Trial Outcomes & Findings for A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational GSK Biologicals' GSK3277511A Vaccine in Adults. (NCT NCT02547974)
NCT ID: NCT02547974
Last Updated: 2018-08-31
Results Overview
Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
120 participants
Primary outcome timeframe
During a 7-day follow-up period (Day 0 to Day 6) after first dose.
Results posted on
2018-08-31
Participant Flow
120 subjects were enrolled in the study. All subjects received at least one dose of the vaccine.
For each subject, the study lasted approximately 15 months, from screening (Pre-Day 0) to study end (Day 420). Vaccination schedules: 0, 2 months (i.e. at Day 0 and Day 60).
Participant milestones
| Measure |
GSK3277513A F1 Group
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
31
|
30
|
44
|
|
Overall Study
COMPLETED
|
14
|
31
|
30
|
44
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
GSK3277513A F1 Group
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational GSK Biologicals' GSK3277511A Vaccine in Adults.
Baseline characteristics by cohort
| Measure |
GSK3277513A F1 Group
n=15 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=30 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=44 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.1 Years
STANDARD_DEVIATION 5.91 • n=5 Participants
|
58.9 Years
STANDARD_DEVIATION 6.49 • n=7 Participants
|
58.5 Years
STANDARD_DEVIATION 5.82 • n=5 Participants
|
47.2 Years
STANDARD_DEVIATION 16.72 • n=4 Participants
|
50.8 Years
STANDARD_DEVIATION 14.83 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / European Heritage
|
15 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period (Day 0 to Day 6) after first dose.Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=15 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=30 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=44 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Any Pain
|
2 Participants
|
19 Participants
|
26 Participants
|
6 Participants
|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Any Redness (mm)
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Any Swelling (mm)
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period (Day 60 to Day 66) after second dosePopulation: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=14 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=29 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=44 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Any Pain
|
7 Participants
|
23 Participants
|
25 Participants
|
8 Participants
|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Any Redness (mm)
|
0 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Any Swelling (mm)
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period (Day 0 to Day 6) after first dose.Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\].
Outcome measures
| Measure |
GSK3277513A F1 Group
n=15 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=30 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=44 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Number of Subjects With Any Solicited General Adverse Events (AEs)
Any Temperature (Oral) (°C)
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited General Adverse Events (AEs)
Any Fatigue
|
3 Participants
|
3 Participants
|
11 Participants
|
10 Participants
|
|
Number of Subjects With Any Solicited General Adverse Events (AEs)
Any Gastrointestinal symptoms
|
1 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any Solicited General Adverse Events (AEs)
Any Headache
|
4 Participants
|
2 Participants
|
10 Participants
|
7 Participants
|
|
Number of Subjects With Any Solicited General Adverse Events (AEs)
Any Myalgia
|
2 Participants
|
6 Participants
|
7 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period (Day 60 to Day 66) after second dose.Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\].
Outcome measures
| Measure |
GSK3277513A F1 Group
n=14 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=29 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=44 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Number of Subjects With Any Solicited General Adverse Events (AEs)
Any Fatigue
|
3 Participants
|
9 Participants
|
13 Participants
|
6 Participants
|
|
Number of Subjects With Any Solicited General Adverse Events (AEs)
Any Myalgia
|
1 Participants
|
9 Participants
|
8 Participants
|
3 Participants
|
|
Number of Subjects With Any Solicited General Adverse Events (AEs)
Any Gastrointestinal symptoms
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited General Adverse Events (AEs)
Any Headache
|
3 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
|
Number of Subjects With Any Solicited General Adverse Events (AEs)
Any Temperature (Oral) (°C)
|
0 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: During a 30-day follow-up period (Day 0 to Day 29) after first dose.Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
Assessed unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=15 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=30 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=44 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs).
|
6 Participants
|
13 Participants
|
14 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: During a 30-day follow-up period (Day 60 to Day 89) after second dosePopulation: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
Assessed unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=15 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=30 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=44 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
6 Participants
|
14 Participants
|
14 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: At Day 7, post-dose 1.Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=15 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=30 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=44 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Basophils below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
ALT below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
ALT above
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
AST below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
AST above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Basophils above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Creatinine below
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Creatinine above
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Eosinophils below
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Eosinophils above
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Erythrocytes below
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Erythrocytes above
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Hemoglobin below
|
0 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Hemoglobin above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Leucocytes below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Leucocytes above
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Lymphocytes below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Lymphocytes above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Monocytes below
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Monocytes above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Neutrophils below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Neutrophils above
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Platelets below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Platelets above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 60, post-dose 1.Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=14 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=30 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=44 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Leucocytes below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
ALT below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
ALT above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
AST below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
AST above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Basophils below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Basophils above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Creatinine below
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Creatinine above
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Eosinophils below
|
5 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Eosinophils above
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Erythrocytes below
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Erythrocytes above
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Hemoglobin below
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Hemoglobin above
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Leucocytes above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Lymphocytes below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Lymphocytes above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Monocytes below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Monocytes above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Neutrophils below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Neutrophils above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Platelets below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Platelets above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 67, post-dose 2.Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=14 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=30 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=44 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Platelets above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Platelets below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
ALT below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
ALT above
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
AST below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
AST above
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Basophils below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Basophils above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Creatinine below
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Creatinine above
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Eosinophils below
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Eosinophils above
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Erythrocytes below
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Erythrocytes above
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Hemoglobin below
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Hemoglobin above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Leucocytes below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Leucocytes above
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Lymphocytes below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Lymphocytes above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Monocytes below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Monocytes above
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Neutrophils below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Neutrophils above
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At Day 210, post-dose 2.Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=14 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=30 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=44 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Neutrophils above
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Leucocytes below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
ALT below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
ALT above
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
AST below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
AST above
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Basophils below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Basophils above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Creatinine below
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Creatinine above
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Eosinophils below
|
4 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Eosinophils above
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Erythrocytes below
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Erythrocytes above
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Hemoglobin below
|
2 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Hemoglobin above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Leucocytes above
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Lymphocytes below
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Lymphocytes above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Monocytes below
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Monocytes above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Neutrophils below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Platelets below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Platelets above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 420, post-dose 2.Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=14 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=30 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=44 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Lymphocytes above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Platelets below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Platelets above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
ALT below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
ALT above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
AST below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
AST above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Basophils below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Basophils above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Creatinine below
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Creatinine above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Eosinophils below
|
4 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Eosinophils above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Erythrocytes below
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Erythrocytes above
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Hemoglobin below
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Hemoglobin above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Leucocytes below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Leucocytes above
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Lymphocytes below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Monocytes below
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Monocytes above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Neutrophils below
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Neutrophils above
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first vaccination up to study conclusion (Day 0 to Day 420)Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
Assessed SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=15 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=30 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=44 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From first vaccination up to study conclusion (Day 0 to Day 420)Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=15 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=30 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=44 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 153 EL.U/mL for anti-PD antibodies.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=14 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=29 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=43 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component
Anti-PD antibody, Day 0
|
109.7 EL.U/mL
Interval 71.2 to 169.1
|
102.8 EL.U/mL
Interval 77.5 to 136.4
|
88.1 EL.U/mL
Interval 72.4 to 107.1
|
89 EL.U/mL
Interval 75.0 to 105.7
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component
Anti-PD antibody, Day 30
|
239.8 EL.U/mL
Interval 123.0 to 467.6
|
569.4 EL.U/mL
Interval 335.9 to 965.3
|
818 EL.U/mL
Interval 532.0 to 1257.8
|
90.8 EL.U/mL
Interval 76.5 to 107.8
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component
Anti-PD antibody, Day 60
|
220.9 EL.U/mL
Interval 121.1 to 402.9
|
327.1 EL.U/mL
Interval 207.4 to 515.6
|
495 EL.U/mL
Interval 307.2 to 797.5
|
88.6 EL.U/mL
Interval 75.2 to 104.3
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component
Anti-PD antibody, Day 90
|
289.2 EL.U/mL
Interval 144.6 to 578.5
|
984.4 EL.U/mL
Interval 662.3 to 1463.2
|
1538.5 EL.U/mL
Interval 1134.6 to 2086.2
|
91.8 EL.U/mL
Interval 77.8 to 108.3
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component
Anti-PD antibody, Day 210
|
179.5 EL.U/mL
Interval 96.7 to 333.5
|
471.8 EL.U/mL
Interval 310.2 to 717.5
|
806.1 EL.U/mL
Interval 560.2 to 1159.9
|
92.9 EL.U/mL
Interval 79.0 to 109.2
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component
Anti-PD antibody, Day 420
|
165.1 EL.U/mL
Interval 89.7 to 303.8
|
370.2 EL.U/mL
Interval 238.2 to 575.3
|
538.1 EL.U/mL
Interval 369.1 to 784.5
|
88.8 EL.U/mL
Interval 77.3 to 102.1
|
SECONDARY outcome
Timeframe: At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 25 EL.U/mL for anti-PE antibodies.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=14 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=29 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=43 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component
Anti-PE antibody, Day 30
|
178.3 EL.U/mL
Interval 64.6 to 491.9
|
627.2 EL.U/mL
Interval 401.0 to 980.9
|
1287.8 EL.U/mL
Interval 816.2 to 2032.0
|
21.3 EL.U/mL
Interval 16.7 to 27.1
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component
Anti-PE antibody, Day 90
|
719.1 EL.U/mL
Interval 357.4 to 1446.8
|
5945.2 EL.U/mL
Interval 4069.5 to 8685.5
|
8983.9 EL.U/mL
Interval 7150.4 to 11287.5
|
21.8 EL.U/mL
Interval 17.1 to 27.8
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component
Anti-PE antibody, Day 210
|
385.8 EL.U/mL
Interval 191.2 to 778.4
|
2390.9 EL.U/mL
Interval 1655.4 to 3453.1
|
3247.6 EL.U/mL
Interval 2285.2 to 4615.3
|
20.7 EL.U/mL
Interval 16.5 to 26.0
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component
Anti-PE antibody, Day 420
|
244.1 EL.U/mL
Interval 112.4 to 529.9
|
1206.6 EL.U/mL
Interval 817.5 to 1781.0
|
1701 EL.U/mL
Interval 1192.1 to 2427.1
|
22.8 EL.U/mL
Interval 17.5 to 29.7
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component
Anti-PE antibody, Day 0
|
31.3 EL.U/mL
Interval 16.4 to 59.7
|
20.6 EL.U/mL
Interval 15.7 to 27.0
|
19.7 EL.U/mL
Interval 14.8 to 26.2
|
21.9 EL.U/mL
Interval 17.0 to 28.1
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component
Anti-PE antibody, Day 60
|
151.9 EL.U/mL
Interval 58.0 to 397.6
|
573.1 EL.U/mL
Interval 360.1 to 912.1
|
1207.1 EL.U/mL
Interval 753.8 to 1932.9
|
20.3 EL.U/mL
Interval 15.9 to 25.9
|
SECONDARY outcome
Timeframe: At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90 (post-dose2).Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 7 EL.U/mL for anti-PilA antibodies.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=14 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=29 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=43 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component
Anti-PilA antibody, Day 0
|
11.6 EL.U/mL
Interval 5.3 to 25.2
|
13.5 EL.U/mL
Interval 8.0 to 22.6
|
17.1 EL.U/mL
Interval 11.0 to 26.5
|
8.8 EL.U/mL
Interval 6.1 to 12.6
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component
Anti-PilA antibody, Day 30
|
37.2 EL.U/mL
Interval 13.6 to 101.5
|
238.6 EL.U/mL
Interval 123.1 to 462.5
|
330.9 EL.U/mL
Interval 211.7 to 517.2
|
9.2 EL.U/mL
Interval 6.4 to 13.3
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component
Anti-PilA antibody, Day 60
|
33.2 EL.U/mL
Interval 11.3 to 97.9
|
177 EL.U/mL
Interval 83.4 to 375.7
|
321.2 EL.U/mL
Interval 210.1 to 491.2
|
9 EL.U/mL
Interval 6.3 to 13.0
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component
Anti-PilA antibody, Day 90
|
165.8 EL.U/mL
Interval 76.7 to 358.4
|
1127.5 EL.U/mL
Interval 751.0 to 1692.8
|
1722.3 EL.U/mL
Interval 1383.4 to 2144.2
|
8.6 EL.U/mL
Interval 5.8 to 12.6
|
SECONDARY outcome
Timeframe: At Day 210 and Day 420 (post-dose2).Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 16 EL.U/mL for anti-PilA antibodies.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=14 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=29 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=43 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component
Anti-PilA antibody, Day 210
|
52 EL.U/mL
Interval 18.4 to 146.8
|
367.2 EL.U/mL
Interval 220.2 to 612.3
|
671 EL.U/mL
Interval 508.6 to 885.2
|
11.5 EL.U/mL
Interval 9.0 to 14.8
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component
Anti-PilA antibody, Day 420
|
40.8 EL.U/mL
Interval 16.5 to 100.7
|
181.8 EL.U/mL
Interval 108.0 to 305.9
|
322.2 EL.U/mL
Interval 233.4 to 444.9
|
11.9 EL.U/mL
Interval 9.2 to 15.5
|
SECONDARY outcome
Timeframe: At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 38 EL.U/mL for anti-UspA2 antibodies.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=14 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=29 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=43 Participants
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component
Anti-UspA2 IgG antibody, Day 0
|
572.5 EL.U/mL
Interval 254.4 to 1288.6
|
384.1 EL.U/mL
Interval 253.0 to 583.2
|
468.1 EL.U/mL
Interval 330.6 to 662.8
|
548.3 EL.U/mL
Interval 399.4 to 752.8
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component
Anti-UspA2 IgG antibody, Day 210
|
775.1 EL.U/mL
Interval 361.3 to 1662.8
|
882.5 EL.U/mL
Interval 629.8 to 1236.7
|
767.2 EL.U/mL
Interval 584.8 to 1006.5
|
525.7 EL.U/mL
Interval 386.8 to 714.5
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component
Anti-UspA2 IgG antibody, Day 420
|
732 EL.U/mL
Interval 339.2 to 1579.5
|
703.6 EL.U/mL
Interval 501.8 to 986.5
|
673.4 EL.U/mL
Interval 504.3 to 899.2
|
552.9 EL.U/mL
Interval 399.7 to 764.9
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component
Anti-UspA2 IgG antibody, Day 30
|
879.9 EL.U/mL
Interval 396.6 to 1952.4
|
1006.7 EL.U/mL
Interval 732.5 to 1383.6
|
913.5 EL.U/mL
Interval 693.3 to 1203.7
|
571.5 EL.U/mL
Interval 416.9 to 783.4
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component
Anti-UspA2 IgG antibody, Day 60
|
780.7 EL.U/mL
Interval 365.4 to 1668.3
|
754.4 EL.U/mL
Interval 533.1 to 1067.6
|
714.7 EL.U/mL
Interval 538.9 to 947.8
|
567 EL.U/mL
Interval 418.0 to 769.1
|
|
Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component
Anti-UspA2 IgG antibody, Day 90
|
1172 EL.U/mL
Interval 654.7 to 2097.9
|
1440.7 EL.U/mL
Interval 1065.8 to 1947.5
|
1279 EL.U/mL
Interval 1026.1 to 1594.4
|
621.5 EL.U/mL
Interval 449.1 to 860.0
|
SECONDARY outcome
Timeframe: At Day 0 (pre-dose 1); at Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
Frequency of specific CD4+ T-cells are measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers (such as Interleukin \[IL\]-2, IL-13, IL-17, Interferon gamma \[FN-γ\], Tumour necrosis factor alpha \[TNF-α\] and CD40L). The frequency of specific CD4+ T-cells are summarised \[descriptive statistics: Mean and standard deviation (SD)\] against each antigen (PD, PE, PilA and UspA2), by group in Step 2 at each time point during which blood samples are collected for CMI.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=16 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=12 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=15 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.PD, Day 0
|
28.3 CD4+ T-cells/million cells
Standard Deviation 42.1
|
81.8 CD4+ T-cells/million cells
Standard Deviation 92.29
|
37.4 CD4+ T-cells/million cells
Standard Deviation 46.29
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.PD, Day 60
|
105.4 CD4+ T-cells/million cells
Standard Deviation 123.95
|
107.8 CD4+ T-cells/million cells
Standard Deviation 117.92
|
55 CD4+ T-cells/million cells
Standard Deviation 91.94
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.PD, Day 90
|
283.3 CD4+ T-cells/million cells
Standard Deviation 236.93
|
349.9 CD4+ T-cells/million cells
Standard Deviation 216.5
|
90.5 CD4+ T-cells/million cells
Standard Deviation 117.41
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.PD, Day 210
|
120.4 CD4+ T-cells/million cells
Standard Deviation 99.23
|
176.9 CD4+ T-cells/million cells
Standard Deviation 101.39
|
78.7 CD4+ T-cells/million cells
Standard Deviation 112.16
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.PD, Day 420
|
154.3 CD4+ T-cells/million cells
Standard Deviation 165.98
|
164.8 CD4+ T-cells/million cells
Standard Deviation 123.33
|
60.3 CD4+ T-cells/million cells
Standard Deviation 82.01
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.PE, Day 210
|
469.1 CD4+ T-cells/million cells
Standard Deviation 381.87
|
337.4 CD4+ T-cells/million cells
Standard Deviation 228.12
|
39.1 CD4+ T-cells/million cells
Standard Deviation 65.14
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.PE, Day 420
|
545 CD4+ T-cells/million cells
Standard Deviation 735.89
|
215.8 CD4+ T-cells/million cells
Standard Deviation 137.79
|
26.6 CD4+ T-cells/million cells
Standard Deviation 51.74
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.PilA, Day 210
|
326 CD4+ T-cells/million cells
Standard Deviation 208.31
|
220.8 CD4+ T-cells/million cells
Standard Deviation 148.59
|
43.7 CD4+ T-cells/million cells
Standard Deviation 69.03
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.PilA, Day 420
|
348.8 CD4+ T-cells/million cells
Standard Deviation 376.87
|
131.1 CD4+ T-cells/million cells
Standard Deviation 75.89
|
59.1 CD4+ T-cells/million cells
Standard Deviation 53.4
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.PilA, Day 0
|
32.8 CD4+ T-cells/million cells
Standard Deviation 43.6
|
60.5 CD4+ T-cells/million cells
Standard Deviation 92.87
|
32.6 CD4+ T-cells/million cells
Standard Deviation 48.69
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.PilA, Day 60
|
169.1 CD4+ T-cells/million cells
Standard Deviation 150.22
|
110.2 CD4+ T-cells/million cells
Standard Deviation 67.81
|
57.1 CD4+ T-cells/million cells
Standard Deviation 99.26
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.PilA, Day 90
|
508.6 CD4+ T-cells/million cells
Standard Deviation 474.31
|
330.5 CD4+ T-cells/million cells
Standard Deviation 412.4
|
99 CD4+ T-cells/million cells
Standard Deviation 152.45
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.UspA2, Day 0
|
115.4 CD4+ T-cells/million cells
Standard Deviation 154.96
|
126.3 CD4+ T-cells/million cells
Standard Deviation 97.92
|
131.1 CD4+ T-cells/million cells
Standard Deviation 182.97
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.PE, Day 0
|
89.2 CD4+ T-cells/million cells
Standard Deviation 199.87
|
41.4 CD4+ T-cells/million cells
Standard Deviation 48.55
|
47.1 CD4+ T-cells/million cells
Standard Deviation 70.65
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.PE, Day 60
|
370.7 CD4+ T-cells/million cells
Standard Deviation 372.5
|
176.9 CD4+ T-cells/million cells
Standard Deviation 172.74
|
50.9 CD4+ T-cells/million cells
Standard Deviation 47.91
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.PE, Day 90
|
1182.2 CD4+ T-cells/million cells
Standard Deviation 1507.29
|
732.7 CD4+ T-cells/million cells
Standard Deviation 804.67
|
52.4 CD4+ T-cells/million cells
Standard Deviation 56.2
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.UspA2, Day 60
|
383.9 CD4+ T-cells/million cells
Standard Deviation 326.2
|
253 CD4+ T-cells/million cells
Standard Deviation 202.76
|
278.7 CD4+ T-cells/million cells
Standard Deviation 672.84
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.UspA2, Day 90
|
1392.6 CD4+ T-cells/million cells
Standard Deviation 1145.48
|
979.2 CD4+ T-cells/million cells
Standard Deviation 807.03
|
143.5 CD4+ T-cells/million cells
Standard Deviation 237.29
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.UspA2, Day 210
|
582.9 CD4+ T-cells/million cells
Standard Deviation 376.54
|
322.8 CD4+ T-cells/million cells
Standard Deviation 273.5
|
143.9 CD4+ T-cells/million cells
Standard Deviation 242.72
|
—
|
|
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD4+.UspA2, Day 420
|
723.2 CD4+ T-cells/million cells
Standard Deviation 763.51
|
385.4 CD4+ T-cells/million cells
Standard Deviation 174.08
|
126.6 CD4+ T-cells/million cells
Standard Deviation 187.52
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (pre-dose 1); at Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
Frequency of specific CD8+ T-cells are measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers (such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L). The frequency of specific CD8+ T-cells are summarised \[descriptive statistics: Mean and standard deviation (SD)\] against each antigen (PD, PE, PilA and UspA2), by group in Step 2 at each time point during which blood samples are collected for CMI.
Outcome measures
| Measure |
GSK3277513A F1 Group
n=15 Participants
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=12 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=13 Participants
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.PD, Day 60
|
29.4 CD8+ T-cells/million cells
Standard Deviation 49.67
|
1 CD8+ T-cells/million cells
Standard Deviation 0
|
20.5 CD8+ T-cells/million cells
Standard Deviation 55.1
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.PE, Day 0
|
42.4 CD8+ T-cells/million cells
Standard Deviation 52.5
|
33.3 CD8+ T-cells/million cells
Standard Deviation 59.32
|
74.4 CD8+ T-cells/million cells
Standard Deviation 175.42
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.PE, Day 90
|
30.4 CD8+ T-cells/million cells
Standard Deviation 52.48
|
19.8 CD8+ T-cells/million cells
Standard Deviation 43.69
|
45.4 CD8+ T-cells/million cells
Standard Deviation 82.76
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.UspA2, Day 0
|
22.5 CD8+ T-cells/million cells
Standard Deviation 35.07
|
34.9 CD8+ T-cells/million cells
Standard Deviation 50.24
|
85.3 CD8+ T-cells/million cells
Standard Deviation 140.42
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.UspA2, Day 210
|
61.5 CD8+ T-cells/million cells
Standard Deviation 89.07
|
17.3 CD8+ T-cells/million cells
Standard Deviation 26.54
|
48.1 CD8+ T-cells/million cells
Standard Deviation 53.97
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.UspA2, Day 420
|
16.7 CD8+ T-cells/million cells
Standard Deviation 24.45
|
25.3 CD8+ T-cells/million cells
Standard Deviation 70.42
|
48.8 CD8+ T-cells/million cells
Standard Deviation 86.71
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.PD, Day 0
|
66 CD8+ T-cells/million cells
Standard Deviation 88.69
|
27.9 CD8+ T-cells/million cells
Standard Deviation 80.68
|
46.9 CD8+ T-cells/million cells
Standard Deviation 73.28
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.PD, Day 90
|
66.5 CD8+ T-cells/million cells
Standard Deviation 97.16
|
7.7 CD8+ T-cells/million cells
Standard Deviation 21.19
|
49 CD8+ T-cells/million cells
Standard Deviation 64.89
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.PD, Day 210
|
66.4 CD8+ T-cells/million cells
Standard Deviation 101.79
|
16.8 CD8+ T-cells/million cells
Standard Deviation 42.84
|
17.7 CD8+ T-cells/million cells
Standard Deviation 33.01
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.PD, Day 420
|
43.2 CD8+ T-cells/million cells
Standard Deviation 51.32
|
10.6 CD8+ T-cells/million cells
Standard Deviation 17.98
|
37.3 CD8+ T-cells/million cells
Standard Deviation 70.58
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.PE, Day 60
|
27.8 CD8+ T-cells/million cells
Standard Deviation 46.77
|
26.1 CD8+ T-cells/million cells
Standard Deviation 40.81
|
42.7 CD8+ T-cells/million cells
Standard Deviation 107.03
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.PE, Day 210
|
31.8 CD8+ T-cells/million cells
Standard Deviation 52.08
|
30.6 CD8+ T-cells/million cells
Standard Deviation 62.25
|
44.2 CD8+ T-cells/million cells
Standard Deviation 85.37
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.PE, Day 420
|
5.7 CD8+ T-cells/million cells
Standard Deviation 10.89
|
27 CD8+ T-cells/million cells
Standard Deviation 58.46
|
19.4 CD8+ T-cells/million cells
Standard Deviation 44.74
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.PilA, Day 0
|
34.6 CD8+ T-cells/million cells
Standard Deviation 57.02
|
16 CD8+ T-cells/million cells
Standard Deviation 40.27
|
44.7 CD8+ T-cells/million cells
Standard Deviation 58.58
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.PilA, Day 60
|
26 CD8+ T-cells/million cells
Standard Deviation 82.07
|
35.1 CD8+ T-cells/million cells
Standard Deviation 39.81
|
28.7 CD8+ T-cells/million cells
Standard Deviation 72.65
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.PilA, Day 90
|
50.8 CD8+ T-cells/million cells
Standard Deviation 82.01
|
27.9 CD8+ T-cells/million cells
Standard Deviation 43.03
|
28.3 CD8+ T-cells/million cells
Standard Deviation 45.69
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.PilA, Day 210
|
11.3 CD8+ T-cells/million cells
Standard Deviation 19.17
|
30.9 CD8+ T-cells/million cells
Standard Deviation 70.04
|
21.4 CD8+ T-cells/million cells
Standard Deviation 35.86
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.PilA, Day 420
|
28 CD8+ T-cells/million cells
Standard Deviation 50.45
|
23 CD8+ T-cells/million cells
Standard Deviation 37.7
|
28 CD8+ T-cells/million cells
Standard Deviation 39.21
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.UspA2, Day 60
|
29.3 CD8+ T-cells/million cells
Standard Deviation 67.7
|
27.7 CD8+ T-cells/million cells
Standard Deviation 50.12
|
21 CD8+ T-cells/million cells
Standard Deviation 36.81
|
—
|
|
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
CD8+.UspA2, Day 90
|
74.1 CD8+ T-cells/million cells
Standard Deviation 99.92
|
20.6 CD8+ T-cells/million cells
Standard Deviation 26.17
|
37.4 CD8+ T-cells/million cells
Standard Deviation 76.73
|
—
|
Adverse Events
GSK3277513A F1 Group
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
GSK3277513A F2 Group
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
GSK3277513A F3 Group
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
PLACEBO Group
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK3277513A F1 Group
n=15 participants at risk
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 participants at risk
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=30 participants at risk
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=44 participants at risk
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/15 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/31 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/30 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
2.3%
1/44 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Infections and infestations
Gastroenteritis
|
6.7%
1/15 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/31 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/30 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/44 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/31 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
3.3%
1/30 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/44 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/15 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/31 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/30 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
2.3%
1/44 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/15 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/31 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
3.3%
1/30 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/44 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/15 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/31 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
3.3%
1/30 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/44 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
Other adverse events
| Measure |
GSK3277513A F1 Group
n=15 participants at risk
Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F2 Group
n=31 participants at risk
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
GSK3277513A F3 Group
n=30 participants at risk
Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
PLACEBO Group
n=44 participants at risk
Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Limb injury
|
6.7%
1/15 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/31 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/30 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/44 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Infections and infestations
Lymph gland infection
|
6.7%
1/15 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/31 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/30 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/44 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/31 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/30 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/44 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
3.2%
1/31 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
10.0%
3/30 • Number of events 3 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
2.3%
1/44 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
2/15 • Number of events 2 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
3.2%
1/31 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/30 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
2.3%
1/44 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
General disorders
Fatigue
|
26.7%
4/15 • Number of events 6 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
32.3%
10/31 • Number of events 12 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
60.0%
18/30 • Number of events 24 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
27.3%
12/44 • Number of events 16 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
26.7%
4/15 • Number of events 4 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
6.5%
2/31 • Number of events 2 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
16.7%
5/30 • Number of events 7 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
6.8%
3/44 • Number of events 4 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
6.7%
1/15 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/31 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/30 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/44 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Nervous system disorders
Headache
|
46.7%
7/15 • Number of events 10 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
22.6%
7/31 • Number of events 8 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
53.3%
16/30 • Number of events 21 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
22.7%
10/44 • Number of events 13 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Infections and infestations
Influenza
|
0.00%
0/15 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
6.5%
2/31 • Number of events 2 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/30 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
4.5%
2/44 • Number of events 2 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
General disorders
Injection site erythema
|
0.00%
0/15 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
16.1%
5/31 • Number of events 6 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
16.7%
5/30 • Number of events 6 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/44 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
General disorders
Injection site pain
|
46.7%
7/15 • Number of events 9 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
80.6%
25/31 • Number of events 43 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
93.3%
28/30 • Number of events 51 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
25.0%
11/44 • Number of events 14 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
General disorders
Injection site swelling
|
0.00%
0/15 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
16.1%
5/31 • Number of events 6 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
10.0%
3/30 • Number of events 3 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/44 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/31 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/30 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
2.3%
1/44 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
General disorders
Malaise
|
6.7%
1/15 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/31 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/30 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/44 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
3/15 • Number of events 3 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
35.5%
11/31 • Number of events 15 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
40.0%
12/30 • Number of events 17 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
13.6%
6/44 • Number of events 7 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
6.7%
1/15 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/31 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/30 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/44 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
3/15 • Number of events 3 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
16.1%
5/31 • Number of events 6 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
23.3%
7/30 • Number of events 10 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
25.0%
11/44 • Number of events 11 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
3.2%
1/31 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/30 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
2.3%
1/44 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Number of events 2 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
9.7%
3/31 • Number of events 3 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
16.7%
5/30 • Number of events 5 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
2.3%
1/44 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/15 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/31 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
6.7%
2/30 • Number of events 2 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
2.3%
1/44 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Renal and urinary disorders
Sterile pyuria
|
6.7%
1/15 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/31 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/30 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/44 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
6.7%
1/15 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
0.00%
0/31 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
3.3%
1/30 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
2.3%
1/44 • Number of events 1 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
6.5%
2/31 • Number of events 2 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
6.7%
2/30 • Number of events 2 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
6.8%
3/44 • Number of events 3 • Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420)
|
Additional Information
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