Trial Outcomes & Findings for A Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' RSV Investigational Vaccine (ChAd155-RSV) (GSK3389245A) in Healthy Adults (NCT NCT02491463)
NCT ID: NCT02491463
Last Updated: 2018-08-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
73 participants
Primary outcome timeframe
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Results posted on
2018-08-20
Participant Flow
Out of 73 subjects originally enrolled in this study, only 72 subjects received the study vaccination and were hence included in the Total Vaccinated Cohort.
Participant milestones
| Measure |
Bexsero Group
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_LD Group
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
7
|
31
|
19
|
|
Overall Study
COMPLETED
|
14
|
5
|
21
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
10
|
4
|
Reasons for withdrawal
| Measure |
Bexsero Group
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_LD Group
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
0
|
|
Overall Study
Migrated/moved from study area
|
1
|
1
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
3
|
Baseline Characteristics
A Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' RSV Investigational Vaccine (ChAd155-RSV) (GSK3389245A) in Healthy Adults
Baseline characteristics by cohort
| Measure |
GSK3389245A_LD Group
n=7 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=31 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.9 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
30.6 Years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
31.3 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
29.5 Years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
30.8 Years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - Central/South Asian Heritage
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - East Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - Japanese Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - South East Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Caucasian / European Heritage
|
7 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented, who had filled in their symptom sheets.
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.
Outcome measures
| Measure |
GSK3389245A_LD Group
n=7 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=30 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Pain Dose 2
|
2 Participants
|
19 Participants
|
0 Participants
|
15 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain Dose 2
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Pain Across doses
|
4 Participants
|
27 Participants
|
1 Participants
|
15 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain Across doses
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Pain Dose 1
|
2 Participants
|
23 Participants
|
1 Participants
|
15 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented, who had filled in their symptom sheets.
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.
Outcome measures
| Measure |
GSK3389245A_LD Group
n=7 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=30 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue Across doses
|
4 Participants
|
19 Participants
|
9 Participants
|
11 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue Dose 1
|
3 Participants
|
19 Participants
|
8 Participants
|
8 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache Dose 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fever Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Fever Dose 2
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Headache Across doses
|
5 Participants
|
16 Participants
|
10 Participants
|
12 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue Dose 1
|
3 Participants
|
19 Participants
|
8 Participants
|
8 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Gastro Dose 1
|
2 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Gastro Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Gastro Dose 1
|
2 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Headache Dose 1
|
5 Participants
|
14 Participants
|
8 Participants
|
10 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Headache Dose 1
|
5 Participants
|
14 Participants
|
8 Participants
|
10 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Fever Dose 1
|
0 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Fever Dose 1
|
0 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue Dose 2
|
1 Participants
|
10 Participants
|
6 Participants
|
9 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue Dose 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue Dose 2
|
1 Participants
|
10 Participants
|
6 Participants
|
9 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Gastro Dose 2
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Gastro Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Gastro Dose 2
|
1 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Headache Dose 2
|
1 Participants
|
6 Participants
|
5 Participants
|
9 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Headache Dose 2
|
1 Participants
|
6 Participants
|
5 Participants
|
9 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fever Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Fever Dose 2
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue Across doses
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue Across doses
|
4 Participants
|
19 Participants
|
9 Participants
|
11 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Gastro Across doses
|
3 Participants
|
7 Participants
|
9 Participants
|
4 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Gastro Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Gastro Across doses
|
2 Participants
|
7 Participants
|
9 Participants
|
4 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Headache Across doses
|
5 Participants
|
16 Participants
|
10 Participants
|
12 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Fever Across doses
|
0 Participants
|
8 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fever Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Fever Across doses
|
0 Participants
|
8 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 1.
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)
Outcome measures
| Measure |
GSK3389245A_LD Group
n=7 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=31 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-B
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-W
|
7 Participants
|
24 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, B-W
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, W-B
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, A-W
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-W
|
1 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-A
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-B
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-W
|
7 Participants
|
21 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-A
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-W
|
7 Participants
|
26 Participants
|
19 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-A
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-W
|
7 Participants
|
27 Participants
|
19 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-A
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-W
|
6 Participants
|
29 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-W
|
7 Participants
|
29 Participants
|
18 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-W
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-B
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-W
|
7 Participants
|
27 Participants
|
13 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-W
|
5 Participants
|
22 Participants
|
13 Participants
|
9 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-A
|
1 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-W
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-A
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-W
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-A
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-W
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-A
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-B
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-W
|
6 Participants
|
27 Participants
|
18 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-A
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-B
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-W
|
6 Participants
|
24 Participants
|
11 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-A
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-W
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-A
|
0 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, B-B
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-B
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, W-W
|
6 Participants
|
27 Participants
|
17 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-W
|
7 Participants
|
31 Participants
|
16 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, B-B
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, W-W
|
6 Participants
|
28 Participants
|
18 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-W
|
5 Participants
|
22 Participants
|
16 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-W
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-W
|
6 Participants
|
29 Participants
|
18 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-B
|
0 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-W
|
7 Participants
|
31 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-W
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-B
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-W
|
6 Participants
|
30 Participants
|
17 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-A
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 3Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 3.
Haematological/ Biochemical parameters assessed were haemoglobin level \[HgL\], red blood cell \[RBC\], 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 3 (U-B), unknown at baseline and within at Day 3 (U-W), unknown at baseline and above at Day 3 (U-A), below at baseline and below at Day 3 (B-B), below at baseline and within at Day 3 (B-W), below at baseline and above at Day 3(B-A), within at baseline and below at Day 3 (W-B), within at baseline and within at Day 3(W-W), within at baseline and above at Day 3(W-A), above at baseline and below at Day 3(A-B), above at baseline and within at Day 3(A-W), above at baseline and above at Day 3(A-A).
Outcome measures
| Measure |
GSK3389245A_LD Group
n=7 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=30 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-W
|
7 Participants
|
29 Participants
|
18 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-W
|
7 Participants
|
26 Participants
|
13 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-W
|
6 Participants
|
27 Participants
|
15 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-W
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-A
|
0 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-B
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-W
|
7 Participants
|
23 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-W
|
6 Participants
|
28 Participants
|
18 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-A
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-B
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-W
|
5 Participants
|
24 Participants
|
10 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-A
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-W
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-W
|
7 Participants
|
27 Participants
|
19 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-W
|
7 Participants
|
30 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-W
|
7 Participants
|
28 Participants
|
17 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-B
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-W
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-B
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-W
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-B
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-W
|
6 Participants
|
29 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-W
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-W
|
0 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-A
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-B
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-W
|
4 Participants
|
24 Participants
|
16 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-B
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-W
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-W
|
4 Participants
|
20 Participants
|
13 Participants
|
10 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-A
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-W
|
2 Participants
|
8 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-B
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-W
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-B
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-W
|
6 Participants
|
29 Participants
|
17 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-B
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-A
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-W
|
5 Participants
|
26 Participants
|
15 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-W
|
7 Participants
|
27 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-B
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-W
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-B
|
1 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-W
|
5 Participants
|
25 Participants
|
16 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-W
|
7 Participants
|
29 Participants
|
17 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-A
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was performed on the Total Vaccinated cohort which which included all subjects with at least one study vaccine administration documented and with available results at Day 7.
Haematological/ Biochemical parameters assessed were haemoglobin level \[HgL\], red blood cell \[RBC\], 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 7 (U-B), unknown at baseline and within at Day 7 (U-W), unknown at baseline and above at Day 7 (U-A), below at baseline and below at Day 7 (B-B), below at baseline and within at Day 7 (B-W), below at baseline and above at Day 7(B-A), within at baseline and below at Day 7 (W-B), within at baseline and within at Day 7(W-W), within at baseline and above at Day 7(W-A), above at baseline and below at Day 7(A-B), above at baseline and within at Day 7(A-W), above at baseline and above at Day 7(A-A).
Outcome measures
| Measure |
GSK3389245A_LD Group
n=7 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=30 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-B
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-B
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-W
|
6 Participants
|
28 Participants
|
18 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-A
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-W
|
5 Participants
|
25 Participants
|
17 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-A
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-B
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-W
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-W
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-A
|
0 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-W
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-B
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-W
|
7 Participants
|
26 Participants
|
17 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-W
|
7 Participants
|
29 Participants
|
17 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-W
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-W
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-W
|
7 Participants
|
27 Participants
|
14 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-W
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-W
|
4 Participants
|
15 Participants
|
12 Participants
|
10 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-A
|
1 Participants
|
7 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-W
|
5 Participants
|
25 Participants
|
15 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-A
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-W
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-A
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-B
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-B
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-W
|
7 Participants
|
23 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-W
|
6 Participants
|
29 Participants
|
18 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-A
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-B
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-W
|
5 Participants
|
26 Participants
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-A
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-W
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-A
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-B
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-W
|
6 Participants
|
29 Participants
|
17 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-B
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-W
|
7 Participants
|
27 Participants
|
16 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-W
|
0 Participants
|
28 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-B
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-B
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-W
|
6 Participants
|
27 Participants
|
15 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-W
|
7 Participants
|
30 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-W
|
7 Participants
|
28 Participants
|
17 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-A
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-W
|
7 Participants
|
29 Participants
|
17 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 30Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 30.
Haematological/Biochemical parameters assessed were haemoglobin level \[HgL\], red blood cell \[RBC\], 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 30(U-B), unknown at baseline and within at Day30(U-W), unknown at baseline and above at Day 30(U-A), below at baseline and below at Day30(B-B), below at baseline and within at Day30(B-W), below at baseline and above at Day 30(B-A), within at baseline and below at Day 30 (W-B), within at baseline and within at Day 30(W-W), within at baseline and above at Day30(W-A), above at baseline and below at Day30(A-B), above at baseline and within at Day30(A-W), above at baseline and above at Day30(A-A).
Outcome measures
| Measure |
GSK3389245A_LD Group
n=7 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=27 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-A
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-B
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-W
|
6 Participants
|
21 Participants
|
15 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-B
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-W
|
7 Participants
|
24 Participants
|
16 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-W
|
5 Participants
|
17 Participants
|
16 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-A
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-W
|
2 Participants
|
7 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-A
|
0 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-B
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-W
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-W
|
6 Participants
|
26 Participants
|
18 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-W
|
7 Participants
|
27 Participants
|
18 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-W
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-B
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-B
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-W
|
7 Participants
|
25 Participants
|
13 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-W
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-B
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-W
|
6 Participants
|
27 Participants
|
18 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-W
|
4 Participants
|
24 Participants
|
16 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-A
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-W
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-W
|
7 Participants
|
26 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-W
|
7 Participants
|
21 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-B
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-W
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-B
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-W
|
5 Participants
|
26 Participants
|
17 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-A
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-W
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-W
|
7 Participants
|
26 Participants
|
17 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-W
|
6 Participants
|
27 Participants
|
19 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-W
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-B
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-W
|
5 Participants
|
20 Participants
|
10 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-A
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-W
|
0 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-A
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-B
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-W
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-W
|
7 Participants
|
25 Participants
|
19 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-W
|
7 Participants
|
26 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-W
|
7 Participants
|
26 Participants
|
18 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 31Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 31.
Haematological/Biochemical parameters assessed were haemoglobin level \[HgL\], red blood cell \[RBC\], 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 31(U-B), unknown at baseline and within at Day31(U-W), unknown at baseline and above at Day 31(U-A), below at baseline and below at Day31(B-B), below at baseline and within at Day31(B-W), below at baseline and above at Day 31(B-A), within at baseline and below at Day 31(W-B), within at baseline and within at Day 31(W-W), within at baseline and above at Day31(W-A), above at baseline and below at Day31(A-B), above at baseline and within at Day31(A-W), above at baseline and above at Day31(A-A).
Outcome measures
| Measure |
GSK3389245A_LD Group
n=7 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=29 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-W
|
7 Participants
|
25 Participants
|
19 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-W
|
7 Participants
|
26 Participants
|
18 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-W
|
5 Participants
|
17 Participants
|
16 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-A
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-W
|
2 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-W
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-B
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-W
|
6 Participants
|
25 Participants
|
18 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-B
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-W
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-W
|
6 Participants
|
27 Participants
|
19 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-B
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-W
|
7 Participants
|
26 Participants
|
15 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-W
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-W
|
5 Participants
|
24 Participants
|
16 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-A
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-B
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-W
|
7 Participants
|
24 Participants
|
16 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-A
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-W
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-W
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-B
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-W
|
6 Participants
|
26 Participants
|
17 Participants
|
7 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-W
|
7 Participants
|
29 Participants
|
15 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-A
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-W
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-A
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-W
|
7 Participants
|
22 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-W
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-W
|
7 Participants
|
27 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-B
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-W
|
6 Participants
|
28 Participants
|
18 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-W
|
7 Participants
|
28 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-A
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-B
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-W
|
5 Participants
|
25 Participants
|
9 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-A
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-W
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-A
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-B
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-B
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-W
|
6 Participants
|
24 Participants
|
15 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-B
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-W
|
5 Participants
|
24 Participants
|
16 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 33Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 33.
Haematological/Biochemical parameters assessed were haemoglobin level \[HgL\], red blood cell \[RBC\], 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 33(U-B), unknown at baseline and within at Day33(U-W), unknown at baseline and above at Day 33(U-A), below at baseline and below at Day33(B-B), below at baseline and within at Day33(B-W), below at baseline and above at Day 33 (B-A), within at baseline and below at Day 33(W-B), within at baseline and within at Day 33(W-W), within at baseline and above at Day33(W-A), above at baseline and below at Day33(A-B), above at baseline and within at Day33(A-W), above at baseline and above at Day33(A-A).
Outcome measures
| Measure |
GSK3389245A_LD Group
n=7 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=28 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-W
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-A
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-W
|
1 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-W
|
6 Participants
|
26 Participants
|
18 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-A
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-W
|
7 Participants
|
27 Participants
|
18 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-W
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-W
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-W
|
7 Participants
|
24 Participants
|
14 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-W
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-B
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-W
|
6 Participants
|
25 Participants
|
19 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-W
|
6 Participants
|
25 Participants
|
16 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-W
|
7 Participants
|
24 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-W
|
6 Participants
|
27 Participants
|
19 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-A
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-B
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-W
|
5 Participants
|
22 Participants
|
10 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-W
|
0 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-A
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-B
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-B
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-W
|
5 Participants
|
22 Participants
|
16 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-B
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-B
|
4 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-W
|
3 Participants
|
23 Participants
|
15 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-W
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-W
|
5 Participants
|
14 Participants
|
14 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-A
|
0 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-A
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-W
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-B
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-W
|
7 Participants
|
26 Participants
|
18 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-W
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-B
|
0 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-W
|
6 Participants
|
21 Participants
|
17 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-W
|
7 Participants
|
28 Participants
|
16 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-W
|
7 Participants
|
25 Participants
|
19 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-W
|
7 Participants
|
28 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-W
|
7 Participants
|
26 Participants
|
19 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 37Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 37.
Haematological/Biochemical parameters assessed were haemoglobin level \[HgL\], red blood cell \[RBC\], 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 37(U-B), unknown at baseline and within at Day37(U-W), unknown at baseline and above at Day 37(U-A), below at baseline and below at Day37(B-B), below at baseline and within at Day37(B-W), below at baseline and above at Day 37(B-A), within at baseline and below at Day 37(W-B), within at baseline and within at Day 37(W-W), within at baseline and above at Day37(W-A), above at baseline and below at Day37(A-B), above at baseline and within at Day37(A-W), above at baseline and above at Day37(A-A).
Outcome measures
| Measure |
GSK3389245A_LD Group
n=7 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=29 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-W
|
7 Participants
|
27 Participants
|
16 Participants
|
10 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-W
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-B
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-A
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-W
|
5 Participants
|
25 Participants
|
14 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-A
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-W
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-A
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-A
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-W
|
0 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-B
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-B
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-A
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-W
|
7 Participants
|
27 Participants
|
15 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-A
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-W
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-B
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-A
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-W
|
7 Participants
|
28 Participants
|
14 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-A
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-W
|
7 Participants
|
24 Participants
|
17 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-W
|
7 Participants
|
27 Participants
|
16 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-W
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-B
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-W
|
7 Participants
|
23 Participants
|
14 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-A
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-W
|
6 Participants
|
26 Participants
|
15 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-W
|
7 Participants
|
23 Participants
|
18 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-W
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-B
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-W
|
6 Participants
|
28 Participants
|
14 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-A
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-B
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-W
|
5 Participants
|
24 Participants
|
8 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-A
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-W
|
5 Participants
|
24 Participants
|
14 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-A
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-W
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-W
|
5 Participants
|
19 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-A
|
0 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-W
|
2 Participants
|
7 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-W
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-B
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-W
|
6 Participants
|
25 Participants
|
16 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-W
|
6 Participants
|
25 Participants
|
13 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-B
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-B
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-W
|
6 Participants
|
23 Participants
|
14 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-W
|
7 Participants
|
29 Participants
|
16 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 60Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 60.
Haematological/Biochemical parameters assessed were haemoglobin level \[HgL\], red blood cell \[RBC\], 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 60(U-B), unknown at baseline and within at Day60(U-W), unknown at baseline and above at Day 60(U-A), below at baseline and below at Day60(B-B), below at baseline and within at Day60(B-W), below at baseline and above at Day60(B-A), within at baseline and below at Day 60(W-B), within at baseline and within at Day 60(W-W), within at baseline and above at Day60(W-A), above at baseline and below at Day60(A-B), above at baseline and within at Day60(A-W), above at baseline and above at Day60(A-A).
Outcome measures
| Measure |
GSK3389245A_LD Group
n=7 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=28 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-B
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-W
|
7 Participants
|
27 Participants
|
17 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-A
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-W
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-W
|
7 Participants
|
28 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-W
|
6 Participants
|
26 Participants
|
18 Participants
|
10 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-W
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-W
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-B
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-W
|
7 Participants
|
24 Participants
|
13 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-W
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-W
|
5 Participants
|
25 Participants
|
15 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-A
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-W
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-W
|
7 Participants
|
23 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-A
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-W
|
6 Participants
|
27 Participants
|
19 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-A
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-B
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-W
|
5 Participants
|
20 Participants
|
11 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-A
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-W
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-A
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-B
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-B
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-W
|
6 Participants
|
22 Participants
|
16 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-B
|
1 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-W
|
6 Participants
|
24 Participants
|
11 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-W
|
3 Participants
|
16 Participants
|
14 Participants
|
10 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-A
|
2 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-W
|
1 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-A
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-B
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-W
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-B
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-W
|
6 Participants
|
26 Participants
|
17 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-W
|
7 Participants
|
25 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-A
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-W
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-B
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-W
|
6 Participants
|
22 Participants
|
18 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-A
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-W
|
7 Participants
|
28 Participants
|
18 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-W
|
6 Participants
|
24 Participants
|
18 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-W
|
7 Participants
|
26 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 180Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented and with available results at Day 180.
Haematological/Biochemical parameters assessed were haemoglobin level \[HgL\], red blood cell \[RBC\], 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 Day180(U-B), unknown at baseline and within at Day180(U-W), unknown at baseline and above at Day180(U-A), below at baseline and below at Day180(B-B), below at baseline and within at Day180(B-W),below at baseline and above at Day180(B-A), within at baseline and below at Day180(W-B),within at baseline and within at Day180(W-W), within at baseline and above at Day180(W-A),above at baseline and below at Day180(A-B),above at baseline and within at Day180(A-W),above at baseline and above at Day180(A-A).
Outcome measures
| Measure |
GSK3389245A_LD Group
n=6 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=23 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=16 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=14 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT,U-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-A
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-W
|
4 Participants
|
21 Participants
|
11 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-A
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-A
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-W
|
5 Participants
|
21 Participants
|
16 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, W-B
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, W-B
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, W-W
|
5 Participants
|
20 Participants
|
14 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-W
|
5 Participants
|
21 Participants
|
13 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-W
|
6 Participants
|
21 Participants
|
14 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-A
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-W
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-B
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-W
|
5 Participants
|
21 Participants
|
14 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-W
|
6 Participants
|
23 Participants
|
14 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-W
|
6 Participants
|
21 Participants
|
15 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-W
|
6 Participants
|
23 Participants
|
15 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-W
|
6 Participants
|
22 Participants
|
14 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-A
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-W
|
6 Participants
|
21 Participants
|
15 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-W
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-B
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-W
|
5 Participants
|
21 Participants
|
11 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-A
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-W
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-B
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-W
|
5 Participants
|
20 Participants
|
15 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-B
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-W
|
6 Participants
|
19 Participants
|
15 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-A
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-B
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-B
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-W
|
5 Participants
|
16 Participants
|
9 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-A
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-W
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-A
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, B-B
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, W-W
|
4 Participants
|
19 Participants
|
14 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Hpg, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, B-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HgL, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH,B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-W
|
4 Participants
|
9 Participants
|
13 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-A
|
0 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-W
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-A
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-W
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-B
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At Day 360Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented and with available results at Day 360.
Haematological/Biochemical parameters assessed were haemoglobin level \[HgL\], red blood cell \[RBC\], 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 Day360(U-B), unknown at baseline and within at Day360(U-W), unknown at baseline and above at Day360(U-A), below at baseline and below at Day360(B-B), below at baseline and within at Day360(B-W),below at baseline and above at Day360(B-A), within at baseline and below at Day360(W-B),within at baseline and within at Day360(W-W), within at baseline and above at Day360(W-A),above at baseline and below at Day360(A-B),above at baseline and within at Day360(A-W),above at baseline and above at Day360(A-A).
Outcome measures
| Measure |
GSK3389245A_LD Group
n=5 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=21 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=15 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=14 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-W
|
5 Participants
|
19 Participants
|
13 Participants
|
10 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-W
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-W
|
5 Participants
|
17 Participants
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-A
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PTT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-W
|
5 Participants
|
19 Participants
|
15 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-W
|
5 Participants
|
17 Participants
|
7 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-W
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RBC, A-A
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-B
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-B
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-W
|
4 Participants
|
17 Participants
|
13 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HPG, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-B
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-W
|
5 Participants
|
19 Participants
|
13 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
HGL, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-W
|
3 Participants
|
12 Participants
|
11 Participants
|
10 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, W-A
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-W
|
2 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LDH, A-A
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-B
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC,B-W
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-B
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-W
|
4 Participants
|
18 Participants
|
13 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
WBC, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-W
|
5 Participants
|
18 Participants
|
14 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-W
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
LYM, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-B
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-W
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-B
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-W
|
4 Participants
|
17 Participants
|
13 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, W-A
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
NEU, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-W
|
5 Participants
|
21 Participants
|
12 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, W-A
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-W
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
ALT, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, W-A
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-B
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-W
|
5 Participants
|
18 Participants
|
13 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
AST, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-W
|
3 Participants
|
17 Participants
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, W-A
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLD, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PLC, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-W
|
5 Participants
|
20 Participants
|
14 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, U-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
PT, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-B
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-W
|
5 Participants
|
21 Participants
|
12 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
RET, A-A
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-W
|
5 Participants
|
17 Participants
|
15 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, W-A
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
CRE, A-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-W
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, B-A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
EOS, W-B
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-W
|
5 Participants
|
20 Participants
|
14 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, W-A
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
BLT, A-W
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented.
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.
Outcome measures
| Measure |
GSK3389245A_LD Group
n=7 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=31 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, UG-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G4-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G4-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G4-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, GTotal-G0
|
7 Participants
|
29 Participants
|
18 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, GTotal-G1
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G0-G0
|
7 Participants
|
28 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G0-G1
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, GTotal-G0
|
7 Participants
|
28 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G0-G0
|
7 Participants
|
28 Participants
|
17 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G3-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G3-G4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, GTotal-G0
|
7 Participants
|
28 Participants
|
17 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, GTotal-G1
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, GTotal-G2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G0-G0
|
6 Participants
|
31 Participants
|
17 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G0-G1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, GTotal-G0
|
6 Participants
|
31 Participants
|
17 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G0-G1
|
5 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G1-G2
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, GTotal-G0
|
2 Participants
|
22 Participants
|
12 Participants
|
10 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, GTotal-G1
|
5 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, G0-G0
|
7 Participants
|
21 Participants
|
18 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, GTotal-G2
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, GTotal-G1
|
2 Participants
|
7 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, GTotal-G2
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, G0-G0
|
7 Participants
|
31 Participants
|
19 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, G0-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, GTotal-G0
|
7 Participants
|
31 Participants
|
19 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, GTotal-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, UG-G0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, UG-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, UG-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, UG-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G0-G0
|
7 Participants
|
29 Participants
|
18 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G0-G1
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, GTotal-G1
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G4-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G4-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, GTotal-G0
|
7 Participants
|
27 Participants
|
17 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, GTotal-G1
|
0 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, GTotal-G0
|
7 Participants
|
31 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G0-G0
|
7 Participants
|
25 Participants
|
17 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G0-G1
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, GTotal-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G1-G1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G1-G1
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, GTotal-G0
|
7 Participants
|
25 Participants
|
17 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, GTotal-G1
|
0 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G0-G0
|
5 Participants
|
22 Participants
|
15 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, UG-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, UG-G1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, UG-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, UG-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G0-G0
|
7 Participants
|
29 Participants
|
18 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G0-G1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G1-G1
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G0-G0
|
2 Participants
|
22 Participants
|
12 Participants
|
10 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G0-G2
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G1-G1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G1-G1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, GTotal-G1
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G0-G1
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G0-G2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G1-G1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G3-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G3-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G3-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, GTotal-G4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, UG-G0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, UG-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, UG-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, UG-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, UG-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, G0-G0
|
7 Participants
|
30 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, G0-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G1-G1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G0-G1
|
1 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G0-G2
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, GTotal-G0
|
5 Participants
|
22 Participants
|
15 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, GTotal-G2
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, G0-G1
|
0 Participants
|
9 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, G0-G2
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, GTotal-G0
|
7 Participants
|
21 Participants
|
18 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, GTotal-G1
|
0 Participants
|
9 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, UG-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G0-G0
|
7 Participants
|
26 Participants
|
17 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G0-G1
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G1-G1
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G4-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G1-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, GTotal-G0
|
7 Participants
|
29 Participants
|
18 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, GTotal-G1
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, G0-G0
|
7 Participants
|
30 Participants
|
19 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, G0-G1
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, GTotal-G0
|
7 Participants
|
30 Participants
|
19 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, GTotal-G1
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 30-day (Days 0-29) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented.
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.
Outcome measures
| Measure |
GSK3389245A_LD Group
n=7 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=31 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
5 Participants
|
21 Participants
|
14 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: From Day 0 to Day 360Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented.
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.
Outcome measures
| Measure |
GSK3389245A_LD Group
n=7 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=31 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
Up to Day 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Serious Adverse Events (SAEs)
Up to Day 360
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to Day 360Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented.
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 360, for the same parameter, e.g. ALT G0-G2.
Outcome measures
| Measure |
GSK3389245A_LD Group
n=7 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=31 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, UG-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G4-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G4-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G4-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, GTotal-G0
|
6 Participants
|
25 Participants
|
17 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G0-G0
|
7 Participants
|
29 Participants
|
18 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G0-G1
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G1-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, GTotal-G0
|
7 Participants
|
29 Participants
|
18 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, GTotal-G1
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCD, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, G0-G0
|
7 Participants
|
29 Participants
|
18 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, G0-G1
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, GTotal-G0
|
7 Participants
|
29 Participants
|
18 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
WBCI, GTotal-G1
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, GTotal-G1
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, UG-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, UG-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, GTotal-G2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, GTotal-G4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, UG-G0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, UG-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, UG-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, UG-G0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, UG-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, UG-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, UG-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, UG-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G0-G0
|
6 Participants
|
24 Participants
|
17 Participants
|
12 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G0-G1
|
1 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G1-G1
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G0-G0
|
6 Participants
|
25 Participants
|
17 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G0-G1
|
1 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G1-G1
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, GTotal-G0
|
6 Participants
|
25 Participants
|
17 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, GTotal-G1
|
1 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
ALT, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, UG-G1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, UG-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, UG-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, UG-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G0-G0
|
7 Participants
|
28 Participants
|
18 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G0-G1
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G1-G1
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G4-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G4-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, G4-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, GTotal-G0
|
7 Participants
|
28 Participants
|
18 Participants
|
11 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, GTotal-G1
|
0 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
APTT, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G0-G0
|
6 Participants
|
28 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G0-G1
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G1-G1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, GTotal-G0
|
6 Participants
|
28 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, GTotal-G1
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
AST, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G0-G0
|
7 Participants
|
28 Participants
|
17 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G0-G1
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G0-G2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G1-G1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G3-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G3-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G3-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G3-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, G3-G4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
TB, GTotal-G0
|
7 Participants
|
28 Participants
|
17 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, G0-G0
|
7 Participants
|
30 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, G0-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, GTotal-G0
|
7 Participants
|
31 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, GTotal-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
CRE, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G0-G0
|
6 Participants
|
31 Participants
|
17 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G0-G1
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G1-G1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, GTotal-G0
|
6 Participants
|
31 Participants
|
17 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, GTotal-G1
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
EOS, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G0-G0
|
2 Participants
|
22 Participants
|
12 Participants
|
9 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G0-G1
|
5 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G0-G2
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G1-G1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G1-G2
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, GTotal-G0
|
2 Participants
|
22 Participants
|
12 Participants
|
9 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, GTotal-G1
|
5 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, GTotal-G2
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
HgD, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, G0-G0
|
7 Participants
|
21 Participants
|
18 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, G0-G1
|
0 Participants
|
9 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, G0-G2
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, GTotal-G0
|
7 Participants
|
21 Participants
|
18 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, GTotal-G1
|
0 Participants
|
9 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, GTotal-G2
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
LYM, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G0-G0
|
5 Participants
|
21 Participants
|
14 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G0-G1
|
1 Participants
|
8 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G0-G2
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G1-G1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, G1-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, GTotal-G0
|
5 Participants
|
21 Participants
|
14 Participants
|
13 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, GTotal-G1
|
2 Participants
|
8 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, GTotal-G2
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
NEU, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, G0-G0
|
7 Participants
|
31 Participants
|
19 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, G0-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, G0-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, GTotal-G0
|
7 Participants
|
31 Participants
|
19 Participants
|
14 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, GTotal-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, GTotal-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, GTotal-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PLA, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, GTotal-G1
|
1 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
PT, GTotal-G4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.
Serum neutralizing antibody titers were reported as the inverse of the serum dilution which yielded a 60% reduction in the number of viral plaques compared to virus control without serum (Estimated Dilution: ED60). Antibody titers were expressed as Geometric Mean Titers (GMTs).
Outcome measures
| Measure |
GSK3389245A_LD Group
n=5 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=28 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=18 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibodies Titers
Anti-RSV, (Day 0)
|
605.9 Titers
Interval 205.1 to 1789.9
|
519.4 Titers
Interval 349.6 to 771.7
|
346.1 Titers
Interval 220.0 to 544.4
|
409.4 Titers
Interval 261.8 to 640.2
|
|
Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibodies Titers
Anti-RSV, (Day 30)
|
1474.1 Titers
Interval 1090.0 to 1993.4
|
1293.1 Titers
Interval 834.8 to 2002.7
|
492.4 Titers
Interval 321.2 to 754.9
|
493.8 Titers
Interval 318.7 to 765.3
|
|
Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibodies Titers
Anti-RSV, (Day 60)
|
847.4 Titers
Interval 605.6 to 1185.7
|
1211.3 Titers
Interval 783.6 to 1872.5
|
347.3 Titers
Interval 234.1 to 515.3
|
376.9 Titers
Interval 220.8 to 643.3
|
SECONDARY outcome
Timeframe: At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.
Pre-defined cut-off values was higher than or equal to (≥) 8 ED60.
Outcome measures
| Measure |
GSK3389245A_LD Group
n=5 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=28 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=18 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-RSV Neutralizing Antibodies Above the Cut-off Value
ANTI-RSV, (Day 30)
|
5 Participants
|
26 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Anti-RSV Neutralizing Antibodies Above the Cut-off Value
ANTI-RSV, (Day 60)
|
5 Participants
|
26 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Anti-RSV Neutralizing Antibodies Above the Cut-off Value
ANTI-RSV, (Day 0)
|
5 Participants
|
28 Participants
|
18 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.
Interferon-gamma specific T-cells, expressed as T-cells per (/) million cells, were determined by the Enzyme Linked ImmunoSpot (ELISpot) assay.
Outcome measures
| Measure |
GSK3389245A_LD Group
n=5 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=27 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=17 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=14 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
RSV F, (Day 0)
|
33.3 T-cells/million cells
Interval 8.3 to 38.3
|
35 T-cells/million cells
Interval 13.3 to 83.3
|
15 T-cells/million cells
Interval 4.2 to 70.0
|
23.3 T-cells/million cells
Interval 3.3 to 38.3
|
|
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
RSV F, (Day 7)
|
28.3 T-cells/million cells
Interval 16.7 to 33.3
|
94.2 T-cells/million cells
Interval 41.7 to 220.0
|
20 T-cells/million cells
Interval 3.3 to 56.7
|
36.7 T-cells/million cells
Interval 10.0 to 50.0
|
|
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
RSV F, (Day 37)
|
18 T-cells/million cells
Interval 1.0 to 53.3
|
75 T-cells/million cells
Interval 52.5 to 132.5
|
33.3 T-cells/million cells
Interval 7.5 to 42.5
|
35 T-cells/million cells
Interval 15.0 to 80.0
|
|
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
RSV M2-1, (Day 0)
|
21.7 T-cells/million cells
Interval 3.3 to 31.7
|
6.7 T-cells/million cells
Interval 3.3 to 13.3
|
2.5 T-cells/million cells
Interval 1.0 to 8.3
|
5 T-cells/million cells
Interval 1.7 to 11.7
|
|
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
RSV M2-1, (Day 7)
|
3.3 T-cells/million cells
Interval 3.3 to 15.0
|
25 T-cells/million cells
Interval 1.7 to 80.0
|
6.7 T-cells/million cells
Interval 1.7 to 15.0
|
3.3 T-cells/million cells
Interval 1.7 to 15.0
|
|
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
RSV M2-1, (Day 30)
|
5 T-cells/million cells
Interval 1.0 to 13.3
|
31.7 T-cells/million cells
Interval 11.7 to 96.7
|
13.3 T-cells/million cells
Interval 1.0 to 41.7
|
7.5 T-cells/million cells
Interval 2.5 to 19.2
|
|
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
RSV M2-1, (Day 37)
|
20.5 T-cells/million cells
Interval 1.0 to 55.8
|
37.5 T-cells/million cells
Interval 21.7 to 64.2
|
5.8 T-cells/million cells
Interval 1.0 to 14.2
|
6.7 T-cells/million cells
Interval 2.5 to 13.3
|
|
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
RSV N, (Day 0)
|
10 T-cells/million cells
Interval 5.0 to 25.0
|
11.7 T-cells/million cells
Interval 3.3 to 25.0
|
5 T-cells/million cells
Interval 1.0 to 38.3
|
10 T-cells/million cells
Interval 1.0 to 25.0
|
|
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
RSV N, (Day 7)
|
3.3 T-cells/million cells
Interval 1.0 to 30.0
|
21.7 T-cells/million cells
Interval 6.7 to 105.0
|
3.3 T-cells/million cells
Interval 1.7 to 38.3
|
11.7 T-cells/million cells
Interval 1.7 to 33.3
|
|
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
RSV N, (Day 37)
|
8.8 T-cells/million cells
Interval 1.0 to 32.5
|
50 T-cells/million cells
Interval 22.5 to 102.5
|
10.8 T-cells/million cells
Interval 3.3 to 25.8
|
18.3 T-cells/million cells
Interval 8.3 to 42.5
|
|
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
RSV N, (Day 60)
|
15 T-cells/million cells
Interval 3.3 to 16.7
|
34.2 T-cells/million cells
Interval 15.8 to 61.7
|
24.2 T-cells/million cells
Interval 7.5 to 48.3
|
20 T-cells/million cells
Interval 10.0 to 73.3
|
|
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
RSV F, (Day 30)
|
1.7 T-cells/million cells
Interval 1.0 to 10.0
|
108.3 T-cells/million cells
Interval 51.7 to 175.0
|
41.7 T-cells/million cells
Interval 13.3 to 80.0
|
41.7 T-cells/million cells
Interval 6.7 to 56.7
|
|
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
RSV F, (Day 60)
|
20 T-cells/million cells
Interval 20.0 to 31.7
|
70.8 T-cells/million cells
Interval 35.0 to 155.0
|
52.5 T-cells/million cells
Interval 28.3 to 72.5
|
48.3 T-cells/million cells
Interval 31.7 to 80.0
|
|
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
RSV M2-1, (Day 60)
|
11.7 T-cells/million cells
Interval 6.7 to 11.7
|
20 T-cells/million cells
Interval 8.3 to 45.8
|
15 T-cells/million cells
Interval 6.7 to 34.5
|
10 T-cells/million cells
Interval 6.7 to 13.3
|
|
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
RSV N, (Day 30)
|
1 T-cells/million cells
Interval 1.0 to 5.0
|
36.7 T-cells/million cells
Interval 21.7 to 106.7
|
18.3 T-cells/million cells
Interval 3.3 to 78.3
|
19.2 T-cells/million cells
Interval 6.7 to 31.7
|
SECONDARY outcome
Timeframe: At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.
IgG/IgA antibody specific B-cells/ expressed as B-cells per million cells, were determined by the ELISpot assay.
Outcome measures
| Measure |
GSK3389245A_LD Group
n=5 Participants
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=28 Participants
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=18 Participants
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 Participants
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)
Memory B-cell IgA, (Day 0)
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)
Memory B-cell IgA, (Day 7)
|
1 B-cells/million cells
Interval 1.0 to 16.7
|
16.7 B-cells/million cells
Interval 5.0 to 30.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)
Memory B-cell IgA, (Day 30)
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)
Memory B-cell IgA, (Day 37)
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)
Memory B-cell IgA, (Day 60)
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)
Memory B-cell IgG, (Day 0)
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)
Memory B-cell IgG, (Day 7)
|
45 B-cells/million cells
Interval 1.0 to 55.0
|
133.3 B-cells/million cells
Interval 56.7 to 240.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)
Memory B-cell IgG, (Day 30)
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)
Memory B-cell IgG, (Day 37)
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 5.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)
Memory B-cell IgG, (Day 60)
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
Adverse Events
GSK3389245A_LD Group
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
GSK3389245A_HD Group
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo Group
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Bexsero Group
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK3389245A_LD Group
n=7 participants at risk
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=31 participants at risk
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 participants at risk
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 participants at risk
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
14.3%
1/7 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
Other adverse events
| Measure |
GSK3389245A_LD Group
n=7 participants at risk
Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30.
|
GSK3389245A_HD Group
n=31 participants at risk
Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30.
|
Placebo Group
n=19 participants at risk
Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30.
|
Bexsero Group
n=15 participants at risk
Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.5%
2/31 • Number of events 2 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.5%
2/31 • Number of events 3 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
42.9%
3/7 • Number of events 4 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
22.6%
7/31 • Number of events 9 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
47.4%
9/19 • Number of events 10 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
26.7%
4/15 • Number of events 5 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.5%
2/31 • Number of events 2 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
General disorders
Chills
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
3.2%
1/31 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
13.3%
2/15 • Number of events 2 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
General disorders
Fatigue
|
71.4%
5/7 • Number of events 6 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
61.3%
19/31 • Number of events 29 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
47.4%
9/19 • Number of events 16 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
73.3%
11/15 • Number of events 17 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
General disorders
Feeling cold
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
General disorders
Hangover
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 2 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
General disorders
Influenza like illness
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
9.7%
3/31 • Number of events 3 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
General disorders
Injection site bruising
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
General disorders
Pain
|
57.1%
4/7 • Number of events 4 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
87.1%
27/31 • Number of events 43 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
100.0%
15/15 • Number of events 30 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
General disorders
Pyrexia
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
35.5%
11/31 • Number of events 13 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
13.3%
2/15 • Number of events 3 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
General disorders
Swelling
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
General disorders
Vaccination site bruising
|
14.3%
1/7 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
General disorders
Vaccination site warmth
|
14.3%
1/7 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Immune system disorders
Food allergy
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Infections and infestations
Candida infection
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.5%
2/31 • Number of events 3 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Infections and infestations
Herpes simplex
|
14.3%
1/7 • Number of events 2 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
9.7%
3/31 • Number of events 3 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
21.1%
4/19 • Number of events 4 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
40.0%
6/15 • Number of events 6 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.5%
2/31 • Number of events 2 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
13.3%
2/15 • Number of events 2 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
3.2%
1/31 • Number of events 2 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Injury, poisoning and procedural complications
Contusion
|
14.3%
1/7 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Injury, poisoning and procedural complications
Limb injury
|
14.3%
1/7 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Injury, poisoning and procedural complications
Sports injury
|
14.3%
1/7 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
3.2%
1/31 • Number of events 2 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
3.2%
1/31 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
10.5%
2/19 • Number of events 3 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 2 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
3.2%
1/31 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
10.5%
2/19 • Number of events 3 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Nervous system disorders
Aphonia
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Nervous system disorders
Headache
|
85.7%
6/7 • Number of events 13 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
58.1%
18/31 • Number of events 35 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
57.9%
11/19 • Number of events 23 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
80.0%
12/15 • Number of events 24 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Nervous system disorders
Migraine
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
3.2%
1/31 • Number of events 2 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.5%
2/31 • Number of events 2 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
21.1%
4/19 • Number of events 4 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
26.7%
4/15 • Number of events 4 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
5.3%
1/19 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/15 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.5%
2/31 • Number of events 3 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
42.9%
3/7 • Number of events 3 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
16.1%
5/31 • Number of events 10 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
15.8%
3/19 • Number of events 4 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
33.3%
5/15 • Number of events 6 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
6.7%
1/15 • Number of events 2 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/7 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/31 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
0.00%
0/19 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
20.0%
3/15 • Number of events 3 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
14.3%
1/7 • Number of events 1 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
3.2%
1/31 • Number of events 2 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
10.5%
2/19 • Number of events 2 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
20.0%
3/15 • Number of events 4 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER