A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: GSK3888550A RSV Maternal vaccine formulation 1; GSK3888550A RSV Maternal vaccine formulation 2; GSK3888550A RSV Maternal vaccine formulation 3; Placebo (Normal Saline)
Intervention description: Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm; Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm; Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm; Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Observer-blind In this study, the subject and study site personnel involved in the clinical evaluations of the subjects are blinded while other study personnel may be aware of the treatment assignments.
Enrollment: 502.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccines; Safety; Immunogenicity; Reactogenicity; Respiratory Syncytial Viruses

Summary:

      The purpose of this study is to evaluate different dose levels of the investigational RSV
      maternal vaccine (GSK3888550A) based on safety/reactogenicity and immune response data.

      As this is the first time the investigational RSV maternal vaccine (GSK3888550A) is being
      been used in humans, this study will be performed in healthy non-pregnant women 18-45 years
      of age before testing in pregnant women.
    

Eligibility criteria:

        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

        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
             investigational 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 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;

          -  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, based on
             medical history and physical examination;

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine;

          -  Any acute or chronic, clinically significant disease, as determined by physical
             examination, laboratory screening tests, subject personal report and/or health care
             provider information. The following conditions will be exclusionary:

               -  Diabetes mellitus,

               -  Respiratory diseases, such as:

                    -  Chronic Pulmonary diseases, including Chronic Obstructive Pulmonary Disease
                       (COPD),

                    -  Bronchopulmonary dysplasia (note: history of past bronchopulmonary dysplasia
                       as a neonate/infant will not be exclusionary),

                    -  Uncontrolled asthma or asthma necessitating treatment with chronic systemic
                       glucocorticoids

               -  Significant and/or uncontrolled psychiatric illness:

                    -  hospitalization for psychiatric illness, history of suicide attempt(s) or
                       confinement for danger to self or others within 10 years

                    -  clinically significant depression

               -  Major neurological disease including:

                    -  seizure or adulthood epilepsy (note: history of febrile convulsion in
                       childhood is not exclusionary)

                    -  myasthenia gravis

                    -  history of repetitive migraine mal/status migrainosus

               -  Significant cardiovascular disease, including:

                    -  Uncontrolled arterial hypertension,

                    -  Congenital heart disease (with the exception of corrected atrial or
                       ventricular septal defects),

                    -  Previous myocardial infarction,

                    -  Valvular heart disease or history of rheumatic fever,

                    -  Previous bacterial endocarditis,

                    -  History of cardiac surgery (with the exception of corrected atrial or
                       ventricular septal defects),

                    -  Personal 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 female;

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions;

          -  Hypersensitivity to latex;

          -  Lymphoproliferative disorder or malignancy within previous 5 years;

          -  Acute disease and/or fever at the time of enrolment;

               -  Fever is defined as temperature ≥ 38°C/100.4°F

               -  For subjects with acute disease and/or fever at the time of enrolment, Visit 1
                  will be rescheduled within the allowed window for the visit.

               -  Subjects with fever at screening may be re-screened 1 time at a later date.

               -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
                  infection) without fever may be enrolled at the discretion of the investigator.

          -  Any clinically significant or any ≥ Grade 2* haematological (haemoglobin level, white
             blood cell, lymphocyte, neutrophil, eosinophil, and platelets) and biochemical
             (alanine aminotransferase [ALT] aspartate aminotransferase [AST], creatinine, blood
             urea nitrogen [BUN]) laboratory abnormality detected at the last screening blood
             sampling; *Grading of laboratory parameters will be based on the FDA Guidance for
             Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled
             in Preventive Vaccine Clinical Trials".

        For Grade 1 laboratory abnormalities, the investigator should use clinical judgement to
        decide which ones are clinically relevant.

        Subjects with haematological/biochemical values out of normal range at screening which are
        expected to be temporary, may be re-screened 1 time at a later date.

          -  Any other condition that the investigator judges may interfere with study procedures
             or findings;

          -  Any medical condition that in the judgment of the investigator would make
             intramuscular injection unsafe;

          -  Alcoholism, drug abuse and/or use disorder within the past two years (as defined in
             Diagnostic and Statistical Manual of Mental Disorders [DSM-5] Diagnostic Criteria);

          -  Planned move to a location that will prohibit participating in the trial until study
             end.