Trial Outcomes & Findings for A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women (NCT NCT03674177)
NCT ID: NCT03674177
Last Updated: 2021-08-13
Results Overview
Assessed solicited local symptoms include pain, redness and swelling, at the injection site. Any = occurrence of the AE regardless of intensity grade. Any Redness and swelling symptom = symptom reported with a surface diameter greater than 20 millimeters. Grade 3 pain = significant pain at rest, pain that prevented normal every day activity. Grade 3 redness/swelling = symptom reported with a surface diameter greater than 100 millimeters.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
502 participants
Primary outcome timeframe
During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)
Results posted on
2021-08-13
Participant Flow
The study was conducted at 11 centers in 3 countries: 4 in Finland, 5 in Germany and 2 in the USA.
Among 579 screened subjects in this study, 77 subjects were screen failure. 502 subjects were enrolled.
Participant milestones
| Measure |
RSV MAT Formulation 1 Group
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
124
|
126
|
126
|
126
|
|
Overall Study
COMPLETED
|
122
|
125
|
126
|
124
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
RSV MAT Formulation 1 Group
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
2
|
Baseline Characteristics
A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women
Baseline characteristics by cohort
| Measure |
RSV MAT Formulation 1 Group
n=124 Participants
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=126 Participants
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=126 Participants
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=126 Participants
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Total
n=502 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.5 Years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
32.1 Years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
31.5 Years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
32.2 Years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
32.1 Years
STANDARD_DEVIATION 7.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
502 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
115 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
466 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)Population: The analysis was performed on the Exposed Set, which included all subjects with the study vaccine administration documented.
Assessed solicited local symptoms include pain, redness and swelling, at the injection site. Any = occurrence of the AE regardless of intensity grade. Any Redness and swelling symptom = symptom reported with a surface diameter greater than 20 millimeters. Grade 3 pain = significant pain at rest, pain that prevented normal every day activity. Grade 3 redness/swelling = symptom reported with a surface diameter greater than 100 millimeters.
Outcome measures
| Measure |
RSV MAT Formulation 1 Group
n=124 Participants
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=125 Participants
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=126 Participants
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=126 Participants
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period
Any Pain
|
59 Participants
|
64 Participants
|
67 Participants
|
20 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period
Grade 3 Pain
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period
Any Redness
|
8 Participants
|
14 Participants
|
10 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period
Grade 3 Redness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period
Any Swelling
|
5 Participants
|
7 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period
Grade 3 Swelling
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)Population: The analysis was performed on the Exposed Set, which included all subjects with the study vaccine administration documented.
Assessed solicited general symptoms include fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and fever. Any Fatigue, gastrointestinal symptoms and headache = occurrence of the symptom regardless of intensity grade and relationship. Any Fever = temperature higher than or equal to 38.0 degrees Celsius (°C), or 100.4 degrees Fahrenheit (°F). Grade 3 Fatigue, gastrointestinal symptoms and headache = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than 39.0 degrees Celsius (°C), or 102.2 degrees Fahrenheit (°F). Related fatigue, gastrointestinal symptoms, headache and fever(\>38°C) = symptoms assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
RSV MAT Formulation 1 Group
n=124 Participants
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=125 Participants
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=126 Participants
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=126 Participants
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period
Grade 3 Gastrointestinal symptoms
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period
Any Fatigue
|
41 Participants
|
49 Participants
|
41 Participants
|
38 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period
Grade 3 Fatigue
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period
Related Fatigue
|
25 Participants
|
34 Participants
|
25 Participants
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period
Any Gastrointestinal symptoms
|
30 Participants
|
29 Participants
|
23 Participants
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period
Related Gastrointestinal symptoms
|
12 Participants
|
16 Participants
|
13 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period
Any Headache
|
37 Participants
|
51 Participants
|
60 Participants
|
32 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period
Grade 3 Headache
|
3 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period
Related Headache
|
17 Participants
|
25 Participants
|
34 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period
Any Fever
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period
Grade 3 Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period
Related Fever
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During a 30-day follow-up period after vaccination (i.e., on the day of vaccination and 29 subsequent days)Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects.
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 outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
RSV MAT Formulation 1 Group
n=124 Participants
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=126 Participants
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=126 Participants
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=126 Participants
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited AEs During a 30-day Follow-up Period
|
45 Participants
|
43 Participants
|
48 Participants
|
44 Participants
|
PRIMARY outcome
Timeframe: From Day 1 (vaccination) up to Day 30 (i.e., on the day of vaccination and 29 subsequent days)Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects.
Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
RSV MAT Formulation 1 Group
n=124 Participants
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=126 Participants
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=126 Participants
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=126 Participants
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) During a 30-day Follow-up Period
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 8Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR). \[e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 8\].
Outcome measures
| Measure |
RSV MAT Formulation 1 Group
n=122 Participants
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=122 Participants
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=125 Participants
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=125 Participants
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Eosinophils, BELOW(SCR), BELOW
|
2 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Eosinophils, BELOW(SCR), WITHIN
|
4 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Eosinophils, WITHIN(SCR), BELOW
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Eosinophils, WITHIN(SCR), WITHIN
|
108 Participants
|
109 Participants
|
112 Participants
|
110 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Eosinophils, WITHIN(SCR), ABOVE
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Eosinophils, ABOVE(SCR), WITHIN
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Eosinophils, ABOVE(SCR), ABOVE
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Hemoglobin, BELOW(SCR), BELOW
|
5 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Hemoglobin, BELOW(SCR), WITHIN
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Hemoglobin, WITHIN(SCR), BELOW
|
2 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Hemoglobin, WITHIN(SCR), WITHIN
|
112 Participants
|
115 Participants
|
120 Participants
|
117 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Hemoglobin, WITHIN(SCR), ABOVE
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Hemoglobin, ABOVE(SCR), WITHIN
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Hemoglobin, ABOVE(SCR), ABOVE
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Lymphocytes, BELOW(SCR), WITHIN
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Lymphocytes, WITHIN(SCR), BELOW
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Lymphocytes, WITHIN(SCR), WITHIN
|
119 Participants
|
116 Participants
|
119 Participants
|
121 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Lymphocytes, WITHIN(SCR), ABOVE
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Lymphocytes, ABOVE(SCR), WITHIN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Lymphocytes, ABOVE(SCR), ABOVE
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Neutrophils, BELOW(SCR), WITHIN
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Neutrophils, WITHIN(SCR), BELOW
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Neutrophils, WITHIN(SCR), WITHIN
|
117 Participants
|
111 Participants
|
117 Participants
|
118 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Neutrophils, WITHIN(SCR), ABOVE
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Neutrophils, ABOVE(SCR), WITHIN
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Neutrophils, ABOVE(SCR), ABOVE
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Platelets, BELOW(SCR), BELOW
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Platelets, BELOW(SCR), WITHIN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Platelets, WITHIN(SCR), BELOW
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Platelets, WITHIN(SCR), WITHIN
|
116 Participants
|
112 Participants
|
115 Participants
|
114 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Platelets, WITHIN(SCR), ABOVE
|
1 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Platelets, ABOVE(SCR), WITHIN
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Platelets, ABOVE(SCR), ABOVE
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
WBC, BELOW(SCR), BELOW
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
WBC, BELOW(SCR), WITHIN
|
3 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
WBC, WITHIN(SCR), BELOW
|
5 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
WBC, WITHIN(SCR), WITHIN
|
111 Participants
|
108 Participants
|
108 Participants
|
115 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
WBC, WITHIN(SCR), ABOVE
|
2 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
WBC, ABOVE(SCR), WITHIN
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
WBC, ABOVE(SCR), ABOVE
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 31Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) \[e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 31\].
Outcome measures
| Measure |
RSV MAT Formulation 1 Group
n=121 Participants
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=124 Participants
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=125 Participants
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=125 Participants
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Lymphocytes, BELOW(SCR), BELOW
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Lymphocytes, BELOW(SCR), WITHIN
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Eosinophils, BELOW(SCR), BELOW
|
3 Participants
|
3 Participants
|
6 Participants
|
8 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Eosinophils, BELOW(SCR), WITHIN
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Eosinophils, WITHIN(SCR), BELOW
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Eosinophils, WITHIN(SCR), WITHIN
|
105 Participants
|
112 Participants
|
115 Participants
|
110 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Eosinophils, WITHIN(SCR), ABOVE
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Eosinophils, ABOVE(SCR), WITHIN
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Eosinophils, ABOVE(SCR), ABOVE
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Hemoglobin, BELOW(SCR), BELOW
|
6 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Hemoglobin, BELOW(SCR), WITHIN
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Hemoglobin, WITHIN(SCR), BELOW
|
2 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Hemoglobin, WITHIN(SCR), WITHIN
|
112 Participants
|
114 Participants
|
121 Participants
|
119 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Hemoglobin, ABOVE(SCR), WITHIN
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Hemoglobin, ABOVE(SCR), ABOVE
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Lymphocytes, WITHIN(SCR), BELOW
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Lymphocytes, WITHIN(SCR), WITHIN
|
119 Participants
|
119 Participants
|
119 Participants
|
119 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Lymphocytes, WITHIN(SCR), ABOVE
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Lymphocytes, ABOVE(SCR), WITHIN
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Lymphocytes, ABOVE(SCR), ABOVE
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Neutrophils, BELOW(SCR), BELOW
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Neutrophils, BELOW(SCR), WITHIN
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Neutrophils, WITHIN(SCR), BELOW
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Neutrophils, WITHIN(SCR), WITHIN
|
116 Participants
|
117 Participants
|
114 Participants
|
116 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Neutrophils, WITHIN(SCR), ABOVE
|
1 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Neutrophils, ABOVE(SCR), WITHIN
|
1 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Neutrophils, ABOVE(SCR), ABOVE
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Platelets, BELOW(SCR), BELOW
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Platelets, BELOW(SCR), WITHIN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Platelets, WITHIN(SCR), BELOW
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Platelets, WITHIN(SCR), WITHIN
|
115 Participants
|
115 Participants
|
111 Participants
|
113 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Platelets, WITHIN(SCR), ABOVE
|
2 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Platelets, ABOVE(SCR), WITHIN
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Platelets, ABOVE(SCR), ABOVE
|
1 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
WBC, BELOW(SCR), BELOW
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
WBC, BELOW(SCR), WITHIN
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
WBC, WITHIN(SCR), BELOW
|
3 Participants
|
5 Participants
|
9 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
WBC, WITHIN(SCR), WITHIN
|
109 Participants
|
107 Participants
|
105 Participants
|
110 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
WBC, WITHIN(SCR), ABOVE
|
5 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
WBC, ABOVE(SCR), WITHIN
|
1 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
WBC, ABOVE(SCR), ABOVE
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 8Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine. Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR)\[e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 8\].
Outcome measures
| Measure |
RSV MAT Formulation 1 Group
n=123 Participants
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=124 Participants
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=126 Participants
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=126 Participants
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
ALT, BELOW(SCR), WITHIN
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
ALT, WITHIN(SCR), WITHIN
|
114 Participants
|
109 Participants
|
120 Participants
|
111 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
ALT, WITHIN(SCR), ABOVE
|
1 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
ALT, ABOVE(SCR), WITHIN
|
3 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
ALT, ABOVE(SCR), ABOVE
|
5 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
AST, BELOW(SCR), WITHIN
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
AST, WITHIN(SCR), BELOW
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
AST, WITHIN(SCR), WITHIN
|
116 Participants
|
115 Participants
|
116 Participants
|
116 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
AST, WITHIN(SCR), ABOVE
|
3 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
AST, ABOVE(SCR), WITHIN
|
3 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
AST, ABOVE(SCR), ABOVE
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
BUN, BELOW(SCR), BELOW
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
BUN, BELOW(SCR), WITHIN
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
BUN, WITHIN(SCR), BELOW
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
BUN, WITHIN(SCR), WITHIN
|
113 Participants
|
115 Participants
|
113 Participants
|
121 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
BUN, WITHIN(SCR), ABOVE
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
BUN, ABOVE(SCR), WITHIN
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
BUN, ABOVE(SCR), ABOVE
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Creatinine, BELOW(SCR), BELOW
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Creatinine, BELOW(SCR), WITHIN
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Creatinine, WITHIN(SCR), BELOW
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Creatinine, WITHIN(SCR), WITHIN
|
117 Participants
|
118 Participants
|
119 Participants
|
118 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Creatinine, WITHIN(SCR), ABOVE
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Creatinine, ABOVE(SCR), WITHIN
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Creatinine, ABOVE(SCR), ABOVE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At Day 31Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine and blood urea nitrogen (BUN). Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) \[e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 31\].
Outcome measures
| Measure |
RSV MAT Formulation 1 Group
n=123 Participants
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=124 Participants
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=126 Participants
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=126 Participants
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
ALT, BELOW(SCR), BELOW
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
ALT, BELOW(SCR), WITHIN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
ALT, WITHIN(SCR), BELOW
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
ALT, WITHIN(SCR), WITHIN
|
112 Participants
|
113 Participants
|
121 Participants
|
110 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
ALT, WITHIN(SCR), ABOVE
|
3 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
ALT, ABOVE(SCR), WITHIN
|
4 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
ALT, ABOVE(SCR), ABOVE
|
4 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
AST, BELOW(SCR), WITHIN
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
AST, WITHIN(SCR), BELOW
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
AST, WITHIN(SCR), WITHIN
|
115 Participants
|
118 Participants
|
120 Participants
|
114 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
AST, WITHIN(SCR), ABOVE
|
4 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
AST, ABOVE(SCR), WITHIN
|
3 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
AST, ABOVE(SCR), ABOVE
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
BUN, BELOW(SCR), BELOW
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
BUN, BELOW(SCR), WITHIN
|
2 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
BUN, WITHIN(SCR), BELOW
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
BUN, WITHIN(SCR), WITHIN
|
113 Participants
|
117 Participants
|
115 Participants
|
120 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
BUN, WITHIN(SCR), ABOVE
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
BUN, ABOVE(SCR), WITHIN
|
3 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
BUN, ABOVE(SCR), ABOVE
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Creatinine, BELOW(SCR), BELOW
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Creatinine, BELOW(SCR), WITHIN
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Creatinine, WITHIN(SCR), BELOW
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Creatinine, WITHIN(SCR), WITHIN
|
118 Participants
|
116 Participants
|
117 Participants
|
116 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Creatinine, WITHIN(SCR), ABOVE
|
1 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Creatinine, ABOVE(SCR), WITHIN
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Creatinine, ABOVE(SCR), ABOVE
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At Day 8Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration \[FDA\] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline \[e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 8\]. "Any" corresponding to any grade and "Grade 0" to normal ranges.
Outcome measures
| Measure |
RSV MAT Formulation 1 Group
n=122 Participants
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=122 Participants
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=125 Participants
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=125 Participants
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
WBC Increase, Grade 1(SCR), GRADE 0
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
WBC Increase, Grade 1(SCR), GRADE 1
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Platelets Decrease, Any(SCR), GRADE 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Eosinophils, Any(SCR), GRADE 0
|
121 Participants
|
120 Participants
|
124 Participants
|
125 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Eosinophils, Any(SCR), GRADE 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Eosinophils, Any(SCR), GRADE 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Eosinophils, Grade 0(SCR), GRADE 0
|
119 Participants
|
120 Participants
|
124 Participants
|
123 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Eosinophils, Grade 0(SCR), GRADE 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Eosinophils, Grade 1(SCR), GRADE 0
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Eosinophils, Grade 1(SCR), GRADE 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Hemoglobin, Any(SCR), GRADE 0
|
110 Participants
|
111 Participants
|
114 Participants
|
110 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Hemoglobin, Any(SCR), GRADE 1
|
11 Participants
|
9 Participants
|
10 Participants
|
15 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Hemoglobin, Any(SCR), GRADE 2
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
WBC Increase, Grade 1(SCR), GRADE 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Hemoglobin, Grade 0(SCR), GRADE 0
|
106 Participants
|
107 Participants
|
110 Participants
|
106 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Hemoglobin, Grade 0(SCR), GRADE 1
|
4 Participants
|
4 Participants
|
5 Participants
|
10 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Hemoglobin, Grade 1(SCR), GRADE 0
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Hemoglobin, Grade 1(SCR), GRADE 1
|
7 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Hemoglobin, Grade 1(SCR), GRADE 2
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Hemoglobin, Grade 2(SCR), GRADE 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Lymphocytes Decrease, Any(SCR), GRADE 0
|
120 Participants
|
118 Participants
|
122 Participants
|
122 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Lymphocytes Decrease, Any(SCR), GRADE 1
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Lymphocytes Decrease, Any(SCR), GRADE 2
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Lymphocytes Decrease, Grade 0(SCR), GRADE 0
|
120 Participants
|
117 Participants
|
118 Participants
|
120 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Lymphocytes Decrease, Grade 0(SCR), GRADE 1
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Lymphocytes Decrease, Grade 0(SCR), GRADE 2
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Lymphocytes Decrease, Grade 1(SCR), GRADE 0
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Lymphocytes Decrease, Grade 1(SCR), GRADE 1
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Lymphocytes Decrease, Grade 2(SCR), GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Neutrophils Decrease, Any(SCR), GRADE 0
|
112 Participants
|
113 Participants
|
116 Participants
|
118 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Neutrophils Decrease, Any(SCR), GRADE 1
|
10 Participants
|
5 Participants
|
8 Participants
|
6 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Neutrophils Decrease, Any(SCR), GRADE 2
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Neutrophils Decrease, Grade 0(SCR), GRADE 0
|
109 Participants
|
109 Participants
|
111 Participants
|
115 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Neutrophils Decrease, Grade 0(SCR), GRADE 1
|
8 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Neutrophils Decrease, Grade 0(SCR), GRADE 2
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Neutrophils Decrease, Grade 1(SCR), GRADE 0
|
3 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Neutrophils Decrease, Grade 1(SCR), GRADE 1
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Neutrophils Decrease, Grade 1(SCR), GRADE 2
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Neutrophils Decrease, Grade 2(SCR), GRADE 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Platelets Decrease, Any(SCR), GRADE 0
|
121 Participants
|
122 Participants
|
125 Participants
|
125 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Platelets Decrease, Grade 0(SCR), GRADE 0
|
121 Participants
|
122 Participants
|
125 Participants
|
123 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Platelets Decrease, Grade 0(SCR), GRADE 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Platelets Decrease, Grade 1(SCR), GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
WBC Decrease, Any(SCR), GRADE 0
|
121 Participants
|
119 Participants
|
125 Participants
|
124 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
WBC Decrease, Any(SCR), GRADE 1
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
WBC Decrease, Grade 0(SCR), GRADE 0
|
120 Participants
|
118 Participants
|
124 Participants
|
120 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
WBC Decrease, Grade 0(SCR), GRADE 1
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
WBC Decrease, Grade 1(SCR), GRADE 0
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
WBC Increase, Any(SCR), GRADE 0
|
119 Participants
|
118 Participants
|
121 Participants
|
125 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
WBC Increase, Any(SCR), GRADE 1
|
3 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
WBC Increase, Any(SCR), GRADE 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
WBC Increase, Grade 0(SCR), GRADE 0
|
118 Participants
|
116 Participants
|
120 Participants
|
122 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
WBC Increase, Grade 0(SCR), GRADE 1
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 31Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration \[FDA\] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline \[e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 31\]. "Any" corresponding to any grade and "Grade 0" to normal ranges.
Outcome measures
| Measure |
RSV MAT Formulation 1 Group
n=121 Participants
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=124 Participants
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=125 Participants
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=125 Participants
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Eosinophils, Any(SCR), GRADE 0
|
118 Participants
|
122 Participants
|
125 Participants
|
125 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Eosinophils, Any(SCR), GRADE 1
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Eosinophils, Grade 0(SCR), GRADE 0
|
117 Participants
|
122 Participants
|
125 Participants
|
123 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Eosinophils, Grade 0(SCR), GRADE 1
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Eosinophils, Grade 1(SCR), GRADE 0
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Eosinophils, Grade 1(SCR), GRADE 1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Hemoglobin, Any(SCR), GRADE 0
|
108 Participants
|
115 Participants
|
112 Participants
|
114 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Hemoglobin, Any(SCR), GRADE 1
|
11 Participants
|
7 Participants
|
13 Participants
|
8 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Hemoglobin, Any(SCR), GRADE 2
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Hemoglobin, Grade 0(SCR), GRADE 0
|
106 Participants
|
112 Participants
|
109 Participants
|
111 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Hemoglobin, Grade 0(SCR), GRADE 1
|
4 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Hemoglobin, Grade 0(SCR), GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Hemoglobin, Grade 1(SCR), GRADE 0
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Hemoglobin, Grade 1(SCR), GRADE 1
|
7 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Hemoglobin, Grade 1(SCR), GRADE 2
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Hemoglobin, Grade 2(SCR), GRADE 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Lymphocytes Decrease, Any(SCR), GRADE 0
|
119 Participants
|
119 Participants
|
121 Participants
|
120 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Lymphocytes Decrease, Any(SCR), GRADE 1
|
2 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Lymphocytes Decrease, Any(SCR), GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Lymphocytes Decrease, Grade 0(SCR), GRADE 0
|
119 Participants
|
118 Participants
|
117 Participants
|
117 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Lymphocytes Decrease, Grade 0(SCR), GRADE 1
|
2 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Lymphocytes Decrease, Grade 1(SCR), GRADE 0
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Lymphocytes Decrease, Grade 1(SCR), GRADE 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Lymphocytes Decrease, Grade 1(SCR), GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Lymphocytes Decrease, Grade 2(SCR), GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Neutrophils Decrease, Any(SCR), GRADE 0
|
111 Participants
|
115 Participants
|
114 Participants
|
116 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Neutrophils Decrease, Any(SCR), GRADE 1
|
8 Participants
|
7 Participants
|
10 Participants
|
8 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Neutrophils Decrease, Any(SCR), GRADE 2
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Neutrophils Decrease, Any(SCR), GRADE 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Neutrophils Decrease, Grade 0(SCR), GRADE 0
|
109 Participants
|
112 Participants
|
109 Participants
|
114 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Neutrophils Decrease, Grade 0(SCR), GRADE 1
|
7 Participants
|
5 Participants
|
10 Participants
|
4 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Neutrophils Decrease, Grade 0(SCR), GRADE 2
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Neutrophils Decrease, Grade 0(SCR), GRADE 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Neutrophils Decrease, Grade 1(SCR), GRADE 0
|
2 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Neutrophils Decrease, Grade 1(SCR), GRADE 1
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Neutrophils Decrease, Grade 1(SCR), GRADE 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Neutrophils Decrease, Grade 2(SCR), GRADE 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Platelets Decrease, Any(SCR), GRADE 0
|
121 Participants
|
124 Participants
|
125 Participants
|
125 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Platelets Decrease, Grade 0(SCR), GRADE 0
|
121 Participants
|
124 Participants
|
125 Participants
|
123 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Platelets Decrease, Grade 1(SCR), GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
WBC Decrease, Any(SCR), GRADE 0
|
119 Participants
|
122 Participants
|
121 Participants
|
123 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
WBC Decrease, Any(SCR), GRADE 1
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
WBC Decrease, Grade 0(SCR), GRADE 0
|
119 Participants
|
121 Participants
|
120 Participants
|
120 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
WBC Decrease, Grade 0(SCR), GRADE 1
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
WBC Decrease, Grade 1(SCR), GRADE 0
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
WBC Decrease, Grade 1(SCR), GRADE 1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
WBC Increase, Any(SCR), GRADE 0
|
120 Participants
|
116 Participants
|
122 Participants
|
122 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
WBC Increase, Any(SCR), GRADE 1
|
1 Participants
|
8 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
WBC Increase, Grade 0(SCR), GRADE 0
|
118 Participants
|
115 Participants
|
118 Participants
|
119 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
WBC Increase, Grade 0(SCR), GRADE 1
|
0 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
WBC Increase, Grade 1(SCR), GRADE 0
|
2 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
WBC Increase, Grade 1(SCR), GRADE 1
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 8Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration \[FDA\] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline \[e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 8\]. "Any" corresponding to any grade and "Grade 0" to normal ranges.
Outcome measures
| Measure |
RSV MAT Formulation 1 Group
n=123 Participants
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=124 Participants
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=126 Participants
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=126 Participants
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
ALT - increase by factor, Any(SCR), GRADE 0
|
118 Participants
|
119 Participants
|
124 Participants
|
117 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
ALT - increase by factor, Any(SCR), GRADE 1
|
5 Participants
|
3 Participants
|
1 Participants
|
7 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
ALT - increase by factor, Any(SCR), GRADE 2
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
ALT - increase by factor, Any(SCR), GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
ALT - increase by factor, Grade 0(SCR), GRADE 0
|
115 Participants
|
115 Participants
|
121 Participants
|
114 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
ALT - increase by factor, Grade 0(SCR), GRADE 1
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
ALT - increase by factor, Grade 0(SCR), GRADE 2
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
ALT - increase by factor, Grade 0(SCR), GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
ALT - increase by factor, Grade 1(SCR), GRADE 0
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
ALT - increase by factor, Grade 1(SCR), GRADE 1
|
3 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
ALT - increase by factor, Grade 1(SCR), GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
ALT - increase by factor, Grade 2(SCR), GRADE 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
AST - increase by factor, Any(SCR), GRADE 0
|
123 Participants
|
120 Participants
|
124 Participants
|
122 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
AST - increase by factor, Any(SCR), GRADE 1
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
AST - increase by factor, Any(SCR), GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
AST - increase by factor, Grade 0(SCR), GRADE 0
|
120 Participants
|
119 Participants
|
124 Participants
|
119 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
AST - increase by factor, Grade 0(SCR), GRADE 1
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
AST - increase by factor, Grade 0(SCR), GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
AST - increase by factor, Grade 1(SCR), GRADE 0
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
AST - increase by factor, Grade 1(SCR), GRADE 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Blood Urea Nitrogen, Any(SCR), GRADE 0
|
122 Participants
|
123 Participants
|
124 Participants
|
125 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Blood Urea Nitrogen, Any(SCR), GRADE 1
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Blood Urea Nitrogen, Any(SCR), GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Blood Urea Nitrogen, Grade 0(SCR), GRADE 0
|
122 Participants
|
123 Participants
|
123 Participants
|
124 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Blood Urea Nitrogen, Grade 0(SCR), GRADE 1
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Blood Urea Nitrogen, Grade 0(SCR), GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Blood Urea Nitrogen, Grade 1(SCR), GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Blood Urea Nitrogen, Grade 2(SCR), GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Creatinine, Any(SCR), GRADE 0
|
122 Participants
|
124 Participants
|
126 Participants
|
126 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Creatinine, Any(SCR), GRADE 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Creatinine, Grade 0(SCR), GRADE 0
|
122 Participants
|
124 Participants
|
126 Participants
|
126 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Creatinine, Grade 0(SCR), GRADE 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 31Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration \[FDA\] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline \[e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 31\]. "Any" corresponding to any grade and "Grade 0" to normal ranges.
Outcome measures
| Measure |
RSV MAT Formulation 1 Group
n=123 Participants
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=124 Participants
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=126 Participants
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=126 Participants
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
ALT - increase by factor, Any(SCR), GRADE 0
|
117 Participants
|
121 Participants
|
125 Participants
|
118 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
ALT - increase by factor, Any(SCR), GRADE 1
|
6 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
ALT - increase by factor, Any(SCR), GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
ALT - increase by factor, Grade 0(SCR), GRADE 0
|
113 Participants
|
117 Participants
|
122 Participants
|
112 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
ALT - increase by factor, Grade 0(SCR), GRADE 1
|
3 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
ALT - increase by factor, Grade 0(SCR), GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
ALT - increase by factor, Grade 1(SCR), GRADE 0
|
4 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
ALT - increase by factor, Grade 1(SCR), GRADE 1
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
ALT - increase by factor, Grade 1(SCR), GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
ALT - increase by factor, Grade 2(SCR), GRADE 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
AST - increase by factor, Any(SCR), GRADE 0
|
121 Participants
|
122 Participants
|
125 Participants
|
121 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
AST - increase by factor, Any(SCR), GRADE 1
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
AST - increase by factor, Any(SCR), GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
AST - increase by factor, Grade 0(SCR), GRADE 0
|
118 Participants
|
121 Participants
|
125 Participants
|
118 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
AST - increase by factor, Grade 0(SCR), GRADE 1
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
AST - increase by factor, Grade 0(SCR), GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
AST - increase by factor, Grade 1(SCR), GRADE 0
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
AST - increase by factor, Grade 1(SCR), GRADE 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
AST - increase by factor, Grade 1(SCR), GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Blood Urea Nitrogen, Any(SCR), GRADE 0
|
123 Participants
|
123 Participants
|
126 Participants
|
125 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Blood Urea Nitrogen, Any(SCR), GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Blood Urea Nitrogen, Any(SCR), GRADE 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Blood Urea Nitrogen, Grade 0(SCR), GRADE 0
|
123 Participants
|
123 Participants
|
125 Participants
|
124 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Blood Urea Nitrogen, Grade 0(SCR), GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Blood Urea Nitrogen, Grade 0(SCR), GRADE 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Blood Urea Nitrogen, Grade 1(SCR), GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Blood Urea Nitrogen, Grade 2(SCR), GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Creatinine, Any(SCR), GRADE 0
|
123 Participants
|
124 Participants
|
126 Participants
|
126 Participants
|
|
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Creatinine, Grade 0(SCR), GRADE 0
|
123 Participants
|
124 Participants
|
126 Participants
|
126 Participants
|
SECONDARY outcome
Timeframe: From Day 1 (vaccination) up to Day 91 and up to Day 181Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects.
Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
RSV MAT Formulation 1 Group
n=124 Participants
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=126 Participants
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=126 Participants
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=126 Participants
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Number of Subjects With SAEs
SAE - Day 91
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With SAEs
SAE - Day 181
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91)Population: The analysis was performed on the Per-protocol set which included all vaccinated subjects, meeting all protocol requirements and for whom immunogenicity results were available for the specified assay at the corresponding time-point.
Anti RSV-A neutralizing antibody titers are given as geometric mean titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60), calculated on subjects with anti-RSV-A neutralizing antibody titer equal to or above the assay cut-off 18 ED60.
Outcome measures
| Measure |
RSV MAT Formulation 1 Group
n=123 Participants
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=125 Participants
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=126 Participants
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=126 Participants
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Neutralizing Antibody (Nab) Titers Against RSV Serotype A
PRE
|
851.1 Titers
Interval 732.88 to 988.3
|
921.6 Titers
Interval 795.52 to 1067.64
|
868.8 Titers
Interval 754.18 to 1000.78
|
746.2 Titers
Interval 639.96 to 870.02
|
|
Neutralizing Antibody (Nab) Titers Against RSV Serotype A
Day 8
|
6720.1 Titers
Interval 5861.07 to 7705.03
|
9843.6 Titers
Interval 8170.69 to 11858.92
|
12638.3 Titers
Interval 10883.83 to 14675.63
|
790.8 Titers
Interval 665.49 to 939.62
|
|
Neutralizing Antibody (Nab) Titers Against RSV Serotype A
Day 31
|
5327.6 Titers
Interval 4640.84 to 6116.06
|
7323.3 Titers
Interval 6236.0 to 8600.25
|
7943.4 Titers
Interval 6942.16 to 9089.07
|
762.9 Titers
Interval 638.74 to 911.18
|
|
Neutralizing Antibody (Nab) Titers Against RSV Serotype A
Day 61
|
5268.4 Titers
Interval 4639.84 to 5982.16
|
6783.1 Titers
Interval 5782.42 to 7956.92
|
7575.8 Titers
Interval 6633.19 to 8652.41
|
875.6 Titers
Interval 734.11 to 1044.4
|
|
Neutralizing Antibody (Nab) Titers Against RSV Serotype A
Day 91
|
4110.7 Titers
Interval 3564.87 to 4740.12
|
5186.7 Titers
Interval 4357.63 to 6173.57
|
5067.9 Titers
Interval 4451.73 to 5769.4
|
840.0 Titers
Interval 717.87 to 982.93
|
SECONDARY outcome
Timeframe: At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91)Population: The analysis was performed on the Per-protocol set which included all vaccinated subjects, meeting all protocol requirements and for whom immunogenicity results were available for the specified assay at the corresponding time-point.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL), calculated on subjects with anti-RSVPreF3 antibody concentration equal to or above the assay cut-off 25 EL.U/mL.
Outcome measures
| Measure |
RSV MAT Formulation 1 Group
n=123 Participants
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=125 Participants
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=126 Participants
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=126 Participants
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations
PRE
|
6753 EL.U/mL
Interval 6032.53 to 7560.61
|
6447 EL.U/mL
Interval 5822.74 to 7138.39
|
6738 EL.U/mL
Interval 5954.89 to 7625.01
|
5583 EL.U/mL
Interval 5014.96 to 6215.1
|
|
Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations
Day 8
|
83187 EL.U/mL
Interval 75159.55 to 92072.87
|
111915 EL.U/mL
Interval 97936.91 to 127887.72
|
145984 EL.U/mL
Interval 131579.66 to 161966.03
|
5902 EL.U/mL
Interval 5270.51 to 6609.37
|
|
Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations
Day 31
|
66153 EL.U/mL
Interval 58990.44 to 74184.52
|
85096 EL.U/mL
Interval 75185.08 to 96313.02
|
94360 EL.U/mL
Interval 86517.06 to 102912.86
|
5856 EL.U/mL
Interval 5165.49 to 6639.47
|
|
Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations
Day 61
|
55170 EL.U/mL
Interval 49687.49 to 61258.0
|
65007 EL.U/mL
Interval 57805.13 to 73106.25
|
71401 EL.U/mL
Interval 66038.58 to 77198.53
|
6100 EL.U/mL
Interval 5355.93 to 6948.09
|
|
Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations
Day 91
|
39602 EL.U/mL
Interval 34650.65 to 45261.85
|
47629 EL.U/mL
Interval 41925.98 to 54108.51
|
51424 EL.U/mL
Interval 46747.32 to 56569.61
|
6692 EL.U/mL
Interval 5722.81 to 7825.0
|
Adverse Events
RSV MAT Formulation 1 Group
Serious events: 0 serious events
Other events: 94 other events
Deaths: 0 deaths
RSV MAT Formulation 2 Group
Serious events: 0 serious events
Other events: 96 other events
Deaths: 0 deaths
RSV MAT Formulation 3 Group
Serious events: 1 serious events
Other events: 105 other events
Deaths: 0 deaths
Control Group
Serious events: 2 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RSV MAT Formulation 1 Group
n=124 participants at risk
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=126 participants at risk
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=126 participants at risk
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=126 participants at risk
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
Other adverse events
| Measure |
RSV MAT Formulation 1 Group
n=124 participants at risk
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 2 Group
n=126 participants at risk
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
RSV MAT Formulation 3 Group
n=126 participants at risk
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
Control Group
n=126 participants at risk
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
|
|---|---|---|---|---|
|
General disorders
Injection site pain
|
47.6%
59/124 • Number of events 59 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
50.8%
64/126 • Number of events 64 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
53.2%
67/126 • Number of events 67 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
15.9%
20/126 • Number of events 20 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Fatigue
|
33.9%
42/124 • Number of events 43 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
38.9%
49/126 • Number of events 49 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
32.5%
41/126 • Number of events 41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
30.2%
38/126 • Number of events 38 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Injection site inflammation
|
6.5%
8/124 • Number of events 8 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
11.1%
14/126 • Number of events 14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
7.9%
10/126 • Number of events 10 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Injection site swelling
|
4.0%
5/124 • Number of events 5 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
5.6%
7/126 • Number of events 7 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
4.8%
6/126 • Number of events 6 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Pyrexia
|
1.6%
2/124 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
3.2%
4/126 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Injection site bruising
|
1.6%
2/124 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Chills
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Peripheral swelling
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Axillary pain
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Influenza like illness
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Feeling cold
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Feeling hot
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Injection site induration
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Injury associated with device
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Pain
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Swelling
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Vaccination site bruising
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
General disorders
Vaccination site haematoma
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Nervous system disorders
Headache
|
34.7%
43/124 • Number of events 50 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
42.1%
53/126 • Number of events 57 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
50.0%
63/126 • Number of events 70 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
30.2%
38/126 • Number of events 50 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Nervous system disorders
Dizziness
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Nervous system disorders
Paraesthesia
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Nervous system disorders
Nerve compression
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Nervous system disorders
Thermohyperaesthesia
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
24.2%
30/124 • Number of events 30 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
23.0%
29/126 • Number of events 29 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
18.3%
23/126 • Number of events 23 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
21.4%
27/126 • Number of events 27 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
2/124 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Gastrointestinal disorders
Nausea
|
0.81%
1/124 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Gastrointestinal disorders
Constipation
|
1.6%
2/124 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
7/124 • Number of events 8 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
5.6%
7/126 • Number of events 7 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
7.9%
10/126 • Number of events 11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
3.2%
4/126 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
2/124 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
3.2%
4/126 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
3.2%
4/126 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
2.4%
3/126 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Sinusitis
|
1.6%
2/124 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
2/124 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Gastroenteritis
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Influenza
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Bronchitis
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Rhinitis
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Laryngitis
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Oral herpes
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Respiratory tract infection
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Viral infection
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Cystitis
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Infection
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
4/124 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
2.4%
3/126 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
4/124 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
2/124 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
2.4%
3/126 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.2%
4/124 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
3.2%
4/126 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
2.4%
3/126 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
2.4%
3/126 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
2.4%
3/126 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.81%
1/124 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Reproductive system and breast disorders
Genital pain
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Ear and labyrinth disorders
Ear pain
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
1.6%
2/126 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Immune system disorders
Food allergy
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Injury, poisoning and procedural complications
Dental restoration failure
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Investigations
Transaminases increased
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Vascular disorders
Flushing
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Vascular disorders
Hypertension
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Cardiac disorders
Tachycardia
|
0.81%
1/124 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/124 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.79%
1/126 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
0.00%
0/126 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER