 40% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
|
60% Formulation
n=500 participants at risk
Subjects in this group received a 60% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
|
100% Formulation
n=1498 participants at risk
Subjects in this group received a 100% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.1%
35/496 • Number of events 40
Adverse events were collected from subjects with follow-up.
|
6.1%
31/509 • Number of events 36
Adverse events were collected from subjects with follow-up.
|
5.8%
29/500 • Number of events 35
Adverse events were collected from subjects with follow-up.
|
4.3%
65/1498 • Number of events 67
Adverse events were collected from subjects with follow-up.
|
|
General disorders
Injection site erythema
|
23.0%
114/496 • Number of events 157
Adverse events were collected from subjects with follow-up.
|
22.8%
116/509 • Number of events 163
Adverse events were collected from subjects with follow-up.
|
22.6%
113/500 • Number of events 157
Adverse events were collected from subjects with follow-up.
|
21.6%
324/1498 • Number of events 436
Adverse events were collected from subjects with follow-up.
|
|
General disorders
Injection site pain
|
81.0%
402/496 • Number of events 863
Adverse events were collected from subjects with follow-up.
|
77.6%
395/509 • Number of events 881
Adverse events were collected from subjects with follow-up.
|
79.0%
395/500 • Number of events 879
Adverse events were collected from subjects with follow-up.
|
79.0%
1184/1498 • Number of events 2535
Adverse events were collected from subjects with follow-up.
|
|
General disorders
Injection site swelling
|
24.0%
119/496 • Number of events 179
Adverse events were collected from subjects with follow-up.
|
25.5%
130/509 • Number of events 201
Adverse events were collected from subjects with follow-up.
|
24.2%
121/500 • Number of events 172
Adverse events were collected from subjects with follow-up.
|
24.0%
359/1498 • Number of events 500
Adverse events were collected from subjects with follow-up.
|
|
General disorders
Pyrexia
|
14.5%
72/496 • Number of events 89
Adverse events were collected from subjects with follow-up.
|
13.6%
69/509 • Number of events 93
Adverse events were collected from subjects with follow-up.
|
10.2%
51/500 • Number of events 59
Adverse events were collected from subjects with follow-up.
|
13.1%
196/1498 • Number of events 238
Adverse events were collected from subjects with follow-up.
|
|
Infections and infestations
Nasopharyngitis
|
4.6%
23/496 • Number of events 23
Adverse events were collected from subjects with follow-up.
|
5.9%
30/509 • Number of events 36
Adverse events were collected from subjects with follow-up.
|
6.0%
30/500 • Number of events 32
Adverse events were collected from subjects with follow-up.
|
4.7%
70/1498 • Number of events 70
Adverse events were collected from subjects with follow-up.
|
|
Nervous system disorders
Dizziness
|
5.0%
25/496 • Number of events 28
Adverse events were collected from subjects with follow-up.
|
1.8%
9/509 • Number of events 13
Adverse events were collected from subjects with follow-up.
|
3.8%
19/500 • Number of events 19
Adverse events were collected from subjects with follow-up.
|
2.6%
39/1498 • Number of events 43
Adverse events were collected from subjects with follow-up.
|
|
Nervous system disorders
Headache
|
25.6%
127/496 • Number of events 202
Adverse events were collected from subjects with follow-up.
|
23.6%
120/509 • Number of events 176
Adverse events were collected from subjects with follow-up.
|
28.6%
143/500 • Number of events 221
Adverse events were collected from subjects with follow-up.
|
23.2%
348/1498 • Number of events 490
Adverse events were collected from subjects with follow-up.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER