Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥50, 29, 41, 59, 29, 22, 15, 20, and 15 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥50, 29, 41, 59, 29, 22, 15, 20, and 15 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥65, 37, 79, 85, 46, 26, 21, 30 and 31 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥34, 25, 32, 26, 15, 10, 10, 14 and 10 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥34, 25, 32, 26, 15, 10, 10, 14 and 10 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL. Although the same name (mMU/mL) is used for the unit of measurement in both cLIA and IgG LIA, the 'cLIA mMU/mL' and the 'IgG LIA mMU/mL' are actually different units of measurement and cannot be directly compared.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type were expressed as mMU/mL. As pre-specified per protocol, participants 20 to 26 years of age and a subset of participants 9 to 15 years of age were included in the analysis.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥50, 29, 41, 59, 29, 22, 15, 20, and 15 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively. As pre-specified per protocol, a subset of participants 9 to 15 years of age were included in the analysis.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type were expressed as mMU/mL.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. The participant or the parent/guardian of the participant was to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 8 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, swelling and induration) is reported.

An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. The percentage of participants with a systemic AE is reported.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. The percentage of participants that experienced 1 or more SAEs is reported.

Participant or participant's legally acceptable representative will be asked to record axillary temperature in the evening after each study vaccination and daily, at the same time of day whenever possible, for 8 days after each study vaccination in the VRC. The percentage of participant's who had an axillary temperature ≥37.1°C is reported.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. The percentage of participants that experienced 1 or more SAEs is reported.

Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.

Total of all reporting groups

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥50, 29, 41, 59, 29, 22, 15, 20, and 15 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

Per protocol, included participants 27-45 and 20-26 years old who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥50, 29, 41, 59, 29, 22, 15, 20, and 15 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥50, 29, 41, 59, 29, 22, 15, 20, and 15 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥65, 37, 79, 85, 46, 26, 21, 30 and 31 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥34, 25, 32, 26, 15, 10, 10, 14 and 10 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥34, 25, 32, 26, 15, 10, 10, 14 and 10 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL. Although the same name (mMU/mL) is used for the unit of measurement in both cLIA and IgG LIA, the 'cLIA mMU/mL' and the 'IgG LIA mMU/mL' are actually different units of measurement and cannot be directly compared.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥50, 29, 41, 59, 29, 22, 15, 20, and 15 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

Per protocol, included participants 9-19 and 20-26 years old who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type were expressed as mMU/mL. As pre-specified per protocol, participants 20 to 26 years of age and a subset of participants 9 to 15 years of age were included in the analysis.

Per protocol, included participants 9-15 and 20-26 years old who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥50, 29, 41, 59, 29, 22, 15, 20, and 15 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively. As pre-specified per protocol, a subset of participants 9 to 15 years of age were included in the analysis.

Per protocol, included participants 9 to 15 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type were expressed as mMU/mL.

Per protocol, included participants 27 to 45 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.

Participants who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine were analyzed.

The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

Participants who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine were analyzed.

An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. The participant or the parent/guardian of the participant was to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 8 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, swelling and induration) is reported.

The analysis population consisted of all participants who received at least 1 dose of study vaccination.

An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. The percentage of participants with a systemic AE is reported.

The analysis population consisted of all participants who received at least 1 dose of study vaccination.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. The percentage of participants that experienced 1 or more SAEs is reported.

The analysis population consisted of all participants who received at least 1 dose of study vaccination.

Participant or participant's legally acceptable representative will be asked to record axillary temperature in the evening after each study vaccination and daily, at the same time of day whenever possible, for 8 days after each study vaccination in the VRC. The percentage of participant's who had an axillary temperature ≥37.1°C is reported.

The analysis population consisted of all participants who received at least 1 dose of study vaccination.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. The percentage of participants that experienced 1 or more SAEs is reported.

The analysis population consisted of all participants 9 to 19 years of age who received at least 1 dose of study vaccination.

Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.

Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.

Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.