A Phase II, randomised, observer-blind, controlled, multi-country study to rank different formulations of GSK Biologicals’ investigational RSV vaccine (GSK3003891A), based on immunogenicity, reactogenicity and safety, when administered to healthy women, aged 18 - 45 years - RSV F-021

GlaxoSmithKline Biologicals0 sites400 target enrollmentSeptember 23, 2016

ConditionsRespiratory Syncytial Virus MedDRA version: 19.0Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Respiratory Syncytial Virus
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 400
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 23, 2016

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility Criteria

Inclusion Criteria

•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 performance of 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
•?\- Non\-childbearing potential is defined as pre\-menarche, hysterectomy, 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 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 after vaccination

Exclusion Criteria

•Use of any investigational or non\-registered product other than the study vaccines within 30 days prior to study vaccination, or planned use during the study period.
•Concurrently participating in the active phase of 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.
•Chronic administration of immunosuppressants or other immune\-modifying drugs, as well as administration of long\-acting immune\-modifying drugs, within 6 months prior to study vaccination, or planned administration until 90 days post\-vaccination. For corticosteroids, this will mean prednisone \= 10 mg/day, or equivalent. Inhaled and topical steroids are allowed.
•Administration of immunoglobulins and/or any blood products during the period starting 3 months before the study vaccination, or planned administration until 90 days post\-vaccination.
•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 neurological disorders or seizures.
•Family history of congenital or hereditary immunodeficiency.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
•History of or current autoimmune disease