A Phase III, placebo-controlled, observer-blind, randomised, multi-centre study to describe the immunogenicity and safety of GSK Biologicals’ Quadrivalent Split Virion Influenza Vaccine 2014/2015 Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) when co-administered with Merck & Co. Inc.’s 23-valent pneumococcal polysaccharide vaccine injected intramuscularly in adults 50 years of age and older at risk for complications from influenza and pneumococcal infections. - FLU D-QIV-010 PRI

GlaxoSmithKline Biologicals0 个研究点目标入组 357 人2015年6月26日

适应症The target population for this study is adults in stable health = 50 years of age at risk for complications of influenza and pneumococcal diseases.MedDRA version: 18.0Level: HLTClassification code 10022005Term: Influenza viral infectionsSystem Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Virus Diseases [C02]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: The target population for this study is adults in stable health = 50 years of age at risk for complications of influenza and pneumococcal diseases.
发起方: GlaxoSmithKline Biologicals
入组人数: 357
状态: 进行中（未招募）
最后更新: 4年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2015年6月26日

结束日期

2015年5月4日

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

GlaxoSmithKline Biologicals

入排标准

入选标准

•1\) Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow\-up visits).
•2\) A male or female aged 50 years or above at the time of the first vaccination at risk for complications from influenza and/or pneumococcal infections, meeting their respective countries’ recommendations for vaccination against influenza and pneumococcal disease.
•\- At risk subjects include adults with chronic respiratory, heart, kidney, liver or neurological disease; human immunodeficiency virus (HIV) disease on combination antiretroviral therapy (cART) with CD4 T\-cell counts greater than 350 cells/mm3; sickle cell disease or coeliac syndrome that may lead to splenic dysfunction (all other asplenics are excluded). The decision to enrol should be based on the investigators clinical judgement.
•3\) Written informed consent obtained from the subject.
•4\) Female subjects of non\-childbearing potential may be enrolled in the study.
•\- Non\-childbearing potential is defined as pre\-menarche, current tubal ligation, hysterectomy, ovariectomy or post\-menopause.
•5\) Female subjects of childbearing potential may be enrolled in the study, if the subject:
•\- has practiced adequate contraception for 30 days prior to vaccination, and
•\- has a negative pregnancy test on the day of vaccination, and
•\- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

排除标准

•1\) Use of any investigational or non\-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•2\) Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune\-modifying drugs within six months prior to the first vaccine dose. Inhaled, topical and low\-dose intra\-articular steroids are allowed.
•3\) Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose and 30 days after the last dose of vaccine.
•4\) Administration of such a vaccine has to be documented in the Concomitant vaccination of the eCRF.
•5\) Administration of long\-acting immune\-modifying drugs/treatment within six months prior to the first vaccine dose or expected administration at any time during the study period. These immunosuppressant drugs/treatment/Biologics include:
•\- Methotrexate
•\- Leflunomide
•\- Azathioprine and 6\-mercaptopurine
•\- Cyclosporin A
•\- Cyclophosphamide