PACTR202306838192573招募中2 期
A Phase 1/2a, observer-blind, randomized, controlled, two-stage, multi-country study to evaluate the safety, reactogenicity, and immune response of the trivalent vaccine against invasive nontyphoidal Salmonella (iNTS) and Typhoid Fever in healthy European and African adults
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 155
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Participants, who, in the opinion of the Investigator, can and will comply with the
- •requirements of the protocol (eg, completion of the pDiary cards, return for
- •follow-up visits).
- •Written or witnessed/thumb printed informed consent obtained from the participant
- •prior to performance of any study-specific procedure.
- •Healthy participants as established by medical history, clinical examination, and
- •laboratory assessment.
- •Participant satisfying screening requirements.
- •A male or female between and including 18 and 50 years of age at the time of the
- •first study intervention administration.
- •Female participants of nonchildbearing potential may be enrolled in the study.
- •Nonchildbearing potential is defined as pre-menarche, current bilateral tubal ligation
- •or occlusion, hysterectomy, bilateral ovariectomy, or post-menopause.
- •Female participants of childbearing potential may be enrolled in the trial if the
- •participant:
- •- Has practiced adequate contraception (as indicated in Appendix 4) for 1 month
- •prior to study intervention administration, and
- •- Has a negative pregnancy test on the day of study intervention administration,
- •- Has agreed to continue adequate contraception during the entire treatment period
- •and for 1 month after completion of the study intervention administration series.
- •Blood sample for simultaneous follicle-stimulating hormone (FSH) and estradiol
- •levels may be collected at the discretion of the Investigator to confirm
- •non-reproductive potential according to local laboratory reference range.
- •Genetic testing for HLA-B27 will be performed at Screening and only participants
- •with a negative result will be allowed to participate in the study*.
- •*Only for Stage 1
- •For Malawi (Stage 2), the participant lives in Blantyre and has agreed to remain in
- •Blantyre for the study duration.
排除标准
- •Known exposure to S. Typhi and NTS from 3 years pre 1st vaccination.
- •History of any reaction or hypersensitivity associated with any component of the
- •study interventions.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition,
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal
- •functional abnormality
- •Recurrent history or uncontrolled neurological disorders or seizures.
- •Any clinically significant* hematological and/or biochemical laboratory
- •abnormality.
- •Clinical conditions representing a contraindication to IM injections and/or blood
- •Any behavioral or cognitive impairment or psychiatric disease that
- •may interfere with the participant’s ability to participate in the study.
- •Confirmed positive COVID-19 from 28 days before the 1st dose
- •Acute or chronic illness which may be severe enough to preclude participation.
- •Any other clinical condition that, might pose additional risk to the participant due to participation in the study.
- •All medical conditions will be assessed by the Investigator who may use his/her
- •discretion to decide if the participant meets the exclusion criteria.
- •History of receiving any typhoid vaccine in the participant’s life.
- •History of receiving any investigational iNTS or GMMA vaccines in the
- •participant’s life.
- •Use of any investigational or non-registered product from
- •(D-30 to 1) before the 1st dose of study interventions, or planned use
- •during the study.
- •A vaccine not foreseen by the study protocol administered 14D pre 1st dose to 28D post last dose, with the exception of flu vaccines or COVID-19 vaccine.
- •Administration of long-acting immune-modifying drugs any time during the study
- •Administration of immunoglobulins and/or any blood products or plasma derivatives
- •From 3Mo before 1st admin or throughout the study.
- •Chronic admin of immunosuppressants or other immune-modifying drugs from 3 Mo before 1st dose.
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate safety, reactogenicity, and immune response of GVGH iNTS TCV vaccine against invasive nontyphoidal Salmonella and Typhoid FeverHealthy volunteers (prevention of invasive nontyphoidal Salmonella disease and typhoid fever)EUCTR2021-005178-25-BEGlaxoSmithKline Biologicals SA155
进行中（未招募）
不适用
A phase I/II, observer-blind, randomized, controlled study to assess the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1/AS04 vaccine administered intramuscularly according to a 0, 1, 6 month schedule in healthy male subjects aged 10-18 years. - HPV-011In female subjects from 10 years of age onwards for the prevention of cervical cancer by protecting against incident and persistent infections, cytological abnormalities including ASC-US, cervical intraepithelial neoplasia (CIN) and pre-cancerous lesions caused by oncogenic human papillomaviruses (HPV). In male subjects from 10 years of age onwards for the prevention of transmission of human papillomaviruses (HPV) causing persistent infections and related clinical outcomes.EUCTR2005-005943-24-FIGlaxoSmithKline Biologicals270
进行中（未招募）
1 期
Respiratory syncytial virus (RSV) investigational vaccine in infants aged 6 and 7 months likely to be unexposed to RSVEUCTR2018-000431-27-PLGlaxoSmithKline Biologicals176
进行中（未招募）
1 期
A study to evaluate safety and immunogenicity of GSK Biologicals' RSV investigational vaccine in RSV-seropositive infants aged 12 to 23 months.Active immunization of infants for the prevention of any lower respiratory tract infections (LRTIbronchiolitis and [broncho]pneumonia) associated with respiratory syncytial virus (RSV [subtypes A and B])MedDRA version: 21.1Level: LLTClassification code 10035692Term: Pneumonia due to respiratory syncytial virusSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.1Level: PTClassification code 10038718Term: Respiratory syncytial virus bronchiolitisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2016-000117-76-ITGLAXOSMITHKLINE BIOLOGICALS96
进行中（未招募）
1 期
Respiratory syncytial virus (RSV) investigational vaccine in infants aged 6 and 7 months likely to be unexposed to RSVActive immunization of infants for the prevention of any lower respiratory tract infections (LRTIbronchiolitis and [broncho] pneumonia) associated with respiratory syncytial virus (RSV).EUCTR2018-000431-27-GBGlaxoSmithKline Biologicals176