GSK3389245A_LD GROUP

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.

Assessed solicited general symptoms were fatigue, fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\] gastrointestinal symptoms (gastro) \[nausea, vomiting, diarrhoea and/or abdominal pain\] and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

Haematological/Biochemical parameters assessed were haemoglobin level \[HgL\], red blood cells \[RBC\], white blood cell \[WBC\], lymphocyte \[LYM\], neutrophil \[NEU\], eosinophil \[EOS\], reticulocyte \[RET\], platelet count \[PLC\], haptoglobin \[Hpg\], prothrombin time \[PT\] and partial thromboplastin time \[PTT\]. alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine \[CRE\], lactate dehydrogenase \[LDH\] and bilirubin direct or total \[BLD/BLT\].Values were: unknown at baseline and below at Day 1 (U-B), unknown at baseline and within at Day 1 (U-W), unknown at baseline and above at Day 1 (U-A), below at baseline and below at Day 1 (B-B), below at baseline and within at Day 1 (B-W), below at baseline and above at Day 1(B-A), within at baseline and below at Day 1 (W-B), within at baseline and within at Day 1(W-W), within at baseline and above at Day 1(W-A), above at baseline and below at Day 1(A-B), above at baseline and within at Day 1 (A-W), above at baseline and above at Day 1(A-A)

Parameters analysed were ALT, activated partial thromboplastin time \[APTT\], AST, total bilirubin \[TB\], CRE, EOS, haemoglobin decrease \[HgD\], LYM, NEU, platelets \[PLA\], PT, white blood cells decrease \[WBCD\] and white blood cells increase \[WBCI\]. Assessed grades were: Unknown \[UG\], grade 0 \[G0\] = no grade, 1 \[G1\] = mild grade, 2 \[G2\] = moderate grade, 3 \[G3\] = severe grade, 4 \[G4\] = potentially life threatening and overall grading \[GTotal\]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 60, for the same parameter, e.g. ALT G0-G2.

An unsolicited AE covers 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 out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.