EUCTR2011-002193-23-IT进行中（未招募）不适用
ong term Immunogenicity of Quadrivalent Human Papillomavirus vaccine (Gardasil) in HIV-infected adolescents and young adults vs. healthy adolescents and young adults: non-randomized controlled clinical study.
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)0 个研究点目标入组 100 人开始时间: 2012年1月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •For both HIV-infected and healthy subjects:
- •Subjects aged 13-27 years
- •Females or males
- •Written informed consent from parent or guardian if applicable (age <18 years)
- •For HIV-infected subjects:
- •HIV-positive
- •Asymptomatic subjects (possible with only generalized lymphadenopathy).
- •Lymphocyte CD4+ count > 350 cell/mm3
- •For subjects receiving HAART:
- •-Goog compliance to therapy
- •-At least two suppressed viral loads HIV-RNA (<37cp/ml) during 6 months prior to enrollment in study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •For female subjects (both HIV-infected and healthy) :
- •Current (within 6 months prior to study entry) abnormal Pap test with confirmed biopsy results of cervical intraepithelial neoplasia CIN 2/3 caused by genotype HPV 16, 18 or cervical cancer within 180 days prior to study entry.
- •Pregnancy or breastfeeding
- •Total hysterectomy. Participants who have undergone partial hysterectomy and have a cervix are not excluded
- •For both females and males (HIV-infected and healthy):
- •Prior vaccination with quadrivalent HPV vaccine (Gardasil) before study entry.
- •History of severe allergic reaction after previous vaccination or hypersensytivity to any vaccine component
- •Any serious chronic or progressive disease (other than HIV) according to the judgment of the investigator:
- •-Acute infection requiring therapy or fever at time of enrollment
- •-Chronic autoimmune or oncologic disease receiving chemotherapy
- •-Tuberculosis
- •-Neurologic disease or history of convulsions
- •Concomitant therapies (other than HAART):
- •-Chronic therapy ( for more than 14 days consecutively) with immunosoppressive or immunomodulating agents or chemotherapy during the 6 months prior to study entry.
- •-Ongoing anti-tubercular therapy
- •-Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation prior to study entry
- •Severe anemia: hemoglobin less than 8.0 g/dL.
- •Acute or chronic impairment of pulmonary, cardiac, hepatic o renal function.
- •Use of investigational agents within 4 weeks prior to study enrollment.
- •Current drug or alcohol use or dependence
- •Documented history of non-adherence to antiretroviral treatment regimen within 12 months prior to study entry.
研究者
相似试验
进行中（未招募）
1 期
Immunogenicity and safety of a 9-valent human papillomavirus vaccine in HIV-positive womeew infection and lesions of papillomavirus in HIV-infected womenEUCTR2019-003486-17-ESCARMEN HIDALGO TENORIO173
进行中（未招募）
不适用
Comparison of vaccine effects of two different vaccines against Human Papillomavirus in HIV infected peopleEUCTR2011-001871-37-DKDepartment of Infectious Diseases - Aarhus University Hospital
尚未招募
4 期
An extension study of participants 60 years of age and older participated in a marketed quadrivalent influenza vaccine to check the long term immunityCTRI/2024/06/069627Dr Nithya Gogtay
进行中（未招募）
1 期
Efficacy of a vaccine with nine subgroups against human papilloma virus in HIV infected sexually active men who have sex with men.The purpose of the study is to investigate the efficacy of a new nonavalent HPV vaccine in sexually active HIV-infected MSM.MedDRA version: 18.1 Level: LLT Classification code 10063001 Term: Human papilloma virus infection System Organ Class: 100000004862MedDRA version: 18.1 Level: LLT Classification code 10071147 Term: Human papilloma virus immunization System Organ Class: 100000004865EUCTR2015-004524-65-DKDepartment of Infectious Diseases80
进行中（未招募）
1 期
Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or Concomitantly with Two Other Vaccines in Healthy AdolescentsMeningococcal infectionMedDRA version: 20.0Level: PTClassification code 10027274Term: Meningococcal infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2020-001665-37-ITSANOFI PASTEUR464