Trial Outcomes & Findings for Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women (NCT NCT02753413)
NCT ID: NCT02753413
Last Updated: 2018-06-26
Results Overview
Among analysed biochemical parameters were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CRE\]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
At Day 7
Results posted on
2018-06-26
Participant Flow
A total of 102 subject numbers were screened, but only 100 subjects were randomized and received vaccination.
Participant milestones
| Measure |
GSK3003891A Group
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
|
Overall Study
COMPLETED
|
49
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women
Baseline characteristics by cohort
| Measure |
GSK3003891A Group
n=49 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
n=51 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.80 Years
STANDARD_DEVIATION 5.90 • n=5 Participants
|
25.60 Years
STANDARD_DEVIATION 6.10 • n=7 Participants
|
25.70 Years
STANDARD_DEVIATION 5.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / European Heritage
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.
Among analysed biochemical parameters were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CRE\]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.
Outcome measures
| Measure |
GSK3003891A Group
n=49 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
n=51 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
|---|---|---|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
ALT, Within-Within
|
48 Participants
|
50 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
ALT, Within-Above
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
ALT, Within-Bellow
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
AST, Within-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
AST, Within-Within
|
48 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
AST, Within-Above
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
AST, Above-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
AST, Above-Within
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
AST, Above-Above
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
CRE, Within-Bellow
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
CRE, Within-Within
|
49 Participants
|
51 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
CRE, Within-Above
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 30Population: The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.
Among analysed biochemical parameters were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CRE\]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.
Outcome measures
| Measure |
GSK3003891A Group
n=49 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
n=51 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
|---|---|---|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
ALT, Within-Bellow
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
ALT, Within-Within
|
48 Participants
|
51 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
ALT, Within-Above
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
AST, Within-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
AST, Within-Within
|
47 Participants
|
51 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
AST, Within-Above
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
AST, Above-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
AST, Above-Within
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
AST, Above-Above
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
CRE, Within-Bellow
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
CRE, Within-Within
|
49 Participants
|
51 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Values.
CRE, Within-Above
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.
Among analysed haematological parameters were eosinophils \[EOS\], haemoglobin \[Hgb\], leukocytes (white blood cells) \[WBC\], lymphocytes \[LYM\], neutrophils \[NEU\] and platelets \[PLT\]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC.
Outcome measures
| Measure |
GSK3003891A Group
n=48 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
n=50 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
|---|---|---|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
EOS, Within-Bellow
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
EOS, Within-Within
|
46 Participants
|
45 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
EOS, Within-Above
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
EOS, Above-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
EOS, Above-Within
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
EOS, Above-Above
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
Hgb, Below-Below
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
Hgb, Below-Within
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
Hgb, Below-Above
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
Hgb, Within-Bellow
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
Hgb, Within-Within
|
47 Participants
|
50 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
Hgb, Within-Above
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
WBC, Within-Bellow
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
WBC, Within-Within
|
46 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
WBC, Within-Above
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
WBC, Above-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
WBC, Above-Within
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
WBC, Above-Above
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At Day 30Population: The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.
Among analysed haematological parameters were eosinophils \[EOS\], haemoglobin \[Hgb\], leukocytes (white blood cells) \[WBC\], lymphocytes \[LYM\], neutrophils \[NEU\] and platelets \[PLT\]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC.
Outcome measures
| Measure |
GSK3003891A Group
n=48 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
n=50 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
|---|---|---|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
EOS, Above-Above
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
Hgb, Below-Below
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
Hgb, Below-Within
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
Hgb, Below-Above
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
Hgb, Within-Bellow
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
Hgb, Within-Within
|
48 Participants
|
50 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
Hgb, Within-Above
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
WBC, Within-Bellow
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
WBC, Within-Within
|
47 Participants
|
45 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
WBC, Within-Above
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
WBC, Above-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
WBC, Above-Within
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
WBC, Above-Above
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
EOS, Within-Bellow
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
EOS, Within-Within
|
41 Participants
|
44 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
EOS, Within-Above
|
7 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
EOS, Above-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
EOS, Above-Within
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.
Among analysed haematological parameters were eosinophils \[EOS\], haemoglobin \[Hgb\], leukocytes (white blood cells) \[WBC\], lymphocytes \[LYM\], neutrophils \[NEU\] and platelets \[PLT\]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT
Outcome measures
| Measure |
GSK3003891A Group
n=48 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
n=50 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
|---|---|---|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Within-Within
|
42 Participants
|
45 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Within-Above
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Above-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Above-Within
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Below-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Below-Within
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Below-Above
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Within-Bellow
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Above-Above
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Below-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Below-Within
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Below-Above
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Within-Bellow
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Within-Within
|
44 Participants
|
44 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Within-Above
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Above-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Above-Within
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Above-Above
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
PLT, Within-Bellow
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
PLT, Within-Within
|
47 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
PLT, Within-Above
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
PLT, Above-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
PLT, Above-Within
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
PLT, Above-Above
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At Day 30Population: The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.
Among analysed haematological parameters were eosinophils \[EOS\], haemoglobin \[Hgb\], leukocytes (white blood cells) \[WBC\], lymphocytes \[LYM\], neutrophils \[NEU\] and platelets \[PLT\]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT.
Outcome measures
| Measure |
GSK3003891A Group
n=48 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
n=50 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
|---|---|---|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Below-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Below-Within
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Below-Above
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Within-Bellow
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Within-Within
|
44 Participants
|
46 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Within-Above
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Above-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Above-Within
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
LYM, Above-Above
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Below-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Below-Within
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Below-Above
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Within-Bellow
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Within-Within
|
46 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Within-Above
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Above-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Above-Within
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
NEU, Above-Above
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
PLT, Within-Bellow
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
PLT, Within-Within
|
47 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
PLT, Within-Above
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
PLT, Above-Below
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
PLT, Above-Within
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Values.
PLT, Above-Above
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Day 7 up to Day 30Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.
Among biochemical parameters tested were ALT, AST and CRE, graded by FDA toxicity grading for biochemistry parameters. Assessed grades were unknown, grade 0 \[G0\], grade 1 \[G1\] (mild), grade 2 \[G2\] (moderate), grade 3 \[G3\] (severe) and grade 4 \[G4\] (potentially life threatening), as compared to baseline at Day 0.
Outcome measures
| Measure |
GSK3003891A Group
n=49 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
n=51 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
|---|---|---|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
ALT, Unknown-Unknown
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
ALT, Unknown-G0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
ALT, Unknown-G1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
ALT, Unknown-G2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
ALT, Unknown-G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
ALT, Unknown-G4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
ALT, G0-Unknown
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
ALT, G0-G0
|
48 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
ALT, G0-G1
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
ALT, G0-G2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
ALT, G0-G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
ALT, G0-G4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
AST, G0-Unknown
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
AST, G0-G0
|
47 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
AST, G0-G1
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
AST, G0-G2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
AST, G0-G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
AST, G0-G4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
AST, G1-Unknown
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
AST, G1-G0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
AST, G1-G1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
AST, G1-G2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
AST, G1-G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
AST, G1-G4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
CRE, G0-Unknown
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
CRE, G0-G0
|
49 Participants
|
51 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
CRE, G0-G1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
CRE, G0-G2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
CRE, G0-G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
CRE, G0-G4
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 7 up to Day 30Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented
Among haematological parameters tested were EOS, decreased Hgb and LYM graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 \[G0\], grade 1 \[G1\] (mild), grade 2 \[G2\] (moderate), grade 3 \[G3\] (severe) and grade 4 \[G4\] (potentially life threatening), as compared to baseline at Day 0.
Outcome measures
| Measure |
GSK3003891A Group
n=49 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
n=51 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
|---|---|---|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
EOS, G0-Unknown
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
EOS, G0-G0
|
48 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
EOS, G0-G1
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
EOS, G0-G2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
EOS, G0-G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
EOS, G0-G4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G0-Unknown
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G0-G0
|
45 Participants
|
46 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G0-G1
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G0-G2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G0-G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G0-G4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G1-Unknown
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G1-G0
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G1-G1
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G1-G2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G1-G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G1-G4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G4-Unknown
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G4-G0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G4-G1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G4-G2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G4-G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Hgb/D, G4-G4
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
LYM, G0-Unknown
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
LYM, G0-G0
|
49 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
LYM, G0-G1
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
LYM, G0-G2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
LYM, G0-G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
LYM, G0-G4
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 7 up to Day 30Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.
Among haematological parameters tested were NEU, PLT, decreased WBC and increased WBC/I, graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 \[G0\], grade 1 \[G1\] (mild), grade 2 \[G2\] (moderate), grade 3 \[G3\] (severe) and grade 4 \[G4\] (potentially life threatening), as compared to baseline at Day 0.
Outcome measures
| Measure |
GSK3003891A Group
n=49 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
n=51 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
|---|---|---|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
NEU, G0-Unknown
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
NEU, G0-G0
|
46 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
NEU, G0-G1
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
NEU, G0-G2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
NEU, G0-G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
NEU, G0-G4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
NEU, G1-Unknown
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
NEU, G1-G0
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
NEU, G1-G1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
NEU, G1-G2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
NEU, G1-G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
NEU, G1-G4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
PLT, G0-Unknown
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
PLT, G0-G0
|
49 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
PLT, G0-G1
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
PLT, G0-G2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
PLT, G0-G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
PLT, G0-G4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/D, G0-Unknown
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/D, G0-G0
|
49 Participants
|
50 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/D, G0-G1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/D, G0-G2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/D, G0-G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/D, G0-G4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/I, G0-Unknown
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/I, G0-G0
|
47 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/I, G0-G1
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/I, G0-G2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/I, G0-G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/I, G0-G4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/I, G1-Unknown
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/I, G1-G0
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/I, G1-G1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/I, G1-G2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/I, G1-G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
WBC/I, G1-G4
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 7 up to Day 30Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.
Assessed laboratory parameter changed from baseline was haemoglobin (Hgb). FDA grading for Hgb (change from baseline) was not applicable a baseline.
Outcome measures
| Measure |
GSK3003891A Group
n=49 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
n=51 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
|---|---|---|
|
Number of Subjects With Haematology Change From Baseline by Maximum Grade
Hgb, G0
|
15 Participants
|
15 Participants
|
|
Number of Subjects With Haematology Change From Baseline by Maximum Grade
Hgb, G1
|
34 Participants
|
35 Participants
|
|
Number of Subjects With Haematology Change From Baseline by Maximum Grade
Hgb, G2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Haematology Change From Baseline by Maximum Grade
Hgb, G3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Haematology Change From Baseline by Maximum Grade
Hgb, G4
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period (from Day 0 to Day 6) after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimetres (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.
Outcome measures
| Measure |
GSK3003891A Group
n=49 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
n=51 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
|---|---|---|
|
Number of Subjects With Solicited Local Symptoms
Any Pain
|
27 Participants
|
46 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period (from Day 0 to Day 6) after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.
Assessed solicited general symptoms were fatigue, temperature (defined as oral temperature equal to or above \[≥\] 37.5 degrees Celsius \[°C\] for oral, axillary or tympanic route), gastrointestinal symptoms (gastro) including nausea, vomiting, diarrhoea and/or abdominal pain; and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK3003891A Group
n=49 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
n=51 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue
|
20 Participants
|
23 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue
|
15 Participants
|
15 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Gastro.
|
14 Participants
|
14 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Gastro.
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Gastro.
|
8 Participants
|
9 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Headache
|
14 Participants
|
17 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Headache
|
5 Participants
|
9 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any temperature
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Temperature
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related temperature
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: During a 30-day follow-up period (from Day 0 to Day 29) after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
GSK3003891A Group
n=49 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
n=51 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
23 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: From vaccination (Day 0) up to study end (Day 30)Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
GSK3003891A Group
n=49 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
n=51 Participants
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
Adverse Events
GSK3003891A Group
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Boostrix Group
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GSK3003891A Group
n=49 participants at risk
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
Boostrix Group
n=51 participants at risk
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
28.6%
14/49 • Number of events 15 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
27.5%
14/51 • Number of events 14 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49 • Number of events 1 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
5.9%
3/51 • Number of events 4 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
|
General disorders
Fatigue
|
40.8%
20/49 • Number of events 20 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
47.1%
24/51 • Number of events 27 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
|
General disorders
Pain
|
55.1%
27/49 • Number of events 27 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
90.2%
46/51 • Number of events 46 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
|
General disorders
Pyrexia
|
4.1%
2/49 • Number of events 2 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
5.9%
3/51 • Number of events 3 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/49 • Number of events 1 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
7.8%
4/51 • Number of events 4 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
|
Infections and infestations
Pharyngitis
|
6.1%
3/49 • Number of events 3 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
2.0%
1/51 • Number of events 1 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
|
Nervous system disorders
Dizziness
|
8.2%
4/49 • Number of events 4 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
0.00%
0/51 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
|
Nervous system disorders
Headache
|
36.7%
18/49 • Number of events 21 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
49.0%
25/51 • Number of events 29 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.1%
2/49 • Number of events 2 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
7.8%
4/51 • Number of events 5 • Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
|
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