Trial Outcomes & Findings for A Study to Rank Different Dosages of Antigen of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A), Based on Their Immune Response and Safety, When Administered to Healthy Adult Women (NCT NCT02956837)
NCT ID: NCT02956837
Last Updated: 2019-07-02
Results Overview
Assessed solicited general AEs were fatigue, gastrointestinal symptoms \[nausea, vomiting, diarrhea and/or abdominal pain\], fever and headache. 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.Grade 2 symptoms = occurrence of symptoms discomforting enough to interfere with daily activities. Grade 3 symptoms = symptoms that prevented normal activities. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
406 participants
Primary outcome timeframe
During the 7-day (Days 0-6) post-vaccination period
Results posted on
2019-07-02
Participant Flow
Out of 406 subjects initially enrolled in the study, 6 subjects had numbers allocated but did not receive any study vaccine dose, hence only 400 subjects were included in the Total Vaccinated Cohort.
Participant milestones
| Measure |
GSK3003891A Vaccine Formulation 1 Group
Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
Subjects in this group received a single 60 µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
Subjects in this group received a single 120 µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
100
|
99
|
99
|
102
|
|
Overall Study
COMPLETED
|
100
|
96
|
97
|
99
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
2
|
3
|
Reasons for withdrawal
| Measure |
GSK3003891A Vaccine Formulation 1 Group
Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
Subjects in this group received a single 60 µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
Subjects in this group received a single 120 µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Overall Study
Serious Adverse Events
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
2
|
0
|
Baseline Characteristics
A Study to Rank Different Dosages of Antigen of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A), Based on Their Immune Response and Safety, When Administered to Healthy Adult Women
Baseline characteristics by cohort
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=100 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=99 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=99 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=102 Participants
Subjects in this group received a single placebo injection at Day 0.
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.2 Years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
29.1 Years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
29.6 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
29.9 Years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
29.7 Years
STANDARD_DEVIATION 7.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
400 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
Geographic Ancestry · African Heritage/African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · Asian - Central/South Asian Heritage
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · Asian - East Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · Asian - South East Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · White - Arabic/North African Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · White - Caucasian/European Heritage
|
96 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
384 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · Unspecified
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Assessed solicited general AEs were fatigue, gastrointestinal symptoms \[nausea, vomiting, diarrhea and/or abdominal pain\], fever and headache. 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.Grade 2 symptoms = occurrence of symptoms discomforting enough to interfere with daily activities. Grade 3 symptoms = symptoms that prevented normal activities. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=100 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=99 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=99 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=102 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Number of Subjects With Any Grade 2 and Grade 3 General Adverse Events (AEs) - Solicited and Unsolicited
|
32 Participants
|
30 Participants
|
24 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptom sheets filled in.
Grade 2 Fever was defined as oral temperature above (\>) 38.5 degrees Celsius (°C) to less than or equal to (≤) 39.5°C. Grade 3 Fever was defined as oral temperature \> 39.5°C. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=100 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=98 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=99 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=102 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Number of Subjects With Grade 2 and Grade 3 Fever
Grade 2 Fever
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Grade 2 and Grade 3 Fever
Grade 3 Fever
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAEs = SAEs assessed by the investigator as related to the vaccination. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=100 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=99 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=99 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=102 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Number of Subjects With Related Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 30, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay at Day 0.
RSV-A is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value greater than or equal to (≥) 8 ED60 (Estimated Dilution 60). This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=98 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=95 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=98 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=100 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Neutralizing Antibody Titers Against RSV-A Subtype
|
228.8 Titers
Interval 193.1 to 271.0
|
249.5 Titers
Interval 213.9 to 290.9
|
285.7 Titers
Interval 244.5 to 333.9
|
247.1 Titers
Interval 211.2 to 289.1
|
PRIMARY outcome
Timeframe: At Day 30Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 30, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay at Day 30.
RSV-A is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value ≥ 8 ED60 (Estimated Dilution 60). This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=98 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=94 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=98 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=100 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Neutralizing Antibody Titers Against RSV-A Subtype
|
858.2 Titers
Interval 724.7 to 1016.3
|
1114.8 Titers
Interval 971.9 to 1278.8
|
1245.5 Titers
Interval 1070.3 to 1449.2
|
271.6 Titers
Interval 228.0 to 323.5
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 30, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay at Day 0.
PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off ≥ 9.6 µg/mL. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=98 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=94 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=96 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=100 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Palivizumab Competing Antibody (PCA) Concentrations
|
5.7 µg/mL
Interval 5.3 to 6.2
|
5.6 µg/mL
Interval 5.2 to 6.1
|
5.8 µg/mL
Interval 5.3 to 6.3
|
6.0 µg/mL
Interval 5.5 to 6.6
|
PRIMARY outcome
Timeframe: At Day 30Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 30, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay at Day 30.
PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off ≥ 9.6 µg/mL. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=98 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=94 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=98 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=100 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Pavilizumab Competing Antibody (PCA) Concentrations
|
66.8 µg/mL
Interval 59.0 to 75.8
|
81.2 µg/mL
Interval 72.5 to 90.9
|
83.7 µg/mL
Interval 73.5 to 95.5
|
6.1 µg/mL
Interval 5.5 to 6.8
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptom sheets filled in.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 2 pain = painful when limb was moved and that interfered with every day activities.Grade 3 pain = significant pain at rest, pain that prevented normal every day activity. Grade 2 redness/swelling = redness/swelling spreading beyond (\>) 50 millimeters (mm) and up to (and including) 100 mm of injection site.Grade 3 redness/swelling = redness/swelling \> 100 mm of injection site. Medically attended symptoms = occurrence of symptoms that required medical advice.
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=100 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=98 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=99 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=102 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs
Any Pain
|
52 Participants
|
52 Participants
|
51 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs
Grade 2 Pain
|
5 Participants
|
5 Participants
|
10 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs
Grade 3 Pain
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs
Medically-attended Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs
Any Redness (mm)
|
6 Participants
|
10 Participants
|
8 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs
Grade 2 Redness (mm)
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs
Grade 3 Redness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs
Medically-attended Redness (mm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs
Any Swelling (mm)
|
4 Participants
|
6 Participants
|
7 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs
Grade 2 Swelling (mm)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs
Grade 3 Swelling (mm)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs
Medically-attended Swelling (mm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptom sheets filled in.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (which include nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 2 symptoms = occurrence of symptoms discomforting enough to interfere with daily activities. Grade 3 symptoms = symptoms that prevented normal activities.Related = symptom assessed by the investigator as related to the vaccination. Medically attended symptom = occurrence of symptom that required medical advice.
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=100 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=98 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=99 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=102 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Any Fatigue
|
47 Participants
|
43 Participants
|
45 Participants
|
42 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Grade 2 Fatigue
|
9 Participants
|
14 Participants
|
8 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Grade 3 Fatigue
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Related Fatigue
|
37 Participants
|
29 Participants
|
36 Participants
|
33 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Medically-attended Fatigue
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Any Gastrointestinal symptoms
|
20 Participants
|
23 Participants
|
14 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Grade 2 Gastrointestinal symptoms
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Grade 3 Gastrointestinal symptoms
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Related Gastrointestinal symptoms
|
13 Participants
|
17 Participants
|
10 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Medically-attended Gastrointestinal symptoms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Any Headache
|
47 Participants
|
42 Participants
|
41 Participants
|
37 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Grade 2 Headache
|
11 Participants
|
11 Participants
|
12 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Grade 3 Headache
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Related Headache
|
30 Participants
|
27 Participants
|
33 Participants
|
29 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Medically-attended Headache
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Any Temperature/(Oral) (°C)
|
8 Participants
|
8 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Related Temperature/(Oral) (°C)
|
5 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Medically-attended Temperature/(Oral) (°C)
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 30-day (Days 0-29) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=100 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=99 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=99 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=102 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited AEs
|
55 Participants
|
52 Participants
|
46 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to study end, at Day 360Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=100 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=99 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=99 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=102 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Number of Subjects With Any SAEs
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Day 7Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 7.
Biochemical parameters assessed included alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine. Hematological parameters assessed included eosinophils, hemoglobin level, lymphocytes, neutrophils, platelet count and White Blood Cells \[WBC\]. Abnormal laboratory values at Day 7 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) \[e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 7\].
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=100 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=98 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=99 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=102 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Within · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Within · Within
|
99 Participants
|
97 Participants
|
99 Participants
|
102 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Within · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Above · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Above · Within
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Above · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Within · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Within · Within
|
99 Participants
|
97 Participants
|
98 Participants
|
100 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Within · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Above · Below
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Above · Within
|
1 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Above · Above
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Below · Below
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Below · Within
|
4 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Below · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Within · Below
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Within · Within
|
92 Participants
|
90 Participants
|
93 Participants
|
99 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Within · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Above · Below
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Above · Within
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Above · Above
|
1 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Unknown · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Unknown · Within
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Unknown · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Below · Below
|
5 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Below · Within
|
7 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Below · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Within · Below
|
3 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Within · Within
|
77 Participants
|
84 Participants
|
79 Participants
|
81 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Within · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Above · Below
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Above · Within
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Above · Above
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Unknown · Below
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Unknown · Within
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Unknown · Above
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Below · Below
|
12 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Below · Within
|
8 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Below · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Within · Below
|
4 Participants
|
1 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Within · Within
|
74 Participants
|
84 Participants
|
84 Participants
|
88 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Within · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Above · Below
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Above · Within
|
—
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Above · Above
|
—
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Unknown · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Unknown · Within
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Unknown · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Below · Below
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Below · Within
|
1 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Below · Above
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Within · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Within · Within
|
92 Participants
|
93 Participants
|
92 Participants
|
94 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Within · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Above · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Above · Within
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Above · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Unknown · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Unknown · Within
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Unknown · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Below · Below
|
2 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Below · Within
|
2 Participants
|
1 Participants
|
—
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Below · Above
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Within · Below
|
2 Participants
|
6 Participants
|
4 Participants
|
8 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Within · Within
|
88 Participants
|
81 Participants
|
86 Participants
|
82 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Within · Above
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Above · Below
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Above · Within
|
—
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Above · Above
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Unknown · Below
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Unknown · Within
|
2 Participants
|
2 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Unknown · Above
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Within · Below
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Within · Within
|
93 Participants
|
95 Participants
|
99 Participants
|
100 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Within · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Above · Below
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Above · Within
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Above · Above
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Unknown · Below
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Unknown · Within
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Unknown · Above
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Below · Below
|
2 Participants
|
—
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Below · Within
|
1 Participants
|
—
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Below · Above
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Within · Below
|
4 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Within · Within
|
90 Participants
|
87 Participants
|
92 Participants
|
87 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Within · Above
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Above · Below
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Above · Within
|
—
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Above · Above
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 30Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 30.
Biochemical parameters assessed included alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine. Hematological parameters assessed included eosinophils, hemoglobin level, lymphocytes, neutrophils, platelet count and White Blood Cells \[WBC\]. Abnormal laboratory values at Day 30 were Below, Within and Above normal ranges, as compared to the baseline values of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) \[e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 30\].
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=99 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=98 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=99 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=102 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Within · Above
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Above · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Above · Within
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Above · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Unknown · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Unknown · Within
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Unknown · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Below · Below
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Below · Within
|
3 Participants
|
1 Participants
|
—
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Below · Above
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Within · Below
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Within · Within
|
88 Participants
|
88 Participants
|
92 Participants
|
88 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Within · Above
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Above · Below
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Above · Within
|
—
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Above · Above
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Unknown · Below
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Unknown · Within
|
2 Participants
|
2 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Unknown · Above
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Within · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Within · Within
|
92 Participants
|
94 Participants
|
99 Participants
|
99 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Within · Above
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Above · Below
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Above · Within
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Above · Above
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Unknown · Below
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Unknown · Within
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Unknown · Above
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Below · Below
|
2 Participants
|
—
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Below · Within
|
1 Participants
|
—
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Below · Above
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Within · Below
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Within · Within
|
90 Participants
|
89 Participants
|
90 Participants
|
90 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Within · Above
|
2 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Above · Below
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Above · Within
|
—
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Above · Above
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Within · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Within · Within
|
93 Participants
|
97 Participants
|
96 Participants
|
101 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Within · Above
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Above · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Above · Within
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Above · Above
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Within · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Within · Within
|
94 Participants
|
97 Participants
|
97 Participants
|
100 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Within · Above
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Above · Below
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Above · Within
|
1 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Above · Above
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Below · Below
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Below · Within
|
5 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Below · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Within · Below
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Within · Within
|
89 Participants
|
91 Participants
|
93 Participants
|
97 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Within · Above
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Above · Below
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Above · Within
|
1 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Above · Above
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Unknown · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Unknown · Within
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Unknown · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Below · Below
|
5 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Below · Within
|
7 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Below · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Within · Below
|
3 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Within · Within
|
80 Participants
|
82 Participants
|
75 Participants
|
83 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Within · Above
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Above · Below
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Above · Within
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Above · Above
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Unknown · Below
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Unknown · Within
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Unknown · Above
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Below · Below
|
13 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Below · Within
|
7 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Below · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Within · Below
|
2 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Within · Within
|
76 Participants
|
79 Participants
|
86 Participants
|
87 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Within · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Above · Below
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Above · Within
|
—
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Above · Above
|
—
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Unknown · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Unknown · Within
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Unknown · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Below · Below
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Below · Within
|
1 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Below · Above
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Within · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Within · Within
|
94 Participants
|
94 Participants
|
97 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: At Day 60Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 60.
Biochemical parameters assessed included alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine. Hematological parameters assessed included eosinophils, hemoglobin level, lymphocytes, neutrophils, platelet count and White Blood Cells \[WBC\]. Abnormal laboratory values at Day 60 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) \[e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 60\].
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=100 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=96 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=98 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=101 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Within · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Within · Within
|
98 Participants
|
95 Participants
|
98 Participants
|
101 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Within · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Above · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Above · Within
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Above · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Within · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Within · Within
|
98 Participants
|
95 Participants
|
97 Participants
|
100 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Within · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Above · Below
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Above · Within
|
1 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Above · Above
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Below · Below
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Below · Within
|
6 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Below · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Within · Below
|
2 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Within · Within
|
89 Participants
|
87 Participants
|
93 Participants
|
91 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Within · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Below · Below
|
5 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Above · Below
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Above · Within
|
1 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Above · Above
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Unknown · Below
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Unknown · Within
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Unknown · Above
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Below · Within
|
7 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Below · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Within · Below
|
6 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Within · Within
|
77 Participants
|
82 Participants
|
77 Participants
|
81 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Within · Above
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Above · Within
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Above · Below
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Above · Within
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Above · Above
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Unknown · Below
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Unknown · Within
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Unknown · Above
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Below · Below
|
13 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Below · Within
|
7 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Below · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Within · Below
|
5 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Within · Within
|
74 Participants
|
78 Participants
|
84 Participants
|
81 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Within · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Above · Below
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Above · Within
|
—
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Above · Above
|
—
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Unknown · Below
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Unknown · Within
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Unknown · Above
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Below · Below
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Below · Within
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Below · Above
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Within · Below
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Within · Within
|
96 Participants
|
94 Participants
|
93 Participants
|
96 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Within · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Above · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Above · Within
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Above · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Unknown · Below
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Unknown · Within
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Unknown · Above
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Below · Below
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Below · Within
|
4 Participants
|
1 Participants
|
—
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Below · Above
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Within · Below
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Within · Within
|
89 Participants
|
84 Participants
|
88 Participants
|
89 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Within · Above
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Above · Below
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Above · Within
|
—
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Above · Above
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Unknown · Below
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Unknown · Within
|
2 Participants
|
2 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Unknown · Above
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Within · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Within · Within
|
93 Participants
|
92 Participants
|
97 Participants
|
98 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Within · Above
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Above · Below
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Above · Above
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Unknown · Below
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Unknown · Within
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Unknown · Above
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Below · Below
|
1 Participants
|
—
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Below · Within
|
2 Participants
|
—
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Below · Above
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Within · Below
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Within · Within
|
92 Participants
|
86 Participants
|
90 Participants
|
87 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Within · Above
|
2 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Above · Below
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Above · Within
|
—
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Above · Above
|
—
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 90Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 90.
Biochemical parameters assessed included alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine. Hematological parameters assessed included eosinophils, hemoglobin level, lymphocytes, neutrophils, platelet count and White Blood Cells \[WBC\]. Abnormal laboratory values at Day 90 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) \[e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 90\].
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=100 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=97 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=97 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=99 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Within · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Within · Within
|
98 Participants
|
95 Participants
|
97 Participants
|
99 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Within · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Above · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Above · Within
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
ALT, Above · Above
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Within · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Within · Within
|
99 Participants
|
95 Participants
|
97 Participants
|
98 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Within · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Above · Below
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Above · Within
|
1 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
AST, Above · Above
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Below · Below
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Below · Within
|
5 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Below · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Within · Below
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Within · Within
|
90 Participants
|
88 Participants
|
91 Participants
|
92 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Within · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Above · Below
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Above · Within
|
1 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Creatinine, Above · Above
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Unknown · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Unknown · Within
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Unknown · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Below · Below
|
6 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Below · Within
|
6 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Below · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Within · Below
|
6 Participants
|
5 Participants
|
8 Participants
|
9 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Within · Within
|
76 Participants
|
81 Participants
|
70 Participants
|
80 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Within · Above
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Above · Below
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Above · Within
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Eosinophils, Above · Above
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Unknown · Below
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Unknown · Within
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Unknown · Above
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Below · Below
|
11 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Below · Within
|
9 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Below · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Within · Below
|
4 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Within · Within
|
75 Participants
|
81 Participants
|
84 Participants
|
82 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Within · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Above · Below
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Above · Within
|
—
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hemoglobin, Above · Above
|
—
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Unknown · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Unknown · Within
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Unknown · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Below · Below
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Below · Within
|
1 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Below · Above
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Within · Below
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Within · Within
|
95 Participants
|
93 Participants
|
90 Participants
|
95 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Within · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Above · Below
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Above · Within
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Lymphocytes, Above · Above
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Unknown · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Unknown · Within
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Unknown · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Below · Below
|
2 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Below · Within
|
2 Participants
|
1 Participants
|
—
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Below · Above
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Within · Below
|
3 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Within · Within
|
89 Participants
|
83 Participants
|
86 Participants
|
91 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Within · Above
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Above · Below
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Above · Within
|
—
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Neutrophils, Above · Above
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Unknown · Below
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Unknown · Within
|
2 Participants
|
2 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Unknown · Above
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Within · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Within · Within
|
91 Participants
|
91 Participants
|
95 Participants
|
95 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Within · Above
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Above · Below
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Above · Within
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Platelet count, Above · Above
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Unknown · Below
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Unknown · Within
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Unknown · Above
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Below · Below
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Below · Within
|
2 Participants
|
—
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Below · Above
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Within · Below
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Within · Within
|
91 Participants
|
89 Participants
|
89 Participants
|
89 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Within · Above
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Above · Below
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Above · Within
|
—
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
WBC, Above · Above
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 7 up to Day 90Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, during the considered period.
The biochemical and hematological parameters analyzed were ALT, AST, creatinine, eosinophils increase, hemoglobin decrease, lymphocytes decrease, neutrophils decrease, platelet count decrease, WBC decrease and WBC increase, which were graded by FDA Toxicity Grading Scale. Assessed grades over the Day 7- Day 90 period were Unknown, Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening), as compared to the baseline status of the same parameters, at Day 0 (Unknown, Grade 1, Grade 2, Grade 3) \[e.g. ALT Grade 0 - Unknown = ALT Grade 0 at baseline versus Unknown grade from Day 7 up to Day 90\].
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=100 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=98 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=99 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=102 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 2 · Unknown
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 2 · Grade 2
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 2 · Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 2 · Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 3 · Unknown
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 3 · Grade 0
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 3 · Grade 1
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 3 · Grade 2
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 3 · Grade 3
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 3 · Grade 4
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Unknown · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Unknown · Grade 0
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Unknown · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Unknown · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Unknown · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Unknown · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 0 · Grade 0
|
90 Participants
|
97 Participants
|
93 Participants
|
99 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 0 · Grade 1
|
5 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 0 · Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 0 · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 0 · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 1 · Unknown
|
0 Participants
|
—
|
0 Participants
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 1 · Grade 0
|
1 Participants
|
—
|
1 Participants
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 1 · Grade 1
|
1 Participants
|
—
|
0 Participants
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 1 · Grade 2
|
0 Participants
|
—
|
0 Participants
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 1 · Grade 3
|
0 Participants
|
—
|
0 Participants
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 1 · Grade 4
|
0 Participants
|
—
|
0 Participants
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 2 · Unknown
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 2 · Grade 0
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 2 · Grade 1
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 2 · Grade 2
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 2 · Grade 3
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Lymphocytes decrease, Grade 2 · Grade 4
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Unknown · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Unknown · Grade 0
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Unknown · Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Unknown · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Unknown · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Unknown · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 0 · Grade 0
|
80 Participants
|
70 Participants
|
82 Participants
|
82 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 0 · Grade 1
|
10 Participants
|
20 Participants
|
11 Participants
|
8 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 0 · Grade 2
|
3 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 0 · Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 0 · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 1 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 1 · Grade 0
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 1 · Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 1 · Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 1 · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 1 · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 2 · Grade 0
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 2 · Grade 1
|
1 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 2 · Grade 2
|
2 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 2 · Grade 3
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Neutrophils decrease, Grade 2 · Grade 4
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Unknown · Unknown
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Unknown · Grade 0
|
2 Participants
|
2 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Unknown · Grade 1
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Unknown · Grade 2
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Unknown · Grade 3
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Unknown · Grade 4
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Grade 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Grade 0 · Grade 0
|
94 Participants
|
94 Participants
|
97 Participants
|
100 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Grade 0 · Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Grade 0 · Grade 2
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Grade 0 · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Grade 0 · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Grade 1 · Unknown
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Grade 1 · Grade 0
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Grade 1 · Grade 1
|
—
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Grade 1 · Grade 2
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Grade 1 · Grade 3
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Platelet count decrease, Grade 1 · Grade 4
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Unknown · Unknown
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Unknown · Grade 0
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Unknown · Grade 1
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 0 · Grade 0
|
96 Participants
|
97 Participants
|
96 Participants
|
101 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 0 · Grade 1
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 0 · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 0 · Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Unknown · Grade 2
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Unknown · Grade 3
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Unknown · Grade 4
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Grade 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Grade 0 · Grade 0
|
92 Participants
|
95 Participants
|
94 Participants
|
94 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Grade 0 · Grade 1
|
6 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Grade 0 · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Grade 0 · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Grade 0 · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Grade 1 · Unknown
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Grade 1 · Grade 0
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Grade 1 · Grade 1
|
1 Participants
|
—
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Grade 1 · Grade 2
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Grade 1 · Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC decrease, Grade 1 · Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Unknown · Unknown
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Unknown · Grade 0
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Unknown · Grade 1
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Unknown · Grade 2
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Unknown · Grade 3
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Unknown · Grade 4
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 0 · Grade 0
|
95 Participants
|
85 Participants
|
91 Participants
|
88 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 0 · Grade 1
|
3 Participants
|
9 Participants
|
5 Participants
|
11 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 0 · Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 0 · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 0 · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 1 · Unknown
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 1 · Grade 0
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 1 · Grade 1
|
—
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 1 · Grade 2
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 0 · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 1 · Unknown
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 1 · Grade 0
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 1 · Grade 1
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 1 · Grade 2
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 1 · Grade 3
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 1 · Grade 4
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 2 · Unknown
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 2 · Grade 0
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 2 · Grade 1
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 2 · Grade 2
|
—
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 2 · Grade 3
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
ALT, Grade 2 · Grade 4
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
AST, Grade 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
AST, Grade 0 · Grade 0
|
98 Participants
|
97 Participants
|
97 Participants
|
101 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 1 · Grade 3
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 1 · Grade 4
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 2 · Unknown
|
—
|
—
|
0 Participants
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 2 · Grade 0
|
—
|
—
|
0 Participants
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 2 · Grade 1
|
—
|
—
|
1 Participants
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 2 · Grade 2
|
—
|
—
|
0 Participants
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 2 · Grade 3
|
—
|
—
|
0 Participants
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
WBC increase, Grade 2 · Grade 4
|
—
|
—
|
0 Participants
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
AST, Grade 0 · Grade 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
AST, Grade 0 · Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
AST, Grade 0 · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
AST, Grade 0 · Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
AST, Grade 1 · Unknown
|
—
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
AST, Grade 1 · Grade 0
|
—
|
0 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
AST, Grade 1 · Grade 1
|
—
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
AST, Grade 1 · Grade 2
|
—
|
1 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
AST, Grade 1 · Grade 3
|
—
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
AST, Grade 1 · Grade 4
|
—
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Creatinine, Grade 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Creatinine, Grade 0 · Grade 0
|
100 Participants
|
98 Participants
|
99 Participants
|
102 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Creatinine, Grade 0 · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Creatinine, Grade 0 · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Creatinine, Grade 0 · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Creatinine, Grade 0 · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Unknown · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Unknown · Grade 0
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Unknown · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Unknown · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Unknown · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Unknown · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 0 · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 0 · Grade 0
|
94 Participants
|
96 Participants
|
95 Participants
|
99 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 0 · Grade 1
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 0 · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 0 · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 1 · Unknown
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 1 · Grade 0
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 1 · Grade 1
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 1 · Grade 2
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 1 · Grade 3
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 1 · Grade 4
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 2 · Unknown
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 2 · Grade 0
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 2 · Grade 1
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 2 · Grade 2
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 2 · Grade 3
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Eosinophils increase, Grade 2 · Grade 4
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Unknown · Unknown
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 2 · Grade 1
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Unknown · Grade 0
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Unknown · Grade 1
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Unknown · Grade 2
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Unknown · Grade 3
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Unknown · Grade 4
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 0 · Grade 0
|
61 Participants
|
74 Participants
|
73 Participants
|
74 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 0 · Grade 1
|
14 Participants
|
12 Participants
|
15 Participants
|
13 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 0 · Grade 2
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 0 · Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 0 · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 1 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 1 · Grade 0
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 1 · Grade 1
|
11 Participants
|
9 Participants
|
5 Participants
|
10 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 1 · Grade 2
|
5 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 1 · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 1 · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 2 · Unknown
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hemoglobin decrease, Grade 2 · Grade 0
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 60 and Day 90Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 90, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay up to Day 90.
RSV-A is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value ≥ 8 ED60.
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=98 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=92 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=96 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=96 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Neutralizing Antibody Titers Against RSV-A Subtype
Anti-RSV.A, Day 60
|
715.4 Titers
Interval 615.8 to 831.1
|
831.9 Titers
Interval 733.0 to 944.1
|
965.1 Titers
Interval 827.7 to 1125.4
|
311.6 Titers
Interval 269.0 to 360.8
|
|
Neutralizing Antibody Titers Against RSV-A Subtype
Anti-RSV.A, Day 90
|
566.5 Titers
Interval 494.9 to 648.4
|
732.1 Titers
Interval 640.2 to 837.2
|
902.8 Titers
Interval 776.4 to 1049.9
|
319.6 Titers
Interval 274.2 to 372.4
|
SECONDARY outcome
Timeframe: At Day 0, Day 30, Day 60 and Day 90Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 90, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay up to Day 90.
RSV-B is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value ≥ 6 ED60.
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=98 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=95 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=98 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=100 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Neutralizing Antibody Titers Against RSV-B Subtype
Anti-RSV.B, Day 0
|
385.6 Titers
Interval 318.4 to 466.9
|
392.1 Titers
Interval 334.3 to 460.0
|
410.6 Titers
Interval 346.5 to 486.5
|
340.2 Titers
Interval 289.0 to 400.4
|
|
Neutralizing Antibody Titers Against RSV-B Subtype
Anti-RSV.B, Day 30
|
909.1 Titers
Interval 778.5 to 1061.6
|
1004.1 Titers
Interval 886.5 to 1137.4
|
1131.7 Titers
Interval 987.3 to 1297.2
|
357.7 Titers
Interval 309.0 to 414.0
|
|
Neutralizing Antibody Titers Against RSV-B Subtype
Anti-RSV.B, Day 60
|
752.1 Titers
Interval 646.7 to 874.6
|
847.1 Titers
Interval 746.8 to 960.9
|
923.6 Titers
Interval 813.2 to 1048.8
|
409.6 Titers
Interval 359.2 to 467.1
|
|
Neutralizing Antibody Titers Against RSV-B Subtype
Anti-RSV.B, Day 90
|
667.8 Titers
Interval 572.8 to 778.7
|
804.9 Titers
Interval 699.4 to 926.3
|
848.6 Titers
Interval 731.4 to 984.7
|
423.2 Titers
Interval 359.2 to 498.6
|
SECONDARY outcome
Timeframe: At Day 60 and Day 90Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 90, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay up to Day 90.
PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off value ≥ 9.6 µg/mL.
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=98 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=92 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=96 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=96 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Palivizumab Competing Antibody (PCA) Concentrations
PCA, Day 60
|
55.2 µg/mL
Interval 48.8 to 62.5
|
69.0 µg/mL
Interval 62.4 to 76.4
|
66.7 µg/mL
Interval 58.7 to 75.8
|
6.4 µg/mL
Interval 5.8 to 7.1
|
|
Palivizumab Competing Antibody (PCA) Concentrations
PCA, Day 90
|
47.6 µg/mL
Interval 42.3 to 53.5
|
57.9 µg/mL
Interval 51.4 to 65.1
|
57.0 µg/mL
Interval 50.0 to 64.9
|
7.4 µg/mL
Interval 6.5 to 8.6
|
SECONDARY outcome
Timeframe: At Day 0 and Day 30Population: This immunogenicity analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom immunogenicity results were available for this assay up to Day 30.
Anti-neogenin (anti-NEO) antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in nanograms per milliliter (ng/mL), for a seropositivity cut-off value ≥ 55 ng/mL.
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=100 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=99 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=99 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=102 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Antibody Concentrations Against Neogenin (NEO) Residual Host Cell Protein
Anti-NEO, Day 0
|
32.9 ng/mL
Interval 29.2 to 37.1
|
32.0 ng/mL
Interval 28.7 to 35.7
|
33.5 ng/mL
Interval 29.3 to 38.3
|
34.5 ng/mL
Interval 30.0 to 39.5
|
|
Antibody Concentrations Against Neogenin (NEO) Residual Host Cell Protein
Anti-NEO, Day 30
|
32.9 ng/mL
Interval 29.5 to 36.7
|
31.5 ng/mL
Interval 28.4 to 34.9
|
33.1 ng/mL
Interval 29.3 to 37.4
|
34.7 ng/mL
Interval 30.2 to 39.9
|
SECONDARY outcome
Timeframe: From Day 0 up to study end, at Day 360Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
MA-RSV-RTIs were defined as a visit to a health care provider for respiratory symptoms including but not limited to cough, sputum production, difficulty breathing.
Outcome measures
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=100 Participants
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=99 Participants
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=99 Participants
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=102 Participants
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Number of Subjects With Any Medically Attended (MA) Respiratory Tract Infections (RTIs) Associated With RSV
|
21 Participants
|
11 Participants
|
10 Participants
|
9 Participants
|
Adverse Events
GSK3003891A Vaccine Formulation 1 Group
Serious events: 1 serious events
Other events: 88 other events
Deaths: 0 deaths
GSK3003891A Vaccine Formulation 2 Group
Serious events: 3 serious events
Other events: 86 other events
Deaths: 0 deaths
GSK3003891A Vaccine Formulation 3 Group
Serious events: 2 serious events
Other events: 83 other events
Deaths: 0 deaths
Control Group
Serious events: 2 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=100 participants at risk
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=99 participants at risk
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=99 participants at risk
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=102 participants at risk
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Biliary colic
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
Other adverse events
| Measure |
GSK3003891A Vaccine Formulation 1 Group
n=100 participants at risk
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 2 Group
n=99 participants at risk
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
GSK3003891A Vaccine Formulation 3 Group
n=99 participants at risk
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
|
Control Group
n=102 participants at risk
Subjects in this group received a single placebo injection at Day 0.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Bone contusion
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
2.0%
2/99 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Nervous system disorders
Cervicobrachial syndrome
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Nervous system disorders
Dizziness
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Nervous system disorders
Facial neuralgia
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Nervous system disorders
Headache
|
54.0%
54/100 • Number of events 61 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
47.5%
47/99 • Number of events 56 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
47.5%
47/99 • Number of events 55 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
46.1%
47/102 • Number of events 53 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Nervous system disorders
Migraine
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Nervous system disorders
Syncope
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Pregnancy, puerperium and perinatal conditions
Retained placenta or membranes
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Psychiatric disorders
Insomnia
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.0%
2/100 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Reproductive system and breast disorders
Menstrual disorder
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Reproductive system and breast disorders
Premenstrual pain
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
5/100 • Number of events 5 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
2.0%
2/99 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
5.1%
5/99 • Number of events 5 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
4.9%
5/102 • Number of events 5 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.0%
9/100 • Number of events 13 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
4.0%
4/99 • Number of events 4 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
4.0%
4/99 • Number of events 4 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
4.9%
5/102 • Number of events 5 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.0%
6/100 • Number of events 6 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
10.1%
10/99 • Number of events 10 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
8.1%
8/99 • Number of events 8 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
2/100 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
2/100 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
2.0%
2/99 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
2.0%
2/102 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
3.0%
3/99 • Number of events 4 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Eye disorders
Blepharospasm
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Eye disorders
Vision blurred
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
2.0%
2/102 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Gastrointestinal disorders
Gastric disorder
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
22.0%
22/100 • Number of events 22 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
24.2%
24/99 • Number of events 24 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
14.1%
14/99 • Number of events 14 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
10.8%
11/102 • Number of events 11 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Gastrointestinal disorders
Nausea
|
2.0%
2/100 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
2.0%
2/99 • Number of events 3 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
2.0%
2/99 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
2.0%
2/102 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
General disorders
Asthenia
|
2.0%
2/100 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
General disorders
Axillary pain
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
3.0%
3/99 • Number of events 3 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
General disorders
Chills
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
General disorders
Fatigue
|
47.0%
47/100 • Number of events 48 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
43.4%
43/99 • Number of events 43 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
45.5%
45/99 • Number of events 46 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
41.2%
42/102 • Number of events 42 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
General disorders
Feeling cold
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
General disorders
Gait disturbance
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
General disorders
Influenza like illness
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
General disorders
Injection site haematoma
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
2.0%
2/99 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
General disorders
Injection site haemorrhage
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
3.0%
3/99 • Number of events 3 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
General disorders
Injection site pruritus
|
2.0%
2/100 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
General disorders
Malaise
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
General disorders
Pain
|
52.0%
52/100 • Number of events 53 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
52.5%
52/99 • Number of events 52 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
51.5%
51/99 • Number of events 51 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
10.8%
11/102 • Number of events 12 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
General disorders
Pyrexia
|
8.0%
8/100 • Number of events 8 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
8.1%
8/99 • Number of events 8 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
6.1%
6/99 • Number of events 6 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
3.9%
4/102 • Number of events 4 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
General disorders
Swelling
|
4.0%
4/100 • Number of events 4 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
6.1%
6/99 • Number of events 6 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
7.1%
7/99 • Number of events 7 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Cystitis
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
3.0%
3/99 • Number of events 4 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Gastroenteritis
|
3.0%
3/100 • Number of events 3 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Genital herpes
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Gingivitis
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Infection
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Infective keratitis
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Influenza
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
2.0%
2/102 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
6/100 • Number of events 7 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
3.0%
3/99 • Number of events 3 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
4.0%
4/99 • Number of events 4 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
3.9%
4/102 • Number of events 5 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Oral herpes
|
1.0%
1/100 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Pharyngitis
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Rhinitis
|
13.0%
13/100 • Number of events 14 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
3.0%
3/99 • Number of events 4 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
7.1%
7/99 • Number of events 7 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
5.9%
6/102 • Number of events 6 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Salpingo-oophoritis
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
2.0%
2/102 • Number of events 2 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
3/100 • Number of events 3 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
9.1%
9/99 • Number of events 10 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
8.1%
8/99 • Number of events 8 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.98%
1/102 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Investigations
Platelet count decreased
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Investigations
White blood cell count decreased
|
1.0%
1/100 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/100 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/99 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
0.00%
0/102 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
4/100 • Number of events 4 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
2.0%
2/99 • Number of events 3 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
1.0%
1/99 • Number of events 1 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
3.9%
4/102 • Number of events 4 • Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
|
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