A study to evaluate different dose levels of GlaxoSmithKline (GSK) Biologicals’ investigational Respiratory Syncytial Virus (RSV) vaccine (GSK3888550A), based on the safety of the vaccine and the antibodies (body defences) that the body produces following the vaccine administration, when given to healthy non-pregnant wome

Phase 1

Conditions: Healthy volunteers (Prevention of RSV LRTI in infants)
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
MedDRA version: 20.1Level: LLTClassification code 10035692Term: Pneumonia due to respiratory syncytial virusSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.1Level: PTClassification code 10038718Term: Respiratory syncytial virus bronchiolitisSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.1Level: LLTClassification code 10066741Term: Respiratory syncytial virus infection recurrentSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.1Level: LLTClassification code 10052200Term: Respiratory syncytial virus infection NOSSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.1Level: LLTClassification code 10067384Term: Respiratory syncytial virus pneumonitisSystem Organ Class: 10021881 - Infections and infestations

Registration Number: EUCTR2018-001340-62-DE

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 500

Inclusion Criteria

Subjects who the investigator believes will comply with the requirements of the protocol (e.g. completion of the diary cards/questionnaires, return for follow-up visits, have regular contact to allow evaluation during the study);
•Written informed consent obtained from the subject;
•Healthy female subjects; as established by medical history and clinical examination, aged 18 to 45 years at the time of the vaccination;
•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 until 90 days after 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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Use of any investigational or non-registered product other than the study vaccine within 30 days preceding vaccination or any 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 in-vestigational or a non-investigational vaccine/product
•Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune-modifying drugs, as well as administration of long acting immune modifying drugs, within 6 months prior to the vaccine dose (for corticosteroids, this will mean prednisone higher than or equal to (=) 5 milligrams per day (mg/day), or equivalent). Inhaled and topical steroids are allowed;
•Administration or planned administration of immunoglobulins and/or any blood products during the period starting 3 months before or 3 months after
•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;
•Presence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports;
•Family history of congenital or hereditary immunodeficiency;
•Any confirmed or suspected immunosuppressive or immunodeficient condition;
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
•Any acute or chronic, clinically significant disease
The following conditions will be exclusionary:
?Diabetes mellitus,
?Respiratory diseases, such as:
oChronic Pulmonary diseases, including Chronic Obstructive Pulmonary Disease (COPD),
oBronchopulmonary dysplasia (note: history of past bronchopulmonary dysplasia as a neonate/infant will not be exclusionary),
oUncontrolled asthma or asthma necessitating treatment with chronic systemic glucocorticoids
?Significant and/or uncontrolled psychiatric illness:
ohospitalization for psychiatric illness, history of suicide attempt(s) or confinement for danger to self or others within 10 years
oclinically significant depression
?Major neurological disease including:
oseizure or adulthood epilepsy
omyasthenia gravis
ohistory of repetitive migraine mal/status mi-grainosus
?Significant cardiovascular disease, including:
oUncontrolled arterial hypertension,
oCongenital heart disease (with the exception of corrected atrial or ventricular septal defects),
oPrevious myocardial infarction,
oValvular heart disease or history of rheumatic fever,
oPrevious bacterial endocarditis,
oHistory of cardiac surgery (with the exception of corrected atrial or ventricular septal defects),
oPersonal or family history of cardiomyopathy or sudden adult death.
?Known or suspected Hepatitis B or Hepatitis C infection,
?Any other significant uncontrolled medical illness, defined as any illness requiring new medical and/or surgical treatment or significant modification of treatment dose due to uncontrolled symptoms or drug toxicity, within 3 months prior to study vaccination.
•History of or current autoimmune disease;
•Body mass index (BMI) > 40 Kilograms (kg)/square meters(m^2);
•Pregnant or lactating femal

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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