Human, Papillomavirus Infections
Conditions
Brief summary
This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).
Detailed description
The original base protocol (V501-018)(NCT00092547) was extended in amendments V501-018-05 and -06 to provide 37 months of follow-up. Additionally, subjects in the Placebo Group during the base study were given 3 doses of open-label GARDASIL™ (V501) at Months 30, 32, and 36. The study was extended again in amendment V501-018-10(NCT00092547), titled A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus \[Types 6, 11, 16, 18\] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of Age to allow a follow-up period to Month 126.
Interventions
BIOLOGICALV501
0.5 mL intramuscular injection of V501
BIOLOGICALComparator: Placebo
0.5 mL intramuscular injection of placebo
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adolescents and preadolescents with no prior sexual history
Exclusion criteria
* Subjects with compromised immune system or have a history of severe allergic reaction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 | Up to Month 18 | Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment. |
| Number of Participants Reporting SAEs From Month 18 Through Month 37 | Month 18 to Month 37 | Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37 |
| Number of Participants Reporting Other (Non-serious) AEs Through Month 18 | Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination | Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18 |
| Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) | A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. |
| Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 | Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) | — |
| Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 | Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group) | — |
| Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 | Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group) | A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. |
| Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 | Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group) | — |
| Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 | Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group) | A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. |
| Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up | Month 37 to Month 126 | A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment. SAEs considered by the investigator to be possibly, probably, or definitely related to study vaccine or a study procedure were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37) | Month 37 (31 Months Post-dose 3) | — |
| Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37) | Month 37 (1 Month Post-dose 3 of qHPV) | — |
| Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18). | Month 18 (12 Months Post-dose 3) | A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. |
| Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males | Up to Month 126 | The HPV types were determined by PCR testing. Combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related penile/perineal/perianal intraepithelial neoplasia (PIN), genital warts, and penile/perineal/perianal cancer was assessed in male participants. |
| Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females | Up to Month 126 | The HPV types were determined by polymerase chain reaction (PCR) testing. The combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), genital warts, and cervical/Vaginal/vulvar cancer was assessed in female participants. |
| Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7) | Month 7 (1 Month Postdose 3) | A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. |
| Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24) | Month 24 (18 Months Post-dose 3) | A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. |
| Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30) | Month 30 (24 Months Post-dose 3) | A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. |
| Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37). | Month 37 (31 Months Post-dose 3) | A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. |
| Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37) | Month 37 (1 Month Post-dose 3 of qHPV) | A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. |
| Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7) | Month 7 (1 Month Post-dose 3) | — |
| Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18) | Month 18 (Month 12 Post-dose 3) | — |
| Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24) | Month 24 (18 Months Post-dose 3) | — |
| Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30) | Month 30 (24 Months Post-dose 3) | — |
Participant flow
Recruitment details
1781 participants were randomized to receive qHPV or Placebo in the Base Study. At month 30, participants who received Placebo in the Base Study were eligible to receive qHPV, and formed the Extension Group. Participants were to be followed for safety and efficacy for up to 10 years.
Participants by arm
| Arm | Count |
|---|---|
| qHPV Vaccine in Base Study Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6 | 1,184 |
| Placebo in Base Study Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6 | 597 |
| Total | 1,781 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Base Follow-up Phase (Month 18 to 30) | Lost to Follow-up | 2 | 0 | 0 |
| Base Follow-up Phase (Month 18 to 30) | Protocol Violation | 1 | 0 | 0 |
| Base Follow-up Phase (Month 18 to 30) | Subject moved | 4 | 2 | 0 |
| Base Follow-up Phase (Month 18 to 30) | Withdrawal by Subject | 1 | 3 | 0 |
| Base Follow-up Phase (Month 7 to 18) | Lost to Follow-up | 13 | 7 | 0 |
| Base Follow-up Phase (Month 7 to 18) | Physician Decision | 1 | 0 | 0 |
| Base Follow-up Phase (Month 7 to 18) | Protocol Violation | 1 | 0 | 0 |
| Base Follow-up Phase (Month 7 to 18) | Subject moved | 1 | 5 | 0 |
| Base Follow-up Phase (Month 7 to 18) | Withdrawal by Subject | 4 | 2 | 0 |
| Base Vaccine Phase (Day 1 to Month 7) | Adverse Event | 4 | 1 | 0 |
| Base Vaccine Phase (Day 1 to Month 7) | Did not meet local regulations | 0 | 1 | 0 |
| Base Vaccine Phase (Day 1 to Month 7) | Lost to Follow-up | 18 | 7 | 0 |
| Base Vaccine Phase (Day 1 to Month 7) | Moved | 3 | 1 | 0 |
| Base Vaccine Phase (Day 1 to Month 7) | Not Vaccinated | 5 | 1 | 0 |
| Base Vaccine Phase (Day 1 to Month 7) | per sponsor request: (noncompliant) | 0 | 1 | 0 |
| Base Vaccine Phase (Day 1 to Month 7) | Refused Vaccination | 5 | 3 | 0 |
| Base Vaccine Phase (Day 1 to Month 7) | Withdrawal by Subject | 28 | 21 | 0 |
| Extension Vaccine Phase (Month 30 to 37) | Lost to Follow-up | 14 | 0 | 7 |
| Extension Vaccine Phase (Month 30 to 37) | Subject moved | 3 | 0 | 0 |
| Extension Vaccine Phase (Month 30 to 37) | Withdrawal by Subject | 6 | 0 | 9 |
| Long-term Follow-up (Month 42 Visit) | Adverse Event | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | qHPV Vaccine in Base Study | Placebo in Base Study | Total |
|---|---|---|---|
| Age, Continuous | 11.9 years STANDARD_DEVIATION 1.9 | 11.8 years STANDARD_DEVIATION 1.9 | 11.9 years STANDARD_DEVIATION 1.9 |
| Age, Customized 17 Years of Age and Over | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 8 Years of Age and Under | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 9 to 16 Years of Age | 1184 Participants | 597 Participants | 1781 Participants |
| Race/Ethnicity, Customized Asian | 149 participants | 70 participants | 219 participants |
| Race/Ethnicity, Customized Black | 50 participants | 21 participants | 71 participants |
| Race/Ethnicity, Customized Hispanic American | 260 participants | 130 participants | 390 participants |
| Race/Ethnicity, Customized Native American | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Other | 9 participants | 6 participants | 15 participants |
| Race/Ethnicity, Customized White | 716 participants | 369 participants | 1085 participants |
| Sex: Female, Male Female | 616 Participants | 322 Participants | 938 Participants |
| Sex: Female, Male Male | 568 Participants | 275 Participants | 843 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 | 918 / 1,165 | 344 / 584 | 0 / 932 | 3 / 481 |
| serious Total, serious adverse events | 6 / 1,165 | 0 / 584 | 2 / 932 | 3 / 481 |
Outcome results
Primary
Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126
Time frame: Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)
Population: Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 | Type 6: n=409, 112 | 88.0 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 | Type 11: n=409, 112 | 74.6 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 | Type 16: n=403, 115 | 320.1 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 | Type 18: n=408, 120 | 36.5 milliMerck units/mL |
| Placebo in Base Study | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 | Type 18: n=408, 120 | 39.6 milliMerck units/mL |
| Placebo in Base Study | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 | Type 6: n=409, 112 | 99.3 milliMerck units/mL |
| Placebo in Base Study | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 | Type 16: n=403, 115 | 351.6 milliMerck units/mL |
| Placebo in Base Study | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 | Type 11: n=409, 112 | 96.0 milliMerck units/mL |
Primary
Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96
Time frame: Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group)
Population: Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 | Type 6: n=451, 141 | 71.4 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 | Type 11: n=451, 141 | 67.5 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 | Type 16: n=447, 143 | 325.5 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 | Type 18: n=452, 152 | 41.6 milliMerck units/mL |
| Placebo in Base Study | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 | Type 18: n=452, 152 | 48.3 milliMerck units/mL |
| Placebo in Base Study | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 | Type 6: n=451, 141 | 91.0 milliMerck units/mL |
| Placebo in Base Study | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 | Type 16: n=447, 143 | 387.4 milliMerck units/mL |
| Placebo in Base Study | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 | Type 11: n=451, 141 | 90.3 milliMerck units/mL |
Primary
Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72
Time frame: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)
Population: Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 | Type 6: n=475, 151 | 118.9 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 | Type 11: n=475, 151 | 135.7 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 | Type 16: n=473, 154 | 521.2 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 | Type 18: n=477, 160 | 70.9 milliMerck units/mL |
| Placebo in Base Study | Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 | Type 18: n=477, 160 | 67.7 milliMerck units/mL |
| Placebo in Base Study | Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 | Type 6: n=475, 151 | 113.9 milliMerck units/mL |
| Placebo in Base Study | Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 | Type 16: n=473, 154 | 485.8 milliMerck units/mL |
| Placebo in Base Study | Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 | Type 11: n=475, 151 | 137.9 milliMerck units/mL |
Primary
Number of Participants Reporting Other (Non-serious) AEs Through Month 18
Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18
Time frame: Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination
Population: All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV Vaccine in Base Study | Number of Participants Reporting Other (Non-serious) AEs Through Month 18 | 918 participants |
| Placebo in Base Study | Number of Participants Reporting Other (Non-serious) AEs Through Month 18 | 340 participants |
Primary
Number of Participants Reporting SAEs From Month 18 Through Month 37
Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37
Time frame: Month 18 to Month 37
Population: All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV Vaccine in Base Study | Number of Participants Reporting SAEs From Month 18 Through Month 37 | 0 participants |
| Placebo in Base Study | Number of Participants Reporting SAEs From Month 18 Through Month 37 | 3 participants |
Primary
Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up
A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment. SAEs considered by the investigator to be possibly, probably, or definitely related to study vaccine or a study procedure were reported.
Time frame: Month 37 to Month 126
Population: The analysis population was all participants who were vaccinated according to actual treatment received and had safety follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV Vaccine in Base Study | Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up | 0 Participants |
| Placebo in Base Study | Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up | 1 Participants |
Primary
Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18
Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment.
Time frame: Up to Month 18
Population: All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV Vaccine in Base Study | Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 | 6 participants |
| Placebo in Base Study | Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 | 0 participants |
Primary
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Time frame: Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)
Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 | Type 6: n=409, 112 | 89.0 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 | Type 11: n=409, 112 | 88.8 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 | Type 16: n=403, 115 | 96.0 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 | Type 18: n=408, 120 | 60.5 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 | Type 18: n=408, 120 | 65.0 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 | Type 6: n=409, 112 | 91.1 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 | Type 16: n=403, 115 | 96.5 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 | Type 11: n=409, 112 | 92.9 Percentage of participants |
Primary
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Time frame: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)
Population: Per-protocol population: participants without protocol violations who received all 3 vaccinations, were seronegative to the respective HPV type at Day 1 (for the Base Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | Type 16: n=473, 154 | 97.9 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | Type 11: n=475, 151 | 96.0 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | Type 18: n=477, 160 | 74.4 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | Type 6: n=475, 151 | 93.3 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | Type 18: n=477, 160 | 79.4 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | Type 11: n=475, 151 | 96.7 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | Type 16: n=473, 154 | 97.4 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | Type 6: n=475, 151 | 91.4 Percentage of participants |
Primary
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Time frame: Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group)
Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 | Type 6: n=451, 141 | 88.2 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 | Type 11: n=451, 141 | 89.1 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 | Type 16: n=447, 143 | 96.9 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 | Type 18: n=452, 152 | 63.9 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 | Type 18: n=452, 152 | 69.1 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 | Type 6: n=451, 141 | 91.5 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 | Type 16: n=447, 143 | 97.9 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 | Type 11: n=451, 141 | 93.6 Percentage of participants |
Secondary
Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females
The HPV types were determined by polymerase chain reaction (PCR) testing. The combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), genital warts, and cervical/Vaginal/vulvar cancer was assessed in female participants.
Time frame: Up to Month 126
Population: Per-Protocol Effectiveness population: male participants without protocol violations who received at least 1 dose of qHPV vaccine and at least 1 effectiveness follow-up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV Vaccine in Base Study | Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females | 0.2 Cases per 100 person-years at risk |
| Placebo in Base Study | Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females | 0.2 Cases per 100 person-years at risk |
Secondary
Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males
The HPV types were determined by PCR testing. Combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related penile/perineal/perianal intraepithelial neoplasia (PIN), genital warts, and penile/perineal/perianal cancer was assessed in male participants.
Time frame: Up to Month 126
Population: Per-Protocol Effectiveness population: male participants without protocol violations who received at least 1 dose of qHPV vaccine and at least 1 effectiveness follow-up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV Vaccine in Base Study | Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males | 0.6 Cases per 100 person-years at risk |
| Placebo in Base Study | Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males | 0.3 Cases per 100 person-years at risk |
Secondary
Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)
Time frame: Month 37 (1 Month Post-dose 3 of qHPV)
Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations within appropriate day ranges, were seronegative to the respective HPV type at Month 30, and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37) | Type 6: n=246 | 768.6 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37) | Type 16: n=246 | 4312.7 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37) | Type 18: n=255 | 830.1 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37) | Type 11: n=246 | 1041.0 milliMerck units/mL |
Secondary
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18)
Time frame: Month 18 (Month 12 Post-dose 3)
Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18) | Type 6: n=937 | 219.3 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18) | Type 11: n=938 | 296.9 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18) | Type 16: n=933 | 1314.8 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18) | Type 18: n=940 | 203.0 milliMerck units/mL |
Secondary
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24)
Time frame: Month 24 (18 Months Post-dose 3)
Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24) | Type 6: n=446 | 143.5 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24) | Type 11: n=447 | 206.6 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24) | Type 16: n=442 | 932.1 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24) | Type 18: n=447 | 136.2 milliMerck units/mL |
Secondary
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7)
Time frame: Month 7 (1 Month Post-dose 3)
Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7) | Type 6: n=953 | 929.2 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7) | Type 11: n=954 | 1362.8 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7) | Type 16: n=949 | 5512.7 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7) | Type 18: n=956 | 1278.9 milliMerck units/mL |
Secondary
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30)
Time frame: Month 30 (24 Months Post-dose 3)
Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30) | Type 6: n=799 | 146.5 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30) | Type 11: n=800 | 177.0 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30) | Type 16: n=795 | 826.1 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30) | Type 18: n=803 | 114.7 milliMerck units/mL |
Secondary
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37)
Time frame: Month 37 (31 Months Post-dose 3)
Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37) | Type 18: n=660 | 102.4 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37) | Type 6: n=657 | 128.6 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37) | Type 11: n=657 | 149.7 milliMerck units/mL |
| qHPV Vaccine in Base Study | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37) | Type 16: n=655 | 680.4 milliMerck units/mL |
Secondary
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18).
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Time frame: Month 18 (12 Months Post-dose 3)
Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18). | Type 6: n=937 | 97.8 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18). | Type 11: n=938 | 99.3 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18). | Type 16: n=933 | 99.6 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18). | Type 18: n=940 | 91.6 Percentage of participants |
Secondary
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24)
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Time frame: Month 24 (18 Months Post-dose 3)
Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24) | Type 6: n=446 | 95.1 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24) | Type 11: n=447 | 98.2 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24) | Type 16: n=442 | 98.4 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24) | Type 18: n=447 | 87.5 Percentage of participants |
Secondary
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7)
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Time frame: Month 7 (1 Month Postdose 3)
Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7) | Type 6: n=953 | 99.8 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7) | Type 11: n=954 | 99.8 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7) | Type 16: n=949 | 99.7 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7) | Type 18: n=956 | 99.7 Percentage of participants |
Secondary
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30)
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Time frame: Month 30 (24 Months Post-dose 3)
Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30) | Type 18: n=803 | 84.3 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30) | Type 6: n=799 | 95.6 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30) | Type 11: n=800 | 97.5 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30) | Type 16: n=795 | 98.6 Percentage of participants |
Secondary
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37).
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Time frame: Month 37 (31 Months Post-dose 3)
Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37). | Type 18: n=660 | 81.1 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37). | Type 6: n=657 | 94.5 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37). | Type 11: n=657 | 96.0 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37). | Type 16: n=655 | 98.2 Percentage of participants |
Secondary
Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37)
A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.
Time frame: Month 37 (1 Month Post-dose 3 of qHPV)
Population: Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Month 30, and had a valid serology result at the specified time for assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV Vaccine in Base Study | Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37) | Type 16: n=246 | 100 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37) | Type 18: n=255 | 98.8 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37) | Type 6: n=246 | 99.6 Percentage of participants |
| qHPV Vaccine in Base Study | Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37) | Type 11: n=246 | 100 Percentage of participants |