A Phase 3 Open-Label Clinical Trial to Study the Immunogenicity and Safety of 9- Valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine (V503) in Chinese Females 9 to 45 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,990
- 试验地点
- 2
- 主要终点
- Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
研究概览
简要总结
This study investigates the immunogenicity and safety of the 9vHPV vaccine in healthy Chinese females 9 to 45 years of age. The study consists of Stage I (Day 1 to Month 7) and Stage II (post Month 7 to Month 60). Stage II will report the long-term immunogenicity and safety in the 9-19 year-old age group only. The dual-primary hypotheses of Stage I are that 9vHPV vaccine induces non-inferior immune responses in females 9 to 19 years of age who are seronegative at Day 1 to the relevant HPV type compared to females 20 to 26 years of age who are seronegative at Day 1 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 1 month post Dose 3, and 9vHPV vaccine induces non-inferior immune responses in females 27 to 45 years of age who are seronegative at Day 1 to the relevant HPV type compared to females 20 to 26 years of age who are seronegative at Day 1 to the relevant HPV type, as measured by the seroconversion percentages to each of HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 1 month post Dose 3. (Each vaccine component will be analyzed separately.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participant is a Chinese female judged to be in good physical health based on medical history and physical examination
- •Not a woman of childbearing potential (WOCBP) or if of WOCBP, 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
- •And the participant understands and agrees that during the Day 1 through Month 7 period, she should not have sexual intercourse with males without effective contraception, and that the use of the rhythm method, withdrawal, and emergency contraception are not acceptable methods
- •Has a lifetime history of 0 to 4 male and/or female sexual partners at the time of enrollment. Male partner is defined as someone with whom the participant has penile penetrative sexual intercourse. Female partner is defined as someone who has contacted, either by penetrative (with fingers or other objects) or non-penetrative means, the participant's genitalia during sexual activity
排除标准
- •Known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed™). An allergy to vaccine components is defined as an allergic reaction that met the criteria for serious adverse event
- •History of severe allergic reaction (e.g. swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention
- •Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
- •Has a fever (defined as an axillary temperature ≥37.1°C) within 24 hours prior to the Day 1 vaccination
- •Has any history of abnormal Pap test showing squamous intraepithelial lesion (SIL) or atypical squamous cells - undetermined significance (ASC-US), atypical squamous cells - cannot exclude HSIL (ASC-H), atypical glandular cells, or biopsy showing cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ or cervical cancer
- •History of external genital wart, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), vulvar cancer or vaginal cancer
- •History of a positive test for HPV
- •Currently immunocompromised or has been 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
- •Donated blood within 1 week prior to the Day 1 vaccination, or intends to donate during Day 1 through Month 7 of the study
- •Expecting to donate eggs during Day 1 through Month 7 of the study
- •Receiving or has received in the year prior to Day 1 vaccination the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), tumor necrosis factor (TNF)-α antagonists, monoclonal antibody therapies (including rituximab [Rituxan™]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a participant will be excluded if she is currently receiving steroid therapy, has recently (defined as within 2 weeks of Day 1 vaccination) 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 corticosteroids are considered eligible for the study
- •Has received immune globulin product (including RhoGAM™ or blood-derived product other than IVIG within 6 months prior to Day 1 vaccination, or plans to receive any such product during Day 1 through Month 7 of the study
- •Has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo
- •Has received inactivated or recombinant vaccines within 14 days prior to Day 1 vaccination or has received live vaccines within 21 days prior to Day 1 vaccination
- •Concurrently enrolled in clinical studies of interventional agents
- •A user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use
研究组 & 干预措施
V503
V503 administered as a 0.5 mL intramuscular injection at Day 1, Month 2 and Month 6.
干预措施: V503 (Biological)
结局指标
主要结局
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
时间窗: Month 24
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.
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
时间窗: Month 48
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.
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
时间窗: Month 12
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.
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
时间窗: Month 36
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.
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
时间窗: Month 48
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.
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
时间窗: Month 60
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.
Stage I: Percentage of Participants 27 to 45 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
时间窗: 1 month post vaccination 3 (Month 7)
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.
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
时间窗: Month 12
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.
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
时间窗: Month 12
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.
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
时间窗: Month 24
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.
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
时间窗: Month 36
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.
Stage I: Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs) for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age and 20 to 26 Years of Age: Month 7
时间窗: 1 month post vaccination 3 (Month 7)
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 milli Merck units/mL (mMU/mL).
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
时间窗: Month 24
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.
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
时间窗: Month 36
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.
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
时间窗: Month 48
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.
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
时间窗: Month 60
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.
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
时间窗: Month 60
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.
Stage II: Immunoglobulin G Luminex Immunoassay (IgG LIA) GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
时间窗: Month 12
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.
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
时间窗: Month 24
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.
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
时间窗: Month 36
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.
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
时间窗: Month 48
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.
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
时间窗: Month 60
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.
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month 36
时间窗: Month 36
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type will be reported in mMU/mL.
Stage I: Competitive Luminex Immunoassay (cLIA) GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age and 20 to 26 Years of Age: Month 7
时间窗: 1 month post vaccination 3 (Month 7)
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type will be reported in mMU/mL.
Stage II: Immunoglobulin G Luminex Immunoassay (IgG LIA) GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month 12
时间窗: Month 12
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using IgG LIA. The GMT for each HPV type will be reported in mMU/mL.
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month 36
时间窗: Month 36
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using IgG LIA. The GMT for each HPV type will be reported in mMU/mL.
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month 48
时间窗: Month 48
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using IgG LIA. The GMT for each HPV type will be reported in mMU/mL.
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month 60
时间窗: Month 60
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using IgG LIA. The GMT for each HPV type will be reported in mMU/mL.
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month24
时间窗: Month 24
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type will be reported in mMU/mL.
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month 48
时间窗: Month 48
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type will be reported in mMU/mL.
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month 60
时间窗: Month 60
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type will be reported in mMU/mL.
Stage II: Percentage of Participants 9 to 19 years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
时间窗: Month 60
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will determined using cLIA. The percentage of participants who are seropositive for each HPV type will be summarized.
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month 24
时间窗: Month 24
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using IgG LIA. The GMT for each HPV type will be reported in mMU/mL.
次要结局
- Stage I: Percentage of Participants 9 to 19 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7(1 month post vaccination 3 (Month 7))
- Stage I: Percentage of Participants 9 to 15 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7(1 month post vaccination 3 (Month 7))
- Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 27 to 45 Years of Age: Month 7(1 month post vaccination 3 (Month 7))
- Stage I: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age: Month 7(1 month post vaccination 3 (Month 7))
- Stage I: Percentage of Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7(1 month post vaccination 3 (Month 7))
- Stage I: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)(Day 1 to Month 7)
- Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 15 Years of Age and 20 to 26 Years of Age: Month 7(1 month post vaccination 3 (Month 7))
- Stage I: Percentage of Participants Who Experience at Least 1 Solicited Injection-site Adverse Event (AE)(Up to 8 days post any vaccination (up to ~Day 192))
- Stage I: Percentage of Participants Who Experience at Least 1 Systemic AE(Up to 31 days post any vaccination (Up to ~Month 7))
- Stage I: Percentage of Participants With Elevated Axillary Temperature (≥37.1 C)(Up to 8 days post any vaccination (Up to ~Day 192))
- Stage II: Percentage of Participants 9 to 19 Years of Age Who Experience at Least 1 Serious Adverse Event (SAE): Month 7 to Month 60(Month 7 to Month 60)
- Stage I: Percentage of Participants with Elevated Axillary Temperature (≥37.1 C)(up to 8 days post any vaccination)
- Stage I: cLIA GMTs for HPV Tys 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 15 Years of Age and 20 to 26 Years of Age: Month 7(1 month post vaccination 3 (Month 7))
- Stage I: Percentage of Participants Who Experience at Least 1 Systemic AE(Up to 30 days post any vaccination)
- Stage I: Percentage of Participants Who Experience at Least 1 Solicited Injection-site AE(Up to 8 days post any vaccination)
- Stage II: Percentage of Participant 9 to 19 years of Age Who Experience at Least 1 Serious Adverse Event (SAE): Month 7 to Month 60(Month 7 to Month 60)