A Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' RSV Investigational Vaccine (ChAd155-RSV) (GSK3389245A) in Healthy Adults
Condition: Respiratory Synctial Virus Infections
MeSH terms: Virus Diseases
Intervention: GSK3389245A_LD GROUP; GSK3389245A_HD GROUP; Bexsero; Placebo
Intervention description: 2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm; 2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm; 2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm; 2 doses administered intramuscularly at Day 0 and Day 30 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, Care Provider, Outcomes Assessor)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Reactogenicity; Safety; Respiratory syncytial virus (RSV); Vaccine; Immunogenicity

Summary:

      The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity
      and immunogenicity of 2 doses of the RSV investigational vaccine, when administered
      intramuscularly according to a 0, 1 month schedule, in healthy adults 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

          -  A male or female between, and including, 18 and 45 years of age at the time of first
             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 vaccina-tion, and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for 2 months after completion of the vaccination series

        Exclusion Criteria:

          -  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

          -  Use of any investigational or non-registered product other than the study vaccines
             during the period starting 30 days before the first dose of study vaccines, or planned
             use during the study period

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within 6
             months prior to 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 the first dose and ending 30 days after the last
             dose of vaccine administration, with the exception of any licensed influenza vaccine
             which may be administered ≥ 15 days before the first dose and ≥ 15 days after the last
             dose of study vaccine

          -  Administration of immunoglobulins and/or any blood products during the period starting
             3 months before the first dose of study vaccines or planned administration during the
             study period

          -  Blood donation within 4 months prior to study entry or planned blood donation at any
             time during the study

          -  Previous vaccination against RSV

          -  Previous vaccination with a recombinant simian or human adenoviral vaccine

          -  Previous Bexsero or other vaccination against Neisseria meningitidis serogroup B

          -  History of or current autoimmune disease

          -  Family history of congenital or hereditary immunodefi-ciency

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the study vaccines.

          -  History of any neurological disorders or seizures

          -  History of transient thrombocytopenia or neurological complications following any
             prior vaccination

          -  Hypersensitivity to latex

          -  Hypersensitivity to Bexsero's active substances or to any of its excipients

          -  Allergic reaction to kanamycin

          -  Any medical condition that in the judgment of the investi-gator would make
             intramuscular injection unsafe

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination

          -  Acute disease and/or fever at the time of enrolment

          -  Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal
             functional abnormality, as de-termined by physical examination or laboratory screening
             tests

          -  Malignancy within previous 5 years or lymphoproliferative disorders

          -  Any clinically significant or any ≥ Grade 2 haematological laboratory abnormality

          -  Body mass index > 40 kg/m2

          -  Current alcohol and/or drug abuse

          -  Pregnant or lactating female

          -  Any other condition that the investigator judges may interfere with study procedures
             or findings

          -  Planned move to a location that will prohibit participating in the trial until study
             end