A Phase II, randomised, observer-blind, controlled, multi-country study to assess the safety, reactogenicity and immunogenicity of a single intramuscular dose of different formulations of GlaxoSmithKline (GSK) Biologicals’ investigational RSV vaccine (GSK3003891A), in healthy women aged 18 to 45 years - 201510,RSVF-020

GlaxoSmithKline Biologicals0 sites500 target enrollmentNovember 27, 2014

Overview

No summary available.

Registry

who.int

Start Date

November 27, 2014

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•\-Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
•\-Written informed consent obtained from the subject prior to performing any study specific procedure.
•\-Non\-pregnant female between, and including, 18 and 45 years of age at the time of study vaccination.
•\-Healthy subjects as established by medical history and clinical examination before entering into the study.
•\-Female subjects of non\-childbearing potential may be enrolled in the study.
•\-Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to study vaccination, and has a negative pregnancy test on the day of study vaccination, and has agreed to continue adequate contraception up to 90 days post\-vaccination
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 500

•\-Use of any investigational or non\-registered product other than the study vaccine within 30 days prior to study vaccination, or planned use during the study period.
•\-Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non\-investigational vaccine/ product.
•\-Any medical condition that in the judgment of the investi\-gator would make intramuscular injection unsafe.
•\-Planned administration/ administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study vaccination, with the exception of any licensed influenza vaccine which may be administered \= 15 days before or after study vaccination.
•\-Previous experimental vaccination against RSV.
•\-History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
•\-History of severe allergic reaction after a previous dose of any tetanus toxoid, diphtheria toxoid, or pertussis antigen\-containing vaccine or to any component of Boostrix.
•\-History of encephalopathy of unknown aetiology occurring within 7 days following a previous vaccination with pertussis\-containing vaccine.
•\-History of any neurological disorders or seizures
•\-History of transient thrombocytopenia or neurological complications following a previous vaccination against diphtheria and/ or tetanus.