A Long Term Follow-up Study up to 4 Years After Study Vaccination to Assess Immunogenicity and Safety of the Investigational Vaccine in Adults
Condition: Respiratory Disorders
MeSH terms: Respiration Disorders; Respiratory Tract Diseases
Intervention: Blood sampling; GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, PE-PilA and UspA2.; GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2.; Placebo
Intervention description: A volume of approximately 20 mL of whole blood should be drawn from each subject, at each study visit, for antibody determination and assay validation/development.; 2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; 2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; 2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 51 Years
Maximum age: 73 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Immunogenicity

Summary:

      The purpose of this long-term follow-up of a Phase I study is to evaluate the kinetics of the
      antibody response to NTHi-Mcat antigens and long-term safety, in subjects aged between 50-71
      years at the time of enrolment in the NTHi-Mcat-001 study. These subjects were previously
      exposed to two adjuvanted formulations of the NTHi-Mcat vaccine administered according to a
      0, 2 months schedule in the NTHi-Mcat-001 (201281) study. The subjects that had received
      saline placebo controls will also be included in this follow-up study to make comparisons
      with the investigational vaccines. No vaccinations will be administered in this trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who previously participated in STEP 2 of study NTHi-Mcat-001 (201281), and
             performed the last study visit (Month 14) and received the 2 study vaccinations.

          -  Subjects who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol (e.g. return for follow-up visits). And subjects' Legally
             Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and
             will comply, with the requirements of the protocol.

          -  Written informed consent obtained from the subject/ LAR(s) of the subject prior to
             performance of any study specific procedure.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) during the
             period starting 30 days before the first follow-up study visit (Month 19 to Month 20),
             or planned use during the study period.

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs since the end of the NTHi-Mcat-001 study. For
             corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and
             topical steroids are allowed.

          -  Administration of long-acting immune-modifying drugs at any time during the study
             period (e.g. infliximab).

          -  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 (pharmaceutical product or device).

          -  Administration of immunoglobulins and/or any blood products during the period starting
             3 months before the first follow-up visit or planned administration during the study
             period.

          -  Current alcoholism and/or drug abuse.

          -  Has significant disease (including significant neurological or psychological
             disorders), in the opinion of the investigator, likely to interfere with the study
             and/or likely to cause death within the study duration.

          -  Any other condition that the investigator judges may interfere with study findings.