A Study to Evaluate the Immunogenicity, Safety and Tolerability of Quadrivalent Human Papillomavirus Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years (V501-213)

A Phase 3 Open-Label Clinical Trial to Study the Immunogenicity, Safety and Tolerability of Recombinant Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03493542

Enrollment

766

Registered

2018-04-10

Start date

2018-08-31

Completion date

2023-10-30

Last updated

2024-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of HPV Types 16- and 18-related Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) 1/2/3, and Cervical Adenocarcinoma in Situ

Brief summary

This study is designed to evaluate the immunogenicity, safety, and tolerability of Gardasil® (quadrivalent human papillomavirus \[qHPV\] vaccine, V501) in Chinese girls aged 9-19 years and young women aged 20-26 years. The primary hypothesis of the study states that at 1 month postdose 3, a 3-dose regimen of V501 induces non-inferior geometric mean titers (GMTs) for serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18 in girls aged 9-19 years compared to young women aged 20-26 years.

Detailed description

The study consists of a Base Stage wherein Chinese girls aged 9-19 years and young women aged 20-26 years receive a 3-dose regimen of V501 and are followed up to 1 month postdose 3 (Month 7). Participants aged 9-19 years who received 3 doses of V501 in the Base Stage will be eligible to participate in the Extension Stage and will be followed up to Month 60. No study vaccine will be administered during the Extension Stage.

Interventions

BIOLOGICALV501

0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

9 Years to 26 Years

Healthy volunteers

Yes

Inclusion criteria

* Not pregnant and 1) not a woman of childbearing potential (WOCBP), or 2) a WOCBP who has not had sex with males or has had sex with males and used effective contraception since the first day of participant's last menstrual period through Day 1 and understands and agrees that during the study she should not have sexual intercourse with males without effective contraception (the rhythm method, withdrawal, and emergency contraception are not acceptable methods per the protocol). * Participant and participant's parent or guardian (participants aged 9-17 years only) provided written informed consent/assent. * Provided a primary and alternative telephone for follow-up purposes. * Extension Stage: participant was enrolled in the 9-19 years old group, received 3 doses of V501 in the Base Stage, and participant and participant's legally acceptable representative (if applicable) provided written informed consent/assent for the study extension.

Exclusion criteria

* History of severe allergic reaction that required medical intervention. * Allergic to any vaccine component, including aluminum, yeast, or Benzonase® (nuclease). * Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections. * Currently immunocompromised or was diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition. * History of splenectomy. * Any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives. * History of recent or ongoing alcohol or other drug abuse. * History of a positive test for HPV. * Any history of abnormal Pap test. * History of external genital wart, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), vulvar cancer or vaginal cancer. * Undergone hysterectomy (either vaginal or total abdominal hysterectomy). * Receiving or has received in the year prior to Day 1 vaccination an excluded immunosuppressive therapy. A participant will be excluded if she is currently receiving steroid therapy, has recently received such therapy, or has received 2 or more courses of corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to Day 1 vaccination. Participants using inhaled, nasal or topical steroids are considered eligible for the study. * Received immune globulin product or blood-derived product within 6 months prior to Day 1 vaccination, or plans to receive any such product during the study. * Received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo. * Received inactivated or recombinant vaccines within 14 days prior to Day 1 vaccination or receipt of live vaccines within 21 days prior to Day 1 vaccination. * Concurrently enrolled in a clinical study of investigational agents. * Had \>4 lifetime sexual partners. * Unlikely to adhere to the study procedures, keep appointments, or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled. * An immediate family member who is investigational site or sponsor staff directly involved with this study. * Extension Stage: reported overdose or received non-study HPV vaccine during the Base Stage.

Design outcomes

Primary

Measure	Time frame	Description
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by IgG LIA	Month 60 post-vaccination 1	The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 12 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Month 12 post-vaccination 1	Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL).
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 24 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Month 24 post-vaccination 1	Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL).
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 36 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Month 36 post-vaccination 1	Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL).
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 48 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Month 48 post-vaccination 1	Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA.
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 60 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Month 60 post-vaccination 1	Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA.
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by IgG LIA	Month 12 post-vaccination 1	The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by IgG LIA	Month 24 post-vaccination 1	The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by IgG LIA	Month 36 post-vaccination 1	The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by IgG LIA	Month 48 post-vaccination 1	The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA)	Month 7 (1 month postdose 3)	Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA	Month 12 post-vaccination 1	Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA	Month 24 post-vaccination 1	Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA	Month 36 post-vaccination 1	Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA	Month 48 post-vaccination 1	Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA	Month 60 post-vaccination 1	Serum antibody titers (Geometric mean titers) for HPV virus-like particles (VLPs) Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA	Month 12 post-vaccination 1	The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA	Month 24 post-vaccination 1	The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA	Month 36 post-vaccination 1	The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA	Month 48 post-vaccination 1	The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA	Month 60 post-vaccination 1	The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.

Secondary

Measure	Time frame	Description
Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA	Month 7 (1 month postdose 3)	Antibodies to HPV Types 6, 11, 16, and 18 were measured using an IgG LIA. Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).
Base Stage: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: IgG LIA	Month 7 (1 month postdose 3)	The percentage of participants who seroconverted to each of HPV Types 6, 11, 16, and 18 was assessed. Antibodies were measured using IgG LIA.
Base Stage: Percentage of Participants Who Experienced a Solicited Injection-site Adverse Event (AE)	Up to 15 days after any vaccination	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site redness, swelling, induration, pain, and pruritus.
Base Stage: Percentage of Participants Participants Who Experienced a Solicited Systemic AE	Up to 15 days after any vaccination	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included hypersensitivity, headache, fatigue, vomiting, nausea, diarrhea, myalgia, pyrexia, and cough.
Base Stage: Percentage of Participants Who Experienced a Serious Adverse Event (SAE)	Up to Month 7 (1 month postdose 3)	An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
Base Stage: Percentage of Participants Who Experienced an AE	Up to 31 days after any vaccination	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment
Base Stage: Maximum Axillary Temperature: Merck Sharp & Dohme (MSD) Criteria	Up to 5 days after any vaccination	In the global studies, fever is defined as an oral temperature of ≥37.8°C or 100.0°F, which is equivalent to axillary temperature of ≥37.2°C, while the definition of fever is axillary temperature of ≥37.1°C in Chinese criteria. To be compliant to Chinese criteria, axillary temperatures of ≥37.1°C was considered as a fever in this study. Body temperature readings assessed orally were converted to the axillary equivalent. The percentage of participants with a maximum axillary or converted axillary temperature was summarized by temperature range.
Extension Stage: Percentage of Participants Who Experienced an SAE	Month 7 up to Month 60	The percentage of participants with an SAE will be assessed. An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
Base Stage: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: cLIA	Month 7 (1 month postdose 3)	Seroconversion is defined as changing serostatus from seronegative at Day 1 to seropositive at 1 month post dose 3. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).

Countries

China

Participant flow

Participants by arm

Arm	Count
Base Study: Chinese Girls Aged 9 to 19 Years Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6	383
Base Study: Chinese Young Women Aged 20 to 26 Years Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6	383
Total	766

Withdrawals & dropouts

Period	Reason	FG001	FG002
Base Study	Withdrawal by Subject	4	0
Extension Study	Consent withdrawal by parent/guardian	0	2
Extension Study	Withdrawal by Subject	0	25

Baseline characteristics

Characteristic	Base Study: Chinese Young Women Aged 20 to 26 Years	Total	Base Study: Chinese Girls Aged 9 to 19 Years
Age, Continuous	23.4 years STANDARD_DEVIATION 1.8	18.8 years STANDARD_DEVIATION 5.3	14.3 years STANDARD_DEVIATION 3.3
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	383 Participants	766 Participants	383 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	383 Participants	766 Participants	383 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants
Sex: Female, Male Female	383 Participants	766 Participants	383 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
deaths Total, all-cause mortality	0 / 383	0 / 383	0 / 365
other Total, other adverse events	216 / 383	238 / 383	0 / 365
serious Total, serious adverse events	6 / 383	11 / 383	8 / 365

Outcome results

Primary

Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA)

Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).

Time frame: Month 7 (1 month postdose 3)

Population: Per protocol, the analysis population included the participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Chinese Girls Aged 9 to 19 Years	Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA)	Anti-HPV 6	975.2 mMU/mL
Chinese Girls Aged 9 to 19 Years	Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA)	Anti-HPV 11	807.4 mMU/mL
Chinese Girls Aged 9 to 19 Years	Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA)	Anti-HPV 16	4573.7 mMU/mL
Chinese Girls Aged 9 to 19 Years	Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA)	Anti-HPV 18	1176.5 mMU/mL
Base Study: Chinese Young Women Aged 20 to 26 Years	Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA)	Anti-HPV 18	708.6 mMU/mL
Base Study: Chinese Young Women Aged 20 to 26 Years	Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA)	Anti-HPV 6	686.6 mMU/mL
Base Study: Chinese Young Women Aged 20 to 26 Years	Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA)	Anti-HPV 16	2989.2 mMU/mL
Base Study: Chinese Young Women Aged 20 to 26 Years	Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA)	Anti-HPV 11	580.2 mMU/mL

Comparison: Anti-HPV 6p-value: <0.000195% CI: [1.28, 1.58]ANOVA

Comparison: Anti-HPV 11p-value: <0.000195% CI: [1.25, 1.55]ANOVA

Comparison: Anti-HPV 16p-value: <0.000195% CI: [1.37, 1.7]ANOVA

Comparison: Anti-HPV 18p-value: <0.000195% CI: [1.45, 1.9]ANOVA

Primary

Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 12 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)

Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL).

Time frame: Month 12 post-vaccination 1

Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 12 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 6	217.0 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 12 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 11	172.1 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 12 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 16	1025.8 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 12 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 18	228.0 mMU/mL

Primary

Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 24 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)

Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL).

Time frame: Month 24 post-vaccination 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 24 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 6	85.5 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 24 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 11	68.6 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 24 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 16	394.9 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 24 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 18	76.9 mMU/mL

Primary

Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 36 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)

Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL).

Time frame: Month 36 post-vaccination 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 36 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 6	66.5 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 36 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 11	52.7 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 36 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 16	304.0 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 36 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 18	57.5 mMU/mL

Primary

Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 48 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)

Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA.

Time frame: Month 48 post-vaccination 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 48 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 6	63.4 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 48 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 11	51.1 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 48 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 18	55.3 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 48 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 16	289.6 mMU/mL

Primary

Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 60 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)

Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA.

Time frame: Month 60 post-vaccination 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 60 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 6	58.6 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 60 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 11	47.2 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 60 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 16	264.3 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 60 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)	Anti-HPV 18	51.0 mMU/mL

Primary

Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA

Time frame: Month 12 post-vaccination 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA	Anti-HPV 6	259.1 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA	Anti-HPV 11	206.7 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA	Anti-HPV 16	1149.8 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA	Anti-HPV 18	284.2 mMU/mL

Primary

Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA

Time frame: Month 24 post-vaccination 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA	Anti-HPV 6	137.9 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA	Anti-HPV 11	110.3 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA	Anti-HPV 16	522.6 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA	Anti-HPV 18	157.2 mMU/mL

Primary

Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA

Time frame: Month 36 post-vaccination 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA	Anti-HPV 6	110.6 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA	Anti-HPV 11	87.0 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA	Anti-HPV 16	400.8 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA	Anti-HPV 18	131.9 mMU/mL

Primary

Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA

Time frame: Month 48 post-vaccination 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA	Anti-HPV 6	103.0 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA	Anti-HPV 11	81.8 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA	Anti-HPV 16	347.5 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA	Anti-HPV 18	130.3 mMU/mL

Primary

Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA

Serum antibody titers (Geometric mean titers) for HPV virus-like particles (VLPs) Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).

Time frame: Month 60 post-vaccination 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA	Anti-HPV 6	87.6 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA	Anti-HPV 11	67.3 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA	Anti-HPV 16	283.2 mMU/mL
Chinese Girls Aged 9 to 19 Years	Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA	Anti-HPV 18	113.6 mMU/mL

Primary

Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.

Time frame: Month 12 post-vaccination 1

Arm	Measure	Group	Value (NUMBER)
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA	Anti-HPV 6	99.1 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA	Anti-HPV 11	99.7 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA	Anti-HPV 16	100.0 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA	Anti-HPV 18	96.9 Percentage of Participants

Primary

Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by IgG LIA

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.

Time frame: Month 12 post-vaccination 1

Arm	Measure	Group	Value (NUMBER)
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by IgG LIA	Anti-HPV 6	100.0 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by IgG LIA	Anti-HPV 11	100.0 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by IgG LIA	Anti-HPV 16	100.0 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by IgG LIA	Anti-HPV 18	100.0 Percentage of Participants

Primary

Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.

Time frame: Month 24 post-vaccination 1

Arm	Measure	Group	Value (NUMBER)
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA	Anti-HPV 6	88.8 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA	Anti-HPV 11	95.3 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA	Anti-HPV 16	99.7 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA	Anti-HPV 18	87.7 Percentage of Participants

Primary

Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by IgG LIA

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.

Time frame: Month 24 post-vaccination 1

Arm	Measure	Group	Value (NUMBER)
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by IgG LIA	Anti-HPV 6	98.4 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by IgG LIA	Anti-HPV 11	98.4 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by IgG LIA	Anti-HPV 16	100.0 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by IgG LIA	Anti-HPV 18	98.1 Percentage of Participants

Primary

Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.

Time frame: Month 36 post-vaccination 1

Arm	Measure	Group	Value (NUMBER)
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA	Anti-HPV 6	83.6 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA	Anti-HPV 11	92.1 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA	Anti-HPV 16	98.8 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA	Anti-HPV 18	84.0 Percentage of Participants

Primary

Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by IgG LIA

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.

Time frame: Month 36 post-vaccination 1

Arm	Measure	Group	Value (NUMBER)
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by IgG LIA	Anti-HPV 6	98.1 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by IgG LIA	Anti-HPV 11	99.4 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by IgG LIA	Anti-HPV 16	100.0 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by IgG LIA	Anti-HPV 18	96.2 Percentage of Participants

Primary

Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.

Time frame: Month 48 post-vaccination 1

Arm	Measure	Group	Value (NUMBER)
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA	Anti-HPV 6	68.5 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA	Anti-HPV 11	85.2 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA	Anti-HPV 16	91.9 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA	Anti-HPV 18	64.6 Percentage of Participants

Primary

Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by IgG LIA

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.

Time frame: Month 48 post-vaccination 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by IgG LIA	Anti-HPV 6	97.4 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by IgG LIA	Anti-HPV 11	98.4 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by IgG LIA	Anti-HPV 16	100.0 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by IgG LIA	Anti-HPV 18	95.1 Percentage of Participants

Primary

Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.

Time frame: Month 60 post-vaccination 1

Arm	Measure	Group	Value (NUMBER)
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA	Anti-HPV 6	61.9 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA	Anti-HPV 11	74.9 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA	Anti-HPV 16	87.1 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA	Anti-HPV 18	58.3 Percentage of Participants

Primary

Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by IgG LIA

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.

Time frame: Month 60 post-vaccination 1

Arm	Measure	Group	Value (NUMBER)
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by IgG LIA	Anti-HPV 6	96.7 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by IgG LIA	Anti-HPV 11	98.4 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by IgG LIA	Anti-HPV 16	100.0 Percentage of Participants
Chinese Girls Aged 9 to 19 Years	Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by IgG LIA	Anti-HPV 18	95.4 Percentage of Participants

Secondary

Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA

Antibodies to HPV Types 6, 11, 16, and 18 were measured using an IgG LIA. Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).

Time frame: Month 7 (1 month postdose 3)

Population: All participants who received the correct dose of all 3 study vaccinations within visit window; was seronegative at Day 1 for the human papilloma virus (HPV) type being analyzed; provided Month 7 serum sample within visit window; and did not meet any exclusion criteria at any time during base stage.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Chinese Girls Aged 9 to 19 Years	Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA	Anti-HPV 6	902.7 mMU/mL
Chinese Girls Aged 9 to 19 Years	Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA	Anti-HPV 11	756.2 mMU/mL
Chinese Girls Aged 9 to 19 Years	Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA	Anti-HPV 16	4170.0 mMU/mL
Chinese Girls Aged 9 to 19 Years	Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA	Anti-HPV 18	1012.8 mMU/mL
Base Study: Chinese Young Women Aged 20 to 26 Years	Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA	Anti-HPV 18	612.0 mMU/mL
Base Study: Chinese Young Women Aged 20 to 26 Years	Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA	Anti-HPV 6	604.5 mMU/mL
Base Study: Chinese Young Women Aged 20 to 26 Years	Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA	Anti-HPV 16	2659.3 mMU/mL
Base Study: Chinese Young Women Aged 20 to 26 Years	Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA	Anti-HPV 11	518.7 mMU/mL

Secondary

Base Stage: Maximum Axillary Temperature: Merck Sharp & Dohme (MSD) Criteria

In the global studies, fever is defined as an oral temperature of ≥37.8°C or 100.0°F, which is equivalent to axillary temperature of ≥37.2°C, while the definition of fever is axillary temperature of ≥37.1°C in Chinese criteria. To be compliant to Chinese criteria, axillary temperatures of ≥37.1°C was considered as a fever in this study. Body temperature readings assessed orally were converted to the axillary equivalent. The percentage of participants with a maximum axillary or converted axillary temperature was summarized by temperature range.

Time frame: Up to 5 days after any vaccination