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A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674177
Recruitment Status : Completed
First Posted : September 17, 2018
Results First Posted : April 15, 2020
Last Update Posted : April 15, 2020
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: GSK3888550A RSV Maternal vaccine formulation 1
Biological: GSK3888550A RSV Maternal vaccine formulation 2
Biological: GSK3888550A RSV Maternal vaccine formulation 3
Drug: Placebo (Normal Saline)
Enrollment 502
Recruitment Details The study was conducted at 11 centers in 3 countries: 4 in Finland, 5 in Germany and 2 in the USA.
Pre-assignment Details Among 579 screened subjects in this study, 77 subjects were screen failure. 502 subjects were enrolled.
Arm/Group Title RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Hide Arm/Group Description Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Period Title: Overall Study
Started 124 126 126 126
Completed 122 125 126 124
Not Completed 2 1 0 2
Reason Not Completed
Lost to Follow-up             2             1             0             2
Arm/Group Title RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group Total
Hide Arm/Group Description Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm Total of all reporting groups
Overall Number of Baseline Participants 124 126 126 126 502
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 124 participants 126 participants 126 participants 126 participants 502 participants
32.5  (7.4) 32.1  (7.9) 31.5  (7.6) 32.2  (7.1) 32.1  (7.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 126 participants 126 participants 126 participants 502 participants
Female
124
 100.0%
126
 100.0%
126
 100.0%
126
 100.0%
502
 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
Number Analyzed 124 participants 126 participants 126 participants 126 participants 502 participants
ASIAN
1
   0.8%
1
   0.8%
2
   1.6%
5
   4.0%
9
   1.8%
BLACK OR AFRICAN AMERICAN
5
   4.0%
5
   4.0%
4
   3.2%
7
   5.6%
21
   4.2%
OTHER
3
   2.4%
0
   0.0%
3
   2.4%
0
   0.0%
6
   1.2%
WHITE
115
  92.7%
120
  95.2%
117
  92.9%
114
  90.5%
466
  92.8%
1.Primary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period
Hide Description

Assessed solicited local symptoms include pain, redness and swelling, at the injection site. Any = occurrence of the AE regardless of intensity grade. Any Redness and swelling symptom = symptom reported with a surface diameter greater than 20 millimeters.

Grade 3 pain = significant pain at rest, pain that prevented normal every day activity. Grade 3 redness/swelling = symptom reported with a surface diameter greater than 100 millimeters.

Time Frame During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Exposed Set, which included all subjects with the study vaccine administration documented.
Arm/Group Title RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 124 125 126 126
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
59
  47.6%
64
  51.2%
67
  53.2%
20
  15.9%
Grade 3 Pain
1
   0.8%
1
   0.8%
0
   0.0%
0
   0.0%
Any Redness
8
   6.5%
14
  11.2%
10
   7.9%
1
   0.8%
Grade 3 Redness
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Swelling
5
   4.0%
7
   5.6%
6
   4.8%
0
   0.0%
Grade 3 Swelling
0
   0.0%
0
   0.0%
1
   0.8%
0
   0.0%
2.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period
Hide Description

Assessed solicited general symptoms include fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and fever.

Any Fatigue, gastrointestinal symptoms and headache = occurrence of the symptom regardless of intensity grade and relationship. Any Fever = temperature higher than or equal to 38.0 degrees Celsius (°C), or 100.4 degrees Fahrenheit (°F).

Grade 3 Fatigue, gastrointestinal symptoms and headache = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than 39.0 degrees Celsius (°C), or 102.2 degrees Fahrenheit (°F).

Related fatigue, gastrointestinal symptoms, headache and fever(>38°C) = symptoms assessed by the investigator as related to the vaccination.

Time Frame During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Exposed Set, which included all subjects with the study vaccine administration documented.
Arm/Group Title RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 124 125 126 126
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue
41
  33.1%
49
  39.2%
41
  32.5%
38
  30.2%
Grade 3 Fatigue
3
   2.4%
5
   4.0%
3
   2.4%
4
   3.2%
Related Fatigue
25
  20.2%
34
  27.2%
25
  19.8%
27
  21.4%
Any Gastrointestinal symptoms
30
  24.2%
29
  23.2%
23
  18.3%
27
  21.4%
Grade 3 Gastrointestinal symptoms
2
   1.6%
2
   1.6%
2
   1.6%
1
   0.8%
Related Gastrointestinal symptoms
12
   9.7%
16
  12.8%
13
  10.3%
17
  13.5%
Any Headache
37
  29.8%
51
  40.8%
60
  47.6%
32
  25.4%
Grade 3 Headache
3
   2.4%
6
   4.8%
2
   1.6%
3
   2.4%
Related Headache
17
  13.7%
25
  20.0%
34
  27.0%
17
  13.5%
Any Fever
2
   1.6%
0
   0.0%
4
   3.2%
0
   0.0%
Grade 3 Fever
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Fever
0
   0.0%
0
   0.0%
2
   1.6%
0
   0.0%
3.Primary Outcome
Title Number of Subjects With Any Unsolicited AEs During a 30-day Follow-up Period
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 is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame During a 30-day follow-up period after vaccination (i.e., on the day of vaccination and 29 subsequent days)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Exposed Set, which included all vaccinated subjects.
Arm/Group Title RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 124 126 126 126
Measure Type: Count of Participants
Unit of Measure: Participants
45
  36.3%
43
  34.1%
48
  38.1%
44
  34.9%
4.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs) During a 30-day Follow-up Period
Hide Description Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Day 1 (vaccination) up to Day 30 (i.e., on the day of vaccination and 29 subsequent days)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Exposed Set, which included all vaccinated subjects.
Arm/Group Title RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 124 126 126 126
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Hide Description Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR). [e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 8].
Time Frame At Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
Arm/Group Title RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 122 122 125 125
Measure Type: Count of Participants
Unit of Measure: Participants
Eosinophils, BELOW(SCR), BELOW Number Analyzed 6 participants 5 participants 7 participants 10 participants
2
  33.3%
3
  60.0%
3
  42.9%
8
  80.0%
Eosinophils, BELOW(SCR), WITHIN Number Analyzed 6 participants 5 participants 7 participants 10 participants
4
  66.7%
2
  40.0%
4
  57.1%
2
  20.0%
Eosinophils, WITHIN(SCR), BELOW Number Analyzed 112 participants 113 participants 117 participants 113 participants
3
   2.7%
1
   0.9%
3
   2.6%
3
   2.7%
Eosinophils, WITHIN(SCR), WITHIN Number Analyzed 112 participants 113 participants 117 participants 113 participants
108
  96.4%
109
  96.5%
112
  95.7%
110
  97.3%
Eosinophils, WITHIN(SCR), ABOVE Number Analyzed 112 participants 113 participants 117 participants 113 participants
1
   0.9%
3
   2.7%
2
   1.7%
0
   0.0%
Eosinophils, ABOVE(SCR), WITHIN Number Analyzed 4 participants 3 participants 0 participants 2 participants
2
  50.0%
0
   0.0%
0
1
  50.0%
Eosinophils, ABOVE(SCR), ABOVE Number Analyzed 4 participants 3 participants 0 participants 2 participants
2
  50.0%
3
 100.0%
0
1
  50.0%
Hemoglobin, BELOW(SCR), BELOW Number Analyzed 7 participants 3 participants 1 participants 2 participants
5
  71.4%
2
  66.7%
1
 100.0%
0
   0.0%
Hemoglobin, BELOW(SCR), WITHIN Number Analyzed 7 participants 3 participants 1 participants 2 participants
2
  28.6%
1
  33.3%
0
   0.0%
2
 100.0%
Hemoglobin, WITHIN(SCR), BELOW Number Analyzed 115 participants 117 participants 122 participants 122 participants
2
   1.7%
2
   1.7%
1
   0.8%
5
   4.1%
Hemoglobin, WITHIN(SCR), WITHIN Number Analyzed 115 participants 117 participants 122 participants 122 participants
112
  97.4%
115
  98.3%
120
  98.4%
117
  95.9%
Hemoglobin, WITHIN(SCR), ABOVE Number Analyzed 115 participants 117 participants 122 participants 122 participants
1
   0.9%
0
   0.0%
1
   0.8%
0
   0.0%
Hemoglobin, ABOVE(SCR), WITHIN Number Analyzed 0 participants 2 participants 2 participants 1 participants
0
1
  50.0%
2
 100.0%
0
   0.0%
Hemoglobin, ABOVE(SCR), ABOVE Number Analyzed 0 participants 2 participants 2 participants 1 participants
0
1
  50.0%
0
   0.0%
1
 100.0%
Lymphocytes, BELOW(SCR), WITHIN Number Analyzed 0 participants 2 participants 2 participants 0 participants
0
2
 100.0%
2
 100.0%
0
Lymphocytes, WITHIN(SCR), BELOW Number Analyzed 120 participants 118 participants 122 participants 124 participants
1
   0.8%
1
   0.8%
1
   0.8%
1
   0.8%
Lymphocytes, WITHIN(SCR), WITHIN Number Analyzed 120 participants 118 participants 122 participants 124 participants
119
  99.2%
116
  98.3%
119
  97.5%
121
  97.6%
Lymphocytes, WITHIN(SCR), ABOVE Number Analyzed 120 participants 118 participants 122 participants 124 participants
0
   0.0%
1
   0.8%
2
   1.6%
2
   1.6%
Lymphocytes, ABOVE(SCR), WITHIN Number Analyzed 2 participants 1 participants 0 participants 1 participants
1
  50.0%
0
   0.0%
0
0
   0.0%
Lymphocytes, ABOVE(SCR), ABOVE Number Analyzed 2 participants 1 participants 0 participants 1 participants
1
  50.0%
1
 100.0%
0
1
 100.0%
Neutrophils, BELOW(SCR), WITHIN Number Analyzed 1 participants 1 participants 0 participants 1 participants
1
 100.0%
1
 100.0%
0
1
 100.0%
Neutrophils, WITHIN(SCR), BELOW Number Analyzed 120 participants 119 participants 120 participants 120 participants
2
   1.7%
4
   3.4%
2
   1.7%
1
   0.8%
Neutrophils, WITHIN(SCR), WITHIN Number Analyzed 120 participants 119 participants 120 participants 120 participants
117
  97.5%
111
  93.3%
117
  97.5%
118
  98.3%
Neutrophils, WITHIN(SCR), ABOVE Number Analyzed 120 participants 119 participants 120 participants 120 participants
1
   0.8%
4
   3.4%
1
   0.8%
1
   0.8%
Neutrophils, ABOVE(SCR), WITHIN Number Analyzed 1 participants 1 participants 4 participants 4 participants
1
 100.0%
1
 100.0%
1
  25.0%
3
  75.0%
Neutrophils, ABOVE(SCR), ABOVE Number Analyzed 1 participants 1 participants 4 participants 4 participants
0
   0.0%
0
   0.0%
3
  75.0%
1
  25.0%
Platelets, BELOW(SCR), BELOW Number Analyzed 0 participants 0 participants 1 participants 2 participants
0 0
0
   0.0%
1
  50.0%
Platelets, BELOW(SCR), WITHIN Number Analyzed 0 participants 0 participants 1 participants 2 participants
0 0
1
 100.0%
1
  50.0%
Platelets, WITHIN(SCR), BELOW Number Analyzed 118 participants 117 participants 119 participants 116 participants
1
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets, WITHIN(SCR), WITHIN Number Analyzed 118 participants 117 participants 119 participants 116 participants
116
  98.3%
112
  95.7%
115
  96.6%
114
  98.3%
Platelets, WITHIN(SCR), ABOVE Number Analyzed 118 participants 117 participants 119 participants 116 participants
1
   0.8%
5
   4.3%
4
   3.4%
2
   1.7%
Platelets, ABOVE(SCR), WITHIN Number Analyzed 4 participants 5 participants 5 participants 7 participants
3
  75.0%
2
  40.0%
3
  60.0%
3
  42.9%
Platelets, ABOVE(SCR), ABOVE Number Analyzed 4 participants 5 participants 5 participants 7 participants
1
  25.0%
3
  60.0%
2
  40.0%
4
  57.1%
WBC, BELOW(SCR), BELOW Number Analyzed 3 participants 2 participants 5 participants 5 participants
0
   0.0%
1
  50.0%
1
  20.0%
5
 100.0%
WBC, BELOW(SCR), WITHIN Number Analyzed 3 participants 2 participants 5 participants 5 participants
3
 100.0%
1
  50.0%
4
  80.0%
0
   0.0%
WBC, WITHIN(SCR), BELOW Number Analyzed 118 participants 117 participants 116 participants 115 participants
5
   4.2%
4
   3.4%
5
   4.3%
0
   0.0%
WBC, WITHIN(SCR), WITHIN Number Analyzed 118 participants 117 participants 116 participants 115 participants
111
  94.1%
108
  92.3%
108
  93.1%
115
 100.0%
WBC, WITHIN(SCR), ABOVE Number Analyzed 118 participants 117 participants 116 participants 115 participants
2
   1.7%
5
   4.3%
3
   2.6%
0
   0.0%
WBC, ABOVE(SCR), WITHIN Number Analyzed 1 participants 3 participants 4 participants 5 participants
0
   0.0%
1
  33.3%
1
  25.0%
5
 100.0%
WBC, ABOVE(SCR), ABOVE Number Analyzed 1 participants 3 participants 4 participants 5 participants
1
 100.0%
2
  66.7%
3
  75.0%
0
   0.0%
6.Primary Outcome
Title Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Hide Description Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) [e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 31].
Time Frame At Day 31
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
Arm/Group Title RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 121 124 125 125
Measure Type: Count of Participants
Unit of Measure: Participants
Eosinophils, BELOW(SCR), BELOW Number Analyzed 7 participants 6 participants 8 participants 11 participants
3
  42.9%
3
  50.0%
6
  75.0%
8
  72.7%
Eosinophils, BELOW(SCR), WITHIN Number Analyzed 7 participants 6 participants 8 participants 11 participants
4
  57.1%
3
  50.0%
2
  25.0%
3
  27.3%
Eosinophils, WITHIN(SCR), BELOW Number Analyzed 110 participants 115 participants 117 participants 112 participants
4
   3.6%
2
   1.7%
1
   0.9%
1
   0.9%
Eosinophils, WITHIN(SCR), WITHIN Number Analyzed 110 participants 115 participants 117 participants 112 participants
105
  95.5%
112
  97.4%
115
  98.3%
110
  98.2%
Eosinophils, WITHIN(SCR), ABOVE Number Analyzed 110 participants 115 participants 117 participants 112 participants
1
   0.9%
1
   0.9%
1
   0.9%
1
   0.9%
Eosinophils, ABOVE(SCR), WITHIN Number Analyzed 4 participants 3 participants 0 participants 2 participants
2
  50.0%
1
  33.3%
0
1
  50.0%
Eosinophils, ABOVE(SCR), ABOVE Number Analyzed 4 participants 3 participants 0 participants 2 participants
2
  50.0%
2
  66.7%
0
1
  50.0%
Hemoglobin, BELOW(SCR), BELOW Number Analyzed 7 participants 3 participants 1 participants 2 participants
6
  85.7%
1
  33.3%
1
 100.0%
2
 100.0%
Hemoglobin, BELOW(SCR), WITHIN Number Analyzed 7 participants 3 participants 1 participants 2 participants
1
  14.3%
2
  66.7%
0
   0.0%
0
   0.0%
Hemoglobin, WITHIN(SCR), BELOW Number Analyzed 114 participants 118 participants 122 participants 122 participants
2
   1.8%
4
   3.4%
1
   0.8%
3
   2.5%
Hemoglobin, WITHIN(SCR), WITHIN Number Analyzed 114 participants 118 participants 122 participants 122 participants
112
  98.2%
114
  96.6%
121
  99.2%
119
  97.5%
Hemoglobin, ABOVE(SCR), WITHIN Number Analyzed 0 participants 3 participants 2 participants 1 participants
0
2
  66.7%
1
  50.0%
0
   0.0%
Hemoglobin, ABOVE(SCR), ABOVE Number Analyzed 0 participants 3 participants 2 participants 1 participants
0
1
  33.3%
1
  50.0%
1
 100.0%
Lymphocytes, BELOW(SCR), BELOW Number Analyzed 0 participants 2 participants 2 participants 0 participants
0
1
  50.0%
0
   0.0%
0
Lymphocytes, BELOW(SCR), WITHIN Number Analyzed 0 participants 2 participants 2 participants 0 participants
0
1
  50.0%
2
 100.0%
0
Lymphocytes, WITHIN(SCR), BELOW Number Analyzed 119 participants 120 participants 123 participants 124 participants
0
   0.0%
1
   0.8%
3
   2.4%
2
   1.6%
Lymphocytes, WITHIN(SCR), WITHIN Number Analyzed 119 participants 120 participants 123 participants 124 participants
119
 100.0%
119
  99.2%
119
  96.7%
119
  96.0%
Lymphocytes, WITHIN(SCR), ABOVE Number Analyzed 119 participants 120 participants 123 participants 124 participants
0
   0.0%
0
   0.0%
1
   0.8%
3
   2.4%
Lymphocytes, ABOVE(SCR), WITHIN Number Analyzed 2 participants 2 participants 0 participants 1 participants
2
 100.0%
1
  50.0%
0
0
   0.0%
Lymphocytes, ABOVE(SCR), ABOVE Number Analyzed 2 participants 2 participants 0 participants 1 participants
0
   0.0%
1
  50.0%
0
1
 100.0%
Neutrophils, BELOW(SCR), BELOW Number Analyzed 1 participants 1 participants 0 participants 1 participants
1
 100.0%
0
   0.0%
0
0
   0.0%
Neutrophils, BELOW(SCR), WITHIN Number Analyzed 1 participants 1 participants 0 participants 1 participants
0
   0.0%
1
 100.0%
0
1
 100.0%
Neutrophils, WITHIN(SCR), BELOW Number Analyzed 119 participants 122 participants 121 participants 120 participants
2
   1.7%
2
   1.6%
3
   2.5%
1
   0.8%
Neutrophils, WITHIN(SCR), WITHIN Number Analyzed 119 participants 122 participants 121 participants 120 participants
116
  97.5%
117
  95.9%
114
  94.2%
116
  96.7%
Neutrophils, WITHIN(SCR), ABOVE Number Analyzed 119 participants 122 participants 121 participants 120 participants
1
   0.8%
3
   2.5%
4
   3.3%
3
   2.5%
Neutrophils, ABOVE(SCR), WITHIN Number Analyzed 1 participants 1 participants 4 participants 4 participants
1
 100.0%
0
   0.0%
4
 100.0%
4
 100.0%
Neutrophils, ABOVE(SCR), ABOVE Number Analyzed 1 participants 1 participants 4 participants 4 participants
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
Platelets, BELOW(SCR), BELOW Number Analyzed 0 participants 0 participants 1 participants 2 participants
0 0
0
   0.0%
1
  50.0%
Platelets, BELOW(SCR), WITHIN Number Analyzed 0 participants 0 participants 1 participants 2 participants
0 0
1
 100.0%
1
  50.0%
Platelets, WITHIN(SCR), BELOW Number Analyzed 117 participants 119 participants 119 participants 116 participants
0
   0.0%
0
   0.0%
2
   1.7%
0
   0.0%
Platelets, WITHIN(SCR), WITHIN Number Analyzed 117 participants 119 participants 119 participants 116 participants
115
  98.3%
115
  96.6%
111
  93.3%
113
  97.4%
Platelets, WITHIN(SCR), ABOVE Number Analyzed 117 participants 119 participants 119 participants 116 participants
2
   1.7%
4
   3.4%
6
   5.0%
3
   2.6%
Platelets, ABOVE(SCR), WITHIN Number Analyzed 4 participants 5 participants 5 participants 7 participants
3
  75.0%
1
  20.0%
3
  60.0%
2
  28.6%
Platelets, ABOVE(SCR), ABOVE Number Analyzed 4 participants 5 participants 5 participants 7 participants
1
  25.0%
4
  80.0%
2
  40.0%
5
  71.4%
WBC, BELOW(SCR), BELOW Number Analyzed 3 participants 2 participants 4 participants 5 participants
2
  66.7%
1
  50.0%
2
  50.0%
4
  80.0%
WBC, BELOW(SCR), WITHIN Number Analyzed 3 participants 2 participants 4 participants 5 participants
1
  33.3%
1
  50.0%
2
  50.0%
1
  20.0%
WBC, WITHIN(SCR), BELOW Number Analyzed 117 participants 119 participants 117 participants 115 participants
3
   2.6%
5
   4.2%
9
   7.7%
1
   0.9%
WBC, WITHIN(SCR), WITHIN Number Analyzed 117 participants 119 participants 117 participants 115 participants
109
  93.2%
107
  89.9%
105
  89.7%
110
  95.7%
WBC, WITHIN(SCR), ABOVE Number Analyzed 117 participants 119 participants 117 participants 115 participants
5
   4.3%
7
   5.9%
3
   2.6%
4
   3.5%
WBC, ABOVE(SCR), WITHIN Number Analyzed 1 participants 3 participants 4 participants 5 participants
1
 100.0%
0
   0.0%
4
 100.0%
5
 100.0%
WBC, ABOVE(SCR), ABOVE Number Analyzed 1 participants 3 participants 4 participants 5 participants
0
   0.0%
3
 100.0%
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Hide Description Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine. Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR)[e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 8].
Time Frame At Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
Arm/Group Title RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 123 124 126 126
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, BELOW(SCR), WITHIN Number Analyzed 0 participants 2 participants 0 participants 0 participants
0
2
 100.0%
0 0
ALT, WITHIN(SCR), WITHIN Number Analyzed 115 participants 116 participants 123 participants 115 participants
114
  99.1%
109
  94.0%
120
  97.6%
111
  96.5%
ALT, WITHIN(SCR), ABOVE Number Analyzed 115 participants 116 participants 123 participants 115 participants
1
   0.9%
7
   6.0%
3
   2.4%
4
   3.5%
ALT, ABOVE(SCR), WITHIN Number Analyzed 8 participants 6 participants 3 participants 10 participants
3
  37.5%
6
 100.0%
3
 100.0%
3
  30.0%
ALT, ABOVE(SCR), ABOVE Number Analyzed 8 participants 6 participants 3 participants 10 participants
5
  62.5%
0
   0.0%
0
   0.0%
7
  70.0%
AST, BELOW(SCR), WITHIN Number Analyzed 1 participants 1 participants 2 participants 0 participants
1
 100.0%
1
 100.0%
2
 100.0%
0
AST, WITHIN(SCR), BELOW Number Analyzed 119 participants 122 participants 120 participants 118 participants
0
   0.0%
1
   0.8%
0
   0.0%
0
   0.0%
AST, WITHIN(SCR), WITHIN Number Analyzed 119 participants 122 participants 120 participants 118 participants
116
  97.5%
115
  94.3%
116
  96.7%
116
  98.3%
AST, WITHIN(SCR), ABOVE Number Analyzed 119 participants 122 participants 120 participants 118 participants
3
   2.5%
6
   4.9%
4
   3.3%
2
   1.7%
AST, ABOVE(SCR), WITHIN Number Analyzed 3 participants 1 participants 4 participants 7 participants
3
 100.0%
1
 100.0%
3
  75.0%
6
  85.7%
AST, ABOVE(SCR), ABOVE Number Analyzed 3 participants 1 participants 4 participants 7 participants
0
   0.0%
0
   0.0%
1
  25.0%
1
  14.3%
BUN, BELOW(SCR), BELOW Number Analyzed 4 participants 4 participants 7 participants 1 participants
3
  75.0%
2
  50.0%
3
  42.9%
1
 100.0%
BUN, BELOW(SCR), WITHIN Number Analyzed 4 participants 4 participants 7 participants 1 participants
1
  25.0%
2
  50.0%
4
  57.1%
0
   0.0%
BUN, WITHIN(SCR), BELOW Number Analyzed 116 participants 119 participants 115 participants 123 participants
1
   0.9%
2
   1.7%
2
   1.7%
1
   0.8%
BUN, WITHIN(SCR), WITHIN Number Analyzed 116 participants 119 participants 115 participants 123 participants
113
  97.4%
115
  96.6%
113
  98.3%
121
  98.4%
BUN, WITHIN(SCR), ABOVE Number Analyzed 116 participants 119 participants 115 participants 123 participants
2
   1.7%
2
   1.7%
0
   0.0%
1
   0.8%
BUN, ABOVE(SCR), WITHIN Number Analyzed 3 participants 1 participants 3 participants 2 participants
2
  66.7%
0
   0.0%
3
 100.0%
2
 100.0%
BUN, ABOVE(SCR), ABOVE Number Analyzed 3 participants 1 participants 3 participants 2 participants
1
  33.3%
1
 100.0%
0
   0.0%
0
   0.0%
Creatinine, BELOW(SCR), BELOW Number Analyzed 2 participants 3 participants 4 participants 4 participants
0
   0.0%
1
  33.3%
1
  25.0%
4
 100.0%
Creatinine, BELOW(SCR), WITHIN Number Analyzed 2 participants 3 participants 4 participants 4 participants
2
 100.0%
2
  66.7%
3
  75.0%
0
   0.0%
Creatinine, WITHIN(SCR), BELOW Number Analyzed 119 participants 121 participants 121 participants 121 participants
1
   0.8%
0
   0.0%
1
   0.8%
3
   2.5%
Creatinine, WITHIN(SCR), WITHIN Number Analyzed 119 participants 121 participants 121 participants 121 participants
117
  98.3%
118
  97.5%
119
  98.3%
118
  97.5%
Creatinine, WITHIN(SCR), ABOVE Number Analyzed 119 participants 121 participants 121 participants 121 participants
1
   0.8%
3
   2.5%
1
   0.8%
0
   0.0%
Creatinine, ABOVE(SCR), WITHIN Number Analyzed 2 participants 0 participants 1 participants 1 participants
2
 100.0%
0
1
 100.0%
0
   0.0%
Creatinine, ABOVE(SCR), ABOVE Number Analyzed 2 participants 0 participants 1 participants 1 participants
0
   0.0%
0
0
   0.0%
1
 100.0%
8.Primary Outcome
Title Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Hide Description Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine and blood urea nitrogen (BUN). Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) [e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 31].
Time Frame At Day 31
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
Arm/Group Title RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 123 124 126 126
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, BELOW(SCR), BELOW Number Analyzed 0 participants 2 participants 0 participants 0 participants
0
1
  50.0%
0 0
ALT, BELOW(SCR), WITHIN Number Analyzed 0 participants 2 participants 0 participants 0 participants
0
1
  50.0%
0 0
ALT, WITHIN(SCR), BELOW Number Analyzed 115 participants 116 participants 123 participants 116 participants
0
   0.0%
0
   0.0%
1
   0.8%
0
   0.0%
ALT, WITHIN(SCR), WITHIN Number Analyzed 115 participants 116 participants 123 participants 116 participants
112
  97.4%
113
  97.4%
121
  98.4%
110
  94.8%
ALT, WITHIN(SCR), ABOVE Number Analyzed 115 participants 116 participants 123 participants 116 participants
3
   2.6%
3
   2.6%
1
   0.8%
6
   5.2%
ALT, ABOVE(SCR), WITHIN Number Analyzed 8 participants 6 participants 3 participants 10 participants
4
  50.0%
5
  83.3%
3
 100.0%
6
  60.0%
ALT, ABOVE(SCR), ABOVE Number Analyzed 8 participants 6 participants 3 participants 10 participants
4
  50.0%
1
  16.7%
0
   0.0%
4
  40.0%
AST, BELOW(SCR), WITHIN Number Analyzed 1 participants 1 participants 2 participants 0 participants
1
 100.0%
1
 100.0%
2
 100.0%
0
AST, WITHIN(SCR), BELOW Number Analyzed 119 participants 122 participants 120 participants 119 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
AST, WITHIN(SCR), WITHIN Number Analyzed 119 participants 122 participants 120 participants 119 participants
115
  96.6%
118
  96.7%
120
 100.0%
114
  95.8%
AST, WITHIN(SCR), ABOVE Number Analyzed 119 participants 122 participants 120 participants 119 participants
4
   3.4%
4
   3.3%
0
   0.0%
4
   3.4%
AST, ABOVE(SCR), WITHIN Number Analyzed 3 participants 1 participants 4 participants 7 participants
3
 100.0%
1
 100.0%
3
  75.0%
6
  85.7%
AST, ABOVE(SCR), ABOVE Number Analyzed 3 participants 1 participants 4 participants 7 participants
0
   0.0%
0
   0.0%
1
  25.0%
1
  14.3%
BUN, BELOW(SCR), BELOW Number Analyzed 4 participants 4 participants 7 participants 1 participants
2
  50.0%
2
  50.0%
2
  28.6%
1
 100.0%
BUN, BELOW(SCR), WITHIN Number Analyzed 4 participants 4 participants 7 participants 1 participants
2
  50.0%
2
  50.0%
5
  71.4%
0
   0.0%
BUN, WITHIN(SCR), BELOW Number Analyzed 116 participants 119 participants 116 participants 123 participants
2
   1.7%
2
   1.7%
0
   0.0%
2
   1.6%
BUN, WITHIN(SCR), WITHIN Number Analyzed 116 participants 119 participants 116 participants 123 participants
113
  97.4%
117
  98.3%
115
  99.1%
120
  97.6%
BUN, WITHIN(SCR), ABOVE Number Analyzed 116 participants 119 participants 116 participants 123 participants
1
   0.9%
0
   0.0%
1
   0.9%
1
   0.8%
BUN, ABOVE(SCR), WITHIN Number Analyzed 3 participants 1 participants 3 participants 2 participants
3
 100.0%
0
   0.0%
3
 100.0%
2
 100.0%
BUN, ABOVE(SCR), ABOVE Number Analyzed 3 participants 1 participants 3 participants 2 participants
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
Creatinine, BELOW(SCR), BELOW Number Analyzed 2 participants 3 participants 4 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
3
  75.0%
Creatinine, BELOW(SCR), WITHIN Number Analyzed 2 participants 3 participants 4 participants 4 participants
2
 100.0%
3
 100.0%
4
 100.0%
1
  25.0%
Creatinine, WITHIN(SCR), BELOW Number Analyzed 119 participants 121 participants 121 participants 121 participants
0
   0.0%
1
   0.8%
0
   0.0%
2
   1.7%
Creatinine, WITHIN(SCR), WITHIN Number Analyzed 119 participants 121 participants 121 participants 121 participants
118
  99.2%
116
  95.9%
117
  96.7%
116
  95.9%
Creatinine, WITHIN(SCR), ABOVE Number Analyzed 119 participants 121 participants 121 participants 121 participants
1
   0.8%
4
   3.3%
4
   3.3%
3
   2.5%
Creatinine, ABOVE(SCR), WITHIN Number Analyzed 2 participants 0 participants 1 participants 1 participants
1
  50.0%
0
1
 100.0%
0
   0.0%
Creatinine, ABOVE(SCR), ABOVE Number Analyzed 2 participants 0 participants 1 participants 1 participants
1
  50.0%
0
0
   0.0%
1
 100.0%
9.Primary Outcome
Title Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Hide Description Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 8]. "Any" corresponding to any grade and "Grade 0" to normal ranges.
Time Frame At Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
Arm/Group Title RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 122 122 125 125
Measure Type: Count of Participants
Unit of Measure: Participants
Eosinophils, Any(SCR), GRADE 0 Number Analyzed 122 participants 121 participants 124 participants 125 participants
121
  99.2%
120
  99.2%
124
 100.0%
125
 100.0%
Eosinophils, Any(SCR), GRADE 1 Number Analyzed 122 participants 121 participants 124 participants 125 participants
1
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils, Any(SCR), GRADE 2 Number Analyzed 122 participants 121 participants 124 participants 125 participants
0
   0.0%
1
   0.8%
0
   0.0%
0
   0.0%
Eosinophils, Grade 0(SCR), GRADE 0 Number Analyzed 120 participants 120 participants 124 participants 123 participants
119
  99.2%
120
 100.0%
124
 100.0%
123
 100.0%
Eosinophils, Grade 0(SCR), GRADE 1 Number Analyzed 120 participants 120 participants 124 participants 123 participants
1
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils, Grade 1(SCR), GRADE 0 Number Analyzed 2 participants 1 participants 0 participants 2 participants
2
 100.0%
0
   0.0%
0
2
 100.0%
Eosinophils, Grade 1(SCR), GRADE 2 Number Analyzed 2 participants 1 participants 0 participants 2 participants
0
   0.0%
1
 100.0%
0
0
   0.0%
Hemoglobin, Any(SCR), GRADE 0 Number Analyzed 122 participants 122 participants 125 participants 125 participants
110
  90.2%
111
  91.0%
114
  91.2%
110
  88.0%
Hemoglobin, Any(SCR), GRADE 1 Number Analyzed 122 participants 122 participants 125 participants 125 participants
11
   9.0%
9
   7.4%
10
   8.0%
15
  12.0%
Hemoglobin, Any(SCR), GRADE 2 Number Analyzed 122 participants 122 participants 125 participants 125 participants
1
   0.8%
2
   1.6%
1
   0.8%
0
   0.0%
Hemoglobin, Grade 0(SCR), GRADE 0 Number Analyzed 110 participants 111 participants 115 participants 116 participants
106
  96.4%
107
  96.4%
110
  95.7%
106
  91.4%
Hemoglobin, Grade 0(SCR), GRADE 1 Number Analyzed 110 participants 111 participants 115 participants 116 participants
4
   3.6%
4
   3.6%
5
   4.3%
10
   8.6%
Hemoglobin, Grade 1(SCR), GRADE 0 Number Analyzed 11 participants 11 participants 10 participants 9 participants
4
  36.4%
4
  36.4%
4
  40.0%
4
  44.4%
Hemoglobin, Grade 1(SCR), GRADE 1 Number Analyzed 11 participants 11 participants 10 participants 9 participants
7
  63.6%
5
  45.5%
5
  50.0%
5
  55.6%
Hemoglobin, Grade 1(SCR), GRADE 2 Number Analyzed 11 participants 11 participants 10 participants 9 participants
0
   0.0%
2
  18.2%
1
  10.0%
0
   0.0%
Hemoglobin, Grade 2(SCR), GRADE 2 Number Analyzed 1 participants 0 participants 0 participants 0 participants
1
 100.0%
0 0 0
Lymphocytes Decrease, Any(SCR), GRADE 0 Number Analyzed 122 participants 121 participants 124 participants 125 participants
120
  98.4%
118
  97.5%
122
  98.4%
122
  97.6%
Lymphocytes Decrease, Any(SCR), GRADE 1 Number Analyzed 122 participants 121 participants 124 participants 125 participants
1
   0.8%
2
   1.7%
2
   1.6%
3
   2.4%
Lymphocytes Decrease, Any(SCR), GRADE 2 Number Analyzed 122 participants 121 participants 124 participants 125 participants
1
   0.8%
1
   0.8%
0
   0.0%
0
   0.0%
Lymphocytes Decrease, Grade 0(SCR), GRADE 0 Number Analyzed 122 participants 119 participants 120 participants 120 participants
120
  98.4%
117
  98.3%
118
  98.3%
120
 100.0%
Lymphocytes Decrease, Grade 0(SCR), GRADE 1 Number Analyzed 122 participants 119 participants 120 participants 120 participants
1
   0.8%
1
   0.8%
2
   1.7%
0
   0.0%
Lymphocytes Decrease, Grade 0(SCR), GRADE 2 Number Analyzed 122 participants 119 participants 120 participants 120 participants
1
   0.8%
1
   0.8%
0
   0.0%
0
   0.0%
Lymphocytes Decrease, Grade 1(SCR), GRADE 0 Number Analyzed 0 participants 2 participants 3 participants 5 participants
0
1
  50.0%
3
 100.0%
2
  40.0%
Lymphocytes Decrease, Grade 1(SCR), GRADE 1 Number Analyzed 0 participants 2 participants 3 participants 5 participants
0
1
  50.0%
0
   0.0%
3
  60.0%
Lymphocytes Decrease, Grade 2(SCR), GRADE 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants
0 0
1
 100.0%
0
Neutrophils Decrease, Any(SCR), GRADE 0 Number Analyzed 122 participants 121 participants 124 participants 125 participants
112
  91.8%
113
  93.4%
116
  93.5%
118
  94.4%
Neutrophils Decrease, Any(SCR), GRADE 1 Number Analyzed 122 participants 121 participants 124 participants 125 participants
10
   8.2%
5
   4.1%
8
   6.5%
6
   4.8%
Neutrophils Decrease, Any(SCR), GRADE 2 Number Analyzed 122 participants 121 participants 124 participants 125 participants
0
   0.0%
3
   2.5%
0
   0.0%
1
   0.8%
Neutrophils Decrease, Grade 0(SCR), GRADE 0 Number Analyzed 117 participants 115 participants 119 participants 119 participants
109
  93.2%
109
  94.8%
111
  93.3%
115
  96.6%
Neutrophils Decrease, Grade 0(SCR), GRADE 1 Number Analyzed 117 participants 115 participants 119 participants 119 participants
8
   6.8%
4
   3.5%
8
   6.7%
4
   3.4%
Neutrophils Decrease, Grade 0(SCR), GRADE 2 Number Analyzed 117 participants 115 participants 119 participants 119 participants
0
   0.0%
2
   1.7%
0
   0.0%
0
   0.0%
Neutrophils Decrease, Grade 1(SCR), GRADE 0 Number Analyzed 4 participants 6 participants 5 participants 6 participants
3
  75.0%
4
  66.7%
5
 100.0%
3
  50.0%
Neutrophils Decrease, Grade 1(SCR), GRADE 1 Number Analyzed 4 participants 6 participants 5 participants 6 participants
1
  25.0%
1
  16.7%
0
   0.0%
2
  33.3%
Neutrophils Decrease, Grade 1(SCR), GRADE 2 Number Analyzed 4 participants 6 participants 5 participants 6 participants
0
   0.0%
1
  16.7%
0
   0.0%
1
  16.7%
Neutrophils Decrease, Grade 2(SCR), GRADE 1 Number Analyzed 1 participants 0 participants 0 participants 0 participants
1
 100.0%
0 0 0
Platelets Decrease, Any(SCR), GRADE 0 Number Analyzed 122 participants 122 participants 125 participants 125 participants
121
  99.2%
122
 100.0%
125
 100.0%
125
 100.0%
Platelets Decrease, Any(SCR), GRADE 1 Number Analyzed 122 participants 122 participants 125 participants 125 participants
1
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets Decrease, Grade 0(SCR), GRADE 0 Number Analyzed 122 participants 122 participants 125 participants 123 participants
121
  99.2%
122
 100.0%
125
 100.0%
123
 100.0%
Platelets Decrease, Grade 0(SCR), GRADE 1 Number Analyzed 122 participants 122 participants 125 participants 123 participants
1
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets Decrease, Grade 1(SCR), GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 2 participants
0 0 0
2
 100.0%
WBC Decrease, Any(SCR), GRADE 0 Number Analyzed 122 participants 122 participants 125 participants 125 participants
121
  99.2%
119
  97.5%
125
 100.0%
124
  99.2%
WBC Decrease, Any(SCR), GRADE 1 Number Analyzed 122 participants 122 participants 125 participants 125 participants
1
   0.8%
3
   2.5%
0
   0.0%
1
   0.8%
WBC Decrease, Grade 0(SCR), GRADE 0 Number Analyzed 121 participants 121 participants 124 participants 121 participants
120
  99.2%
118
  97.5%
124
 100.0%
120
  99.2%
WBC Decrease, Grade 0(SCR), GRADE 1 Number Analyzed 121 participants 121 participants 124 participants 121 participants
1
   0.8%
3
   2.5%
0
   0.0%
1
   0.8%
WBC Decrease, Grade 1(SCR), GRADE 0 Number Analyzed 1 participants 1 participants 1 participants 4 participants
1
 100.0%
1
 100.0%
1
 100.0%
4
 100.0%
WBC Increase, Any(SCR), GRADE 0 Number Analyzed 122 participants 122 participants 125 participants 125 participants
119
  97.5%
118
  96.7%
121
  96.8%
125
 100.0%
WBC Increase, Any(SCR), GRADE 1 Number Analyzed 122 participants 122 participants 125 participants 125 participants
3
   2.5%
3
   2.5%
4
   3.2%
0
   0.0%
WBC Increase, Any(SCR), GRADE 2 Number Analyzed 122 participants 122 participants 125 participants 125 participants
0
   0.0%
1
   0.8%
0
   0.0%
0
   0.0%
WBC Increase, Grade 0(SCR), GRADE 0 Number Analyzed 119 participants 118 participants 121 participants 122 participants
118
  99.2%
116
  98.3%
120
  99.2%
122
 100.0%
WBC Increase, Grade 0(SCR), GRADE 1 Number Analyzed 119 participants 118 participants 121 participants 122 participants
1
   0.8%
2
   1.7%
1
   0.8%
0
   0.0%
WBC Increase, Grade 1(SCR), GRADE 0 Number Analyzed 3 participants 4 participants 4 participants 3 participants
1
  33.3%
2
  50.0%
1
  25.0%
3
 100.0%
WBC Increase, Grade 1(SCR), GRADE 1 Number Analyzed 3 participants 4 participants 4 participants 3 participants
2
  66.7%
1
  25.0%
3
  75.0%
0
   0.0%
WBC Increase, Grade 1(SCR), GRADE 2 Number Analyzed 3 participants 4 participants 4 participants 3 participants
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
10.Primary Outcome
Title Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Hide Description Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 31]. "Any" corresponding to any grade and "Grade 0" to normal ranges.
Time Frame At Day 31
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
Arm/Group Title RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 121 124 125 125
Measure Type: Count of Participants
Unit of Measure: Participants
Eosinophils, Any(SCR), GRADE 0 Number Analyzed 121 participants 124 participants 125 participants 125 participants
118
  97.5%
122
  98.4%
125
 100.0%
125
 100.0%
Eosinophils, Any(SCR), GRADE 1 Number Analyzed 121 participants 124 participants 125 participants 125 participants
3
   2.5%
2
   1.6%
0
   0.0%
0
   0.0%
Eosinophils, Grade 0(SCR), GRADE 0 Number Analyzed 119 participants 123 participants 125 participants 123 participants
117
  98.3%
122
  99.2%
125
 100.0%
123
 100.0%
Eosinophils, Grade 0(SCR), GRADE 1 Number Analyzed 119 participants 123 participants 125 participants 123 participants
2
   1.7%
1
   0.8%
0
   0.0%
0
   0.0%
Eosinophils, Grade 1(SCR), GRADE 0 Number Analyzed 2 participants 1 participants 0 participants 2 participants
1
  50.0%
0
   0.0%
0
2
 100.0%
Eosinophils, Grade 1(SCR), GRADE 1 Number Analyzed 2 participants 1 participants 0 participants 2 participants
1
  50.0%
1
 100.0%
0
0
   0.0%
Hemoglobin, Any(SCR), GRADE 0 Number Analyzed 121 participants 124 participants 125 participants 125 participants
108
  89.3%
115
  92.7%
112
  89.6%
114
  91.2%
Hemoglobin, Any(SCR), GRADE 1 Number Analyzed 121 participants 124 participants 125 participants 125 participants
11
   9.1%
7
   5.6%
13
  10.4%
8
   6.4%
Hemoglobin, Any(SCR), GRADE 2 Number Analyzed 121 participants 124 participants 125 participants 125 participants
2
   1.7%
2
   1.6%
0
   0.0%
3
   2.4%
Hemoglobin, Grade 0(SCR), GRADE 0 Number Analyzed 110 participants 113 participants 115 participants 116 participants
106
  96.4%
112
  99.1%
109
  94.8%
111
  95.7%
Hemoglobin, Grade 0(SCR), GRADE 1 Number Analyzed 110 participants 113 participants 115 participants 116 participants
4
   3.6%
1
   0.9%
6
   5.2%
3
   2.6%
Hemoglobin, Grade 0(SCR), GRADE 2 Number Analyzed 110 participants 113 participants 115 participants 116 participants
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.7%
Hemoglobin, Grade 1(SCR), GRADE 0 Number Analyzed 10 participants 11 participants 10 participants 9 participants
2
  20.0%
3
  27.3%
3
  30.0%
3
  33.3%
Hemoglobin, Grade 1(SCR), GRADE 1 Number Analyzed 10 participants 11 participants 10 participants 9 participants
7
  70.0%
6
  54.5%
7
  70.0%
5
  55.6%
Hemoglobin, Grade 1(SCR), GRADE 2 Number Analyzed 10 participants 11 participants 10 participants 9 participants
1
  10.0%
2
  18.2%
0
   0.0%
1
  11.1%
Hemoglobin, Grade 2(SCR), GRADE 2 Number Analyzed 1 participants 0 participants 0 participants 0 participants
1
 100.0%
0 0 0
Lymphocytes Decrease, Any(SCR), GRADE 0 Number Analyzed 121 participants 124 participants 125 participants 125 participants
119
  98.3%
119
  96.0%
121
  96.8%
120
  96.0%
Lymphocytes Decrease, Any(SCR), GRADE 1 Number Analyzed 121 participants 124 participants 125 participants 125 participants
2
   1.7%
5
   4.0%
4
   3.2%
4
   3.2%
Lymphocytes Decrease, Any(SCR), GRADE 2 Number Analyzed 121 participants 124 participants 125 participants 125 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
Lymphocytes Decrease, Grade 0(SCR), GRADE 0 Number Analyzed 121 participants 122 participants 121 participants 120 participants
119
  98.3%
118
  96.7%
117
  96.7%
117
  97.5%
Lymphocytes Decrease, Grade 0(SCR), GRADE 1 Number Analyzed 121 participants 122 participants 121 participants 120 participants
2
   1.7%
4
   3.3%
4
   3.3%
3
   2.5%
Lymphocytes Decrease, Grade 1(SCR), GRADE 0 Number Analyzed 0 participants 2 participants 3 participants 5 participants
0
1
  50.0%
3
 100.0%
3
  60.0%
Lymphocytes Decrease, Grade 1(SCR), GRADE 1 Number Analyzed 0 participants 2 participants 3 participants 5 participants
0
1
  50.0%
0
   0.0%
1
  20.0%
Lymphocytes Decrease, Grade 1(SCR), GRADE 2 Number Analyzed 0 participants 2 participants 3 participants 5 participants
0
0
   0.0%
0
   0.0%
1
  20.0%
Lymphocytes Decrease, Grade 2(SCR), GRADE 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants
0 0
1
 100.0%
0
Neutrophils Decrease, Any(SCR), GRADE 0 Number Analyzed 121 participants 124 participants 125 participants 125 participants
111
  91.7%
115
  92.7%
114
  91.2%
116
  92.8%
Neutrophils Decrease, Any(SCR), GRADE 1 Number Analyzed 121 participants 124 participants 125 participants 125 participants
8
   6.6%
7
   5.6%
10
   8.0%
8
   6.4%
Neutrophils Decrease, Any(SCR), GRADE 2 Number Analyzed 121 participants 124 participants 125 participants 125 participants
1
   0.8%
2
   1.6%
1
   0.8%
1
   0.8%
Neutrophils Decrease, Any(SCR), GRADE 3 Number Analyzed 121 participants 124 participants 125 participants 125 participants
1
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils Decrease, Grade 0(SCR), GRADE 0 Number Analyzed 117 participants 118 participants 120 participants 119 participants
109
  93.2%
112
  94.9%
109
  90.8%
114
  95.8%
Neutrophils Decrease, Grade 0(SCR), GRADE 1 Number Analyzed 117 participants 118 participants 120 participants 119 participants
7
   6.0%
5
   4.2%
10
   8.3%
4
   3.4%
Neutrophils Decrease, Grade 0(SCR), GRADE 2 Number Analyzed 117 participants 118 participants 120 participants 119 participants
0
   0.0%
1
   0.8%
1
   0.8%
1
   0.8%
Neutrophils Decrease, Grade 0(SCR), GRADE 3 Number Analyzed 117 participants 118 participants 120 participants 119 participants
1
   0.9%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils Decrease, Grade 1(SCR), GRADE 0 Number Analyzed 3 participants 6 participants 5 participants 6 participants
2
  66.7%
3
  50.0%
5
 100.0%
2
  33.3%
Neutrophils Decrease, Grade 1(SCR), GRADE 1 Number Analyzed 3 participants 6 participants 5 participants 6 participants
1
  33.3%
2
  33.3%
0
   0.0%
4
  66.7%
Neutrophils Decrease, Grade 1(SCR), GRADE 2 Number Analyzed 3 participants 6 participants 5 participants 6 participants
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
Neutrophils Decrease, Grade 2(SCR), GRADE 2 Number Analyzed 1 participants 0 participants 0 participants 0 participants
1
 100.0%
0 0 0
Platelets Decrease, Any(SCR), GRADE 0 Number Analyzed 121 participants 124 participants 125 participants 125 participants
121
 100.0%
124
 100.0%
125
 100.0%
125
 100.0%
Platelets Decrease, Grade 0(SCR), GRADE 0 Number Analyzed 121 participants 124 participants 125 participants 123 participants
121
 100.0%
124
 100.0%
125
 100.0%
123
 100.0%
Platelets Decrease, Grade 1(SCR), GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 2 participants
0 0 0
2
 100.0%
WBC Decrease, Any(SCR), GRADE 0 Number Analyzed 121 participants 124 participants 125 participants 125 participants
119
  98.3%
122
  98.4%
121
  96.8%
123
  98.4%
WBC Decrease, Any(SCR), GRADE 1 Number Analyzed 121 participants 124 participants 125 participants 125 participants
2
   1.7%
2
   1.6%
4
   3.2%
2
   1.6%
WBC Decrease, Grade 0(SCR), GRADE 0 Number Analyzed 120 participants 123 participants 124 participants 121 participants
119
  99.2%
121
  98.4%
120
  96.8%
120
  99.2%
WBC Decrease, Grade 0(SCR), GRADE 1 Number Analyzed 120 participants 123 participants 124 participants 121 participants
1
   0.8%
2
   1.6%
4
   3.2%
1
   0.8%
WBC Decrease, Grade 1(SCR), GRADE 0 Number Analyzed 1 participants 1 participants 1 participants 4 participants
0
   0.0%
1
 100.0%
1
 100.0%
3
  75.0%
WBC Decrease, Grade 1(SCR), GRADE 1 Number Analyzed 1 participants 1 participants 1 participants 4 participants
1
 100.0%
0
   0.0%
0
   0.0%
1
  25.0%
WBC Increase, Any(SCR), GRADE 0 Number Analyzed 121 participants 124 participants 125 participants 125 participants
120
  99.2%
116
  93.5%
122
  97.6%
122
  97.6%
WBC Increase, Any(SCR), GRADE 1 Number Analyzed 121 participants 124 participants 125 participants 125 participants
1
   0.8%
8
   6.5%
3
   2.4%
3
   2.4%
WBC Increase, Grade 0(SCR), GRADE 0 Number Analyzed 118 participants 120 participants 121 participants 122 participants
118
 100.0%
115
  95.8%
118
  97.5%
119
  97.5%
WBC Increase, Grade 0(SCR), GRADE 1 Number Analyzed 118 participants 120 participants 121 participants 122 participants
0
   0.0%
5
   4.2%
3
   2.5%
3
   2.5%
WBC Increase, Grade 1(SCR), GRADE 0 Number Analyzed 3 participants 4 participants 4 participants 3 participants
2
  66.7%
1
  25.0%
4
 100.0%
3
 100.0%
WBC Increase, Grade 1(SCR), GRADE 1 Number Analyzed 3 participants 4 participants 4 participants 3 participants
1
  33.3%
3
  75.0%
0
   0.0%
0
   0.0%
11.Primary Outcome
Title Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Hide Description Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 8]. "Any" corresponding to any grade and "Grade 0" to normal ranges.
Time Frame At Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
Arm/Group Title RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 123 124 126 126
Measure Type: Count of Participants
Unit of Measure: Participants
ALT - increase by factor, Any(SCR), GRADE 0 Number Analyzed 123 participants 124 participants 126 participants 125 participants
118
  95.9%
119
  96.0%
124
  98.4%
117
  93.6%
ALT - increase by factor, Any(SCR), GRADE 1 Number Analyzed 123 participants 124 participants 126 participants 125 participants
5
   4.1%
3
   2.4%
1
   0.8%
7
   5.6%
ALT - increase by factor, Any(SCR), GRADE 2 Number Analyzed 123 participants 124 participants 126 participants 125 participants
0
   0.0%
1
   0.8%
1
   0.8%
0
   0.0%
ALT - increase by factor, Any(SCR), GRADE 3 Number Analyzed 123 participants 124 participants 126 participants 125 participants
0
   0.0%
1
   0.8%
0
   0.0%
1
   0.8%
ALT - increase by factor, Grade 0(SCR), GRADE 0 Number Analyzed 116 participants 120 participants 123 participants 116 participants
115
  99.1%
115
  95.8%
121
  98.4%
114
  98.3%
ALT - increase by factor, Grade 0(SCR), GRADE 1 Number Analyzed 116 participants 120 participants 123 participants 116 participants
1
   0.9%
3
   2.5%
1
   0.8%
2
   1.7%
ALT - increase by factor, Grade 0(SCR), GRADE 2 Number Analyzed 116 participants 120 participants 123 participants 116 participants
0
   0.0%
1
   0.8%
1
   0.8%
0
   0.0%
ALT - increase by factor, Grade 0(SCR), GRADE 3 Number Analyzed 116 participants 120 participants 123 participants 116 participants
0
   0.0%
1
   0.8%
0
   0.0%
0
   0.0%
ALT - increase by factor, Grade 1(SCR), GRADE 0 Number Analyzed 6 participants 4 participants 3 participants 9 participants
3
  50.0%
4
 100.0%
3
 100.0%
3
  33.3%
ALT - increase by factor, Grade 1(SCR), GRADE 1 Number Analyzed 6 participants 4 participants 3 participants 9 participants
3
  50.0%
0
   0.0%
0
   0.0%
5
  55.6%
ALT - increase by factor, Grade 1(SCR), GRADE 3 Number Analyzed 6 participants 4 participants 3 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
ALT - increase by factor, Grade 2(SCR), GRADE 1 Number Analyzed 1 participants 0 participants 0 participants 0 participants
1
 100.0%
0 0 0
AST - increase by factor, Any(SCR), GRADE 0 Number Analyzed 123 participants 124 participants 126 participants 125 participants
123
 100.0%
120
  96.8%
124
  98.4%
122
  97.6%
AST - increase by factor, Any(SCR), GRADE 1 Number Analyzed 123 participants 124 participants 126 participants 125 participants
0
   0.0%
3
   2.4%
2
   1.6%
3
   2.4%
AST - increase by factor, Any(SCR), GRADE 3 Number Analyzed 123 participants 124 participants 126 participants 125 participants
0
   0.0%
1
   0.8%
0
   0.0%
0
   0.0%
AST - increase by factor, Grade 0(SCR), GRADE 0 Number Analyzed 120 participants 123 participants 125 participants 121 participants
120
 100.0%
119
  96.7%
124
  99.2%
119
  98.3%
AST - increase by factor, Grade 0(SCR), GRADE 1 Number Analyzed 120 participants 123 participants 125 participants 121 participants
0
   0.0%
3
   2.4%
1
   0.8%
2
   1.7%
AST - increase by factor, Grade 0(SCR), GRADE 3 Number Analyzed 120 participants 123 participants 125 participants 121 participants
0
   0.0%
1
   0.8%
0
   0.0%
0
   0.0%
AST - increase by factor, Grade 1(SCR), GRADE 0 Number Analyzed 3 participants 1 participants 1 participants 4 participants
3
 100.0%
1
 100.0%
0
   0.0%
3
  75.0%
AST - increase by factor, Grade 1(SCR), GRADE 1 Number Analyzed 3 participants 1 participants 1 participants 4 participants
0
   0.0%
0
   0.0%
1
 100.0%
1
  25.0%
Blood Urea Nitrogen, Any(SCR), GRADE 0 Number Analyzed 123 participants 124 participants 125 participants 126 participants
122
  99.2%
123
  99.2%
124
  99.2%
125
  99.2%
Blood Urea Nitrogen, Any(SCR), GRADE 1 Number Analyzed 123 participants 124 participants 125 participants 126 participants
1
   0.8%
1
   0.8%
1
   0.8%
0
   0.0%
Blood Urea Nitrogen, Any(SCR), GRADE 2 Number Analyzed 123 participants 124 participants 125 participants 126 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
Blood Urea Nitrogen, Grade 0(SCR), GRADE 0 Number Analyzed 123 participants 124 participants 124 participants 125 participants
122
  99.2%
123
  99.2%
123
  99.2%
124
  99.2%
Blood Urea Nitrogen, Grade 0(SCR), GRADE 1 Number Analyzed 123 participants 124 participants 124 participants 125 participants
1
   0.8%
1
   0.8%
1
   0.8%
0
   0.0%
Blood Urea Nitrogen, Grade 0(SCR), GRADE 2 Number Analyzed 123 participants 124 participants 124 participants 125 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
Blood Urea Nitrogen, Grade 1(SCR), GRADE 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants
0 0
1
 100.0%
0
Blood Urea Nitrogen, Grade 2(SCR), GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 1 participants
0 0 0
1
 100.0%
Creatinine, Any(SCR), GRADE 0 Number Analyzed 123 participants 124 participants 126 participants 126 participants
122
  99.2%
124
 100.0%
126
 100.0%
126
 100.0%
Creatinine, Any(SCR), GRADE 3 Number Analyzed 123 participants 124 participants 126 participants 126 participants
1
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine, Grade 0(SCR), GRADE 0 Number Analyzed 123 participants 124 participants 126 participants 126 participants
122
  99.2%
124
 100.0%
126
 100.0%
126
 100.0%
Creatinine, Grade 0(SCR), GRADE 3 Number Analyzed 123 participants 124 participants 126 participants 126 participants
1
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
12.Primary Outcome
Title Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Hide Description Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 31]. "Any" corresponding to any grade and "Grade 0" to normal ranges.
Time Frame At Day 31
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
Arm/Group Title RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 123 124 126 126
Measure Type: Count of Participants
Unit of Measure: Participants
ALT - increase by factor, Any(SCR), GRADE 0 Number Analyzed 123 participants 124 participants 126 participants 126 participants
117
  95.1%
121
  97.6%
125
  99.2%
118
  93.7%
ALT - increase by factor, Any(SCR), GRADE 1 Number Analyzed 123 participants 124 participants 126 participants 126 participants
6
   4.9%
3
   2.4%
1
   0.8%
6
   4.8%
ALT - increase by factor, Any(SCR), GRADE 2 Number Analyzed 123 participants 124 participants 126 participants 126 participants
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.6%
ALT - increase by factor, Grade 0(SCR), GRADE 0 Number Analyzed 116 participants 120 participants 123 participants 117 participants
113
  97.4%
117
  97.5%
122
  99.2%
112
  95.7%
ALT - increase by factor, Grade 0(SCR), GRADE 1 Number Analyzed 116 participants 120 participants 123 participants 117 participants
3
   2.6%
3
   2.5%
1
   0.8%
4
   3.4%
ALT - increase by factor, Grade 0(SCR), GRADE 2 Number Analyzed 116 participants 120 participants 123 participants 117 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.9%
ALT - increase by factor, Grade 1(SCR), GRADE 0 Number Analyzed 6 participants 4 participants 3 participants 9 participants
4
  66.7%
4
 100.0%
3
 100.0%
6
  66.7%
ALT - increase by factor, Grade 1(SCR), GRADE 1 Number Analyzed 6 participants 4 participants 3 participants 9 participants
2
  33.3%
0
   0.0%
0
   0.0%
2
  22.2%
ALT - increase by factor, Grade 1(SCR), GRADE 2 Number Analyzed 6 participants 4 participants 3 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
ALT - increase by factor, Grade 2(SCR), GRADE 1 Number Analyzed 1 participants 0 participants 0 participants 0 participants
1
 100.0%
0 0 0
AST - increase by factor, Any(SCR), GRADE 0 Number Analyzed 123 participants 124 participants 126 participants 126 participants
121
  98.4%
122
  98.4%
125
  99.2%
121
  96.0%
AST - increase by factor, Any(SCR), GRADE 1 Number Analyzed 123 participants 124 participants 126 participants 126 participants
2
   1.6%
2
   1.6%
1
   0.8%
3
   2.4%
AST - increase by factor, Any(SCR), GRADE 2 Number Analyzed 123 participants 124 participants 126 participants 126 participants
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.6%
AST - increase by factor, Grade 0(SCR), GRADE 0 Number Analyzed 120 participants 123 participants 125 participants 122 participants
118
  98.3%
121
  98.4%
125
 100.0%
118
  96.7%
AST - increase by factor, Grade 0(SCR), GRADE 1 Number Analyzed 120 participants 123 participants 125 participants 122 participants
2
   1.7%
2
   1.6%
0
   0.0%
3
   2.5%
AST - increase by factor, Grade 0(SCR), GRADE 2 Number Analyzed 120 participants 123 participants 125 participants 122 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
AST - increase by factor, Grade 1(SCR), GRADE 0 Number Analyzed 3 participants 1 participants 1 participants 4 participants
3
 100.0%
1
 100.0%
0
   0.0%
3
  75.0%
AST - increase by factor, Grade 1(SCR), GRADE 1 Number Analyzed 3 participants 1 participants 1 participants 4 participants
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
AST - increase by factor, Grade 1(SCR), GRADE 2 Number Analyzed 3 participants 1 participants 1 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
Blood Urea Nitrogen, Any(SCR), GRADE 0 Number Analyzed 123 participants 124 participants 126 participants 126 participants
123
 100.0%
123
  99.2%
126
 100.0%
125
  99.2%
Blood Urea Nitrogen, Any(SCR), GRADE 1 Number Analyzed 123 participants 124 participants 126 participants 126 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
Blood Urea Nitrogen, Any(SCR), GRADE 2 Number Analyzed 123 participants 124 participants 126 participants 126 participants
0
   0.0%
1
   0.8%
0
   0.0%
0
   0.0%
Blood Urea Nitrogen, Grade 0(SCR), GRADE 0 Number Analyzed 123 participants 124 participants 125 participants 125 participants
123
 100.0%
123
  99.2%
125
 100.0%
124
  99.2%
Blood Urea Nitrogen, Grade 0(SCR), GRADE 1 Number Analyzed 123 participants 124 participants 125 participants 125 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
Blood Urea Nitrogen, Grade 0(SCR), GRADE 2 Number Analyzed 123 participants 124 participants 125 participants 125 participants
0
   0.0%
1
   0.8%
0
   0.0%
0
   0.0%
Blood Urea Nitrogen, Grade 1(SCR), GRADE 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants
0 0
1
 100.0%
0
Blood Urea Nitrogen, Grade 2(SCR), GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 1 participants
0 0 0
1
 100.0%
Creatinine, Any(SCR), GRADE 0 Number Analyzed 123 participants 124 participants 126 participants 126 participants
123
 100.0%
124
 100.0%
126
 100.0%
126
 100.0%
Creatinine, Grade 0(SCR), GRADE 0 Number Analyzed 123 participants 124 participants 126 participants 126 participants
123
 100.0%
124
 100.0%
126
 100.0%
126
 100.0%
13.Secondary Outcome
Title Number of Subjects With SAEs
Hide Description Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Day 1 (vaccination) up to Day 91 and up to Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Exposed Set, which included all vaccinated subjects.
Arm/Group Title RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Hide Arm/Group Description:
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 124 126 126 126
Measure Type: Count of Participants
Unit of Measure: Participants
SAE - Day 91
0
   0.0%
0
   0.0%
1
   0.8%
1
   0.8%
SAE - Day 181
0
   0.0%
0
   0.0%
1
   0.8%
2
   1.6%
14.Secondary Outcome
Title Neutralizing Antibody (Nab) Titers Against RSV Serotype A
Hide Description [Not Specified]
Time Frame At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91)
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Anti-Respiratory Syncytial Virus Prefusion 3 (RSVPreF3) Immunoglobulin G (IgG) Antibody Concentrations
Hide Description [Not Specified]
Time Frame At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91)
Outcome Measure Data Not Reported
Time Frame Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Hide Arm/Group Description Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
All-Cause Mortality
RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/124 (0.00%)      0/126 (0.00%)      0/126 (0.00%)      0/126 (0.00%)    
Hide Serious Adverse Events
RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/124 (0.00%)      0/126 (0.00%)      1/126 (0.79%)      2/126 (1.59%)    
Gastrointestinal disorders         
Umbilical hernia  1  0/124 (0.00%)  0 0/126 (0.00%)  0 1/126 (0.79%)  1 0/126 (0.00%)  0
Infections and infestations         
Appendicitis  1  0/124 (0.00%)  0 0/126 (0.00%)  0 0/126 (0.00%)  0 1/126 (0.79%)  1
Diverticulitis  1  0/124 (0.00%)  0 0/126 (0.00%)  0 0/126 (0.00%)  0 1/126 (0.79%)  1
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
RSV MAT Formulation 1 Group RSV MAT Formulation 2 Group RSV MAT Formulation 3 Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   94/124 (75.81%)      96/126 (76.19%)      105/126 (83.33%)      83/126 (65.87%)    
Blood and lymphatic system disorders         
Lymphadenopathy  1  1/124 (0.81%)  1 2/126 (1.59%)  2 3/126 (2.38%)  3 1/126 (0.79%)  1
Lymphadenitis  1  0/124 (0.00%)  0 0/126 (0.00%)  0 1/126 (0.79%)  1 0/126 (0.00%)  0
Neutropenia  1  0/124 (0.00%)  0 1/126 (0.79%)  1 0/126 (0.00%)  0 0/126 (0.00%)  0
Cardiac disorders         
Tachycardia  1  1/124 (0.81%)  1 0/126 (0.00%)  0 0/126 (0.00%)  0 0/126 (0.00%)  0
Ear and labyrinth disorders         
Ear pain  1  1/124 (0.81%)  1 0/126 (0.00%)  0 0/126 (0.00%)  0 0/126 (0.00%)  0
External ear pain  1  0/124 (0.00%)  0 0/126 (0.00%)  0 0/126 (0.00%)  0 1/126 (0.79%)  1
Hyperacusis  1  0/124 (0.00%)  0 0/126 (0.00%)  0 0/126 (0.00%)  0 1/126 (0.79%)  1
Vertigo  1  0/124 (0.00%)  0 0/126 (0.00%)  0 1/126 (0.79%)  1 0/126 (0.00%)  0
Gastrointestinal disorders         
Gastrointestinal disorder  1  30/124 (24.19%)  30 29/126 (23.02%)  29 23/126 (18.25%)  23 27/126 (21.43%)  27
Diarrhoea  1  2/124 (1.61%)  2 1/126 (0.79%)  1 0/126 (0.00%)  0 2/126 (1.59%)  2
Nausea  1  1/124 (0.81%)  2 1/126 (0.79%)  1 0/126 (0.00%)  0 2/126 (1.59%)  2
Abdominal pain  1  0/124 (0.00%)  0 2/126 (1.59%)  2 1/126 (0.79%)  1 1/126 (0.79%)  1
Constipation  1  2/124 (1.61%)  2 0/126 (0.00%)  0 0/126 (0.00%)  0 0/126 (0.00%)  0
Abdominal pain upper  1  0/124 (0.00%)  0 0/126 (0.00%)  0 1/126 (0.79%)  2 0/126 (0.00%)  0
Food poisoning  1  0/124 (0.00%)  0 1/126 (0.79%)  1 0/126 (0.00%)  0 0/126 (0.00%)  0
Gastrointestinal pain  1  0/124 (0.00%)  0 1/126 (0.79%)  1 0/126 (0.00%)  0 0/126 (0.00%)  0
Vomiting  1  0/124 (0.00%)  0 1/126 (0.79%)  1 0/126 (0.00%)  0 0/126 (0.00%)  0
General disorders         
Injection site pain  1  59/124 (47.58%)  59 64/126 (50.79%)  64 67/126 (53.17%)  67 20/126 (15.87%)  20
Fatigue  1  42/124 (33.87%)  43 49/126 (38.89%)  49 41/126 (32.54%)  41 38/126 (30.16%)  38
Injection site inflammation  1  8/124 (6.45%)  8 14/126 (11.11%)  14 10/126 (7.94%)  10 1/126 (0.79%)  1
Injection site swelling  1  5/124 (4.03%)  5 7/126 (5.56%)  7 6/126 (4.76%)  6 0/126 (0.00%)  0
Pyrexia  1  2/124 (1.61%)  2 0/126 (0.00%)  0 4/126 (3.17%)  4 1/126 (0.79%)  1
Injection site bruising  1  2/124 (1.61%)  2 1/126 (0.79%)  1 1/126 (0.79%)  1 2/126 (1.59%)  2
Chills  1  0/124 (0.00%)  0 1/126 (0.79%)  1 1/126 (0.79%)  1 0/126 (0.00%)  0
Peripheral swelling  1  0/124 (0.00%)  0 1/126 (0.79%)  1 1/126 (0.79%)  1 0/126 (0.00%)  0
Axillary pain  1  0/124 (0.00%)  0 0/126 (0.00%)  0 2/126 (1.59%)  2 0/126 (0.00%)  0
Influenza like illness  1  1/124 (0.81%)  1 0/126 (0.00%)  0 0/126 (0.00%)  0 0/126 (0.00%)  0
Feeling cold  1  0/124 (0.00%)  0 0/126 (0.00%)  0 0/126 (0.00%)  0 1/126 (0.79%)  1
Feeling hot  1  0/124 (0.00%)  0 1/126 (0.79%)  1 0/126 (0.00%)  0 0/126 (0.00%)  0
Injection site induration  1  0/124 (0.00%)  0 0/126 (0.00%)  0 1/126 (0.79%)  1 0/126 (0.00%)  0
Injury associated with device  1  0/124 (0.00%)  0 1/126 (0.79%)  1 0/126 (0.00%)  0 0/126 (0.00%)  0
Pain  1  0/124 (0.00%)  0 0/126 (0.00%)  0 1/126 (0.79%)  1 0/126 (0.00%)  0
Swelling  1  0/124 (0.00%)  0 0/126 (0.00%)  0 1/126 (0.79%)  1 0/126 (0.00%)  0
Vaccination site bruising  1  0/124 (0.00%)  0 0/126 (0.00%)  0 0/126 (0.00%)  0 1/126 (0.79%)  1
Vaccination site haematoma  1  0/124 (0.00%)  0 1/126 (0.79%)  1 0/126 (0.00%)  0 0/126 (0.00%)  0
Hepatobiliary disorders         
Hypertransaminasaemia  1  0/124 (0.00%)  0