An Open-label, Long-term Extension Study to Evaluate the Persistence of Immune Responses to a Bivalent Human Papillomavirus Vaccine (Pichia Pastoris) in Healthy Females Who Were Aged 9 to 26 Years at Enrollment in Study 311-HPV-1004
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 348
- 试验地点
- 2
- 主要终点
- Geometric Mean Titer of HPV-16 Neutralizing Antibodies
研究概览
简要总结
This long-term extension study evaluates the persistence of neutralizing antibody responses to a bivalent human papillomavirus vaccine in females who previously participated in study 311-HPV-1004 (NCT02740777). Participants belonged to one of three vaccination cohorts in the base study: adolescents who received two doses at Months 0 and 6, adolescents who received three doses at Months 0, 2, and 6, and adults who received three doses at Months 0, 2, and 6. No vaccine is administered in the extension study. Blood samples are collected at Months 84, 108, and 132 after the first dose in the base study and tested for HPV-16 and HPV-18 neutralizing antibodies using a high-throughput pseudovirus-based neutralization assay.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 34 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The participant, and the participant's legal guardian when applicable, is able to understand the study information and voluntarily sign the informed consent form for the extension study.
- •In the investigator's judgment, the participant is able to comply with protocol requirements, including attending scheduled visits and responding to follow-up telephone contacts.
- •The participant was enrolled in study 311-HPV-1004 and completed blood collection at Day 0 and Months 7, 12, 24, and 36.
排除标准
- •Receipt of any HPV vaccine other than the study vaccine during study 311-HPV-1004 or between completion of that study and enrollment in this extension study.
- •Use of an investigational or unregistered product, other than the study vaccine, during study 311-HPV-1004 or between completion of that study and enrollment in this extension study.
- •Seropositivity for both HPV-16 and HPV-18 antibodies at baseline in study 311-HPV-
- •Long-term use of immunosuppressive agents or
研究组 & 干预措施
2-dose adolescent cohort
Participants who were aged 9 to 14 years at enrollment in the base study and received the bivalent HPV vaccine at Months 0 and 6. No vaccine is administered in the extension study.
干预措施: Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris) (Biological)
3-dose adolescent cohort
Participants who were aged 9 to 14 years at enrollment in the base study and received the bivalent HPV vaccine at Months 0, 2, and 6. No vaccine is administered in the extension study.
干预措施: Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris) (Biological)
3-dose adult cohort
Participants who were aged 18 to 26 years at enrollment in the base study and received the bivalent HPV vaccine at Months 0, 2, and 6. No vaccine is administered in the extension study.
干预措施: Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris) (Biological)
结局指标
主要结局
Geometric Mean Titer of HPV-16 Neutralizing Antibodies
时间窗: Months 84, 108, and 132 after the first dose in the base study
The geometric mean and two-sided 95% confidence interval of HPV-16 neutralizing antibody titers are summarized separately for each prior-vaccination cohort using the high-throughput pseudovirus-based neutralization assay.
Geometric Mean Titer of HPV-18 Neutralizing Antibodies
时间窗: Months 84, 108, and 132 after the first dose in the base study
The geometric mean and two-sided 95% confidence interval of HPV-18 neutralizing antibody titers are summarized separately for each prior-vaccination cohort using the high-throughput pseudovirus-based neutralization assay.
Seropositivity Rate for HPV-16 Neutralizing Antibodies
时间窗: Months 84, 108, and 132 after the first dose in the base study
The percentage of participants meeting the assay-defined seropositivity threshold for HPV-16 neutralizing antibodies and its exact two-sided 95% confidence interval are summarized separately for each prior-vaccination cohort.
Seropositivity Rate for HPV-18 Neutralizing Antibodies
时间窗: Months 84, 108, and 132 after the first dose in the base study
The percentage of participants meeting the assay-defined seropositivity threshold for HPV-18 neutralizing antibodies and its exact two-sided 95% confidence interval are summarized separately for each prior-vaccination cohort.
次要结局
- Geometric Mean Titer of HPV-16 Neutralizing Antibodies in Stored Serum Samples(Before the first dose on Day 0 and at Months 7, 12, 24, and 36 after the first dose in the base study)
- Geometric Mean Titer of HPV-18 Neutralizing Antibodies in Stored Serum Samples(Before the first dose on Day 0 and at Months 7, 12, 24, and 36 after the first dose in the base study)
- Seropositivity Rate for HPV-16 Neutralizing Antibodies in Stored Serum Samples(Before the first dose on Day 0 and at Months 7, 12, 24, and 36 after the first dose in the base study)
- Seropositivity Rate for HPV-18 Neutralizing Antibodies in Stored Serum Samples(Before the first dose on Day 0 and at Months 7, 12, 24, and 36 after the first dose in the base study)