A placebo 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study.

Anti-HPV levels >20 mMU/mL neutralize a large input load of HPV 11 virions in vitro; thus, the number of participants with anti-HPV 11 ≥16 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.

Anti-HPV levels >20 mMU/mL neutralize a large input load of HPV 16 pseudovirions in vitro; thus, the number of participants with anti-HPV 16 ≥20 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.

Anti-HPV levels >20 mMU/mL neutralize a large input load of HPV 18 pseudovirions in vitro; thus, the number of participants with anti-HPV 18 ≥24 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.

This measure is defined to have occurred when, on a single cervical biopsy, endocervical curettage (ECC), loop electrosurgical excision procedure (LEEP), or conization specimen, there was HPV Vaccine Nordic pathology panel (NPP) consensus diagnosis of CIN 2 or worse related to nonvaccine HPV types up to 14 years after the first vaccination. For this measure, CIN 2 or worse includes CIN 2, CIN 3, AIS or cervical cancer related to nonvaccine HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, or 59. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU are included. Because the objective was to demonstrate qHPV vaccine prophylactic efficacy at 14 years, Cohort 2 was not included in the analysis.

This measure was defined to have occurred if on a single biopsy or excised tissue, there was the NPP consensus diagnosis of CIN 1, CIN 2, CIN 3, AIS, cervical cancer, vulvar cancer or vaginal cancer AND at least 1 of HPV types 6, 11, 16 or 18 was detected by Thin-section PCR in an adjacent section from the same tissue block. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU are included. Because the objective was to demonstrate qHPV vaccine prophylactic efficacy at 14 years, Cohort 2 was not included in the analysis.

This measure is defined to have occurred if on a single biopsy or excised tissue, there is the NPP consensus diagnosis of CIN 1, CIN 2, CIN 3, AIS, cervical cancer, vulvar cancer or vaginal cancer AND at least 1 of HPV types 6, 11, 16 or 18 is detected by Thin-section PCR in an adjacent section from the same tissue block.

Antibodies to human papillomavirus (HPV) types were measured using cLIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.

Antibodies to human papillomavirus (HPV) types were measured using cLIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.

Antibodies to human papillomavirus (HPV) types were measured using cLIA. Seropositivity was assessed by competitive Luminex Immunoassay (cLIA); the serostatus cut-offs for anti-HPV 6, 11, 16 and 18 serum cLIA were 20, 16, 20 and 24 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.

Antibodies to human papillomavirus (HPV) types were measured using cLIA. Seropositivity was assessed by cLIA; the serostatus cut-offs for anti-HPV 6, 11, 16 and 18 serum cLIA were 20, 16, 20 and 24 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.

Antibodies to human papillomavirus (HPV) types were measured using IgG LIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.

Antibodies to human papillomavirus (HPV) types were measured using IgG LIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.

Antibodies to HPV types were measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 at Month 108 were 15, 15, 7, and 10 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.

Antibodies to HPV types were measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 at Month 168 were 9, 6, 5, and 5 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.

Antibodies to human papillomavirus (HPV) types will be measured using IgG LIA..

Antibodies to HPV types will be measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 are 15, 15, 7, and 10 milliMerck units (mMU)/mL, respectively. The percentage of participants that are seropositive for each type will be summarized.

Antibodies to human papillomavirus (HPV) types will be measured using IgG LIA..

Antibodies to HPV types will be measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 are 15, 15, 7, and 10 milliMerck units (mMU)/mL, respectively. The percentage of participants that are seropositive for each type will be summarized.

Eligible and consented to inclusion in registry-based searches for effectiveness information

Eligible and consented to provide blood samples for immunogenicity anaysis

Eligible and consented to inclusion in registry-based searches for safety information

Total of all reporting groups

During the Base Study, participants received 3 placebo vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.

This measure is defined to have occurred when, on a single cervical biopsy, endocervical curettage (ECC), loop electrosurgical excision procedure (LEEP), or conization specimen, there was HPV Vaccine Nordic pathology panel (NPP) consensus diagnosis of CIN 2 or worse up to 14 years after the first vaccination. For this measure, CIN 2 or worse includes CIN 2, CIN 3, AIS or cervical cancer related to HPV 16 or 18. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU are included. Because the objective was to demonstrate qHPV vaccine prophylactic efficacy at 14 years, Cohort 2 was not included in the analysis.

Participants in Cohort 1 who received 3 qHPV vaccine doses in 1 year, had no protocol violations that could affect evaluation of efficacy, had been PCR-negative and seronegative based on cLIA at Day 1 and PCR-negative through Month 7 of the Base Study to the relevant HPV type(s), and had LTFU data available.

This measure is defined to have occurred when, on a single cervical biopsy, ECC, LEEP, or conization specimen, there was HPV Vaccine NPP consensus diagnosis of CIN 2 or worse up to 22 years after the first vaccination. For this measure, CIN 2 or worse includes CIN 2, CIN 3, AIS or cervical cancer related to HPV 16 or 18. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU will be included.

Anti-HPV levels >20 mMU/mL neutralize a large input load of HPV 6 pseudovirions in vitro; thus, the number of participants with anti-HPV 6 ≥20 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.

Participants who received 3 qHPV vaccine doses and had Month 7 results within acceptable ranges, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were polymerase chain reaction (PCR)-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.

Anti-HPV levels >20 mMU/mL neutralize a large input load of HPV 11 virions in vitro; thus, the number of participants with anti-HPV 11 ≥16 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.

Participants who received 3 qHPV vaccine doses and had Month 7 results within acceptable ranges, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were polymerase chain reaction (PCR)-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.

Anti-HPV levels >20 mMU/mL neutralize a large input load of HPV 16 pseudovirions in vitro; thus, the number of participants with anti-HPV 16 ≥20 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.

Participants who received 3 qHPV vaccine doses and had Month 7 results within acceptable ranges, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were polymerase chain reaction (PCR)-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.

Anti-HPV levels >20 mMU/mL neutralize a large input load of HPV 18 pseudovirions in vitro; thus, the number of participants with anti-HPV 18 ≥24 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.

Participants who received 3 qHPV vaccine doses and had Month 7 results within acceptable ranges, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were polymerase chain reaction (PCR)-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.

This measure is defined to have occurred when, on a single cervical biopsy, endocervical curettage (ECC), loop electrosurgical excision procedure (LEEP), or conization specimen, there was HPV Vaccine Nordic pathology panel (NPP) consensus diagnosis of CIN 2 or worse related to nonvaccine HPV types up to 14 years after the first vaccination. For this measure, CIN 2 or worse includes CIN 2, CIN 3, AIS or cervical cancer related to nonvaccine HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, or 59. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU are included. Because the objective was to demonstrate qHPV vaccine prophylactic efficacy at 14 years, Cohort 2 was not included in the analysis.

Participants in Cohort 1 who had received ≥1 qHPV vaccination, had any follow up visit in the LTFU, and had been PCR-negative and seronegative based on cLIA to the appropriate HPV type(s) at Day 1.

This measure was defined to have occurred if on a single biopsy or excised tissue, there was the NPP consensus diagnosis of CIN 1, CIN 2, CIN 3, AIS, cervical cancer, vulvar cancer or vaginal cancer AND at least 1 of HPV types 6, 11, 16 or 18 was detected by Thin-section PCR in an adjacent section from the same tissue block. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU are included. Because the objective was to demonstrate qHPV vaccine prophylactic efficacy at 14 years, Cohort 2 was not included in the analysis.

Participants in Cohort 1 who received 3 qHPV vaccine doses in 1 year, had no protocol violations that could affect efficacy, had been PCR-negative and seronegative based on cLIA at Day 1 and PCR-negative through Month 7 of the Base Study to relevant HPV type(s), and had LTFU data available.

This measure is defined to have occurred if on a single biopsy or excised tissue, there is the NPP consensus diagnosis of CIN 1, CIN 2, CIN 3, AIS, cervical cancer, vulvar cancer or vaginal cancer AND at least 1 of HPV types 6, 11, 16 or 18 is detected by Thin-section PCR in an adjacent section from the same tissue block.

Antibodies to human papillomavirus (HPV) types were measured using cLIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.

Participants in Cohort 1 who received 3 qHPV vaccine doses in 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were PCR-negative and seronegative based on cLIA to relevant type at Day 1 and PCR-negative to the relevant type through Month 7. No data were collected for Cohort 2.

Antibodies to human papillomavirus (HPV) types were measured using cLIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.

Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.

Antibodies to human papillomavirus (HPV) types were measured using cLIA. Seropositivity was assessed by competitive Luminex Immunoassay (cLIA); the serostatus cut-offs for anti-HPV 6, 11, 16 and 18 serum cLIA were 20, 16, 20 and 24 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.

Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7. No data were collected for Cohort 2.

Antibodies to human papillomavirus (HPV) types were measured using cLIA. Seropositivity was assessed by cLIA; the serostatus cut-offs for anti-HPV 6, 11, 16 and 18 serum cLIA were 20, 16, 20 and 24 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.

Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.

Antibodies to human papillomavirus (HPV) types were measured using IgG LIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.

Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7. No data were collected for Cohort 2.

Antibodies to human papillomavirus (HPV) types were measured using IgG LIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.

Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.

Antibodies to HPV types were measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 at Month 108 were 15, 15, 7, and 10 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.

Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7. No data were collected for Cohort 2.

Antibodies to HPV types were measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 at Month 168 were 9, 6, 5, and 5 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.

Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.

Antibodies to human papillomavirus (HPV) types will be measured using IgG LIA..

Antibodies to HPV types will be measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 are 15, 15, 7, and 10 milliMerck units (mMU)/mL, respectively. The percentage of participants that are seropositive for each type will be summarized.

Antibodies to human papillomavirus (HPV) types will be measured using IgG LIA..

Antibodies to HPV types will be measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 are 15, 15, 7, and 10 milliMerck units (mMU)/mL, respectively. The percentage of participants that are seropositive for each type will be summarized.

Participants received 3 placebo vaccinations (at Day 1, Month 2 and Month 6) during the Base Study Vaccination Period, and then received 3 qHPV vaccinations during the 4-year Base Study EXT.

Participants who received placebo (N=581) or an incomplete qHPV vaccine regimen (N=13) were enrolled to receive qHPV vaccine during the base study extension; participants designated as "Not Completed" are those who did not complete all three vaccinations and/or all required follow-up visits.

Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.

Participants who received placebo in the Base Study and qHPV vaccine after completion of the Base Study and prior to entry into the LTFU. Cohort 2 provided a total of approximately 10 years of follow-up post-vaccination in the LTFU.