A Phase IIA, open-label study to evaluate the immunogenicity and safety of sequential use of GSK's investigational vaccine GSK3277511A when administered to healthy smokers and ex-smokers aged 50 to 80 years following receipt of Shingrix vaccine - NTHI MCAT-009

GlaxoSmithKline Biologicals0 sites540 target enrollmentJanuary 30, 2019

Overview

No summary available.

Registry

who.int

Start Date

January 30, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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).
•Written informed consent obtained from the subject prior to performance of any study specific procedure.
•A male or female between, and including, 50 years and 80 years of age at the time of the first vaccination.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Current or former smoker with a cigarette smoking history \=10 pack\-years.
•Female subjects of non\-childbearing potential may be enrolled in the study. Non\-childbearing potential is defined as pre\-menarche, current bilateral tubal ligation or occlu\-sion, hysterectomy, bilateral ovariectomy or post\-menopause.
•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•Medical conditions
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•History of potential immune\-mediated disease (pIMD).
•Note: If the subject has any condition on the list of pIMDs specified in the protocol, they must be excluded unless the aetiology is clearly documented to be non\-immune mediated. The investigator will exercise his/her medical and scientific judgement in deciding whether other diseases have an autoimmune origin and thus meet the exclusion criteria.
•Diagnosis of COPD regardless of severity.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. Additionally, consider allergic reactions to other material or equipment related to study participation (such as materials that may possibly contain latex –gloves, syringes, etc).
•Has significant disease (including significant psychological disorders), in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration.
•History of or current condition preventing intramuscular injection as bleeding or coagulation disorder.
•Malignancies within previous 5 years (excluding non\-melanoma skin cancer) or lymphoproliferative disorders.
•Prior/concomitant therapy