Immunogenicity and Safety of HPV-4 Vaccine With or Without Td Vaccine in Children
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
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Rini Mulia Sari, MD
- 电话号码：14102 +622033755
- 邮箱：rini.mulia@biofarma.co.id
研究联系人备份
- 姓名：Mita Puspita, MD
- 电话号码：5045 +622033755
- 邮箱：mita.puspita@biofarma.co.id
学习地点
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East Java
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Surabaya、East Java、印度尼西亚
- RSUD Dr. Soetomo
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
- Age 9-15 years;
- Healthy;
- Subject/parent or LAR appropriately informed and consent/assent signed;
- Willing to comply with investigator instructions and study schedule.
Exclusion Criteria:
- 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; 6. Pregnancy/breastfeeding;
7. Abnormality/chronic disease interfering with objectives; 8. History of HPV/diphtheria/tetanus infection; 9. Previous HPV vaccination.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：4vHPV + Td vaccine
Participants receive a single dose of quadrivalent HPV vaccine co-administered with Td vaccine.
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A single 0.5 mL dose of quadrivalent recombinant human papillomavirus (HPV) vaccine targeting HPV types 6, 11, 16, and 18, administered by intramuscular injection.
A single 0.5 mL dose of Adsorbed Td (Tetanus-Diphtheria Toxoid) Vaccine Bio Farma containing purified tetanus toxoid and purified diphtheria toxoid.
其他名称：
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有源比较器：4vHPV alone
Participants receive a single dose of quadrivalent HPV vaccine alone.
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A single 0.5 mL dose of quadrivalent recombinant human papillomavirus (HPV) vaccine targeting HPV types 6, 11, 16, and 18, administered by intramuscular injection.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number and percentage of subjects seroconverted for anti-HPV types 6, 11, 16, and 18
大体时间：28 days after vaccination
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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.
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28 days after vaccination
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合作者和调查者
赞助
调查人员
- 首席研究员：Dominicus Husada, Professor、Dr. Soetomo General Hospital
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.