Healthy Adult Female Participants, Prevention, Papillomavirus Infection, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
Conditions
Brief summary
This study was conducted to assess the safety, immunogenicity, efficacy and long-term effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV) infection and disease in mid-adult women.
Detailed description
The Base study vaccination period (V501-019) encompassed Day 1 through Month 7, during which time participants received randomly assigned, blinded Gardasil™ (V501, qHPV vaccine) or placebo at Day 1, Month 2 and Month 6. The Base study follow-up period continued through approximately Month 48. The base study was extended in protocol V501-019-10 (EXT1). Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the Base Study were offered a complete, open-label, 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7. A Long Term Follow-Up (LTFU) extension study V501-019-21 (EXT2) was added to observe the long term safety, effectiveness, and immunogenicity of qHPV vaccine in approximately 1,600 women who participated in the Base Study at sites in Colombia. Data were collected over a period of 6-10 years following participant's enrollment in the original Base Study.
Interventions
qHPV intramuscular injection in three 0.5 mL doses over 6 months in the Base Study or EXT1
BIOLOGICALComparator: Placebo
Placebo intramuscular injection in three 0.5 mL doses over 6 months.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
24 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* No history of genital warts, vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN) * Not pregnant and agrees to use effective contraception through Month 7 of the study * Additional criteria applied
Exclusion criteria
* Pregnant * Concurrently enrolled in a clinical study involving collection of cervical specimens * Previously received any HPV vaccine * History of severe allergic reaction that required medical intervention * Received any immune globulin or blood-derived products within 3 months prior to the first study injection * History of splenectomy, known immune disorders, or receiving immunosuppressives * Immunocompromised or diagnosed with human immunodeficiency virus (HIV) infection * Known thrombocytopenia or any coagulation disorders that could contraindicate intramuscular injections * History of recent or ongoing alcohol or drug abuse * Prior treatment for genital warts, VIN, or VaIN * History of cervical disease (ie, surgical treatment for cervical lesions) * Hysterectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study | Month 120 (114 months after the third dose of qHPV vaccine in the Base Study) | Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study. |
| Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study | Month 7 (1 month after the third dose of qHPV vaccine in the Base Study) | Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study. |
| Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study | Month 12 (6 months after the third dose of qHPV vaccine in the Base Study) | Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study. |
| Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study | Month 24 (18 months after the third dose of qHPV vaccine in the Base Study) | Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study. |
| Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study | Month 36 (30 months after the third dose of qHPV vaccine in the Base Study) | Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study. |
| Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study | Month 48 (42 months after the third dose of qHPV vaccine in the Base Study) | Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study. |
| Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study | Month 72 (66 months after the third dose of qHPV vaccine in the Base Study) | Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study. |
| Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study | Month 96 (90 months after the third dose of qHPV vaccine in the Base Study) | Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study. |
| Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study | Month 120 (114 months after the third dose of qHPV vaccine in the Base Study) | Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study. |
| Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study | Month 7 (1 month after the third dose of qHPV vaccine in the Base Study) | Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study. |
| Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study | Month 12 (6 months after the third dose of qHPV vaccine in the Base Study) | Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study. |
| Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study | Month 24 (18 months after the third dose of qHPV vaccine in the Base Study) | Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study. |
| Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study | Month 36 (30 months after the third dose of qHPV vaccine in the Base Study) | Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study. |
| Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study | Month 48 (42 months after the third dose of qHPV vaccine in the Base Study) | Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study. |
| Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study | Month 72 (66 months after the third dose of qHPV vaccine in the Base Study) | Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study. |
| Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study | Month 96 (96 months after the third dose of qHPV vaccine in the Base Study) | Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study. |
| Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer | Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by polymerase chain reaction (PCR) testing. VIN = vulvar intraepithelial neoplasia; VaIN = vaginal intraepithelial neoplasia; AIS = adenocarcinoma in situ. |
| Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine. |
| Number of Participants With Vaccine-Related SAEs After Vaccine Administration | qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120 | An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine. |
| Number of Participants With an SAE Resulting in Death After Vaccine Administration | qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120 | An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. |
| Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4 | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4, conditional on having been event-free at Day 1. |
| Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8 | From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8, conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval. |
| Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10 | From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10, conditional on having been event-free from Day 1 to Year 6. |
| Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4 | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | The four HPV types were determined by PCR testing. |
| Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8 | From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval. |
| Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10 | From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by PCR testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Incidence of HPV 6/11-related Condyloma: Year 4 to Year 8 | From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8 conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval. |
| Cumulative Incidence of HPV 6/11-related Condyloma: Year 6 to Year 10 | From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6. |
| Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Day 1 to Year 4 | Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study | The four HPV types were determined by PCR testing. |
| Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 4 to Year 8 | From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval. |
| Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 6 to Year 10 | From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6. |
| Incidence Rate of HPV 31/33/35/52/58 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | This outcome measure was not analyzed because of diminished interest by experts in composite efficacy endpoints associated with these HPV types |
| Incidence Rate of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | HPV 6/11: The two types of HPV (types 6/11) were determined by PCR testing |
| Cumulative Incidence of HPV 6/11-related Condyloma: Day 1 to Year 4 | Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study | The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4 conditional on having been event-free at Day 1. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of HPV 16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | HPV 16/18: The two types of HPV (types 16/18) were determined by PCR testing |
| Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 4 to 8 | From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8 conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval. |
| Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 6 to 10 | From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6. |
| Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Day 1 to Year 4 | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | The four HPV types were determined by PCR testing. |
| Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 4 to 8 | From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval. |
| Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 6 to 10 | From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by PCR testing. |
| Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Day 1 to Year 4 | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4 conditional on having been event-free at Day 1. |
Participant flow
Recruitment details
Base Study Vaccination Period covers Day 1 to Month 7; Base Study Follow-up Period covers Month 7 up to approximately Month 48; Extension 1 (EXT1) Period covers approximately Month 60 to Month 67; Long-term Follow-up (LTFU, EXT2) covers approximately Month 72 up to Month 120
Participants by arm
| Arm | Count |
|---|---|
| qHPV Vaccine in Base Study Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study | 1,911 |
| Placebo in Base Study Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study | 1,908 |
| Total | 3,819 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Base Study Follow-up Period | Adverse Event | 6 | 1 | 0 | 0 | 0 | 0 |
| Base Study Follow-up Period | Lost to Follow-up | 88 | 78 | 0 | 0 | 0 | 0 |
| Base Study Follow-up Period | Other | 19 | 21 | 0 | 0 | 0 | 0 |
| Base Study Follow-up Period | Patient Moved | 20 | 28 | 0 | 0 | 0 | 0 |
| Base Study Follow-up Period | Withdrawal by Subject | 27 | 36 | 0 | 0 | 0 | 0 |
| Base Study Vaccination Period | Adverse Event | 6 | 1 | 0 | 0 | 0 | 0 |
| Base Study Vaccination Period | Lost to Follow-up | 24 | 28 | 0 | 0 | 0 | 0 |
| Base Study Vaccination Period | Other | 4 | 4 | 0 | 0 | 0 | 0 |
| Base Study Vaccination Period | Patient Moved | 6 | 2 | 0 | 0 | 0 | 0 |
| Base Study Vaccination Period | Randomized not Vaccinated | 1 | 1 | 0 | 0 | 0 | 0 |
| Base Study Vaccination Period | Withdrawal by Subject | 23 | 27 | 0 | 0 | 0 | 0 |
| Extension 1 (EXT1) | Adverse Event | 0 | 0 | 4 | 0 | 0 | 0 |
| Extension 1 (EXT1) | Lost to Follow-up | 0 | 0 | 22 | 0 | 0 | 0 |
| Extension 1 (EXT1) | Moved | 0 | 0 | 2 | 1 | 0 | 0 |
| Extension 1 (EXT1) | Other reason | 0 | 0 | 2 | 0 | 0 | 0 |
| Extension 1 (EXT1) | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 |
| Extension 1 (EXT1) | Withdrawal by Subject | 0 | 0 | 25 | 0 | 0 | 0 |
| Long-term Follow-up (EXT2) | Death | 0 | 0 | 0 | 0 | 1 | 1 |
| Long-term Follow-up (EXT2) | Lost to Follow-up | 0 | 0 | 0 | 0 | 38 | 23 |
| Long-term Follow-up (EXT2) | Other | 0 | 0 | 0 | 0 | 1 | 0 |
| Long-term Follow-up (EXT2) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 4 | 4 |
Baseline characteristics
| Characteristic | Total | qHPV Vaccine in Base Study | Placebo in Base Study |
|---|---|---|---|
| Age, Continuous | 34.3 years STANDARD_DEVIATION 6.3 | 35 Years | 34 Years |
| Race/Ethnicity, Customized Asian | 1192 participants | 596 participants | 596 participants |
| Race/Ethnicity, Customized Black | 182 participants | 100 participants | 82 participants |
| Race/Ethnicity, Customized Hispanic American | 1649 participants | 822 participants | 827 participants |
| Race/Ethnicity, Customized Multi-Racial | 7 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized Native American | 3 participants | 2 participants | 1 participants |
| Race/Ethnicity, Customized Polynesian | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 785 participants | 388 participants | 397 participants |
| Sex: Female, Male Female | 3819 Participants | 1911 Participants | 1908 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 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 | 1,565 / 1,890 | 1,390 / 1,888 | 2 / 1,327 | 0 / 1,336 |
| serious Total, serious adverse events | 15 / 1,890 | 17 / 1,888 | 6 / 1,327 | 6 / 1,336 |
Outcome results
Primary
Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4, conditional on having been event-free at Day 1.
Time frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4 | 0.0006 Cumulative Incidence Probability |
| Placebo in Base Study | Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4 | 0.0124 Cumulative Incidence Probability |
Primary
Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8, conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.
Time frame: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8 | 0.0000 Cumulative Incidence Probability |
Primary
Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10, conditional on having been event-free from Day 1 to Year 6.
Time frame: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10 | 0.0000 Cumulative Incidence Probability |
Primary
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Time frame: Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 6: n=441, 181, 260 | 46.9 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 11: n=441, 181, 260 | 42.3 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 16: n=443, 179, 264 | 140.9 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 18: n=498, 216, 282 | 16.0 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 18: n=498, 216, 282 | 16.6 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 6: n=441, 181, 260 | 45.7 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 16: n=443, 179, 264 | 147.0 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 11: n=441, 181, 260 | 45.2 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 18: n=498, 216, 282 | 15.5 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 11: n=441, 181, 260 | 40.4 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 16: n=443, 179, 264 | 136.9 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 6: n=441, 181, 260 | 47.7 mMU/mL |
Primary
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Time frame: Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 11: n=1207, 579, 628 | 77.6 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 18: n=1378, 673, 705 | 28.3 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 16: n=1225, 583, 642 | 278.9 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 6: n=1207, 579, 628 | 70.3 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 16: n=1225, 583, 642 | 287.3 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 18: n=1378, 673, 705 | 31.0 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 11: n=1207, 579, 628 | 82.5 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 6: n=1207, 579, 628 | 71.3 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 18: n=1378, 673, 705 | 26.0 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 6: n=1207, 579, 628 | 69.3 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 16: n=1225, 583, 642 | 271.4 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 11: n=1207, 579, 628 | 73.4 mMU/mL |
Primary
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Time frame: Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 6: n=1249, 605, 644 | 416.2 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 11: n=1249, 605, 644 | 551.2 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 16: n=1269, 612, 657 | 2225.9 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 18: n=1430, 708, 722 | 356.9 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 18: n=1430, 708, 722 | 393.1 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 6: n=1249, 605, 644 | 437.4 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 16: n=1269, 612, 657 | 2334.2 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 11: n=1249, 605, 644 | 595.1 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 18: n=1430, 708, 722 | 324.6 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 11: n=1249, 605, 644 | 512.8 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 16: n=1269, 612, 657 | 2129.5 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 6: n=1249, 605, 644 | 397.3 mMU/mL |
Primary
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Time frame: Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 11: n=1169, 551, 618 | 81.0 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 6: n=1169, 551, 618 | 80.8 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 16: n=1190, 559, 631 | 285.7 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 18: n=1331, 642, 689 | 29.4 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 18: n=1331, 642, 689 | 32.2 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 16: n=1190, 559, 631 | 296.2 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 6: n=1169, 551, 618 | 80.5 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 11: n=1169, 551, 618 | 85.3 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 6: n=1169, 551, 618 | 81.1 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 11: n=1169, 551, 618 | 77.4 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 16: n=1190, 559, 631 | 276.7 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 18: n=1331, 642, 689 | 27.0 mMU/mL |
Primary
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Time frame: Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 6: n=1152, 536, 616 | 60.9 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 11: n=1152, 536, 616 | 65.9 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 16: n=1172, 544, 628 | 202.1 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 18: n=1313, 625, 688 | 23.1 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 18: n=1313, 625, 688 | 25.3 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 6: n=1152, 536, 616 | 59.6 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 16: n=1172, 544, 628 | 213.4 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 11: n=1152, 536, 616 | 69.7 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 18: n=1313, 625, 688 | 21.2 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 11: n=1152, 536, 616 | 62.7 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 16: n=1172, 544, 628 | 192.8 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 6: n=1152, 536, 616 | 62.0 mMU/mL |
Primary
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Time frame: Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 18: n=530, 237, 293 | 20.9 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 16: n=473, 197, 276 | 219.5 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 11: n=466, 196, 270 | 64.3 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 6: n=468, 198, 270 | 64.3 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 16: n=473, 197, 276 | 220.3 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 11: n=466, 196, 270 | 68.9 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 6: n=468, 198, 270 | 60.7 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 18: n=530, 237, 293 | 22.8 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 11: n=466, 196, 270 | 61.1 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 6: n=468, 198, 270 | 67.0 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 18: n=530, 237, 293 | 19.5 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 16: n=473, 197, 276 | 218.9 mMU/mL |
Primary
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Time frame: Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 18: n=1387, 678, 709 | 79.2 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 6: n=1225, 589, 636 | 155.1 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 11: n=1225, 589, 636 | 176.9 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 16: n=1236, 588, 648 | 719.6 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 6: n=1225, 589, 636 | 157.3 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 11: n=1225, 589, 636 | 184.5 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 16: n=1236, 588, 648 | 743.4 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 18: n=1387, 678, 709 | 84.2 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 16: n=1236, 588, 648 | 698.6 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 11: n=1225, 589, 636 | 170.2 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 18: n=1387, 678, 709 | 74.7 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 6: n=1225, 589, 636 | 153.2 mMU/mL |
Primary
Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study
Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Time frame: Month 96 (90 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 6: n=459, 193, 266 | 56.7 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 11: n=459, 193, 266 | 45.9 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 16: n=464, 192, 272 | 168.3 mMU/mL |
| qHPV in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 18: n=519, 230, 289 | 18.3 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 18: n=519, 230, 289 | 19.1 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 6: n=459, 193, 266 | 56.1 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 16: n=464, 192, 272 | 174.1 mMU/mL |
| Placebo in Base Study | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 11: n=459, 193, 266 | 49.6 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 18: n=519, 230, 289 | 17.7 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 11: n=459, 193, 266 | 43.5 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 16: n=464, 192, 272 | 164.4 mMU/mL |
| qHPV in Base Study: Participants 35 to 45 Years Old | Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 6: n=459, 193, 266 | 57.2 mMU/mL |
Primary
Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4
The four HPV types were determined by PCR testing.
Time frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4 | 0.0 Incidence per 100 person-years |
| Placebo in Base Study | Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4 | 0.4 Incidence per 100 person-years |
Primary
Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8
The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.
Time frame: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8 | 0.0 Incidence per 100 person-years |
Primary
Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10
The four HPV types were determined by PCR testing.
Time frame: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10 | 0.0 Incidence per 100 person-years |
Primary
Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer
The four HPV types were determined by polymerase chain reaction (PCR) testing. VIN = vulvar intraepithelial neoplasia; VaIN = vaginal intraepithelial neoplasia; AIS = adenocarcinoma in situ.
Time frame: Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer | 0.2 Incidence per 100 person-years |
| Placebo in Base Study | Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer | 1.7 Incidence per 100 person-years |
95% CI: [78.1, 94.8]
Primary
Number of Participants With an SAE Resulting in Death After Vaccine Administration
An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose.
Time frame: qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120
Population: Participants who received \>=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Number of Participants With an SAE Resulting in Death After Vaccine Administration | 8 Participants |
| Placebo in Base Study | Number of Participants With an SAE Resulting in Death After Vaccine Administration | 4 Participants |
Primary
Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study
An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine.
Time frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received \>=1 qHPV vaccination or placebo injection in the Base Study and had safety follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study | 0 Participants |
| Placebo in Base Study | Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study | 0 Participants |
Primary
Number of Participants With Vaccine-Related SAEs After Vaccine Administration
An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine.
Time frame: qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120
Population: Participants who received \>=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Number of Participants With Vaccine-Related SAEs After Vaccine Administration | 0 Participants |
| Placebo in Base Study | Number of Participants With Vaccine-Related SAEs After Vaccine Administration | 1 Participants |
Primary
Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Time frame: Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 6: n=441, 181, 260 | 78.7 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 11: n=441, 181, 260 | 85.0 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 16: n=443, 179, 264 | 93.9 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 18: n=498, 216, 282 | 35.9 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 18: n=498, 216, 282 | 38.9 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 6: n=441, 181, 260 | 79.0 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 16: n=443, 179, 264 | 95.0 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 11: n=441, 181, 260 | 86.7 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 18: n=498, 216, 282 | 33.7 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 11: n=441, 181, 260 | 83.8 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 16: n=443, 179, 264 | 93.2 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study | HPV Type 6: n=441, 181, 260 | 78.5 Percentage of participants |
Primary
Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Time frame: Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 16: n=1225, 583, 642 | 96.5 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 6: n=1207, 579, 628 | 89.3 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 18: n=1378, 673, 705 | 54.6 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 11: n=1207, 579, 628 | 92.4 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 16: n=1225, 583, 642 | 96.9 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 11: n=1207, 579, 628 | 94.0 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 6: n=1207, 579, 628 | 89.5 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 18: n=1378, 673, 705 | 57.4 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 18: n=1378, 673, 705 | 52.1 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 6: n=1207, 579, 628 | 89.2 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 11: n=1207, 579, 628 | 90.9 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study | HPV Type 16: n=1225, 583, 642 | 96.1 Percentage of participants |
Primary
Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Time frame: Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 6: n=1249, 605, 644 | 98.4 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 11: n=1249, 605, 644 | 98.1 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 16: n=1269, 612, 657 | 98.8 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 18: n=1430, 708, 722 | 97.3 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 18: n=1430, 708, 722 | 98.3 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 6: n=1249, 605, 644 | 98.7 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 16: n=1269, 612, 657 | 99.5 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 11: n=1249, 605, 644 | 98.5 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 18: n=1430, 708, 722 | 96.4 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 11: n=1249, 605, 644 | 97.7 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 16: n=1269, 612, 657 | 98.2 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study | HPV Type 6: n=1249, 605, 644 | 98.1 Percentage of participants |
Primary
Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Time frame: Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 6: n=1169, 551, 618 | 91.5 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 11: n=1169, 551, 618 | 95.5 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 16: n=1190, 559, 631 | 98.7 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 18: n=1331, 642, 689 | 55.5 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 18: n=1331, 642, 689 | 58.7 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 6: n=1169, 551, 618 | 92.0 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 16: n=1190, 559, 631 | 99.1 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 11: n=1169, 551, 618 | 96.7 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 18: n=1331, 642, 689 | 52.5 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 11: n=1169, 551, 618 | 94.3 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 16: n=1190, 559, 631 | 98.4 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study | HPV Type 6: n=1169, 551, 618 | 91.1 Percentage of participants |
Primary
Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Time frame: Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 6: n=1152, 536, 616 | 85.6 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 11: n=1152, 536, 616 | 92.0 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 16: n=1172, 544, 628 | 97.4 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 18: n=1313, 625, 688 | 47.9 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 18: n=1313, 625, 688 | 50.7 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 6: n=1152, 536, 616 | 86.2 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 16: n=1172, 544, 628 | 97.8 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 11: n=1152, 536, 616 | 93.8 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 18: n=1313, 625, 688 | 45.3 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 11: n=1152, 536, 616 | 90.4 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 16: n=1172, 544, 628 | 97.0 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study | HPV Type 6: n=1152, 536, 616 | 85.1 Percentage of participants |
Primary
Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Time frame: Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 18: n=530, 237, 293 | 45.3 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 11: n=466, 196, 270 | 92.1 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 16: n=473, 197, 276 | 97.3 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 6: n=468, 198, 270 | 89.1 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 11: n=466, 196, 270 | 94.4 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 16: n=473, 197, 276 | 97.5 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 6: n=468, 198, 270 | 89.4 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 18: n=530, 237, 293 | 48.5 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 16: n=473, 197, 276 | 97.1 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 6: n=468, 198, 270 | 88.9 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 18: n=530, 237, 293 | 42.7 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study | HPV Type 11: n=466, 196, 270 | 90.4 Percentage of participants |
Primary
Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Time frame: Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 6: n=1225, 589, 636 | 98.7 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 11: n=1225, 589, 636 | 98.8 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 16: n=1236, 588, 648 | 99.7 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 18: n=1387, 678, 709 | 84.6 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 18: n=1387, 678, 709 | 86.1 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 6: n=1225, 589, 636 | 98.6 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 16: n=1236, 588, 648 | 99.8 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 11: n=1225, 589, 636 | 99.3 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 18: n=1387, 678, 709 | 83.2 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 11: n=1225, 589, 636 | 98.3 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 16: n=1236, 588, 648 | 99.5 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study | HPV Type 6: n=1225, 589, 636 | 98.7 Percentage of participants |
Primary
Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study
Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were \>20 for Type 6, \>16 for Type 11, \>20 for Type 16, and \>24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.
Time frame: Month 96 (96 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 18: n=519, 230, 289 | 40.1 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 6: n=459, 193, 266 | 84.7 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 16: n=464, 192, 272 | 95.5 Percentage of participants |
| qHPV in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 11: n=459, 193, 266 | 85.0 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 16: n=464, 192, 272 | 95.8 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 18: n=519, 230, 289 | 41.3 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 11: n=459, 193, 266 | 90.7 Percentage of participants |
| Placebo in Base Study | Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 6: n=459, 193, 266 | 85.0 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 18: n=519, 230, 289 | 39.1 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 11: n=459, 193, 266 | 80.8 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 16: n=464, 192, 272 | 95.2 Percentage of participants |
| qHPV in Base Study: Participants 35 to 45 Years Old | Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study | HPV Type 6: n=459, 193, 266 | 84.6 Percentage of participants |
Secondary
Cumulative Incidence of HPV 6/11-related Condyloma: Day 1 to Year 4
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4 conditional on having been event-free at Day 1.
Time frame: Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Cumulative Incidence of HPV 6/11-related Condyloma: Day 1 to Year 4 | 0.0000 Cumulative Incidence Probability |
| Placebo in Base Study | Cumulative Incidence of HPV 6/11-related Condyloma: Day 1 to Year 4 | 0.0055 Cumulative Incidence Probability |
Secondary
Cumulative Incidence of HPV 6/11-related Condyloma: Year 4 to Year 8
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8 conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.
Time frame: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Cumulative Incidence of HPV 6/11-related Condyloma: Year 4 to Year 8 | 0.0000 Cumulative Incidence Probability |
Secondary
Cumulative Incidence of HPV 6/11-related Condyloma: Year 6 to Year 10
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.
Time frame: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Cumulative Incidence of HPV 6/11-related Condyloma: Year 6 to Year 10 | 0.0000 Cumulative Incidence Probability |
Secondary
Incidence Rate of HPV 31/33/35/52/58 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer
This outcome measure was not analyzed because of diminished interest by experts in composite efficacy endpoints associated with these HPV types
Time frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
Secondary
Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Day 1 to Year 4
The four HPV types were determined by PCR testing.
Time frame: Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Day 1 to Year 4 | 0.0 Incidence per 100 person-years |
| Placebo in Base Study | Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Day 1 to Year 4 | 0.2 Incidence per 100 person-years |
Secondary
Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 4 to Year 8
The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.
Time frame: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 4 to Year 8 | 0.0 Incidence per 100 person-years |
Secondary
Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 6 to Year 10
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.
Time frame: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 6 to Year 10 | 0.0 Incidence per 100 person-years |
Secondary
Incidence Rate of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer
HPV 6/11: The two types of HPV (types 6/11) were determined by PCR testing
Time frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Incidence Rate of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer | 0.0 Incidence per 100 person-years |
| Placebo in Base Study | Incidence Rate of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer | 0.9 Incidence per 100 person-years |
95% CI: [79.9, 99.4]
Other Pre-specified
Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Day 1 to Year 4
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4 conditional on having been event-free at Day 1.
Time frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Day 1 to Year 4 | 0.0007 Cumulative Incidence Probability |
| Placebo in Base Study | Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Day 1 to Year 4 | 0.0041 Cumulative Incidence Probability |
Other Pre-specified
Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 4 to 8
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8 conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.
Time frame: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 4 to 8 | 0.0000 Cumulative Incidence Probability |
Other Pre-specified
Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 6 to 10
The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.
Time frame: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 6 to 10 | 0.0000 Cumulative Incidence Probability |
Other Pre-specified
Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Day 1 to Year 4
The four HPV types were determined by PCR testing.
Time frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Day 1 to Year 4 | 0.0 Incidence per 100 person-years |
| Placebo in Base Study | Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Day 1 to Year 4 | 0.1 Incidence per 100 person-years |
Other Pre-specified
Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 4 to 8
The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.
Time frame: From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 4 to 8 | 0.0 Incidence per 100 person-years |
Other Pre-specified
Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 6 to 10
The four HPV types were determined by PCR testing.
Time frame: From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 6 to 10 | 0.0 Incidence per 100 person-years |
Other Pre-specified
Incidence Rate of HPV 16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer
HPV 16/18: The two types of HPV (types 16/18) were determined by PCR testing
Time frame: Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
Population: Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qHPV in Base Study | Incidence Rate of HPV 16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer | 0.2 Incidence per 100 person-years |
| Placebo in Base Study | Incidence Rate of HPV 16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer | 1.0 Incidence per 100 person-years |
95% CI: [67.5, 93.7]