Formulation 1: NTHi/Mcat vaccine GSK3277513A

Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\].

Assessed unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Assessed unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.

Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.

Assessed SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.