Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: RSV vaccine GSK3003891A; Boostrix
Intervention description: Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.; Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 102.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine; Safety; Reactogenicity; Respiratory syncytial virus (RSV)

Summary:

      The purpose of this study is to assess the safety and reactogenicity of a single
      intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant
      women aged 18 to 45 years.
    

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 performing any study
             specific procedure.

          -  Non-pregnant female between, and including, 18 and 45 years of age at the time of
             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 vaccination, and

               -  has a negative pregnancy test on the day of vaccination and

               -  has agreed to continue adequate contraception during the entire study period.

        Exclusion Criteria:

          -  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.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs, as well
             as administration of long-acting immune-modifying drugs during the period starting 6
             months prior to study vaccination, or planned administration during the study period.
             Inhaled and topical steroids are allowed.

          -  Administration of immunoglobulins and/or any blood products during the period starting
             3 months before study vaccination or planned administration during the study period.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             in the period starting 30 days before and ending 30 days after the 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.

          -  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 auto-immune disease.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality as determined by physical examination and/or Medical History.

          -  Lymphoproliferative disorder or malignancy within previous 5 years.

          -  History of hypersensitivity after a previous dose of any tetanus, diphtheria, or
             pertussis 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.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the study vaccines.

          -  Hypersensitivity to latex.

          -  Any medical condition that in the judgment of the investigator would make
             intramuscular injection unsafe.

          -  Current chronic alcohol consumption and/or drug abuse.

          -  Acute disease and/or fever at the time of enrolment.

          -  Body mass index (BMI) > 40 kg/m2.

          -  Pregnant or lactating female.

          -  Planned move to a location that will prohibit participating in the trial until study
             end.

          -  Any other condition that the investigator judges may interfere with study procedures.