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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

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ClinicalTrials.gov Identifier: NCT02956837
Recruitment Status : Completed
First Posted : November 7, 2016
Results First Posted : November 20, 2018
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Respiratory Syncytial Virus Infections
Interventions Biological: RSV Vaccine (GSK3003891A) formulation 1
Biological: RSV Vaccine (GSK3003891A) formulation 2
Biological: RSV Vaccine (GSK3003891A) formulation 3
Drug: Placebo (Formulation buffer S9b)
Enrollment 406
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60 µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120 µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Period Title: Overall Study
Started 100 99 99 102
Completed 100 96 97 99
Not Completed 0 3 2 3
Reason Not Completed
Serious Adverse Events             0             1             0             0
Withdrawal by Subject             0             1             0             3
Lost to Follow-up             0             1             2             0
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group Total
Hide Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0. Total of all reporting groups
Overall Number of Baseline Participants 100 99 99 102 400
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 99 participants 99 participants 102 participants 400 participants
30.2  (6.7) 29.1  (7.2) 29.6  (7.1) 29.9  (6.9) 29.7  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 99 participants 99 participants 102 participants 400 participants
Female
100
 100.0%
99
 100.0%
99
 100.0%
102
 100.0%
400
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Geographic Ancestry Number Analyzed 100 participants 99 participants 99 participants 102 participants 400 participants
African Heritage/African American
1
   1.0%
0
   0.0%
2
   2.0%
1
   1.0%
4
   1.0%
Asian - Central/South Asian Heritage
1
   1.0%
1
   1.0%
0
   0.0%
0
   0.0%
2
   0.5%
Asian - East Asian Heritage
0
   0.0%
0
   0.0%
1
   1.0%
0
   0.0%
1
   0.3%
Asian - South East Asian Heritage
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.0%
1
   0.3%
White - Arabic/North African Heritage
0
   0.0%
1
   1.0%
2
   2.0%
1
   1.0%
4
   1.0%
White - Caucasian/European Heritage
96
  96.0%
97
  98.0%
93
  93.9%
98
  96.1%
384
  96.0%
Unspecified
2
   2.0%
0
   0.0%
1
   1.0%
1
   1.0%
4
   1.0%
1.Primary Outcome
Title Number of Subjects With Any Grade 2 and Grade 3 General Adverse Events (AEs) - Solicited and Unsolicited
Hide Description 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).
Time Frame During the 7-day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single placebo injection at Day 0.
Overall Number of Participants Analyzed 100 99 99 102
Measure Type: Count of Participants
Unit of Measure: Participants
32
  32.0%
30
  30.3%
24
  24.2%
27
  26.5%
2.Primary Outcome
Title Number of Subjects With Grade 2 and Grade 3 Fever
Hide Description 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).
Time Frame During the 7-day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptom sheets filled in.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single placebo injection at Day 0.
Overall Number of Participants Analyzed 100 98 99 102
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 2 Fever
0
   0.0%
2
   2.0%
1
   1.0%
0
   0.0%
Grade 3 Fever
0
   0.0%
1
   1.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Subjects With Related Serious Adverse Events (SAEs)
Hide Description 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).
Time Frame During the 7-day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single placebo injection at Day 0.
Overall Number of Participants Analyzed 100 99 99 102
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Neutralizing Antibody Titers Against RSV-A Subtype
Hide Description 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).
Time Frame At Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single placebo injection at Day 0.
Overall Number of Participants Analyzed 98 95 98 100
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
228.8
(193.1 to 271.0)
249.5
(213.9 to 290.9)
285.7
(244.5 to 333.9)
247.1
(211.2 to 289.1)
5.Primary Outcome
Title Neutralizing Antibody Titers Against RSV-A Subtype
Hide Description 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).
Time Frame At Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 60 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 120 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single placebo injection at Day 0.
Overall Number of Participants Analyzed 98 94 98 100
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
858.2
(724.7 to 1016.3)
1114.8
(971.9 to 1278.8)
1245.5
(1070.3 to 1449.2)
271.6
(228.0 to 323.5)
6.Primary Outcome
Title Palivizumab Competing Antibody (PCA) Concentrations
Hide Description 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).
Time Frame At Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single placebo injection at Day 0.
Overall Number of Participants Analyzed 98 94 96 100
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
5.7
(5.3 to 6.2)
5.6
(5.2 to 6.1)
5.8
(5.3 to 6.3)
6.0
(5.5 to 6.6)
7.Primary Outcome
Title Pavilizumab Competing Antibody (PCA) Concentrations
Hide Description 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).
Time Frame At Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 60 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 120 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single placebo injection at Day 0.
Overall Number of Participants Analyzed 98 94 98 100
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
66.8
(59.0 to 75.8)
81.2
(72.5 to 90.9)
83.7
(73.5 to 95.5)
6.1
(5.5 to 6.8)
8.Secondary Outcome
Title Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs
Hide Description 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.
Time Frame During the 7-day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptom sheets filled in.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single placebo injection at Day 0.
Overall Number of Participants Analyzed 100 98 99 102
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
52
  52.0%
52
  53.1%
51
  51.5%
11
  10.8%
Grade 2 Pain
5
   5.0%
5
   5.1%
10
  10.1%
1
   1.0%
Grade 3 Pain
1
   1.0%
0
   0.0%
1
   1.0%
0
   0.0%
Medically-attended Pain
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Redness (mm)
6
   6.0%
10
  10.2%
8
   8.1%
1
   1.0%
Grade 2 Redness (mm)
2
   2.0%
2
   2.0%
1
   1.0%
0
   0.0%
Grade 3 Redness
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Medically-attended Redness (mm)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Swelling (mm)
4
   4.0%
6
   6.1%
7
   7.1%
0
   0.0%
Grade 2 Swelling (mm)
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Swelling (mm)
0
   0.0%
1
   1.0%
0
   0.0%
0
   0.0%
Medically-attended Swelling (mm)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Hide Description 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.
Time Frame During the 7-day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptom sheets filled in.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single placebo injection at Day 0.
Overall Number of Participants Analyzed 100 98 99 102
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue
47
  47.0%
43
  43.9%
45
  45.5%
42
  41.2%
Grade 2 Fatigue
9
   9.0%
14
  14.3%
8
   8.1%
12
  11.8%
Grade 3 Fatigue
3
   3.0%
3
   3.1%
2
   2.0%
1
   1.0%
Related Fatigue
37
  37.0%
29
  29.6%
36
  36.4%
33
  32.4%
Medically-attended Fatigue
0
   0.0%
1
   1.0%
1
   1.0%
0
   0.0%
Any Gastrointestinal symptoms
20
  20.0%
23
  23.5%
14
  14.1%
11
  10.8%
Grade 2 Gastrointestinal symptoms
4
   4.0%
3
   3.1%
1
   1.0%
1
   1.0%
Grade 3 Gastrointestinal symptoms
1
   1.0%
2
   2.0%
0
   0.0%
1
   1.0%
Related Gastrointestinal symptoms
13
  13.0%
17
  17.3%
10
  10.1%
7
   6.9%
Medically-attended Gastrointestinal symptoms
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Headache
47
  47.0%
42
  42.9%
41
  41.4%
37
  36.3%
Grade 2 Headache
11
  11.0%
11
  11.2%
12
  12.1%
10
   9.8%
Grade 3 Headache
3
   3.0%
2
   2.0%
1
   1.0%
3
   2.9%
Related Headache
30
  30.0%
27
  27.6%
33
  33.3%
29
  28.4%
Medically-attended Headache
0
   0.0%
1
   1.0%
1
   1.0%
0
   0.0%
Any Temperature/(Oral) (°C)
8
   8.0%
8
   8.2%
6
   6.1%
4
   3.9%
Related Temperature/(Oral) (°C)
5
   5.0%
1
   1.0%
6
   6.1%
2
   2.0%
Medically-attended Temperature/(Oral) (°C)
0
   0.0%
3
   3.1%
1
   1.0%
0
   0.0%
10.Secondary Outcome
Title Number of Subjects With Any Unsolicited AEs
Hide Description 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.
Time Frame During the 30-day (Days 0-29) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single placebo injection at Day 0.
Overall Number of Participants Analyzed 100 99 99 102
Measure Type: Count of Participants
Unit of Measure: Participants
55
  55.0%
52
  52.5%
46
  46.5%
49
  48.0%
11.Secondary Outcome
Title Number of Subjects With Any SAEs
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame From Day 0 up to study end, at Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single placebo injection at Day 0.
Overall Number of Participants Analyzed 100 99 99 102
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.0%
3
   3.0%
2
   2.0%
2
   2.0%
12.Secondary Outcome
Title Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hide Description 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].
Time Frame At Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 7.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single placebo injection at Day 0.
Overall Number of Participants Analyzed 100 98 99 102
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Below Number Analyzed 0 participants 0 participants 0 participants 0 participants
Below
Within
Above
ALT, Within Number Analyzed 99 participants 97 participants 99 participants 102 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
99
 100.0%
97
 100.0%
99
 100.0%
102
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT, Above Number Analyzed 1 participants 1 participants 0 participants 0 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
AST, Below Number Analyzed 0 participants 0 participants 0 participants 0 participants
Below
Within
Above
AST, Within Number Analyzed 99 participants 97 participants 99 participants 100 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
99
 100.0%
97
 100.0%
98
  99.0%
100
 100.0%
Above
0
   0.0%
0
   0.0%
1
   1.0%
0
   0.0%
AST, Above Number Analyzed 1 participants 1 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine, Below Number Analyzed 6 participants 5 participants 2 participants 2 participants
Below
2
  33.3%
3
  60.0%
2
 100.0%
0
   0.0%
Within
4
  66.7%
2
  40.0%
0
   0.0%
2
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine, Within Number Analyzed 93 participants 92 participants 97 participants 99 participants
Below
1
   1.1%
2
   2.2%
4
   4.1%
0
   0.0%
Within
92
  98.9%
90
  97.8%
93
  95.9%
99
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine, Above Number Analyzed 1 participants 1 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
0
   0.0%
1
 100.0%
0
   0.0%
Above
1
 100.0%
0
   0.0%
1
 100.0%
Eosinophils, Unknown Number Analyzed 1 participants 1 participants 1 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils, Below Number Analyzed 12 participants 8 participants 10 participants 8 participants
Below
5
  41.7%
5
  62.5%
3
  30.0%
6
  75.0%
Within
7
  58.3%
3
  37.5%
7
  70.0%
2
  25.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils, Within Number Analyzed 81 participants 86 participants 83 participants 89 participants
Below
3
   3.7%
2
   2.3%
4
   4.8%
5
   5.6%
Within
77
  95.1%
84
  97.7%
79
  95.2%
81
  91.0%
Above
1
   1.2%
0
   0.0%
0
   0.0%
3
   3.4%
Eosinophils, Above Number Analyzed 2 participants 0 participants 0 participants 0 participants
Below
0
   0.0%
Within
1
  50.0%
Above
1
  50.0%
Hemoglobin, Unknown Number Analyzed 1 participants 0 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
Hemoglobin, Below Number Analyzed 20 participants 11 participants 8 participants 11 participants
Below
12
  60.0%
7
  63.6%
7
  87.5%
7
  63.6%
Within
8
  40.0%
4
  36.4%
1
  12.5%
4
  36.4%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin, Within Number Analyzed 79 participants 85 participants 91 participants 90 participants
Below
4
   5.1%
1
   1.2%
7
   7.7%
2
   2.2%
Within
74
  93.7%
84
  98.8%
84
  92.3%
88
  97.8%
Above
1
   1.3%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin, Above Number Analyzed 0 participants 2 participants 0 participants 0 participants
Below
0
   0.0%
Within
1
  50.0%
Above
1
  50.0%
Lymphocytes, Unknown Number Analyzed 1 participants 1 participants 1 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes, Below Number Analyzed 1 participants 0 participants 0 participants 1 participants
Below
0
   0.0%
1
 100.0%
Within
1
 100.0%
0
   0.0%
Above
0
   0.0%
0
   0.0%
Lymphocytes, Within Number Analyzed 93 participants 93 participants 93 participants 96 participants
Below
1
   1.1%
0
   0.0%
0
   0.0%
0
   0.0%
Within
92
  98.9%
93
 100.0%
92
  98.9%
94
  97.9%
Above
0
   0.0%
0
   0.0%
1
   1.1%
2
   2.1%
Lymphocytes, Above Number Analyzed 1 participants 1 participants 0 participants 0 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
Neutrophils, Unknown Number Analyzed 1 participants 1 participants 1 participants 1 participants
Below
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
0
   0.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils, Below Number Analyzed 4 participants 1 participants 0 participants 3 participants
Below
2
  50.0%
0
   0.0%
1
  33.3%
Within
2
  50.0%
1
 100.0%
2
  66.7%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils, Within Number Analyzed 91 participants 89 participants 90 participants 93 participants
Below
2
   2.2%
6
   6.7%
4
   4.4%
8
   8.6%
Within
88
  96.7%
81
  91.0%
86
  95.6%
82
  88.2%
Above
1
   1.1%
2
   2.2%
0
   0.0%
3
   3.2%
Neutrophils, Above Number Analyzed 0 participants 4 participants 3 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
4
 100.0%
3
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Platelet count, Unknown Number Analyzed 2 participants 2 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
2
 100.0%
2
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Platelet count, Below Number Analyzed 0 participants 0 participants 0 participants 0 participants
Below
Within
Above
Platelet count, Within Number Analyzed 95 participants 96 participants 99 participants 100 participants
Below
1
   1.1%
1
   1.0%
0
   0.0%
0
   0.0%
Within
93
  97.9%
95
  99.0%
99
 100.0%
100
 100.0%
Above
1
   1.1%
0
   0.0%
0
   0.0%
0
   0.0%
Platelet count, Above Number Analyzed 1 participants 0 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
WBC, Unknown Number Analyzed 1 participants 0 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
WBC, Below Number Analyzed 3 participants 0 participants 1 participants 5 participants
Below
2
  66.7%
0
   0.0%
2
  40.0%
Within
1
  33.3%
1
 100.0%
3
  60.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
WBC, Within Number Analyzed 95 participants 93 participants 94 participants 94 participants
Below
4
   4.2%
4
   4.3%
1
   1.1%
4
   4.3%
Within
90
  94.7%
87
  93.5%
92
  97.9%
87
  92.6%
Above
1
   1.1%
2
   2.2%
1
   1.1%
3
   3.2%
WBC, Above Number Analyzed 0 participants 4 participants 3 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
3
  75.0%
3
 100.0%
1
 100.0%
Above
1
  25.0%
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hide Description 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].
Time Frame At Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 30.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single placebo injection at Day 0.
Overall Number of Participants Analyzed 99 98 99 102
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Below Number Analyzed 0 participants 0 participants 0 participants 0 participants
Below
Within
Above
ALT, Within Number Analyzed 96 participants 97 participants 99 participants 102 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
93
  96.9%
97
 100.0%
96
  97.0%
101
  99.0%
Above
3
   3.1%
0
   0.0%
3
   3.0%
1
   1.0%
ALT, Above Number Analyzed 1 participants 1 participants 0 participants 0 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
0
   0.0%
Above
0
   0.0%
1
 100.0%
AST, Below Number Analyzed 0 participants 0 participants 0 participants 0 participants
Below
Within
Above
AST, Within Number Analyzed 96 participants 97 participants 99 participants 101 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
94
  97.9%
97
 100.0%
97
  98.0%
100
  99.0%
Above
2
   2.1%
0
   0.0%
2
   2.0%
1
   1.0%
AST, Above Number Analyzed 1 participants 1 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
0
   0.0%
1
 100.0%
Above
0
   0.0%
1
 100.0%
0
   0.0%
Creatinine, Below Number Analyzed 6 participants 5 participants 2 participants 2 participants
Below
1
  16.7%
2
  40.0%
2
 100.0%
2
 100.0%
Within
5
  83.3%
3
  60.0%
0
   0.0%
0
   0.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine, Within Number Analyzed 90 participants 92 participants 97 participants 99 participants
Below
1
   1.1%
0
   0.0%
3
   3.1%
2
   2.0%
Within
89
  98.9%
91
  98.9%
93
  95.9%
97
  98.0%
Above
0
   0.0%
1
   1.1%
1
   1.0%
0
   0.0%
Creatinine, Above Number Analyzed 1 participants 1 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
0
   0.0%
1
 100.0%
Above
0
   0.0%
1
 100.0%
0
   0.0%
Eosinophils, Unknown Number Analyzed 1 participants 1 participants 1 participants 1 participants
Below
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
0
   0.0%
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils, Below Number Analyzed 12 participants 8 participants 11 participants 8 participants
Below
5
  41.7%
4
  50.0%
4
  36.4%
4
  50.0%
Within
7
  58.3%
4
  50.0%
7
  63.6%
4
  50.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils, Within Number Analyzed 84 participants 88 participants 86 participants 90 participants
Below
3
   3.6%
6
   6.8%
8
   9.3%
7
   7.8%
Within
80
  95.2%
82
  93.2%
75
  87.2%
83
  92.2%
Above
1
   1.2%
0
   0.0%
3
   3.5%
0
   0.0%
Eosinophils, Above Number Analyzed 2 participants 0 participants 0 participants 0 participants
Below
0
   0.0%
Within
1
  50.0%
Above
1
  50.0%
Hemoglobin, Unknown Number Analyzed 1 participants 0 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
Hemoglobin, Below Number Analyzed 20 participants 11 participants 8 participants 11 participants
Below
13
  65.0%
6
  54.5%
6
  75.0%
7
  63.6%
Within
7
  35.0%
5
  45.5%
2
  25.0%
4
  36.4%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin, Within Number Analyzed 78 participants 84 participants 91 participants 90 participants
Below
2
   2.6%
4
   4.8%
5
   5.5%
3
   3.3%
Within
76
  97.4%
79
  94.0%
86
  94.5%
87
  96.7%
Above
0
   0.0%
1
   1.2%
0
   0.0%
0
   0.0%
Hemoglobin, Above Number Analyzed 0 participants 2 participants 0 participants 0 participants
Below
0
   0.0%
Within
1
  50.0%
Above
1
  50.0%
Lymphocytes, Unknown Number Analyzed 1 participants 1 participants 1 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes, Below Number Analyzed 1 participants 0 participants 0 participants 1 participants
Below
0
   0.0%
1
 100.0%
Within
1
 100.0%
0
   0.0%
Above
0
   0.0%
0
   0.0%
Lymphocytes, Within Number Analyzed 96 participants 95 participants 97 participants 97 participants
Below
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
94
  97.9%
94
  98.9%
97
 100.0%
95
  97.9%
Above
1
   1.0%
1
   1.1%
0
   0.0%
2
   2.1%
Lymphocytes, Above Number Analyzed 1 participants 1 participants 0 participants 0 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
Neutrophils, Unknown Number Analyzed 1 participants 1 participants 1 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils, Below Number Analyzed 4 participants 1 participants 0 participants 3 participants
Below
1
  25.0%
0
   0.0%
0
   0.0%
Within
3
  75.0%
1
 100.0%
3
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils, Within Number Analyzed 94 participants 91 participants 94 participants 94 participants
Below
4
   4.3%
1
   1.1%
1
   1.1%
3
   3.2%
Within
88
  93.6%
88
  96.7%
92
  97.9%
88
  93.6%
Above
2
   2.1%
2
   2.2%
1
   1.1%
3
   3.2%
Neutrophils, Above Number Analyzed 0 participants 4 participants 3 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
3
  75.0%
3
 100.0%
1
 100.0%
Above
1
  25.0%
0
   0.0%
0
   0.0%
Platelet count, Unknown Number Analyzed 2 participants 2 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
2
 100.0%
2
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Platelet count, Below Number Analyzed 0 participants 0 participants 0 participants 0 participants
Below
Within
Above
Platelet count, Within Number Analyzed 94 participants 95 participants 99 participants 100 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
92
  97.9%
94
  98.9%
99
 100.0%
99
  99.0%
Above
2
   2.1%
1
   1.1%
0
   0.0%
1
   1.0%
Platelet count, Above Number Analyzed 1 participants 0 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
WBC, Unknown Number Analyzed 1 participants 0 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
WBC, Below Number Analyzed 3 participants 0 participants 2 participants 4 participants
Below
2
  66.7%
1
  50.0%
0
   0.0%
Within
1
  33.3%
1
  50.0%
4
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
WBC, Within Number Analyzed 95 participants 93 participants 94 participants 95 participants
Below
3
   3.2%
1
   1.1%
3
   3.2%
0
   0.0%
Within
90
  94.7%
89
  95.7%
90
  95.7%
90
  94.7%
Above
2
   2.1%
3
   3.2%
1
   1.1%
5
   5.3%
WBC, Above Number Analyzed 0 participants 4 participants 3 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
2
  50.0%
2
  66.7%
1
 100.0%
Above
2
  50.0%
1
  33.3%
0
   0.0%
14.Secondary Outcome
Title Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hide Description 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].
Time Frame At Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 60.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single placebo injection at Day 0.
Overall Number of Participants Analyzed 100 96 98 101
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Below Number Analyzed 0 participants 0 participants 0 participants 0 participants
Below
Within
Above
ALT, Within Number Analyzed 98 participants 95 participants 98 participants 101 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
98
 100.0%
95
 100.0%
98
 100.0%
101
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT, Above Number Analyzed 1 participants 1 participants 0 participants 0 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
AST, Below Number Analyzed 0 participants 0 participants 0 participants 0 participants
Below
Within
Above
AST, Within Number Analyzed 98 participants 95 participants 98 participants 100 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
98
 100.0%
95
 100.0%
97
  99.0%
100
 100.0%
Above
0
   0.0%
0
   0.0%
1
   1.0%
0
   0.0%
AST, Above Number Analyzed 1 participants 1 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine, Below Number Analyzed 6 participants 5 participants 2 participants 2 participants
Below
0
   0.0%
3
  60.0%
2
 100.0%
2
 100.0%
Within
6
 100.0%
2
  40.0%
0
   0.0%
0
   0.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine, Within Number Analyzed 92 participants 90 participants 96 participants 98 participants
Below
2
   2.2%
3
   3.3%
3
   3.1%
6
   6.1%
Within
89
  96.7%
87
  96.7%
93
  96.9%
91
  92.9%
Above
1
   1.1%
0
   0.0%
0
   0.0%
1
   1.0%
Creatinine, Above Number Analyzed 1 participants 1 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils, Unknown Number Analyzed 1 participants 0 participants 1 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils, Below Number Analyzed 12 participants 8 participants 10 participants 9 participants
Below
5
  41.7%
2
  25.0%
4
  40.0%
5
  55.6%
Within
7
  58.3%
6
  75.0%
6
  60.0%
4
  44.4%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils, Within Number Analyzed 85 participants 87 participants 85 participants 91 participants
Below
6
   7.1%
4
   4.6%
5
   5.9%
7
   7.7%
Within
77
  90.6%
82
  94.3%
77
  90.6%
81
  89.0%
Above
2
   2.4%
1
   1.1%
3
   3.5%
3
   3.3%
Eosinophils, Above Number Analyzed 2 participants 0 participants 0 participants 0 participants
Below
0
   0.0%
Within
0
   0.0%
Above
2
 100.0%
Hemoglobin, Unknown Number Analyzed 1 participants 0 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
Hemoglobin, Below Number Analyzed 20 participants 11 participants 8 participants 11 participants
Below
13
  65.0%
6
  54.5%
5
  62.5%
8
  72.7%
Within
7
  35.0%
5
  45.5%
3
  37.5%
3
  27.3%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin, Within Number Analyzed 79 participants 82 participants 90 participants 89 participants
Below
5
   6.3%
4
   4.9%
6
   6.7%
7
   7.9%
Within
74
  93.7%
78
  95.1%
84
  93.3%
81
  91.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.1%
Hemoglobin, Above Number Analyzed 0 participants 2 participants 0 participants 0 participants
Below
0
   0.0%
Within
1
  50.0%
Above
1
  50.0%
Lymphocytes, Unknown Number Analyzed 1 participants 0 participants 1 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes, Below Number Analyzed 1 participants 0 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
Lymphocytes, Within Number Analyzed 97 participants 94 participants 95 participants 99 participants
Below
1
   1.0%
0
   0.0%
1
   1.1%
0
   0.0%
Within
96
  99.0%
94
 100.0%
93
  97.9%
96
  97.0%
Above
0
   0.0%
0
   0.0%
1
   1.1%
3
   3.0%
Lymphocytes, Above Number Analyzed 1 participants 1 participants 0 participants 0 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
Neutrophils, Unknown Number Analyzed 1 participants 0 participants 1 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils, Below Number Analyzed 4 participants 1 participants 0 participants 3 participants
Below
0
   0.0%
0
   0.0%
1
  33.3%
Within
4
 100.0%
1
 100.0%
2
  66.7%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils, Within Number Analyzed 95 participants 90 participants 92 participants 96 participants
Below
4
   4.2%
4
   4.4%
4
   4.3%
4
   4.2%
Within
89
  93.7%
84
  93.3%
88
  95.7%
89
  92.7%
Above
2
   2.1%
2
   2.2%
0
   0.0%
3
   3.1%
Neutrophils, Above Number Analyzed 0 participants 4 participants 3 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
4
 100.0%
3
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Platelet count, Unknown Number Analyzed 2 participants 2 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
2
 100.0%
2
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Platelet count, Below Number Analyzed 0 participants 0 participants 0 participants 0 participants
Below
Within
Above
Platelet count, Within Number Analyzed 94 participants 93 participants 98 participants 99 participants
Below
0
   0.0%
0
   0.0%
1
   1.0%
0
   0.0%
Within
93
  98.9%
92
  98.9%
97
  99.0%
98
  99.0%
Above
1
   1.1%
1
   1.1%
0
   0.0%
1
   1.0%
Platelet count, Above Number Analyzed 1 participants 0 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
WBC, Unknown Number Analyzed 1 participants 0 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
WBC, Below Number Analyzed 3 participants 0 participants 2 participants 5 participants
Below
1
  33.3%
2
 100.0%
3
  60.0%
Within
2
  66.7%
0
   0.0%
2
  40.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
WBC, Within Number Analyzed 96 participants 91 participants 93 participants 94 participants
Below
2
   2.1%
1
   1.1%
2
   2.2%
1
   1.1%
Within
92
  95.8%
86
  94.5%
90
  96.8%
87
  92.6%
Above
2
   2.1%
4
   4.4%
1
   1.1%
6
   6.4%
WBC, Above Number Analyzed 0 participants 4 participants 3 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
3
  75.0%
2
  66.7%
1
 100.0%
Above
1
  25.0%
1
  33.3%
0
   0.0%
15.Secondary Outcome
Title Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Hide Description 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].
Time Frame At Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 90.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single placebo injection at Day 0.
Overall Number of Participants Analyzed 100 97 97 99
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Below Number Analyzed 0 participants 0 participants 0 participants 0 participants
Below
Within
Above
ALT, Within Number Analyzed 99 participants 95 participants 97 participants 99 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
98
  99.0%
95
 100.0%
97
 100.0%
99
 100.0%
Above
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT, Above Number Analyzed 1 participants 1 participants 0 participants 0 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
AST, Below Number Analyzed 0 participants 0 participants 0 participants 0 participants
Below
Within
Above
AST, Within Number Analyzed 99 participants 95 participants 97 participants 98 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
99
 100.0%
95
 100.0%
97
 100.0%
98
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST, Above Number Analyzed 1 participants 1 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine, Below Number Analyzed 6 participants 5 participants 2 participants 2 participants
Below
1
  16.7%
2
  40.0%
2
 100.0%
2
 100.0%
Within
5
  83.3%
3
  60.0%
0
   0.0%
0
   0.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine, Within Number Analyzed 93 participants 90 participants 95 participants 96 participants
Below
3
   3.2%
2
   2.2%
4
   4.2%
3
   3.1%
Within
90
  96.8%
88
  97.8%
91
  95.8%
92
  95.8%
Above
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.0%
Creatinine, Above Number Analyzed 1 participants 1 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
0
   0.0%
1
 100.0%
Above
0
   0.0%
1
 100.0%
0
   0.0%
Eosinophils, Unknown Number Analyzed 1 participants 1 participants 1 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils, Below Number Analyzed 12 participants 8 participants 11 participants 9 participants
Below
6
  50.0%
2
  25.0%
4
  36.4%
4
  44.4%
Within
6
  50.0%
6
  75.0%
7
  63.6%
5
  55.6%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils, Within Number Analyzed 84 participants 87 participants 80 participants 89 participants
Below
6
   7.1%
5
   5.7%
8
  10.0%
9
  10.1%
Within
76
  90.5%
81
  93.1%
70
  87.5%
80
  89.9%
Above
2
   2.4%
1
   1.1%
2
   2.5%
0
   0.0%
Eosinophils, Above Number Analyzed 2 participants 0 participants 0 participants 0 participants
Below
0
   0.0%
Within
2
 100.0%
Above
0
   0.0%
Hemoglobin, Unknown Number Analyzed 1 participants 0 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
Hemoglobin, Below Number Analyzed 20 participants 11 participants 7 participants 11 participants
Below
11
  55.0%
5
  45.5%
6
  85.7%
7
  63.6%
Within
9
  45.0%
6
  54.5%
1
  14.3%
4
  36.4%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin, Within Number Analyzed 79 participants 84 participants 89 participants 87 participants
Below
4
   5.1%
3
   3.6%
4
   4.5%
5
   5.7%
Within
75
  94.9%
81
  96.4%
84
  94.4%
82
  94.3%
Above
0
   0.0%
0
   0.0%
1
   1.1%
0
   0.0%
Hemoglobin, Above Number Analyzed 0 participants 2 participants 0 participants 0 participants
Below
0
   0.0%
Within
1
  50.0%
Above
1
  50.0%
Lymphocytes, Unknown Number Analyzed 1 participants 1 participants 1 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes, Below Number Analyzed 1 participants 0 participants 0 participants 1 participants
Below
0
   0.0%
1
 100.0%
Within
1
 100.0%
0
   0.0%
Above
0
   0.0%
0
   0.0%
Lymphocytes, Within Number Analyzed 96 participants 94 participants 91 participants 97 participants
Below
1
   1.0%
0
   0.0%
1
   1.1%
1
   1.0%
Within
95
  99.0%
93
  98.9%
90
  98.9%
95
  97.9%
Above
0
   0.0%
1
   1.1%
0
   0.0%
1
   1.0%
Lymphocytes, Above Number Analyzed 1 participants 1 participants 0 participants 0 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
0
   0.0%
Above
0
   0.0%
1
 100.0%
Neutrophils, Unknown Number Analyzed 1 participants 1 participants 1 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils, Below Number Analyzed 4 participants 1 participants 0 participants 3 participants
Below
2
  50.0%
0
   0.0%
1
  33.3%
Within
2
  50.0%
1
 100.0%
2
  66.7%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils, Within Number Analyzed 94 participants 90 participants 88 participants 94 participants
Below
3
   3.2%
5
   5.6%
2
   2.3%
1
   1.1%
Within
89
  94.7%
83
  92.2%
86
  97.7%
91
  96.8%
Above
2
   2.1%
2
   2.2%
0
   0.0%
2
   2.1%
Neutrophils, Above Number Analyzed 0 participants 4 participants 3 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
4
 100.0%
3
 100.0%
0
   0.0%
Above
0
   0.0%
0
   0.0%
1
 100.0%
Platelet count, Unknown Number Analyzed 3 participants 2 participants 0 participants 1 participants
Below
1
  33.3%
0
   0.0%
0
   0.0%
Within
2
  66.7%
2
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
Platelet count, Below Number Analyzed 0 participants 0 participants 0 participants 0 participants
Below
Within
Above
Platelet count, Within Number Analyzed 94 participants 94 participants 96 participants 95 participants
Below
0
   0.0%
1
   1.1%
0
   0.0%
0
   0.0%
Within
91
  96.8%
91
  96.8%
95
  99.0%
95
 100.0%
Above
3
   3.2%
2
   2.1%
1
   1.0%
0
   0.0%
Platelet count, Above Number Analyzed 1 participants 0 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
WBC, Unknown Number Analyzed 1 participants 0 participants 0 participants 1 participants
Below
0
   0.0%
0
   0.0%
Within
1
 100.0%
1
 100.0%
Above
0
   0.0%
0
   0.0%
WBC, Below Number Analyzed 3 participants 0 participants 2 participants 5 participants
Below
1
  33.3%
1
  50.0%
1
  20.0%
Within
2
  66.7%
1
  50.0%
4
  80.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
WBC, Within Number Analyzed 96 participants 93 participants 91 participants 92 participants
Below
2
   2.1%
1
   1.1%
1
   1.1%
0
   0.0%
Within
91
  94.8%
89
  95.7%
89
  97.8%
89
  96.7%
Above
3
   3.1%
3
   3.2%
1
   1.1%
3
   3.3%
WBC, Above Number Analyzed 0 participants 4 participants 3 participants 1 participants
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
3
  75.0%
3
 100.0%
0
   0.0%
Above
1
  25.0%
0
   0.0%
1
 100.0%
16.Secondary Outcome
Title Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Hide Description 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].
Time Frame From Day 7 up to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Subjects in this group received a single placebo injection at Day 0.
Overall Number of Participants Analyzed 100 98 99 102
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Grade 0 Number Analyzed 99 participants 97 participants 99 participants 102 participants
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 0
96
  97.0%
97
 100.0%
96
  97.0%
101
  99.0%
Grade 1
2
   2.0%
0
   0.0%
3
   3.0%
1
   1.0%
Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT, Grade 1 Number Analyzed 1 participants 0 participants 0 participants 0 participants
Unknown
0
   0.0%
Grade 0
1
 100.0%
Grade 1
0
   0.0%
Grade 2
0
   0.0%
Grade 3
0
   0.0%
Grade 4
0
   0.0%
ALT, Grade 2 Number Analyzed 0 participants 1 participants 0 participants 0 participants
Unknown
0
   0.0%
Grade 0
0
   0.0%
Grade 1
0
   0.0%
Grade 2
1
 100.0%
Grade 3
0
   0.0%
Grade 4
0
   0.0%
AST, Grade 0 Number Analyzed 100 participants 97 participants 99 participants 101 participants
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 0
98
  98.0%
97
 100.0%
97
  98.0%
101
 100.0%
Grade 1
0
   0.0%
0
   0.0%
2
   2.0%
0
   0.0%
Grade 2
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST, Grade 1 Number Analyzed 0 participants 1 participants 0 participants 1 participants
Unknown
0
   0.0%
0
   0.0%
Grade 0
0
   0.0%
1
 100.0%
Grade 1
0
   0.0%
0
   0.0%
Grade 2
1
 100.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
Creatinine, Grade 0 Number Analyzed 100 participants 98 participants 99 participants 102 participants
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 0
100
 100.0%
98
 100.0%
99
 100.0%
102
 100.0%
Grade 1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils increase, Unknown Number Analyzed 1 participants 1 participants 1 participants 1 participants
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 0
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
Grade 1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils increase, Grade 0 Number Analyzed 97 participants 97 participants 98 participants 101 participants
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 0
94
  96.9%
96
  99.0%
95
  96.9%
99
  98.0%
Grade 1
3
   3.1%
1
   1.0%
3
   3.1%
2
   2.0%
Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils increase, Grade 1 Number Analyzed 1 participants 0 participants 0 participants 0 participants
Unknown
0
   0.0%
Grade 0
0
   0.0%
Grade 1
1
 100.0%
Grade 2
0
   0.0%
Grade 3
0
   0.0%
Grade 4
0
   0.0%
Eosinophils increase, Grade 2 Number Analyzed 1 participants 0 participants 0 participants 0 participants
Unknown
0
   0.0%
Grade 0
0
   0.0%
Grade 1
0
   0.0%
Grade 2
1