Cervical Cancer, Genital Warts
Conditions
Brief summary
The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents.
Interventions
BIOLOGICALV501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 23 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adolescents and pre-adolescents with no prior sexual history * Healthy women who have an intact uterus with lifetime history of 0-4 sexual partners
Exclusion criteria
* Prior Human Papillomavirus (HPV) vaccination * Prior abnormal Paps * Prior history of genital warts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | Week 4 Postdose 3 (Month 7) | 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). |
| Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3 | Week 4 Postdose 3 (Month 7) | — |
| Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | Week 4 Postdose 3 (Month 7) | 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). |
| Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3 | Week 4 Postdose 3 (Month 7) | — |
| Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | Week 4 Postdose 3 (Month 7) | 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. |
| Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3 | Week 4 Postdose 3 (Month 7) | — |
| Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | Week 4 Postdose 3 (Month 7) | 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). |
| Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3 | Week 4 Postdose 3 (Month 7) | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 504 |
| 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. | 514 |
| 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 | 508 |
| 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. | 1,529 |
| Total | 3,055 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| 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 |
| Base Study Vaccination Period | Adverse Event | 1 | 0 | 0 | 3 | 0 |
| Base Study Vaccination Period | *Clinical AE | 1 | 0 | 1 | 2 | 0 |
| Base Study Vaccination Period | Extended | 0 | 0 | 0 | 1 | 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 | *Other reasons | 1 | 0 | 0 | 1 | 0 |
| Base Study Vaccination Period | Parent Withdrew Consent | 1 | 1 | 1 | 5 | 0 |
| Base Study Vaccination Period | Pregnancy | 2 | 0 | 0 | 0 | 0 |
| Base Study Vaccination Period | *Pregnancy | 0 | 2 | 5 | 7 | 0 |
| Base Study Vaccination Period | Protocol Violation | 1 | 0 | 0 | 0 | 0 |
| Base Study Vaccination Period | Randomized Not Vaccinated | 1 | 1 | 0 | 4 | 0 |
| Base Study Vaccination Period | Withdrawal by Subject | 9 | 10 | 14 | 25 | 0 |
Baseline characteristics
| Characteristic | Total | 40% Formulation qHPV Vaccine | 20% Formulation qHPV Vaccine | 60% Formulation qHPV Vaccine | 100% Formulation qHPV Vaccine |
|---|---|---|---|---|---|
| Age, Continuous | 15.7 years FULL_RANGE 10 | 16.5 years | 16.2 years | 16.2 years | 15.1 years |
| Age, Customized 10 to 11 Years of Age | 528 participants | 77 participants | 75 participants | 74 participants | 302 participants |
| Age, Customized 12 to 13 Years of Age | 676 participants | 95 participants | 110 participants | 101 participants | 370 participants |
| Age, Customized 14 to 15 Years of Age | 571 participants | 83 participants | 67 participants | 77 participants | 344 participants |
| Age, Customized 16 to 17 Years of Age | 176 participants | 24 participants | 40 participants | 35 participants | 77 participants |
| Age, Customized 18 to 19 Years of Age | 316 participants | 62 participants | 58 participants | 71 participants | 125 participants |
| Age, Customized 20 to 21 Years of Age | 434 participants | 86 participants | 90 participants | 93 participants | 165 participants |
| Age, Customized 22 to 23 Years of Age | 353 participants | 86 participants | 64 participants | 57 participants | 146 participants |
| Age, Customized Over 23 Years of Age | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants |
| Sex: Female, Male Female | 2545 Participants | 514 Participants | 504 Participants | 508 Participants | 1019 Participants |
| Sex: Female, Male Male | 510 Participants | 0 Participants | 0 Participants | 0 Participants | 510 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 434 / 496 | 426 / 509 | 431 / 500 | 1,276 / 1,498 |
| serious Total, serious adverse events | 5 / 496 | 2 / 509 | 1 / 500 | 4 / 1,498 |
Outcome results
Primary
Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls 10-15 Years | Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3 | 632.1 mMU/mL |
| Boys 10-15 Years | Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3 | 804.7 mMU/mL |
| Women 16-23 Years | Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3 | 836.2 mMU/mL |
| 100% Formulation qHPV Vaccine | Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3 | 1003.2 mMU/mL |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Primary
Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls 10-15 Years | Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3 | 1264.0 mMU/mL |
| Boys 10-15 Years | Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3 | 1396.5 mMU/mL |
| Women 16-23 Years | Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3 | 739.2 mMU/mL |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Primary
Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls 10-15 Years | Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3 | 4848.8 mMU/mL |
| Boys 10-15 Years | Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3 | 5923.0 mMU/mL |
| Women 16-23 Years | Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3 | 2753.0 mMU/mL |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Primary
Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls 10-15 Years | Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3 | 2401.1 mMU/mL |
| Boys 10-15 Years | Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3 | 2963.3 mMU/mL |
| Women 16-23 Years | Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3 | 3105.3 mMU/mL |
| 100% Formulation qHPV Vaccine | Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3 | 3824.6 mMU/mL |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Primary
Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls 10-15 Years | Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3 | 544.0 mMU/mL |
| Boys 10-15 Years | Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3 | 640.4 mMU/mL |
| Women 16-23 Years | Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3 | 647.5 mMU/mL |
| 100% Formulation qHPV Vaccine | Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3 | 696.9 mMU/mL |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Primary
Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls 10-15 Years | Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3 | 953.6 mMU/mL |
| Boys 10-15 Years | Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3 | 1232.9 mMU/mL |
| Women 16-23 Years | Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3 | 470.5 mMU/mL |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Primary
Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls 10-15 Years | Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3 | 584.2 mMU/mL |
| Boys 10-15 Years | Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3 | 704.5 mMU/mL |
| Women 16-23 Years | Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3 | 707.5 mMU/mL |
| 100% Formulation qHPV Vaccine | Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3 | 798.4 mMU/mL |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Primary
Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls 10-15 Years | Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3 | 987.3 mMU/mL |
| Boys 10-15 Years | Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3 | 1116.1 mMU/mL |
| Women 16-23 Years | Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3 | 603.0 mMU/mL |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Primary
Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Girls 10-15 Years | Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | HPV 11 ≥ 16 mMU/mL | 423 Subjects |
| Girls 10-15 Years | Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | HPV 11 < 16 mMU/mL | 0 Subjects |
| Boys 10-15 Years | Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | HPV 11 ≥ 16 mMU/mL | 428 Subjects |
| Boys 10-15 Years | Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | HPV 11 < 16 mMU/mL | 0 Subjects |
| Women 16-23 Years | Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | HPV 11 ≥ 16 mMU/mL | 320 Subjects |
| Women 16-23 Years | Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | HPV 11 < 16 mMU/mL | 0 Subjects |
p-value: <0.001Miettinen and Nurminen
p-value: <0.001Miettinen and Nurminen
Primary
Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Girls 10-15 Years | Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | HPV 11 ≥ 16 mMU/mL | 373 Subjects |
| Girls 10-15 Years | Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | HPV 11 < 16 mMU/mL | 0 Subjects |
| Boys 10-15 Years | Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | HPV 11 < 16 mMU/mL | 0 Subjects |
| Boys 10-15 Years | Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | HPV 11 ≥ 16 mMU/mL | 391 Subjects |
| Women 16-23 Years | Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | HPV 11 ≥ 16 mMU/mL | 364 Subjects |
| Women 16-23 Years | Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | HPV 11 < 16 mMU/mL | 1 Subjects |
| 100% Formulation qHPV Vaccine | Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | HPV 11 ≥ 16 mMU/mL | 743 Subjects |
| 100% Formulation qHPV Vaccine | Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | HPV 11 < 16 mMU/mL | 0 Subjects |
p-value: <0.001Miettinen and Nurminen
p-value: <0.001Miettinen and Nurminen
p-value: <0.001Miettinen and Nurminen
Primary
Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Girls 10-15 Years | Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | HPV 16 ≥ 20 mMU/mL | 424 mMU/mL |
| Girls 10-15 Years | Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | HPV 16 < 20 mMU/mL | 0 mMU/mL |
| Boys 10-15 Years | Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | HPV 16 ≥ 20 mMU/mL | 427 mMU/mL |
| Boys 10-15 Years | Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | HPV 16 < 20 mMU/mL | 0 mMU/mL |
| Women 16-23 Years | Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | HPV 16 ≥ 20 mMU/mL | 306 mMU/mL |
| Women 16-23 Years | Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | HPV 16 < 20 mMU/mL | 0 mMU/mL |
p-value: <0.001Miettinen and Nurminen
p-value: <0.001Miettinen and Nurminen
Primary
Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Girls 10-15 Years | Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | HPV 16 ≥ 20 mMU/mL | 365 Subjects |
| Girls 10-15 Years | Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | HPV 16 < 20 mMU/mL | 0 Subjects |
| Boys 10-15 Years | Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | HPV 16 < 20 mMU/mL | 0 Subjects |
| Boys 10-15 Years | Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | HPV 16 ≥ 20 mMU/mL | 375 Subjects |
| Women 16-23 Years | Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | HPV 16 ≥ 20 mMU/mL | 364 Subjects |
| Women 16-23 Years | Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | HPV 16 < 20 mMU/mL | 1 Subjects |
| 100% Formulation qHPV Vaccine | Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | HPV 16 ≥ 20 mMU/mL | 730 Subjects |
| 100% Formulation qHPV Vaccine | Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | HPV 16 < 20 mMU/mL | 0 Subjects |
p-value: <0.01Miettinen and Nurminen
p-value: <0.001Miettinen and Nurminen
p-value: <0.001Miettinen and Nurminen
Primary
Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Girls 10-15 Years | Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | HPV 18 ≥ 24 mMU/mL | 426 Subjects |
| Girls 10-15 Years | Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | HPV 18 < 24 mMU/mL | 0 Subjects |
| Boys 10-15 Years | Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | HPV 18 ≥ 24 mMU/mL | 428 Subjects |
| Boys 10-15 Years | Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | HPV 18 < 24 mMU/mL | 1 Subjects |
| Women 16-23 Years | Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | HPV 18 ≥ 24 mMU/mL | 337 Subjects |
| Women 16-23 Years | Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | HPV 18 < 24 mMU/mL | 3 Subjects |
p-value: <0.001Miettinen and Nurminen
p-value: <0.001Miettinen and Nurminen
Primary
Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Girls 10-15 Years | Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | HPV 18 ≥ 24 mMU/mL | 381 Subjects |
| Girls 10-15 Years | Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | HPV 18 < 24 mMU/mL | 1 Subjects |
| Boys 10-15 Years | Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | HPV 18 < 24 mMU/mL | 3 Subjects |
| Boys 10-15 Years | Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | HPV 18 ≥ 24 mMU/mL | 403 Subjects |
| Women 16-23 Years | Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | HPV 18 ≥ 24 mMU/mL | 375 Subjects |
| Women 16-23 Years | Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | HPV 18 < 24 mMU/mL | 4 Subjects |
| 100% Formulation qHPV Vaccine | Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | HPV 18 ≥ 24 mMU/mL | 763 Subjects |
| 100% Formulation qHPV Vaccine | Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | HPV 18 < 24 mMU/mL | 3 Subjects |
p-value: <0.001Miettinen and Nurminen
p-value: <0.001Miettinen and Nurminen
p-value: <0.001Miettinen and Nurminen
Primary
Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Girls 10-15 Years | Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | HPV 6 ≥ 20 mMU/mL | 423 Subjects |
| Girls 10-15 Years | Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | HPV 6 < 20 mMU/mL | 0 Subjects |
| Boys 10-15 Years | Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | HPV 6 ≥ 20 mMU/mL | 428 Subjects |
| Boys 10-15 Years | Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | HPV 6 < 20 mMU/mL | 0 Subjects |
| Women 16-23 Years | Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | HPV 6 ≥ 20 mMU/mL | 320 Subjects |
| Women 16-23 Years | Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | HPV 6 < 20 mMU/mL | 0 Subjects |
p-value: <0.001Miettinen and Nurminen
p-value: <0.001Miettinen and Nurminen
Primary
Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Girls 10-15 Years | Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | HPV 6 ≥ 20 mMU/mL | 372 Subjects |
| Girls 10-15 Years | Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | HPV 6 < 20 mMU/mL | 0 Subjects |
| Boys 10-15 Years | Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | HPV 6 < 20 mMU/mL | 0 Subjects |
| Boys 10-15 Years | Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | HPV 6 ≥ 20 mMU/mL | 391 Subjects |
| Women 16-23 Years | Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | HPV 6 ≥ 20 mMU/mL | 363 Subjects |
| Women 16-23 Years | Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | HPV 6 < 20 mMU/mL | 1 Subjects |
| 100% Formulation qHPV Vaccine | Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | HPV 6 ≥ 20 mMU/mL | 743 Subjects |
| 100% Formulation qHPV Vaccine | Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | HPV 6 < 20 mMU/mL | 0 Subjects |
p-value: <0.001Miettinen and Nurminen
p-value: <0.001Miettinen and Nurminen
p-value: <0.001Miettinen and Nurminen