EUCTR2022-003339-24-Outside-EU/EEA进行中（未招募）1 期
A Phase 3, Open-Label, Randomized Trial to Investigate the Immunogenicity and Safety of the Co-administration of a Subcutaneous Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) and an Intramuscular Recombinant 9-Valent Human Papillomavirus (9vHPV) Vaccine in Subjects Aged =9 to <15 Years in an Endemic Country for Dengue
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Participants who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and the clinical judgment of the investigator.
- •2. Participants who can comply with trial procedures and are available for the duration of follow-up.
- •3. The participant is aged =9 to <15 years.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 618
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Has an elevated oral temperature =38°C (=100.4°F) within 3 days of the intended date of vaccination.
- •2. Participants with contraindications, warnings and/or precautions to vaccination with Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) vaccine as specified within the prescribing information.
- •3. Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease.
- •4. Known or suspected impairment/alteration of immune function, including:
- •-Chronic use of oral steroids (equivalent to 20 mg/day prednisone =12 weeks/=2 mg/kg body weight/day prednisone =2 weeks) within 60 days prior to Day 1 (Month 0) (use of inhaled, intranasal, or topical corticosteroids is allowed).
- •-Receipt of parenteral steroids (equivalent to 20 mg/day prednisone =12 weeks/=2 mg/kg body weight/day prednisone =2 weeks) within 60 days prior to Day 1 (Month 0).
- •-Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (Month 0) or planned administration during the trial.
- •-Receipt of immunostimulants within 60 days prior to Day 1 (Month 0).
- •-Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (Month 0).
- •-Human immunodeficiency virus (HIV) infection or HIV-related disease.
- •-Hepatitis B virus infection.
- •-Hepatitis C virus infection.
- •-Genetic immunodeficiency.
- •5. Abnormalities of splenic or thymic function.
- •6. Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- •7. Who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of trial vaccine administration.
- •8. Who have used antipyretics and/or analgesic medications within 24 hours prior to vaccination. The reason for their use (prophylaxis versus treatment) must be documented. Trial entry should be delayed to allow for a full 24 hours to have passed since last use of antipyretics and/or analgesic medications.
- •9. Previous and planned vaccination (during the trial conduct), against any flavivirus (except Japanese encephalitis [JE]) including dengue, yellow fever (YF) viruses or tick-borne encephalitis.
- •10. Previous and planned vaccination (during the trial conduct) against HPV.
- •11. Previous participation in any clinical trial of a dengue or other flavivirus (eg, West e [WN] virus) candidate vaccine, except for participants who received placebo in those trials.
- •12. Has a current or previous infection with a flavivirus such as Zika, YF, JE, WN fever, tick-borne encephalitis or Murray Valley encephalitis.
- •13. Pregnant or breastfeeding
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