Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Td Vaccines in Healthy Population Aged 9-15 Years Old in Indonesia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- PT Bio Farma
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Number and percentage of subjects seroconverted for anti-HPV types 6, 11, 16, and 18
研究概览
简要总结
This study will evaluate the safety and immune response of a single dose of a quadrivalent human papillomavirus (HPV) vaccine when given together with a tetanus-diphtheria (Td) vaccine in healthy children and adolescents aged 9 to 15 years. The study will compare participants who receive the HPV vaccine together with the Td vaccine with those who receive the HPV vaccine alone. The study will assess whether giving the two vaccines together produces an immune response to HPV that is not lower than giving the HPV vaccine alone.
详细描述
This study is a randomized, open-label, two-arm, parallel-group, prospective interventional Phase III trial designed to evaluate the immunogenicity and safety of a quadrivalent human papillomavirus (HPV) vaccine when administered concomitantly with a tetanus-diphtheria (Td) vaccine in healthy children and adolescents aged 9 to 15 years.
Participants will be assigned to receive the quadrivalent HPV vaccine together with the Td vaccine or the quadrivalent HPV vaccine alone. The study will assess antibody responses to the HPV vaccine antigens. Safety will be evaluated throughout the study by monitoring solicited and unsolicited adverse events, serious adverse events, and other clinically relevant safety findings.
The study is intended to provide clinical evidence on the concomitant administration of the quadrivalent HPV vaccine with Td vaccine in the target pediatric population.
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
- None
入排标准
- 年龄范围
- 9 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 9-15 years;
- •Subject/parent or LAR appropriately informed and consent/assent signed;
- •Willing to comply with investigator instructions and study schedule.
排除标准
- •Concurrent/other trial;
- •Evolving illness/fever ≥37.5°C;
- •Allergy to vaccine components;
- •Uncontrolled coagulopathy/blood disorder contraindicating IM injection;
- •Recent treatment likely to alter immune response;
- •Pregnancy/breastfeeding;
- •7. Abnormality/chronic disease interfering with objectives;
- •History of HPV/diphtheria/tetanus infection;
- •Previous HPV vaccination.
研究组 & 干预措施
4vHPV + Td vaccine
Participants receive a single dose of quadrivalent HPV vaccine co-administered with Td vaccine.
干预措施: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine (Biological)
4vHPV + Td vaccine
Participants receive a single dose of quadrivalent HPV vaccine co-administered with Td vaccine.
干预措施: Tetanus-Diphtheria booster (Biological)
4vHPV alone
Participants receive a single dose of quadrivalent HPV vaccine alone.
干预措施: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine (Biological)
结局指标
主要结局
Number and percentage of subjects seroconverted for anti-HPV types 6, 11, 16, and 18
时间窗: 28 days after vaccination
Number and percentage of subjects who seroconvert for anti-HPV types 6, 11, 16, and 18. Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined lower limit of quantification (LLOQ) in the serum of subjects who are seronegative before vaccination, as measured by enzyme-linked immunosorbent assay (ELISA). The seroconversion rate in the group receiving 4vHPV vaccine co-administered with Td vaccine will be compared with that in the group receiving 4vHPV vaccine alone to evaluate non-inferiority.
次要结局
未报告次要终点