A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Immunogenicity and Safety of V503 in Chinese Females Aged 10 to 45 Years Who Have Previously Received a Bivalent Human Papillomavirus (HPV) Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 930
- 主要终点
- Percentage of Participants Who Are Seropositive by Competitive Luminex Immunoassay (cLIA) to HPV Types 6, 11, 31, 33, 45, 52, and 58 (Month 7)
研究概览
简要总结
Researchers want to learn if V503 (also called the 9-valent human papillomavirus [9vHPV] vaccine, recombinant) can induce an immune response to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Chinese females who previously received the bivalent HPV (2vHPV) vaccine.
The 9vHPV vaccine protects against diseases caused by 9 types of HPV (6, 11, 16, 18, 31, 33, 45, 52, and 58) and the 2vHPV vaccine protects against diseases caused by 2 types of HPV (16 and 18).
The goals of the trial are to learn:
- If the 9vHPV vaccine can induce an immune response to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in participants who received the 2vHPV vaccine
- About the safety of the 9vHPV vaccine in prior 2vHPV vaccine recipients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •For participants to be enrolled in prior 2vHPV (bivalent human papillomavirus [HPV] vaccine) vaccine groups: has received at least one dose of any one of the three currently marketed 2vHPV vaccines, with the last dose administered at least one year prior to Day
- •For participants to be enrolled in HPV vaccine naïve groups: has never received any HPV vaccine.
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
- •Has a history of abnormal Pap test showing low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL) or atypical squamous cells - undetermined significance (ASC-US), atypical squamous cells - cannot exclude HSIL (ASC-H), atypical glandular cells, or biopsy showing CIN, AIS, or cervical cancer.
- •Has a history of external genital wart, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), AIN, vulvar cancer, vaginal cancer, or anal cancer.
- •Has a history of a positive test for HPV (including HPV types not in the vaccine).
- •Is 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.
- •Has a history of splenectomy.
- •Has received, is receiving, or plans to receive the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), tumor necrosis factor alpha (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 the participant is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of corticosteroids (orally or parenterally) lasting at least 1 week within 12 months prior to enrollment. Participants using inhaled, nasal, or topical corticosteroids are considered eligible for the study.
- •Has received, is receiving, or plans to receive any immune globulin product (including RhoGAM™ [Ortho-Clinical Diagnostics]) or blood derived product other than IVIG.
- •Has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
- •Has received any marketed HPV vaccine other than the 2vHPV vaccines.
研究组 & 干预措施
Prior 2vHPV Vaccine Recipients Receiving Placebo
Participants will receive Placebo at Day 1, Month 2, and Month 6
干预措施: Placebo (Biological)
HPV Vaccine-Naïve Participants Receiving V503
Participants will receive V503 at Day 1, Month 2, and Month 6
干预措施: V503 (Biological)
HPV Vaccine-Naïve Participants Receiving Placebo
Participants will receive Placebo at Day 1, Month 2, and Month 6
干预措施: Placebo (Biological)
Prior 2vHPV Vaccine Recipients Receiving V503
Participants will receive V503 at Day 1, Month 2, and Month 6
干预措施: V503 (Biological)
结局指标
主要结局
Percentage of Participants Who Are Seropositive by Competitive Luminex Immunoassay (cLIA) to HPV Types 6, 11, 31, 33, 45, 52, and 58 (Month 7)
时间窗: Up to approximately 1 month post vaccination 3 (Up to approximately Month 7)
The percentage of participants who are seropositive for HPV types 6, 11, 31, 33, 45, 52, and 58 in the Prior 2vHPV Vaccine Recipients Receiving V503 group will be determined using cLIA. Seropositivity is defined as having a titer at or above the prespecified seropositivity cutoff for a given HPV type.
Percentage of Participants Who Experience at Least 1 Solicited Injection-site Adverse Event (AE)
时间窗: Up to approximately Day 8 post any vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. AEs such as redness/erythema, swelling, pain, and induration at the injection site are recorded. The percentage of participants who experience 1 or more injection-site AE will be reported.
Percentage of Participants Who Experience at Least 1 Solicited Systemic AE
时间窗: Up to approximately Day 8 post any vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Systemic AEs are those not categorized as injection-site AEs. The percentage of participants who experience 1 or more systemic AE will be reported.
Percentage of Participants Who Experience at Least 1 Serious AE (SAE)
时间窗: Up to approximately Month 12
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. 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 who experience 1 or more SAEs will be reported.
次要结局
- Percentage of Participants Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58(Up to approximately 1 month post vaccination (Up to approximately 7 months))
- cLIA Geometric Mean Titers (GMTs) for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58(Up to approximately 1 month post vaccination (Up to approximately 7 months))
- Difference in Percentage of Participants Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Between Prior 2vHPV Vaccine Recipients and HPV Vaccine-Naïve Participants(Up to approximately 1 month post vaccination (Up to approximately 7 months))