Trial Outcomes & Findings for Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults (NCT NCT00814489)
NCT ID: NCT00814489
Last Updated: 2018-08-08
Results Overview
Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom was defined as occurrence of any solicited local symptom regardless of intensity grade. Solicited general symptoms assessed were fatigue, gastrointestinal, headache, malaise, myalgia and temperature Any temperature was defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C). For other symptoms: Any = any general symptom reported irrespective of intensity grade and relationship to vaccination.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
During a 7-day follow up period after any vaccination
Results posted on
2018-08-08
Participant Flow
Participant milestones
| Measure |
GSK2254233A Group
Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
GSK2254232A Group
Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Engerix Group
Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
17
|
8
|
|
Overall Study
COMPLETED
|
13
|
17
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
GSK2254233A Group
Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
GSK2254232A Group
Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Engerix Group
Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Overall Study
Other
|
2
|
0
|
1
|
Baseline Characteristics
Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults
Baseline characteristics by cohort
| Measure |
GSK2254233A Group
n=15 Participants
Subjects received 2 doses of GSK2254233A adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2.The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
GSK2254232A Group
n=17 Participants
Subjects received 2 doses of non-adjuvanted GSK2254232A Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Engerix Group
n=8 Participants
Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.9 Years
STANDARD_DEVIATION 5.91 • n=5 Participants
|
24.3 Years
STANDARD_DEVIATION 3.69 • n=7 Participants
|
26.6 Years
STANDARD_DEVIATION 5.50 • n=5 Participants
|
25.7 Years
STANDARD_DEVIATION 5.01 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During a 7-day follow up period after any vaccinationPopulation: The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.
Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom was defined as occurrence of any solicited local symptom regardless of intensity grade. Solicited general symptoms assessed were fatigue, gastrointestinal, headache, malaise, myalgia and temperature Any temperature was defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C). For other symptoms: Any = any general symptom reported irrespective of intensity grade and relationship to vaccination.
Outcome measures
| Measure |
GSK2254233A Group
n=15 Participants
Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
GSK2254232A Group
n=17 Participants
Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Engerix Group
n=8 Participants
Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any Solicited Local and General Symptoms
Any pain
|
15 Subjects
|
16 Subjects
|
4 Subjects
|
|
Number of Subjects With Any Solicited Local and General Symptoms
Any redness
|
10 Subjects
|
7 Subjects
|
1 Subjects
|
|
Number of Subjects With Any Solicited Local and General Symptoms
Any swelling
|
6 Subjects
|
7 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Solicited Local and General Symptoms
Any fatigue
|
12 Subjects
|
13 Subjects
|
5 Subjects
|
|
Number of Subjects With Any Solicited Local and General Symptoms
Any gastrointestinal
|
4 Subjects
|
6 Subjects
|
1 Subjects
|
|
Number of Subjects With Any Solicited Local and General Symptoms
Any headache
|
11 Subjects
|
10 Subjects
|
5 Subjects
|
|
Number of Subjects With Any Solicited Local and General Symptoms
Any malaise
|
6 Subjects
|
7 Subjects
|
2 Subjects
|
|
Number of Subjects With Any Solicited Local and General Symptoms
Any myalgia
|
13 Subjects
|
8 Subjects
|
3 Subjects
|
|
Number of Subjects With Any Solicited Local and General Symptoms
Any temperature
|
10 Subjects
|
7 Subjects
|
2 Subjects
|
PRIMARY outcome
Timeframe: During a 30-day (Days 0-29) follow up period after any vaccinationPopulation: The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Outcome measures
| Measure |
GSK2254233A Group
n=15 Participants
Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
GSK2254232A Group
n=17 Participants
Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Engerix Group
n=8 Participants
Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AE)
|
10 Subjects
|
10 Subjects
|
6 Subjects
|
PRIMARY outcome
Timeframe: From Day 0 to Day 420Population: The analysis was based on the Total Vaccinated Cohort, which included subjects with at least one study vaccine administration documented.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
GSK2254233A Group
n=15 Participants
Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
GSK2254232A Group
n=17 Participants
Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Engerix Group
n=8 Participants
Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
PRIMARY outcome
Timeframe: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.
Biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA) and urea (URE). Abnormalities reported include values outside the normal ranges. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3.
Outcome measures
| Measure |
GSK2254233A Group
n=15 Participants
Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
GSK2254232A Group
n=17 Participants
Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Engerix Group
n=8 Participants
Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
URE, Post Dose 2 or 3 (Day 300) [N=15,16,5]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
ALT, Pre Dose 1 (Day 0) [N=2,2,0]
|
0 Subjects
|
0 Subjects
|
NA Subjects
This parameter was not measured at Day 0 for subjects in the Engerix Group.
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
ALT, Post Dose 1 (Day 7) [N=15,17,8]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
ALT, Post Dose 1 (Day 60) [N=15,17,7]
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
ALT, Post Dose 2 (Day 67) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
ALT, Post Dose 2 (Day 180) [N=14,17,7]
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
ALT, Post Dose 2 or 3 (Day 300) [N=15,16,6]
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
ALT, Post Dose 2 or 3 (Day 420) [N=14,16,7]
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
AST, Pre Dose 1 (Day 0) [N=2,3,0]
|
0 Subjects
|
0 Subjects
|
NA Subjects
This parameter was not measured at Day 0 for subjects in the Engerix Group.
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
AST, Post Dose 1 (Day 7) [N=15,17,8]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
AST, Post Dose 1 (Day 60) [N=15,17,7]
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
AST, Post Dose 2 (Day 67) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
AST, Post Dose 2 (Day 180) [N=15,17,7]
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
AST, Post Dose 2 or 3 (Day 300) [N=15,16,6]
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
AST, Post Dose 2 or 3 (Day 420) [N=14,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
CREA, Pre Dose 1 (Day 0) [N=2,3,0]
|
0 Subjects
|
0 Subjects
|
NA Subjects
This parameter was not measured at Day 0 for subjects in the Engerix Group.
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
CREA, Post Dose 1 (Day 7) [N=15,17,8]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
CREA, Post Dose 1 (Day 60) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
CREA, Post Dose 2 (Day 67) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
CREA, Post Dose 2 (Day 180) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
CREA, Post Dose 2 or 3 (Day 300) [N=15,16,5]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
CREA, Post Dose 2 or 3 (Day 420) [N=14,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
URE, Pre Dose 1 (Day 0) [N=2,3,0]
|
0 Subjects
|
0 Subjects
|
NA Subjects
This parameter was not measured at Day 0 for subjects in the Engerix Group.
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
URE, Post Dose 1 (Day 7) [N=15,17,8]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
URE, Post Dose 1 (Day 60) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
URE, Post Dose 2 (Day 67) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
URE, Post Dose 2 (Day 180) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Biochemical Laboratory Abnormalities
URE, Post Dose 2 or 3 (Day 420) [N=14,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
PRIMARY outcome
Timeframe: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.Population: The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.
Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges. This outcome presents results for RBC, WBC High and Low, PLA and HEM. Time points were presented as before (pre) or after (post) doses 1, 2 or 3.
Outcome measures
| Measure |
GSK2254233A Group
n=15 Participants
Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
GSK2254232A Group
n=17 Participants
Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Engerix Group
n=8 Participants
Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
WBC Low, Post Dose 1 (Day 60) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
WBC Low, Post Dose 2 (Day 67) [N=15,17,7]
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
WBC Low, Post Dose 2 (Day 180) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
WBC Low, Post Dose 2 or 3 (Day 300) [N=15,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
WBC Low, Post Dose 2 or 3 (Day 420) [N=14,16,7]
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
PLA, Pre Dose 1 (Day 0) [N=2,3,0]
|
0 Subjects
|
0 Subjects
|
NA Subjects
This parameter was not assessed at Day 0 for subjects in the Engerix Group.
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
PLA, Pre Dose 1 (Day 7) [N=15,17,8]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
PLA, Post Dose 1 (Day 60) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
PLA, Post Dose 2 (Day 67) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
RBC, Post Dose 2 (Day 180) [N=15,17,7]
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
RBC, Post Dose 2 or 3 (Day 300) [N=15,16,7]
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
RBC, Post Dose 2 or 3 (Day 420) [N=14,16,7]
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
RBC, Post Dose 2 (Day 67) [N=15,17,7]
|
3 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
WBC High, Pre Dose 1 (Day 0) [N=2,4,0]
|
0 Subjects
|
0 Subjects
|
NA Subjects
This parameter was not assessed at Day 0 for subjects in the Engerix Group.
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
WBC High, Post Dose 1 (Day 7) [N=15,17,8]
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
WBC High, Post Dose 1 (Day 60) [N=15,17,7]
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
WBC High, Post Dose 2 (Day 67) [N=15,17,7]
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
WBC High, Post Dose 2 (Day 180) [N=15,17,7]
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
WBC High, Post Dose 2 or 3 (Day 300) [N=15,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
WBC High, Post Dose 2 or 3 (Day 420) [N=14,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
WBC Low, Pre Dose 1 (Day 0) [N=2,4,0]
|
0 Subjects
|
0 Subjects
|
NA Subjects
This parameter was not assessed at Day 0 for subjects in the Engerix Group.
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
WBC Low, Post Dose 1 (Day 7) [N=15,17,8]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
RBC, Pre Dose 1 (Day 0) [N=2,3,0]
|
0 Subjects
|
0 Subjects
|
NA Subjects
This parameter was not assessed at Day 0 for subjects in the Engerix Group.
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
RBC, Post Dose 1 (Day 7) [N=15,17,8]
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
RBC, Post Dose 1 (Day 60) [N=15,17,7]
|
1 Subjects
|
4 Subjects
|
2 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
PLA, Post Dose 2 (Day 180) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
PLA, Post Dose 2 or 3 (Day 300) [N=15,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
PLA, Post Dose 2 or 3 (Day 420) [N=14,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
HEM, Pre Dose 1 (Day 0) [N=2,3,0]
|
0 Subjects
|
0 Subjects
|
NA Subjects
This parameter was not assessed at Day 0 for subjects in the Engerix Group.
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
HEM, Post Dose 1 (Day 7) [N=15,17,8]
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
HEM, Post Dose 1 (Day 60) [N=15,17,7]
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
HEM, Post Dose 2 (Day 67) [N=15,17,7]
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
HEM, Post Dose 2 (Day 180) [N=15,17,7]
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
HEM, Post Dose 2 or 3 (Day 300) [N=15,16,7]
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
HEM, Post Dose 2 or 3 (Day 420) [N=14,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
PRIMARY outcome
Timeframe: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.Population: The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.
Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON)), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges. This outcome presents results for BAS, NEU, LYM, EOS and MON. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3.
Outcome measures
| Measure |
GSK2254233A Group
n=15 Participants
Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
GSK2254232A Group
n=17 Participants
Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Engerix Group
n=8 Participants
Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
BAS, Pre Dose 1 (Day 0) [N=2,4,0]
|
0 Subjects
|
0 Subjects
|
NA Subjects
This parameter was not assessed at Day 0 for subjects in the Engerix Group.
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
BAS, Post Dose 1 (Day 7) [N=15,17,8]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
BAS, Post Dose 1 (Day 60) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
BAS, Post Dose 2 (Day 67) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
BAS, Post Dose 2 (Day 180) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
BAS, Post Dose 2 or 3 (Day 300) [N=15,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
BAS, Post Dose 2 or 3 (Day 420) [N=14,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
NEU, Pre Dose 1 (Day 0) [N=2,4,0]
|
0 Subjects
|
0 Subjects
|
NA Subjects
This parameter was not assessed at Day 0 for subjects in the Engerix Group.
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
NEU, Post Dose 1 (Day 7) [N=15,17,8]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
NEU, Post Dose 1 (Day 60) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
NEU, Post Dose 2 (Day 67) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
NEU, Post Dose 2 (Day 180) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
NEU, Post Dose 2 or 3 (Day 300) [N=15,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
NEU, Post Dose 2 or 3 (Day 420) [N=14,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
LYM, Pre Dose 1 (Day 0) [N=2,4,0]
|
0 Subjects
|
0 Subjects
|
NA Subjects
This parameter was not assessed at Day 0 for subjects in the Engerix Group.
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
LYM, Post Dose 1 (Day 7) [N=15,17,8]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
LYM, Post Dose 1 (Day 60) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
LYM, Post Dose 2 (Day 67) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
LYM, Post Dose 2 (Day 180) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
LYM, Post Dose 2 or 3 (Day 300) [N=15,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
LYM, Post Dose 2 or 3 (Day 420) [N=14,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
EOS, Pre Dose 1 (Day 0) [N=2,4,0]
|
0 Subjects
|
0 Subjects
|
NA Subjects
This parameter was not assessed at Day 0 for subjects in the Engerix Group.
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
EOS, Post Dose 1 (Day 7) [N=15,17,8]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
EOS, Post Dose 1 (Day 60) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
EOS, Post Dose 2 (Day 67) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
EOS, Post Dose 2 (Day 180) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
EOS, Post Dose 2 or 3 (Day 300) [N=15,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
EOS, Post Dose 2 or 3 (Day 420) [N=14,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
MON, Pre Dose 1 (Day 0) [N=2,4,0]
|
0 Subjects
|
0 Subjects
|
NA Subjects
This parameter was not assessed at Day 0 for subjects in the Engerix Group.
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
MON, Post Dose 1 (Day 7) [N=15,17,8]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
MON, Post Dose 1 (Day 60) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
MON, Post Dose 2 (Day 67) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
MON, Post Dose 2 (Day 180) [N=15,17,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
MON, Post Dose 2 or 3 (Day 300) [N=15,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any Hematological Laboratory Abnormalities
MON, Post Dose 2 or 3 (Day 420) [N=14,16,7]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Days 0, 30, 60, 90, 180 and 420.Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.
Concentrations were given as Geometric Mean Concentrations (GMCs). The cut-off values were 112 Luminex Units per milliliter (LU/mL) for Anti-PD, 391 LU/mL for Anti-PhtD and 591 LU/mL for Anti-Ply.
Outcome measures
| Measure |
GSK2254233A Group
n=15 Participants
Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
GSK2254232A Group
n=17 Participants
Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Engerix Group
n=7 Participants
Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-PD, Day 0 [N=15,17,7]
|
128.4 LU/mL
Interval 84.3 to 195.5
|
92.3 LU/mL
Interval 63.0 to 135.2
|
286.9 LU/mL
Interval 178.9 to 460.1
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-PD, Day 30 [N=15,17,7]
|
1314.4 LU/mL
Interval 908.5 to 1901.7
|
611.8 LU/mL
Interval 383.2 to 976.5
|
274.9 LU/mL
Interval 173.7 to 435.2
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-PD, Day 60 [N=15,17,7]
|
791.3 LU/mL
Interval 548.4 to 1141.7
|
322.6 LU/mL
Interval 198.3 to 524.8
|
242.9 LU/mL
Interval 149.0 to 395.8
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-PD, Day 90 [N=15,17,7]
|
2142.2 LU/mL
Interval 1224.5 to 3747.6
|
940.9 LU/mL
Interval 534.9 to 1655.0
|
271.2 LU/mL
Interval 173.7 to 423.5
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-PD, Day 180 [N=14,17,7]
|
1351.9 LU/mL
Interval 711.6 to 2568.3
|
416.2 LU/mL
Interval 221.8 to 781.2
|
242.8 LU/mL
Interval 124.8 to 472.5
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-PD, Day 420 [N=13,16,6]
|
943.4 LU/mL
Interval 486.1 to 1830.8
|
278.9 LU/mL
Interval 152.4 to 510.2
|
230.4 LU/mL
Interval 104.8 to 506.9
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-PhtD, Day 0 [N=15,17,7]
|
21128.2 LU/mL
Interval 14752.8 to 30258.6
|
23633.0 LU/mL
Interval 15894.5 to 35139.1
|
18313.4 LU/mL
Interval 10213.3 to 32837.6
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-PhtD, Day 30 [N=15,17,7]
|
78690.3 LU/mL
Interval 52101.6 to 118848.0
|
56628.0 LU/mL
Interval 36231.6 to 88506.4
|
17881.4 LU/mL
Interval 9569.3 to 33413.6
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-PhtD, Day 60 [N=15,17,7]
|
87193.5 LU/mL
Interval 54264.6 to 140104.3
|
58419.9 LU/mL
Interval 36277.8 to 94076.3
|
16396.0 LU/mL
Interval 8813.5 to 30501.9
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-PhtD, Day 90 [N=15,17,7]
|
140774.7 LU/mL
Interval 99455.4 to 199260.3
|
110714.0 LU/mL
Interval 72468.8 to 169142.8
|
20184.0 LU/mL
Interval 10800.8 to 37719.1
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-PhtD, Day 180 [N=14,17,7]
|
87320.6 LU/mL
Interval 61726.8 to 123526.3
|
73013.5 LU/mL
Interval 50712.8 to 105120.8
|
14537.6 LU/mL
Interval 8965.9 to 23571.9
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-PhtD, Day 420 [N=13,16,7]
|
52951.7 LU/mL
Interval 36919.6 to 75945.6
|
52798.1 LU/mL
Interval 36302.4 to 76789.3
|
14432.0 LU/mL
Interval 7243.1 to 28755.7
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-Ply, Day 0 [N=15,17,7]
|
14298.4 LU/mL
Interval 10112.9 to 20216.2
|
14059.5 LU/mL
Interval 9488.5 to 20832.6
|
17523.6 LU/mL
Interval 8747.5 to 35104.6
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-Ply, Day 30 [N=15,17,7]
|
170818.2 LU/mL
Interval 116569.1 to 250313.8
|
106387.7 LU/mL
Interval 50833.5 to 222655.3
|
20190.6 LU/mL
Interval 9177.3 to 44420.5
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-Ply, Day 60 [N=15,17,7]
|
161893.6 LU/mL
Interval 104981.6 to 249658.5
|
87557.0 LU/mL
Interval 41715.7 to 183773.6
|
18387.8 LU/mL
Interval 8281.0 to 40829.5
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-Ply, Day 90 [N=15,17,7]
|
274366.3 LU/mL
Interval 206601.5 to 364357.6
|
163653.4 LU/mL
Interval 92214.9 to 290434.8
|
21144.8 LU/mL
Interval 10650.6 to 41978.8
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-Ply, Day 180 [N=14,17,7]
|
139883.3 LU/mL
Interval 103879.1 to 188366.5
|
91157.5 LU/mL
Interval 53308.3 to 155880.0
|
16737.4 LU/mL
Interval 7740.2 to 36193.1
|
|
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Anti-Ply, Day 420 [N=13,16,7]
|
92790.4 LU/mL
Interval 64466.4 to 133558.8
|
59059.5 LU/mL
Interval 34604.5 to 100797.0
|
15832.6 LU/mL
Interval 8103.3 to 30934.3
|
SECONDARY outcome
Timeframe: Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.
The mean number was calculated for CD4+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) or pneumolysin toxoid (dPly), identified as producing T-lymphocyte Helper 1 cells (Th1) versus Th2 cytokines (interferon-gamma (IFN-g) and interleukin-13 (IL-13) respectively, as measured by intracellular staining (ICS) on Peripheral Blood Mononuclear Cells (PBMCs). The outcome presents results for cells producing the following combinations: Th1=IFN-g, Th 2=IL13 and/or IL5 and Th17=IL17.
Outcome measures
| Measure |
GSK2254233A Group
n=14 Participants
Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
GSK2254232A Group
n=17 Participants
Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Engerix Group
n=7 Participants
Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 1, PD specific, Day 0 [N=14,17,7]
|
13.4 T-cells/million cells
Standard Deviation 32.1
|
6.8 T-cells/million cells
Standard Deviation 23.5
|
10.4 T-cells/million cells
Standard Deviation 21.4
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 1, PD specific, Day 14 [N=13,17,6]
|
22.2 T-cells/million cells
Standard Deviation 42.5
|
7.7 T-cells/million cells
Standard Deviation 35.9
|
7.2 T-cells/million cells
Standard Deviation 29.0
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 1, PD specific, Day 74 [N=13,17,7]
|
157.6 T-cells/million cells
Standard Deviation 239.1
|
37.9 T-cells/million cells
Standard Deviation 39.9
|
-6.0 T-cells/million cells
Standard Deviation 32.1
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 1, PD specific, Day 480 [N=11,17,6]
|
8.0 T-cells/million cells
Standard Deviation 38.5
|
-5.8 T-cells/million cells
Standard Deviation 23.0
|
58.7 T-cells/million cells
Standard Deviation 94.4
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 1, PhtD specific, Day 0 [N=14,17,7]
|
0.0 T-cells/million cells
Standard Deviation 30.8
|
-2.4 T-cells/million cells
Standard Deviation 21.4
|
-5.1 T-cells/million cells
Standard Deviation 16.6
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 1, PhtD specific, Day 14 [N=13,17,6]
|
177.5 T-cells/million cells
Standard Deviation 263.9
|
61.6 T-cells/million cells
Standard Deviation 122.3
|
6.3 T-cells/million cells
Standard Deviation 20.1
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 1, PhtD specific, Day 74 [N=13,17,7]
|
552.3 T-cells/million cells
Standard Deviation 374.0
|
305.4 T-cells/million cells
Standard Deviation 294.4
|
-1.9 T-cells/million cells
Standard Deviation 34.9
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 1, PhtD specific, Day 480 [N=11,17,6]
|
34.0 T-cells/million cells
Standard Deviation 65.1
|
16.8 T-cells/million cells
Standard Deviation 37.4
|
14.5 T-cells/million cells
Standard Deviation 25.9
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 1, dPly specific, Day 0 [N=14,17,7]
|
75.9 T-cells/million cells
Standard Deviation 63.1
|
27.0 T-cells/million cells
Standard Deviation 52.6
|
133.4 T-cells/million cells
Standard Deviation 209.9
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 1, dPly specific, Day 14 [N=13,17,6]
|
233.1 T-cells/million cells
Standard Deviation 199.0
|
99.3 T-cells/million cells
Standard Deviation 163.7
|
92.5 T-cells/million cells
Standard Deviation 138.8
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 1, dPly specific, Day 74 [N=13,17,7]
|
576.1 T-cells/million cells
Standard Deviation 348.2
|
214.8 T-cells/million cells
Standard Deviation 235.5
|
76.7 T-cells/million cells
Standard Deviation 90.6
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 1, dPly specific, Day 480 [N=11,17,6]
|
14.9 T-cells/million cells
Standard Deviation 33.8
|
0.8 T-cells/million cells
Standard Deviation 22.1
|
8.5 T-cells/million cells
Standard Deviation 13.4
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 2, PD specific, Day 0 [N=14,17,7]
|
24.6 T-cells/million cells
Standard Deviation 287.7
|
-35.4 T-cells/million cells
Standard Deviation 328.2
|
267.3 T-cells/million cells
Standard Deviation 887.7
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 2, PD specific, Day 14 [N=13,17,6]
|
-46.1 T-cells/million cells
Standard Deviation 350.3
|
40.0 T-cells/million cells
Standard Deviation 120.7
|
381.5 T-cells/million cells
Standard Deviation 1016.8
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 2, PD specific, Day 74 [N=13,17,7]
|
-56.1 T-cells/million cells
Standard Deviation 183.0
|
-42.0 T-cells/million cells
Standard Deviation 265.8
|
-43.6 T-cells/million cells
Standard Deviation 242.6
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 2, PD specific, Day 480 [N=11,17,6]
|
1.1 T-cells/million cells
Standard Deviation 141.7
|
13.2 T-cells/million cells
Standard Deviation 176.1
|
161.0 T-cells/million cells
Standard Deviation 394.8
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 2, PhtD specific, Day 0 [N=14,17,7]
|
-82.4 T-cells/million cells
Standard Deviation 212.4
|
-15.6 T-cells/million cells
Standard Deviation 305.5
|
238.1 T-cells/million cells
Standard Deviation 1001.4
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 2, PhtD specific, Day 14 [N=13,17,6]
|
-72.7 T-cells/million cells
Standard Deviation 373.4
|
-47.0 T-cells/million cells
Standard Deviation 242.2
|
339.8 T-cells/million cells
Standard Deviation 1056.8
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 2, PhtD specific, Day 74 [N=13,17,7]
|
-100.8 T-cells/million cells
Standard Deviation 245.0
|
-100.9 T-cells/million cells
Standard Deviation 252.9
|
-125.6 T-cells/million cells
Standard Deviation 453.7
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 2, PhtD specific, Day 480 [N=11,17,6]
|
14.9 T-cells/million cells
Standard Deviation 139.4
|
-8.9 T-cells/million cells
Standard Deviation 103.0
|
196.2 T-cells/million cells
Standard Deviation 351.7
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 2, dPly specific, Day 0 [N=14,17,7]
|
-76.3 T-cells/million cells
Standard Deviation 212.4
|
-31.2 T-cells/million cells
Standard Deviation 236.8
|
256.0 T-cells/million cells
Standard Deviation 1009.3
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 2, dPly specific, Day 14 [N=13,17,6]
|
-2.4 T-cells/million cells
Standard Deviation 236.8
|
-11.5 T-cells/million cells
Standard Deviation 128.3
|
407.2 T-cells/million cells
Standard Deviation 1227.7
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 2, dPly specific, Day 74 [N=13,17,7]
|
-4.9 T-cells/million cells
Standard Deviation 335.7
|
-15.7 T-cells/million cells
Standard Deviation 150.3
|
-126.9 T-cells/million cells
Standard Deviation 271.5
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 2, dPly specific, Day 480 [N=11,17,6]
|
6.9 T-cells/million cells
Standard Deviation 183.4
|
-14.7 T-cells/million cells
Standard Deviation 146.5
|
195.0 T-cells/million cells
Standard Deviation 414.8
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 17, PD specific, Day 0 [N=12,17,7]
|
24.7 T-cells/million cells
Standard Deviation 80.1
|
17.5 T-cells/million cells
Standard Deviation 39.7
|
8.0 T-cells/million cells
Standard Deviation 23.0
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 17, PD specific, Day 14 [N=12,17,6]
|
19.5 T-cells/million cells
Standard Deviation 58.6
|
-4.8 T-cells/million cells
Standard Deviation 42.7
|
-5.5 T-cells/million cells
Standard Deviation 71.0
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 17, PD specific, Day 74 [N=12,17,7]
|
31.1 T-cells/million cells
Standard Deviation 65.2
|
16.2 T-cells/million cells
Standard Deviation 66.7
|
-17.0 T-cells/million cells
Standard Deviation 52.8
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 17, PD specific, Day 480 [N=11,17,6]
|
13.5 T-cells/million cells
Standard Deviation 34.1
|
-4.6 T-cells/million cells
Standard Deviation 18.7
|
7.3 T-cells/million cells
Standard Deviation 15.3
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 17, PhtD specific, Day 0 [N=12,17,7]
|
23.4 T-cells/million cells
Standard Deviation 76.5
|
29.5 T-cells/million cells
Standard Deviation 56.4
|
12.4 T-cells/million cells
Standard Deviation 41.5
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 17, PhtD specific, Day 14 [N=12,17,6]
|
70.5 T-cells/million cells
Standard Deviation 94.3
|
26.1 T-cells/million cells
Standard Deviation 52.9
|
2.4 T-cells/million cells
Standard Deviation 49.9
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 17, PhtD specific, Day 74 [N=12,17,7]
|
360.8 T-cells/million cells
Standard Deviation 267.3
|
114.1 T-cells/million cells
Standard Deviation 112.3
|
-10.1 T-cells/million cells
Standard Deviation 45.3
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 17, PhtD specific, Day 480 [N=11,17,6]
|
7.6 T-cells/million cells
Standard Deviation 44.9
|
-0.5 T-cells/million cells
Standard Deviation 28.1
|
9.8 T-cells/million cells
Standard Deviation 20.2
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 17, dPly specific, Day 0 [N=12,17,7]
|
80.3 T-cells/million cells
Standard Deviation 83.0
|
63.9 T-cells/million cells
Standard Deviation 79.4
|
122.1 T-cells/million cells
Standard Deviation 158.8
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 17, dPly specific, Day 14 [N=12,17,6]
|
141.1 T-cells/million cells
Standard Deviation 90.5
|
95.4 T-cells/million cells
Standard Deviation 88.9
|
88.7 T-cells/million cells
Standard Deviation 57.5
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 17, dPly specific, Day 74 [N=12,17,7]
|
256.3 T-cells/million cells
Standard Deviation 137.3
|
169.9 T-cells/million cells
Standard Deviation 125.6
|
82.3 T-cells/million cells
Standard Deviation 83.0
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Th 17, dPly specific, Day 480 [N=11,17,6]
|
6.9 T-cells/million cells
Standard Deviation 30.7
|
14.0 T-cells/million cells
Standard Deviation 26.4
|
10.2 T-cells/million cells
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.
The mean number was calculated for CD8+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) and pneumolysin toxoid (dPly) and expressing the following citokine combinations: C1= at least interleukin 2 (IL2), tumor necrosis factor alpha (TNFa) and/or interferon-gamma (IFNg) and C2= at least interleukin 17 (IL17).
Outcome measures
| Measure |
GSK2254233A Group
n=14 Participants
Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
GSK2254232A Group
n=17 Participants
Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Engerix Group
n=7 Participants
Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C1, dPly specific, Day 480 [N=11,17,6]
|
-219.1 T-cells/million cells
Standard Deviation 655.0
|
58.1 T-cells/million cells
Standard Deviation 230.8
|
-15.2 T-cells/million cells
Standard Deviation 114.2
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C2, PD specific, Day 0 [N=12,17,7]
|
-19.0 T-cells/million cells
Standard Deviation 150.8
|
74.5 T-cells/million cells
Standard Deviation 195.7
|
38.7 T-cells/million cells
Standard Deviation 79.5
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C1, dPly specific, Day 14 [N=13,17,6]
|
5.0 T-cells/million cells
Standard Deviation 267.1
|
-29.8 T-cells/million cells
Standard Deviation 208.2
|
-104.0 T-cells/million cells
Standard Deviation 220.2
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C1, dPly specific, Day 74 [N=13,17,7]
|
-29.8 T-cells/million cells
Standard Deviation 253.7
|
41.6 T-cells/million cells
Standard Deviation 226.5
|
-88.1 T-cells/million cells
Standard Deviation 182.3
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C1, PD specific, Day 0 [N=14,17,7]
|
-65.0 T-cells/million cells
Standard Deviation 166.5
|
28.0 T-cells/million cells
Standard Deviation 115.3
|
3.3 T-cells/million cells
Standard Deviation 218.3
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C1, PD specific, Day 14 [N=13,17,6]
|
-164.8 T-cells/million cells
Standard Deviation 247.9
|
-20.7 T-cells/million cells
Standard Deviation 109.2
|
-44.3 T-cells/million cells
Standard Deviation 224.5
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C1, PD specific, Day 74 [N=13,17,7]
|
-133.3 T-cells/million cells
Standard Deviation 225.1
|
7.9 T-cells/million cells
Standard Deviation 238.8
|
-67.1 T-cells/million cells
Standard Deviation 162.7
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C1, PD specific, Day 480 [N=11,17,6]
|
-9.5 T-cells/million cells
Standard Deviation 525.9
|
68.1 T-cells/million cells
Standard Deviation 373.3
|
32.7 T-cells/million cells
Standard Deviation 77.3
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C1, PhtD specific, Day 0 [N=14,17,7]
|
36.8 T-cells/million cells
Standard Deviation 276.2
|
53.5 T-cells/million cells
Standard Deviation 154.8
|
68.6 T-cells/million cells
Standard Deviation 271.0
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C1, PhtD specific, Day 14 [N=13,17,6]
|
-53.2 T-cells/million cells
Standard Deviation 277.0
|
52.9 T-cells/million cells
Standard Deviation 170.8
|
-54.3 T-cells/million cells
Standard Deviation 190.7
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C1, PhtD specific, Day 74 [N=13,17,7]
|
-41.2 T-cells/million cells
Standard Deviation 269.3
|
122.5 T-cells/million cells
Standard Deviation 244.6
|
-7.4 T-cells/million cells
Standard Deviation 229.8
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C1, PhtD specific, Day 480 [N=11,17,6]
|
4.6 T-cells/million cells
Standard Deviation 517.1
|
105.6 T-cells/million cells
Standard Deviation 216.7
|
84.7 T-cells/million cells
Standard Deviation 114.5
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C1, dPly specific, Day 0 [N=14,17,7]
|
-25.2 T-cells/million cells
Standard Deviation 188.5
|
15.3 T-cells/million cells
Standard Deviation 129.5
|
-14.0 T-cells/million cells
Standard Deviation 192.1
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C2, PD specific, Day 14 [N=12,17,6]
|
81.8 T-cells/million cells
Standard Deviation 105.4
|
8.2 T-cells/million cells
Standard Deviation 98.8
|
-35.2 T-cells/million cells
Standard Deviation 77.5
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C2, PD specific, Day 74 [N=12,17,7]
|
19.0 T-cells/million cells
Standard Deviation 69.5
|
-11.9 T-cells/million cells
Standard Deviation 149.0
|
21.9 T-cells/million cells
Standard Deviation 81.1
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C2, PD specific, Day 480 [N=11,17,6]
|
-18.9 T-cells/million cells
Standard Deviation 91.9
|
103.5 T-cells/million cells
Standard Deviation 236.9
|
78.0 T-cells/million cells
Standard Deviation 110.9
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C2, PhtD specific, Day 0 [N=12,17,7]
|
-30.4 T-cells/million cells
Standard Deviation 144.8
|
56.0 T-cells/million cells
Standard Deviation 160.6
|
64.7 T-cells/million cells
Standard Deviation 106.9
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C2, PhtD specific, Day 14 [N=12,17,6]
|
28.8 T-cells/million cells
Standard Deviation 121.9
|
58.8 T-cells/million cells
Standard Deviation 130.8
|
15.7 T-cells/million cells
Standard Deviation 146.4
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C2, PhtD specific, Day 74 [N=12,17,7]
|
134.3 T-cells/million cells
Standard Deviation 321.7
|
20.5 T-cells/million cells
Standard Deviation 118.6
|
11.3 T-cells/million cells
Standard Deviation 68.2
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C2, PhtD specific, Day 480 [N=11,17,6]
|
7.9 T-cells/million cells
Standard Deviation 60.0
|
37.8 T-cells/million cells
Standard Deviation 233.5
|
109.8 T-cells/million cells
Standard Deviation 210.1
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C2, dPly specific, Day 0 [N=12,17,7]
|
-45.8 T-cells/million cells
Standard Deviation 119.5
|
31.0 T-cells/million cells
Standard Deviation 110.0
|
15.6 T-cells/million cells
Standard Deviation 83.3
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C2, dPly specific, Day 14 [N=12,17,6]
|
-4.6 T-cells/million cells
Standard Deviation 54.0
|
66.2 T-cells/million cells
Standard Deviation 124.1
|
1.9 T-cells/million cells
Standard Deviation 145.1
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C2, dPly specific, Day 74 [N=12,17,7]
|
7.3 T-cells/million cells
Standard Deviation 74.0
|
-30.5 T-cells/million cells
Standard Deviation 82.2
|
-17.1 T-cells/million cells
Standard Deviation 62.5
|
|
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
C2, dPly specific, Day 480 [N=11,17,6]
|
-3.7 T-cells/million cells
Standard Deviation 150.5
|
38.7 T-cells/million cells
Standard Deviation 174.5
|
50.3 T-cells/million cells
Standard Deviation 66.1
|
Adverse Events
GSK2254233A Group
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
GSK2254232A Group
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Engerix Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GSK2254233A Group
n=15 participants at risk
Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
GSK2254232A Group
n=17 participants at risk
Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Engerix Group
n=8 participants at risk
Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
6.7%
1/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
1/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
5.9%
1/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
12.5%
1/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
1/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
General disorders
Chills
|
26.7%
4/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
General disorders
Fatigue
|
80.0%
12/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
76.5%
13/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
62.5%
5/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
General disorders
Feeling hot
|
6.7%
1/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
General disorders
Influenza like illness
|
6.7%
1/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
General disorders
Injection site reaction
|
13.3%
2/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
11.8%
2/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
General disorders
Pyrexia
|
0.00%
0/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
11.8%
2/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
2/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
17.6%
3/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
12.5%
1/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Infections and infestations
Sinusitis
|
13.3%
2/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Infections and infestations
Tonsilitis
|
0.00%
0/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
12.5%
1/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Infections and infestations
Vaginal infection
|
6.7%
1/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Infections and infestations
Viral infection
|
0.00%
0/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
12.5%
1/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
5.9%
1/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
5.9%
1/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.7%
1/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Musculoskeletal and connective tissue disorders
Muscoskeletal pain
|
0.00%
0/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
5.9%
1/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Musculoskeletal and connective tissue disorders
Muscoskeletal stiffness
|
0.00%
0/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
5.9%
1/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
25.0%
2/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
5.9%
1/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
5.9%
1/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
5.9%
1/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
17.6%
3/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
25.0%
2/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
12.5%
1/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.3%
2/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
17.6%
3/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
12.5%
1/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
5.9%
1/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
5.9%
1/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
General disorders
Pain
|
100.0%
15/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
94.1%
16/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
50.0%
4/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
General disorders
Redness
|
66.7%
10/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
41.2%
7/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
12.5%
1/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
General disorders
Swelling
|
40.0%
6/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
41.2%
7/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
0.00%
0/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
General disorders
Gastrointestinal symptoms
|
26.7%
4/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
35.3%
6/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
12.5%
1/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
General disorders
Headache
|
73.3%
11/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
58.8%
10/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
62.5%
5/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
General disorders
Malaise
|
40.0%
6/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
41.2%
7/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
25.0%
2/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
General disorders
Myalgia
|
86.7%
13/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
47.1%
8/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
37.5%
3/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
|
General disorders
Fever
|
66.7%
10/15 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
41.2%
7/17 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
25.0%
2/8 • Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER