Download PDF

Clinical Trial Results:
A Phase II, randomised, observer-blind, controlled, multi-country study to rank different formulations of GSK Biologicals’ investigational RSV vaccine (GSK3003891A), based on immunogenicity, reactogenicity and safety, when administered to healthy women, aged 18-45 years.

Summary
EudraCT number	2016-001135-12
Trial protocol	DE EE BE FR
Global end of trial date	05 Feb 2018

Results information
Results version number	v1(current)
This version publication date	14 Sep 2018
First version publication date	14 Sep 2018
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

204812

ISRCTN number

US NCT number

NCT02956837

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline Biologicals

Sponsor organisation address

Rue de l’Institut 89, Rixensart, Belgium, B-1330

Public contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com

Scientific contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

05 Feb 2018

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

05 Feb 2018

Was the trial ended prematurely?

Main objective of the trial

To rank different formulations of the investigational GSK3003891A respiratory syncytial virus (RSV) vaccine based on safety/reactogenicity and immunogenicity data up to 1 month post-vaccination (Day 30).

Protection of trial subjects

Study procedures related to the protection of trial subjects included close observation of the subject for at least 30 minutes following study vaccination, with appropriate medical treatment readily available in case of anaphylaxis.

Background therapy

Evidence for comparator

Actual start date of recruitment

10 Nov 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 100

Country: Number of subjects enrolled

Estonia: 100

Country: Number of subjects enrolled

France: 97

Country: Number of subjects enrolled

Germany: 109

Worldwide total number of subjects

406

EEA total number of subjects

406

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

406

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

The study started enrolling subjects in 2016 and concluded in 2018.

Screening 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.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Assessor

Blinding implementation details

Observer-Blinding in Epoch 001 (up to Day 90). In an observer-blind study, the subject and the site and sponsor personnel involved in the clinical evaluation of the subjects are blinded while other study personnel may be aware of the treatment assignment. Single Blinding in Epoch 002 (up to Day 360). In a single-blind study, the investigator and/or his staff are aware of the treatment assignment but the subject is not.

Are arms mutually exclusive

Yes

GSK3003891A vaccine formulation 1 Group

Arm description

Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0.

Arm type

Experimental

Investigational medicinal product name

GSK3003891A

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single 30 µg dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.

GSK3003891A vaccine formulation 2 Group

Arm description

Subjects in this group received a single 60 µg dose injection of the investigational GSK3003891A vaccine at Day 0.

Arm type

Experimental

Investigational medicinal product name

GSK3003891A

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single 60 µg dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.

GSK3003891A vaccine formulation 3 Group

Arm description

Subjects in this group received a single 120 µg dose injection of the investigational GSK3003891A vaccine at Day 0.

Arm type

Experimental

Investigational medicinal product name

GSK3003891A

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single 120 µg dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.

Control Group

Arm description

Subjects in this group received a single placebo injection at Day 0.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.

Number of subjects in period 1 ^[1]	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Started	100	99	99	102
Completed	100	96	97	99
Not completed	0	3	2	3
Consent withdrawn by subject	-	1	-	3
Serious Adverse Events	-	1	-	-
Lost to follow-up	-	1	2	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: 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.

Baseline characteristics

Top of page

Reporting group title

GSK3003891A vaccine formulation 1 Group

Reporting group description

Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0.

Reporting group title

GSK3003891A vaccine formulation 2 Group

Reporting group description

Subjects in this group received a single 60 µg dose injection of the investigational GSK3003891A vaccine at Day 0.

Reporting group title

GSK3003891A vaccine formulation 3 Group

Reporting group description

Subjects in this group received a single 120 µg dose injection of the investigational GSK3003891A vaccine at Day 0.

Reporting group title

Control Group

Reporting group description

Subjects in this group received a single placebo injection at Day 0.

Reporting group values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group	Total
Number of subjects	100	99	99	102
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	30.2 ± 6.7	29.1 ± 7.2	29.6 ± 7.1	29.9 ± 6.9	-
Gender categorical
Units: Subjects
Female	100	99	99	102	400
Male	0	0	0	0	0
Race/Ethnicity, Customized
Units: Subjects
African Heritage/African American	1	0	2	1	4
Asian - Central/South Asian Heritage	1	1	0	0	2
Asian - East Asian Heritage	0	0	1	0	1
Asian - South East Asian Heritage	0	0	0	1	1
White - Arabic/North African Heritage	0	1	2	1	4
White - Caucasian/European Heritage	96	97	93	98	384
Unspecified	2	0	1	1	4

End points

Top of page

Reporting group title

GSK3003891A vaccine formulation 1 Group

Reporting group description

Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0.

Reporting group title

GSK3003891A vaccine formulation 2 Group

Reporting group description

Subjects in this group received a single 60 µg dose injection of the investigational GSK3003891A vaccine at Day 0.

Reporting group title

GSK3003891A vaccine formulation 3 Group

Reporting group description

Subjects in this group received a single 120 µg dose injection of the investigational GSK3003891A vaccine at Day 0.

Reporting group title

Control Group

Reporting group description

Subjects in this group received a single placebo injection at Day 0.

Primary: Number of subjects with any Grade 2 and Grade 3 general Adverse Events (AEs) - solicited and unsolicited

Top of page

End point title

Number of subjects with any Grade 2 and Grade 3 general Adverse Events (AEs) - solicited and unsolicited ^[1]

End point 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).

End point type

Primary

End point timeframe

During the 7-day (Days 0-6) post-vaccination period

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	100	99	99	102
Units: Participants
Participants	32	30	24	27

No statistical analyses for this end point

Primary: Number of subjects with Grade 2 and Grade 3 fever

Top of page

End point title

Number of subjects with Grade 2 and Grade 3 fever ^[2]

End point 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).

End point type

Primary

End point timeframe

During the 7-day (Days 0-6) post-vaccination period

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	100	98	99	102
Units: Participants
Grade 2 Fever	0	2	1	0
Grade 3 Fever	0	1	0	0

No statistical analyses for this end point

Primary: Number of subjects with related serious adverse events (SAEs)

Top of page

End point title

Number of subjects with related serious adverse events (SAEs) ^[3]

End point 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).

End point type

Primary

End point timeframe

During the 7-day (Days 0-6) post-vaccination period

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	100	99	99	102
Units: Participants
Participants	0	0	0	0

No statistical analyses for this end point

Primary: Neutralizing antibody titers against RSV-A subtype

Top of page

End point title

Neutralizing antibody titers against RSV-A subtype ^[4]

End point 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).

End point type

Primary

End point timeframe

At Day 0

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	98	95	98	100
Units: Titers
geometric mean (confidence interval 95%)
Anti-RSV.A	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)

No statistical analyses for this end point

Primary: Neutralizing antibody titers against RSV-A subtype

Top of page

End point title

Neutralizing antibody titers against RSV-A subtype ^[5]

End point 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).

End point type

Primary

End point timeframe

At Day 30

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	98	94	98	100
Units: Titers
geometric mean (confidence interval 95%)
Anti-RSV.A	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)

No statistical analyses for this end point

Primary: Palivizumab competing antibody (PCA) concentrations

Top of page

End point title

Palivizumab competing antibody (PCA) concentrations ^[6]

End point 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).

End point type

Primary

End point timeframe

At Day 0

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	98	94	96	100
Units: µg/mL
geometric mean (confidence interval 95%)
Anti-PCA	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)

No statistical analyses for this end point

Primary: Pavilizumab competing antibody (PCA) concentrations

Top of page

End point title

Pavilizumab competing antibody (PCA) concentrations ^[7]

End point description

End point type

Primary

End point timeframe

At Day 30

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	98	94	98	100
Units: µg/mL
geometric mean (confidence interval 95%)
Anti-PCA	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)

No statistical analyses for this end point

Secondary: Number of subjects with any, Grade 2, Grade 3 and medically attended solicited local AEs

Top of page

End point title

Number of subjects with any, Grade 2, Grade 3 and medically attended solicited local AEs

End point 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.

End point type

Secondary

End point timeframe

During the 7-day (Days 0-6) post-vaccination period

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	100	98	99	102
Units: Participants
Any Pain	52	52	51	11
Grade 2 Pain	5	5	10	1
Grade 3 Pain	1	0	1	0
Medically-attended Pain	0	0	0	0
Any Redness (mm)	6	10	8	1
Grade 2 Redness (mm)	2	2	1	0
Grade 3 Redness	0	0	0	0
Medically-attended Redness (mm)	0	0	0	0
Any Swelling (mm)	4	6	7	0
Grade 2 Swelling (mm)	1	0	0	0
Grade 3 Swelling (mm)	0	1	0	0
Medically-attended Swelling (mm)	0	0	0	0

No statistical analyses for this end point

Secondary: Number of subjects with any, Grade 2, Grade 3, related and medically attended solicited general AEs

Top of page

End point title

Number of subjects with any, Grade 2, Grade 3, related and medically attended solicited general AEs

End point 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.

End point type

Secondary

End point timeframe

During the 7-day (Days 0-6) post-vaccination period

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	100	98	99	102
Units: Participants
Any Fatigue	47	43	45	42
Grade 2 Fatigue	9	14	8	12
Grade 3 Fatigue	3	3	2	1
Related Fatigue	37	29	36	33
Medically-attended Fatigue	0	1	1	0
Any Gastrointestinal symptoms	20	23	14	11
Grade 2 Gastrointestinal symptoms	4	3	1	1
Grade 3 Gastrointestinal symptoms	1	2	0	1
Related Gastrointestinal symptoms	13	17	10	7
Medically-attended Gastrointestinal symptoms	0	0	0	0
Any Headache	47	42	41	37
Grade 2 Headache	11	11	12	10
Grade 3 Headache	3	2	1	3
Related Headache	30	27	33	29
Medically-attended Headache	0	1	1	0
Any Temperature/(Oral) (°C)	8	8	6	4
Related Temperature/(Oral) (°C)	5	1	6	2
Medically-attended Temperature/(Oral) (°C)	0	3	1	0

No statistical analyses for this end point

Secondary: Number of subjects with any unsolicited AEs

Top of page

End point title

Number of subjects with any unsolicited AEs

End point 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.

End point type

Secondary

End point timeframe

During the 30-day (Days 0-29) post-vaccination period

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	100	99	99	102
Units: Participants
Participants	55	52	46	49

No statistical analyses for this end point

Secondary: Number of subjects with any SAEs

Top of page

End point title

Number of subjects with any SAEs

End point description

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

End point type

Secondary

End point timeframe

From Day 0 up to study end, at Day 360

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	100	99	99	102
Units: Participants
Participants	1	3	2	2

No statistical analyses for this end point

Secondary: Number of subjects with any biochemical and hematological laboratory abnormalities

Top of page

End point title

Number of subjects with any biochemical and hematological laboratory abnormalities

End point 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].

End point type

Secondary

End point timeframe

At Day 7

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	100	98	99	102
Units: Participants
ALT, Below-Below [N=0;0;0;0]	0	0	0	0
ALT, Below-Within [N=0;0;0;0]	0	0	0	0
ALT, Below-Above [N=0;0;0;0]	0	0	0	0
ALT, Within-Below [N=99;97;99;102]	0	0	0	0
ALT, Within-Within [N=99;97;99;102]	99	97	99	102
ALT, Within-Above [N=99;97;99;102]	0	0	0	0
ALT, Above-Below [N=1;1;0;0]	0	0	0	0
ALT, Above-Within [N=1;1;0;0]	1	1	0	0
ALT, Above-Above [N=1;1;0;0]	0	0	0	0
AST, Below-Below [N=0;0;0;0]	0	0	0	0
AST, Below-Within [N=0;0;0;0]	0	0	0	0
AST, Below-Above [N=0;0;0;0]	0	0	0	0
AST, Within-Below [N=99;97;99;100]	0	0	0	0
AST, Within-Within [N=99;97;99;100]	99	97	98	100
AST, Within-Above [N=99;97;99;100]	0	0	1	0
AST, Above-Below [N=1;1;0;1]	0	0	0	0
AST, Above-Within [N=1;1;0;1]	1	1	0	1
AST, Above-Above [N=1;1;0;1]	0	0	0	0
Creatinine, Below-Below [N=6;5;2;2]	2	3	2	0
Creatinine, Below-Within [N=6;5;2;2]	4	2	0	2
Creatinine, Below-Above [N=6;5;2;2]	0	0	0	0
Creatinine, Within-Below [N=93;92;97;99]	1	2	4	0
Creatinine, Within-Within [N=93;92;97;99]	92	90	93	99
Creatinine, Within-Above [N=93;92;97;99]	0	0	0	0
Creatinine, Above-Below [N=1;1;0;1]	0	0	0	0
Creatinine, Above-Within [N=1;1;0;1]	0	1	0	0
Creatinine, Above-Above [N=1;1;0;1]	1	0	0	1
Eosinophils, Unknown-Below [N=1;1;1;1]	0	0	0	0
Eosinophils, Unknown-Within [N=1;1;1;1]	1	1	1	1
Eosinophils, Unknown-Above [N=1;1;1;1]	0	0	0	0
Eosinophils, Below-Below [N=12;8;10;8]	5	5	3	6
Eosinophils, Below-Within [N=12;8;10;8]	7	3	7	2
Eosinophils, Below-Above [N=12;8;10;8]	0	0	0	0
Eosinophils, Within-Below [N=81;86;83;89]	3	2	4	5
Eosinophils, Within-Within [N=81;86;83;89]	77	84	79	81
Eosinophils, Within-Above [N=81;86;83;89]	1	0	0	3
Eosinophils, Above-Below [N=2;0;0;0]	0	0	0	0
Eosinophils, Above-Within [N=2;0;0;0]	1	0	0	0
Eosinophils, Above-Above [N=2;0;0;0]	1	0	0	0
Hemoglobin, Unknown-Below [N=1;0;0;1]	0	0	0	0
Hemoglobin, Unknown-Within [N=1;0;0;1]	1	0	0	1
Hemoglobin, Unknown-Above [N=1;0;0;1]	0	0	0	0
Hemoglobin, Below-Below [N=20;11;8;11]	12	7	7	7
Hemoglobin, Below-Within [N=20;11;8;11]	8	4	1	4
Hemoglobin, Below-Above [N=20;11;8;11]	0	0	0	0
Hemoglobin, Within-Below [N=79;85;91;90]	4	1	7	2
Hemoglobin, Within-Within [N=79;85;91;90]	74	84	84	88
Hemoglobin, Within-Above [N=79;85;91;90]	1	0	0	0
Hemoglobin, Above-Below [N=0;2;0;0]	0	0	0	0
Hemoglobin, Above-Within [N=0;2;0;0]	0	1	0	0
Hemoglobin, Above-Above [N=0;2;0;0]	0	1	0	0
Lymphocytes, Unknown-Below [N=1;1;1;1]	0	0	0	0
Lymphocytes, Unknown-Within [N=1;1;1;1]	1	1	1	1
Lymphocytes, Unknown-Above [N=1;1;1;1]	0	0	0	0
Lymphocytes, Below-Below [N=1;0;0;1]	0	0	0	1
Lymphocytes, Below-Within [N=1;0;0;1]	1	0	0	0
Lymphocytes, Below-Above [N=1;0;0;1]	0	0	0	0
Lymphocytes, Within-Below [N=93;93;93;96]	1	0	0	0
Lymphocytes, Within-Within [N=93;93;93;96]	92	93	92	94
Lymphocytes, Within-Above [N=93;93;93;96]	0	0	1	2
Lymphocytes, Above-Below [N=1;1;0;0]	0	0	0	0
Lymphocytes, Above-Within [N=1;1;0;0]	1	1	0	0
Lymphocytes, Above-Above [N=1;1;0;0]	0	0	0	0
Neutrophils, Unknown-Below [N=1;1;1;1]	0	0	1	0
Neutrophils, Unknown-Within [N=1;1;1;1]	1	1	0	1
Neutrophils, Unknown-Above [N=1;1;1;1]	0	0	0	0
Neutrophils, Below-Below [N=4;1;0;3]	2	0	0	1
Neutrophils, Below-Within [N=4;1;0;3]	2	1	0	2
Neutrophils, Below-Above [N=4;1;0;3]	0	0	0	0
Neutrophils, Within-Below [N=91;89;90;93]	2	6	4	8
Neutrophils, Within-Within [N=91;89;90;93]	88	81	86	82
Neutrophils, Within-Above [N=91;89;90;93]	1	2	0	3
Neutrophils, Above-Below [N=0;4;3;1]	0	0	0	0
Neutrophils, Above-Within [N=0;4;3;1]	0	4	3	1
Neutrophils, Above-Above [N=0;4;3;1]	0	0	0	0
Platelet count, Unknown-Below [N=2;2;0;1]	0	0	0	0
Platelet count, Unknown-Within [N=2;2;0;1]	2	2	0	1
Platelet count, Unknown-Above [N=2;2;0;1]	0	0	0	0
Platelet count, Below-Below [N=0;0;0;0]	0	0	0	0
Platelet count, Below-Within [N=0;0;0;0]	0	0	0	0
Platelet count, Below-Above [N=0;0;0;0]	0	0	0	0
Platelet count, Within-Below [N=95;96;99;100]	1	1	0	0
Platelet count, Within-Within [N=95;96;99;100]	93	95	99	100
Platelet count, Within-Above [N=95;96;99;100]	1	0	0	0
Platelet count, Above-Below [N=1;0;0;1]	0	0	0	0
Platelet count, Above-Within [N=1;0;0;1]	1	0	0	1
Platelet count, Above-Above [N=1;0;0;1]	0	0	0	0
WBC, Unknown-Below [N=1;0;0;1]	0	0	0	0
WBC, Unknown-Within [N=1;0;0;1]	1	0	0	1
WBC, Unknown-Above [N=1;0;0;1]	0	0	0	0
WBC, Below-Below [N=3;0;1;5]	2	0	0	2
WBC, Below-Within [N=3;0;1;5]	1	0	1	3
WBC, Below-Above [N=3;0;1;5]	0	0	0	0
WBC, Within-Below [N=95;93;94;94]	4	4	1	4
WBC, Within-Within [N=95;93;94;94]	90	87	92	87
WBC, Within-Above [N=95;93;94;94]	1	2	1	3
WBC, Above-Below [N=0;4;3;1]	0	0	0	0
WBC, Above-Within [N=0;4;3;1]	0	3	3	1
WBC, Above-Above [N=0;4;3;1]	0	1	0	0

No statistical analyses for this end point

Secondary: Number of subjects with any biochemical and hematological laboratory abnormalities

Top of page

End point title

Number of subjects with any biochemical and hematological laboratory abnormalities

End point 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].

End point type

Secondary

End point timeframe

At Day 30

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	99	98	99	102
Units: Participants
ALT, Below-Below [N=0;0;0;0]	0	0	0	0
ALT, Below-Within [N=0;0;0;0]	0	0	0	0
ALT, Below-Above [N=0;0;0;0]	0	0	0	0
ALT, Within-Below [N=96;97;99;102]	0	0	0	0
ALT, Within-Within [N=96;97;99;102]	93	97	96	101
ALT, Within-Above [N=96;97;99;102]	3	0	3	1
ALT, Above-Below [N=1;1;0;0]	0	0	0	0
ALT, Above-Within [N=1;1;0;0]	1	0	0	0
ALT, Above-Above [N=1;1;0;0]	0	1	0	0
AST, Below-Below [N=0;0;0;0]	0	0	0	0
AST, Below-Within [N=0;0;0;0]	0	0	0	0
AST, Below-Above [N=0;0;0;0]	0	0	0	0
AST, Within-Below [N=96;97;99;101]	0	0	0	0
AST, Within-Within [N=96;97;99;101]	94	97	97	100
AST, Within-Above [N=96;97;99;101]	2	0	2	1
AST, Above-Below [N=1;1;0;1]	0	0	0	0
AST, Above-Within [N=1;1;0;1]	1	0	0	1
AST, Above-Above [N=1;1;0;1]	0	1	0	0
Creatinine, Below-Below [N=6;5;2;2]	1	2	2	2
Creatinine, Below-Within [N=6;5;2;2]	5	3	0	0
Creatinine, Below-Above [N=6;5;2;2]	0	0	0	0
Creatinine, Within-Below [N=90;92;97;99]	1	0	3	2
Creatinine, Within-Within [N=90;92;97;99]	89	91	93	97
Creatinine, Within-Above [N=90;92;97;99]	0	1	1	0
Creatinine, Above-Below [N=1;1;0;1]	0	0	0	0
Creatinine, Above-Within [N=1;1;0;1]	1	0	0	1
Creatinine, Above-Above [N=1;1;0;1]	0	1	0	0
Eosinophils, Unknown-Below [N=1;1;1;1]	0	1	0	0
Eosinophils, Unknown-Within [N=1;1;1;1]	1	0	1	1
Eosinophils, Unknown-Above [N=1;1;1;1]	0	0	0	0
Eosinophils, Below-Below [N=12;8;11;8]	5	4	4	4
Eosinophils, Below-Within [N=12;8;11;8]	7	4	7	4
Eosinophils, Below-Above [N=12;8;11;8]	0	0	0	0
Eosinophils, Within-Below [N=84;88;86;90]	3	6	8	7
Eosinophils, Within-Within [N=84;88;86;90]	80	82	75	83
Eosinophils, Within-Above [N=84;88;86;90]	1	0	3	0
Eosinophils, Above-Below [N=2;0;0;0]	0	0	0	0
Eosinophils, Above-Within [N=2;0;0;0]	1	0	0	0
Eosinophils, Above-Above [N=2;0;0;0]	1	0	0	0
Hemoglobin, Unknown-Below [N=1;0;0;1]	0	0	0	0
Hemoglobin, Unknown-Within [N=1;0;0;1]	1	0	0	1
Hemoglobin, Unknown-Above [N=1;0;0;1]	0	0	0	0
Hemoglobin, Below-Below [N=20;11;8;11]	13	6	6	7
Hemoglobin, Below-Within [N=20;11;8;11]	7	5	2	4
Hemoglobin, Below-Above [N=20;11;8;11]	0	0	0	0
Hemoglobin, Within-Below [N=78;84;91;90]	2	4	5	3
Hemoglobin, Within-Within [N=78;84;91;90]	76	79	86	87
Hemoglobin, Within-Above [N=78;84;91;90]	0	1	0	0
Hemoglobin, Above-Below [N=0;2;0;0]	0	0	0	0
Hemoglobin, Above-Within [N=0;2;0;0]	0	1	0	0
Hemoglobin, Above-Above [N=0;2;0;0]	0	1	0	0
Lymphocytes, Unknown-Below [N=1;1;1;1]	0	0	0	0
Lymphocytes, Unknown-Within [N=1;1;1;1]	1	1	1	1
Lymphocytes, Unknown-Above [N=1;1;1;1]	0	0	0	0
Lymphocytes, Below-Below [N=1;0;0;1]	0	0	0	1
Lymphocytes, Below-Within [N=1;0;0;1]	1	0	0	0
Lymphocytes, Below-Above [N=1;0;0;1]	0	0	0	0
Lymphocytes, Within-Below [N=96;95;97;97]	1	0	0	0
Lymphocytes, Within-Within [N=96;95;97;97]	94	94	97	95
Lymphocytes, Within-Above [N=96;95;97;97]	1	1	0	2
Lymphocytes, Above-Below [N=1;1;0;0]	0	0	0	0
Lymphocytes, Above-Within [N=1;1;0;0]	1	1	0	0
Lymphocytes, Above-Above [N=1;1;0;0]	0	0	0	0
Neutrophils, Unknown-Below [N=1;1;1;1]	0	0	0	0
Neutrophils, Unknown-Within [N=1;1;1;1]	1	1	1	1
Neutrophils, Unknown-Above [N=1;1;1;1]	0	0	0	0
Neutrophils, Below-Below [N=4;1;0;3]	1	0	0	0
Neutrophils, Below-Within [N=4;1;0;3]	3	1	0	3
Neutrophils, Below-Above [N=4;1;0;3]	0	0	0	0
Neutrophils, Within-Below [N=94;91;94;94]	4	1	1	3
Neutrophils, Within-Within [N=94;91;94;94]	88	88	92	88
Neutrophils, Within-Above [N=94;91;94;94]	2	2	1	3
Neutrophils, Above-Below [N=0;4;3;1]	0	0	0	0
Neutrophils, Above-Within [N=0;4;3;1]	0	3	3	1
Neutrophils, Above-Above [N=0;4;3;1]	0	1	0	0
Platelet count, Unknown-Below [N=2;2;0;1]	0	0	0	0
Platelet count, Unknown-Within [N=2;2;0;1]	2	2	0	1
Platelet count, Unknown-Above [N=2;2;0;1]	0	0	0	0
Platelet count, Below-Below [N=0;0;0;0]	0	0	0	0
Platelet count, Below-Within [N=0;0;0;0]	0	0	0	0
Platelet count, Below-Above [N=0;0;0;0]	0	0	0	0
Platelet count, Within-Below [N=94;95;99;100]	0	0	0	0
Platelet count, Within-Within [N=94;95;99;100]	92	94	99	99
Platelet count, Within-Above [N=94;95;99;100]	2	1	0	1
Platelet count, Above-Below [N=1;0;0;1]	0	0	0	0
Platelet count, Above-Within [N=1;0;0;1]	1	0	0	1
Platelet count, Above-Above [N=1;0;0;1]	0	0	0	0
WBC, Unknown-Below [N=1;0;0;1]	0	0	0	0
WBC, Unknown-Within [N=1;0;0;1]	1	0	0	1
WBC, Unknown-Above [N=1;0;0;1]	0	0	0	0
WBC, Below-Below [N=3;0;2;4]	2	0	1	0
WBC, Below-Within [N=3;0;2;4]	1	0	1	4
WBC, Below-Above [N=3;0;2;4]	0	0	0	0
WBC, Within-Below [N=95;93;94;95]	3	1	3	0
WBC, Within-Within [N=95;93;94;95]	90	89	90	90
WBC, Within-Above [N=95;93;94;95]	2	3	1	5
WBC, Above-Below [N=0;4;3;1]	0	0	0	0
WBC, Above-Within [N=0;4;3;1]	0	2	2	1
WBC, Above-Above [N=0;4;3;1]	0	2	1	0

No statistical analyses for this end point

Secondary: Number of subjects with any biochemical and hematological laboratory abnormalities

Top of page

End point title

Number of subjects with any biochemical and hematological laboratory abnormalities

End point 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].

End point type

Secondary

End point timeframe

At Day 60

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	100	96	98	101
Units: Participants
ALT, Below-Below [N=0;0;0;0]	0	0	0	0
ALT, Below-Within [N=0;0;0;0]	0	0	0	0
ALT, Below-Above [N=0;0;0;0]	0	0	0	0
ALT, Within-Below [N=98;95;98;101]	0	0	0	0
ALT, Within-Within [N=98;95;98;101]	98	95	98	101
ALT, Within-Above [N=98;95;98;101]	0	0	0	0
ALT, Above-Below [N=1;1;0;0]	0	0	0	0
ALT, Above-Within [N=1;1;0;0]	1	1	0	0
ALT, Above-Above [N=1;1;0;0]	0	0	0	0
AST, Below-Below [N=0;0;0;0]	0	0	0	0
AST, Below-Within [N=0;0;0;0]	0	0	0	0
AST, Below-Above [N=0;0;0;0]	0	0	0	0
AST, Within-Below [N=98;95;98;100]	0	0	0	0
AST, Within-Within [N=98;95;98;100]	98	95	97	100
AST, Within-Above [N=98;95;98;100]	0	0	1	0
AST, Above-Below [N=1;1;0;1]	0	0	0	0
AST, Above-Within [N=1;1;0;1]	1	1	0	1
AST, Above-Above [N=1;1;0;1]	0	0	0	0
Creatinine, Below-Below [N=6;5;2;2]	0	3	2	2
Creatinine, Below-Within [N=6;5;2;2]	6	2	0	0
Creatinine, Below-Above [N=6;5;2;2]	0	0	0	0
Creatinine, Within-Below [N=92;90;96;98]	2	3	3	6
Creatinine, Within-Within [N=92;90;96;98]	89	87	93	91
Creatinine, Within-Above [N=92;90;96;98]	1	0	0	1
Creatinine, Above-Below [N=1;1;0;1]	0	0	0	0
Creatinine, Above-Within [N=1;1;0;1]	1	1	0	1
Creatinine, Above-Above [N=1;1;0;1]	0	0	0	0
Eosinophils, Unknown-Below [N=1;0;1;1]	0	0	0	0
Eosinophils, Unknown-Within [N=1;0;1;1]	1	0	1	1
Eosinophils, Unknown-Above [N=1;0;1;1]	0	0	0	0
Eosinophils, Below-Below [N=12;8;10;9]	5	2	4	5
Eosinophils, Below-Within [N=12;8;10;9]	7	6	6	4
Eosinophils, Below-Above [N=12;8;10;9]	0	0	0	0
Eosinophils, Within-Below [N=85;87;85;91]	6	4	5	7
Eosinophils, Within-Within [N=85;87;85;91]	77	82	77	81
Eosinophils, Within-Above [N=85;87;85;91]	2	1	3	3
Eosinophils, Above-Below [N=2;0;0;0]	0	0	0	0
Eosinophils, Above-Within [N=2;0;0;0]	0	0	0	0
Eosinophils, Above-Above [N=2;0;0;0]	2	0	0	0
Hemoglobin, Unknown-Below [N=1;0;0;1]	0	0	0	0
Hemoglobin, Unknown-Within [N=1;0;0;1]	1	0	0	1
Hemoglobin, Unknown-Above [N=1;0;0;1]	0	0	0	0
Hemoglobin, Below-Below [N=20;11;8;11]	13	6	5	8
Hemoglobin, Below-Within [N=20;11;8;11]	7	5	3	3
Hemoglobin, Below-Above [N=20;11;8;11]	0	0	0	0
Hemoglobin, Within-Below [N=79;82;90;89]	5	4	6	7
Hemoglobin, Within-Within [N=79;82;90;89]	74	78	84	81
Hemoglobin, Within-Above [N=79;82;90;89]	0	0	0	1
Hemoglobin, Above-Below [N=0;2;0;0]	0	0	0	0
Hemoglobin, Above-Within [N=0;2;0;0]	0	1	0	0
Hemoglobin, Above-Above [N=0;2;0;0]	0	1	0	0
Lymphocytes, Unknown-Below [N=1;0;1;1]	0	0	0	0
Lymphocytes, Unknown-Within [N=1;0;1;1]	1	0	1	1
Lymphocytes, Unknown-Above [N=1;0;1;1]	0	0	0	0
Lymphocytes, Below-Below [N=1;0;0;1]	0	0	0	0
Lymphocytes, Below-Within [N=1;0;0;1]	1	0	0	1
Lymphocytes, Below-Above [N=1;0;0;1]	0	0	0	0
Lymphocytes, Within-Below [N=97;94;95;99]	1	0	1	0
Lymphocytes, Within-Within [N=97;94;95;99]	96	94	93	96
Lymphocytes, Within-Above [N=97;94;95;99]	0	0	1	3
Lymphocytes, Above-Below [N=1;1;0;0]	0	0	0	0
Lymphocytes, Above-Within [N=1;1;0;0]	1	1	0	0
Lymphocytes, Above-Above [N=1;1;0;0]	0	0	0	0
Neutrophils, Unknown-Below [N=1;0;1;1]	0	0	0	0
Neutrophils, Unknown-Within [N=1;0;1;1]	1	0	1	1
Neutrophils, Unknown-Above [N=1;0;1;1]	0	0	0	0
Neutrophils, Below-Below [N=4;1;0;3]	0	0	0	1
Neutrophils, Below-Within [N=4;1;0;3]	4	1	0	2
Neutrophils, Below-Above [N=4;1;0;3]	0	0	0	0
Neutrophils, Within-Below [N=95;90;92;96]	4	4	4	4
Neutrophils, Within-Within [N=95;90;92;96]	89	84	88	89
Neutrophils, Within-Above [N=95;90;92;96]	2	2	0	3
Neutrophils, Above-Below [N=0;4;3;1]	0	0	0	0
Neutrophils, Above-Within [N=0;4;3;1]	0	4	3	1
Neutrophils, Above-Above [N=0;4;3;1]	0	0	0	0
Platelet count, Unknown-Below [N=2;2;0;1]	0	0	0	0
Platelet count, Unknown-Within [N=2;2;0;1]	2	2	0	1
Platelet count, Unknown-Above [N=2;2;0;1]	0	0	0	0
Platelet count, Below-Below [N=0;0;0;0]	0	0	0	0
Platelet count, Below-Within [N=0;0;0;0]	0	0	0	0
Platelet count, Below-Above [N=0;0;0;0]	0	0	0	0
Platelet count, Within-Below [N=94;93;98;99]	0	0	1	0
Platelet count, Within-Within [N=94;93;98;99]	93	92	97	98
Platelet count, Within-Above [N=94;93;98;99]	1	1	0	1
Platelet count, Above-Below [N=1;0;0;1]	0	0	0	0
Platelet count, Above-Within [N=1;0;0;1]	1	0	0	1
Platelet count, Above-Above [N=1;0;0;1]	0	0	0	0
WBC, Unknown-Below [N=1;0;0;1]	0	0	0	0
WBC, Unknown-Within [N=1;0;0;1]	1	0	0	1
WBC, Unknown-Above [N=1;0;0;1]	0	0	0	0
WBC, Below-Below [N=3;0;2;5]	1	0	2	3
WBC, Below-Within [N=3;0;2;5]	2	0	0	2
WBC, Below-Above [N=3;0;2;5]	0	0	0	0
WBC, Within-Below [N=96;91;93;94]	2	1	2	1
WBC, Within-Within [N=96;91;93;94]	92	86	90	87
WBC, Within-Above [N=96;91;93;94]	2	4	1	6
WBC, Above-Below [N=0;4;3;1]	0	0	0	0
WBC, Above-Within [N=0;4;3;1]	0	3	2	1
WBC, Above-Above [N=0;4;3;1]	0	1	1	0

No statistical analyses for this end point

Secondary: Number of subjects with any biochemical and hematological laboratory abnormalities

Top of page

End point title

Number of subjects with any biochemical and hematological laboratory abnormalities

End point 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].

End point type

Secondary

End point timeframe

At Day 90

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	100	97	97	99
Units: Participants
ALT, Below-Below [N=0;0;0;0]	0	0	0	0
ALT, Below-Within [N=0;0;0;0]	0	0	0	0
ALT, Below-Above [N=0;0;0;0]	0	0	0	0
ALT, Within-Below [N=99;95;97;99]	0	0	0	0
ALT, Within-Within [N=99;95;97;99]	98	95	97	99
ALT, Within-Above [N=99;95;97;99]	1	0	0	0
ALT, Above-Below [N=1;1;0;0]	0	0	0	0
ALT, Above-Within [N=1;1;0;0]	1	1	0	0
ALT, Above-Above [N=1;1;0;0]	0	0	0	0
AST, Below-Below [N=0;0;0;0]	0	0	0	0
AST, Below-Within [N=0;0;0;0]	0	0	0	0
AST, Below-Above [N=0;0;0;0]	0	0	0	0
AST, Within-Below [N=99;95;97;98]	0	0	0	0
AST, Within-Within [N=99;95;97;98]	99	95	97	98
AST, Within-Above [N=99;95;97;98]	0	0	0	0
AST, Above-Below [N=1;1;0;1]	0	0	0	0
AST, Above-Within [N=1;1;0;1]	1	1	0	1
AST, Above-Above [N=1;1;0;1]	0	0	0	0
Creatinine, Below-Below [N=6;5;2;2]	1	2	2	2
Creatinine, Below-Within [N=6;5;2;2]	5	3	0	0
Creatinine, Below-Above [N=6;5;2;2]	0	0	0	0
Creatinine, Within-Below [N=93;90;95;96]	3	2	4	3
Creatinine, Within-Within [N=93;90;95;96]	90	88	91	92
Creatinine, Within-Above [N=93;90;95;96]	0	0	0	1
Creatinine, Above-Below [N=1;1;0;1]	0	0	0	0
Creatinine, Above-Within [N=1;1;0;1]	1	0	0	1
Creatinine, Above-Above [N=1;1;0;1]	0	1	0	0
Eosinophils, Unknown-Below [N=1;1;1;1]	0	0	0	0
Eosinophils, Unknown-Within [N=1;1;1;1]	1	1	1	1
Eosinophils, Unknown-Above [N=1;1;1;1]	0	0	0	0
Eosinophils, Below-Below [N=12;8;11;9]	6	2	4	4
Eosinophils, Below-Within [N=12;8;11;9]	6	6	7	5
Eosinophils, Below-Above [N=12;8;11;9]	0	0	0	0
Eosinophils, Within-Below [N=84;87;80;89]	6	5	8	9
Eosinophils, Within-Within [N=84;87;80;89]	76	81	70	80
Eosinophils, Within-Above [N=84;87;80;89]	2	1	2	0
Eosinophils, Above-Below [N=2;0;0;0]	0	0	0	0
Eosinophils, Above-Within [N=2;0;0;0]	2	0	0	0
Eosinophils, Above-Above [N=2;0;0;0]	0	0	0	0
Hemoglobin, Unknown-Below [N=1;0;0;1]	0	0	0	0
Hemoglobin, Unknown-Within [N=1;0;0;1]	1	0	0	1
Hemoglobin, Unknown-Above [N=1;0;0;1]	0	0	0	0
Hemoglobin, Below-Below [N=20;11;7;11]	11	5	6	7
Hemoglobin, Below-Within [N=20;11;7;11]	9	6	1	4
Hemoglobin, Below-Above [N=20;11;7;11]	0	0	0	0
Hemoglobin, Within-Below [N=79;84;89;87]	4	3	4	5
Hemoglobin, Within-Within [N=79;84;89;87]	75	81	84	82
Hemoglobin, Within-Above [N=79;84;89;87]	0	0	1	0
Hemoglobin, Above-Below [N=0;2;0;0]	0	0	0	0
Hemoglobin, Above-Within [N=0;2;0;0]	0	1	0	0
Hemoglobin, Above-Above [N=0;2;0;0]	0	1	0	0
Lymphocytes, Unknown-Below [N=1;1;1;1]	0	0	0	0
Lymphocytes, Unknown-Within [N=1;1;1;1]	1	1	1	1
Lymphocytes, Unknown-Above [N=1;1;1;1]	0	0	0	0
Lymphocytes, Below-Below [N=1;0;0;1]	0	0	0	1
Lymphocytes, Below-Within [N=1;0;0;1]	1	0	0	0
Lymphocytes, Below-Above [N=1;0;0;1]	0	0	0	0
Lymphocytes, Within-Below [N=96;94;91;97]	1	0	1	1
Lymphocytes, Within-Within [N=96;94;91;97]	95	93	90	95
Lymphocytes, Within-Above [N=96;94;91;97]	0	1	0	1
Lymphocytes, Above-Below [N=1;1;0;0]	0	0	0	0
Lymphocytes, Above-Within [N=1;1;0;0]	1	0	0	0
Lymphocytes, Above-Above [N=1;1;0;0]	0	1	0	0
Neutrophils, Unknown-Below [N=1;1;1;1]	0	0	0	0
Neutrophils, Unknown-Within [N=1;1;1;1]	1	1	1	1
Neutrophils, Unknown-Above [N=1;1;1;1]	0	0	0	0
Neutrophils, Below-Below [N=4;1;0;3]	2	0	0	1
Neutrophils, Below-Within [N=4;1;0;3]	2	1	0	2
Neutrophils, Below-Above [N=4;1;0;3]	0	0	0	0
Neutrophils, Within-Below [N=94;90;88;94]	3	5	2	1
Neutrophils, Within-Within [N=94;90;88;94]	89	83	86	91
Neutrophils, Within-Above [N=94;90;88;94]	2	2	0	2
Neutrophils, Above-Below [N=0;4;3;1]	0	0	0	0
Neutrophils, Above-Within [N=0;4;3;1]	0	4	3	0
Neutrophils, Above-Above [N=0;4;3;1]	0	0	0	1
Platelet count, Unknown-Below [N=3;2;0;1]	1	0	0	0
Platelet count, Unknown-Within [N=3;2;0;1]	2	2	0	1
Platelet count, Unknown-Above [N=3;2;0;1]	0	0	0	0
Platelet count, Below-Below [N=0;0;0;0]	0	0	0	0
Platelet count, Below-Within [N=0;0;0;0]	0	0	0	0
Platelet count, Below-Above [N=0;0;0;0]	0	0	0	0
Platelet count, Within-Below [N=94;94;96;95]	0	1	0	0
Platelet count, Within-Within [N=94;94;96;95]	91	91	95	95
Platelet count, Within-Above [N=94;94;96;95]	3	2	1	0
Platelet count, Above-Below [N=1;0;0;1]	0	0	0	0
Platelet count, Above-Within [N=1;0;0;1]	1	0	0	1
Platelet count, Above-Above [N=1;0;0;1]	0	0	0	0
WBC, Unknown-Below [N=1;0;0;1]	0	0	0	0
WBC, Unknown-Within [N=1;0;0;1]	1	0	0	1
WBC, Unknown-Above [N=1;0;0;1]	0	0	0	0
WBC, Below-Below [N=3;0;2;5]	1	0	1	1
WBC, Below-Within [N=3;0;2;5]	2	0	1	4
WBC, Below-Above [N=3;0;2;5]	0	0	0	0
WBC, Within-Below [N=96;93;91;92]	2	1	1	0
WBC, Within-Within [N=96;93;91;92]	91	89	89	89
WBC, Within-Above [N=96;93;91;92]	3	3	1	3
WBC, Above-Below [N=0;4;3;1]	0	0	0	0
WBC, Above-Within [N=0;4;3;1]	0	3	3	0
WBC, Above-Above [N=0;4;3;1]	0	1	0	1

No statistical analyses for this end point

Secondary: Number of subjects with any biochemical and hematological laboratory abnormalities, by maximum grading

Top of page

End point title

Number of subjects with any biochemical and hematological laboratory abnormalities, by maximum grading

End point 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 (U), Grade 0 (G0=no grade), Grade 1 (G1=mild), Grade 2 (G2=moderate), Grade 3 (G3=severe) and Grade 4 (G4=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].

End point type

Secondary

End point timeframe

From Day 7 up to Day 90

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	100	98	99	102
Units: Participants
ALT, G0-U [N=99;97;99;102]	0	0	0	0
ALT, G0-G0 [N=99;97;99;102]	96	97	96	101
ALT, G0-G1 [N=99;97;99;102]	2	0	3	1
ALT, G0-G2 [N=99;97;99;102]	0	0	0	0
ALT, G0-G3 [N=99;97;99;102]	1	0	0	0
ALT, G0-G4 [N=99;97;99;102]	0	0	0	0
ALT, G1-U [N=1;0;0;0]	0	0	0	0
ALT, G1-G0 [N=1;0;0;0]	1	0	0	0
ALT, G1-G1 [N=1;0;0;0]	0	0	0	0
ALT, G1-G2 [N=1;0;0;0]	0	0	0	0
ALT, G1-G3 [N=1;0;0;0]	0	0	0	0
ALT, G1-G4 [N=1;0;0;0]	0	0	0	0
ALT, G2-U [N=0;1;0;0]	0	0	0	0
ALT, G2-G0 [N=0;1;0;0]	0	0	0	0
ALT, G2-G1 [N=0;1;0;0]	0	0	0	0
ALT, G2-G2 [N=0;1;0;0]	0	1	0	0
ALT, G2-G3 [N=0;1;0;0]	0	0	0	0
ALT, G2-G4 [N=0;1;0;0]	0	0	0	0
AST, G0-U [N=100;97;99;101]	0	0	0	0
AST, G0-G0 [N=100;97;99;101]	98	97	97	101
AST, G0-G1 [N=100;97;99;101]	0	0	2	0
AST, G0-G2 [N=100;97;99;101]	1	0	0	0
AST, G0-G3 [N=100;97;99;101]	0	0	0	0
AST, G0-G4 [N=100;97;99;101]	1	0	0	0
AST, G1-U [N=0;1;0;1]	0	0	0	0
AST, G1-G0 [N=0;1;0;1]	0	0	0	1
AST, G1-G1 [N=0;1;0;1]	0	0	0	0
AST, G1-G2 [N=0;1;0;1]	0	1	0	0
AST, G1-G3 [N=0;1;0;1]	0	0	0	0
AST, G1-G4 [N=0;1;0;1]	0	0	0	0
Creatinine, G0-U [N=100;98;99;102]	0	0	0	0
Creatinine, G0-G0 [N=100;98;99;102]	100	98	99	102
Creatinine, G0-G1 [N=100;98;99;102]	0	0	0	0
Creatinine, G0-G2 [N=100;98;99;102]	0	0	0	0
Creatinine, G0-G3 [N=100;98;99;102]	0	0	0	0
Creatinine, G0-G4 [N=100;98;99;102]	0	0	0	0
Eosinophils increase, U-U [N=1;1;1;1]	0	0	0	0
Eosinophils increase, U-G0 [N=1;1;1;1]	1	1	1	1
Eosinophils increase, U-G1 [N=1;1;1;1]	0	0	0	0
Eosinophils increase, U-G2 [N=1;1;1;1]	0	0	0	0
Eosinophils increase, U-G3 [N=1;1;1;1]	0	0	0	0
Eosinophils increase, U-G4 [N=1;1;1;1]	0	0	0	0
Eosinophils increase, G0-U [N=97;97;98;101]	0	0	0	0
Eosinophils increase, G0-G0 [N=97;97;98;101]	94	96	95	99
Eosinophils increase, G0-G1 [N=97;97;98;101]	3	1	3	2
Eosinophils increase, G0-G2 [N=97;97;98;101]	0	0	0	0
Eosinophils increase, G0-G3 [N=97;97;98;101]	0	0	0	0
Eosinophils increase, G0-G4 [N=97;97;98;101]	0	0	0	0
Eosinophils increase, G1-U [N=1;0;0;0]	0	0	0	0
Eosinophils increase, G1-G0 [N=1;0;0;0]	0	0	0	0
Eosinophils increase, G1-G1 [N=1;0;0;0]	1	0	0	0
Eosinophils increase, G1-G2 [N=1;0;0;0]	0	0	0	0
Eosinophils increase, G1-G3 [N=1;0;0;0]	0	0	0	0
Eosinophils increase, G1-G4 [N=1;0;0;0]	0	0	0	0
Eosinophils increase, G2-U [N=1;0;0;0]	0	0	0	0
Eosinophils increase, G2-G0 [N=1;0;0;0]	0	0	0	0
Eosinophils increase, G2-G1 [N=1;0;0;0]	0	0	0	0
Eosinophils increase, G2-G2 [N=1;0;0;0]	1	0	0	0
Eosinophils increase, G2-G3 [N=1;0;0;0]	0	0	0	0
Eosinophils increase, G2-G4 [N=1;0;0;0]	0	0	0	0
Hemoglobin decrease, U-U [N=1;0;0;1]	0	0	0	0
Hemoglobin decrease, U-G0 [N=1;0;0;1]	1	0	0	1
Hemoglobin decrease, U-G1 [N=1;0;0;1]	0	0	0	0
Hemoglobin decrease, U-G2 [N=1;0;0;1]	0	0	0	0
Hemoglobin decrease, U-G3 [N=1;0;0;1]	0	0	0	0
Hemoglobin decrease, U-G4 [N=1;0;0;1]	0	0	0	0
Hemoglobin decrease, G0-U [N=78;86;88;88]	0	0	0	0
Hemoglobin decrease, G0-G0 [N=78;86;88;88]	61	74	73	74
Hemoglobin decrease, G0-G1 [N=78;86;88;88]	14	12	15	13
Hemoglobin decrease, G0-G2 [N=78;86;88;88]	2	0	0	1
Hemoglobin decrease, G0-G3 [N=78;86;88;88]	1	0	0	0
Hemoglobin decrease, G0-G4 [N=78;86;88;88]	0	0	0	0
Hemoglobin decrease, G1-U [N=19;12;9;12]	0	0	0	0
Hemoglobin decrease, G1-G0 [N=19;12;9;12]	3	2	2	0
Hemoglobin decrease, G1-G1 [N=19;12;9;12]	11	9	5	10
Hemoglobin decrease, G1-G2 [N=19;12;9;12]	5	1	2	2
Hemoglobin decrease, G1-G3 [N=19;12;9;12]	0	0	0	0
Hemoglobin decrease, G1-G4 [N=19;12;9;12]	0	0	0	0
Hemoglobin decrease, G2-U [N=1;0;2;1]	0	0	0	0
Hemoglobin decrease, G2-G0 [N=1;0;2;1]	0	0	0	0
Hemoglobin decrease, G2-G1 [N=1;0;2;1]	0	0	1	0
Hemoglobin decrease, G2-G2 [N=1;0;2;1]	1	0	1	1
Hemoglobin decrease, G2-G3 [N=1;0;2;1]	0	0	0	0
Hemoglobin decrease, G2-G4 [N=1;0;2;1]	0	0	0	0
Hemoglobin decrease, G3-U [N=1;0;0;0]	0	0	0	0
Hemoglobin decrease, G3-G0 [N=1;0;0;0]	0	0	0	0
Hemoglobin decrease, G3-G1 [N=1;0;0;0]	0	0	0	0
Hemoglobin decrease, G3-G2 [N=1;0;0;0]	1	0	0	0
Hemoglobin decrease, G3-G3 [N=1;0;0;0]	0	0	0	0
Hemoglobin decrease, G3-G4 [N=1;0;0;0]	0	0	0	0
Lymphocytes decrease, U-U [N=1;1;1;1]	0	0	0	0
Lymphocytes decrease, U-G0 [N=1;1;1;1]	1	1	1	1
Lymphocytes decrease, U-G1 [N=1;1;1;1]	0	0	0	0
Lymphocytes decrease, U-G2 [N=1;1;1;1]	0	0	0	0
Lymphocytes decrease, U-G3 [N=1;1;1;1]	0	0	0	0
Lymphocytes decrease, U-G4 [N=1;1;1;1]	0	0	0	0
Lymphocytes decrease, G0-U [N=96;97;97;100]	0	0	0	0
Lymphocytes decrease, G0-G0 [N=96;97;97;100]	90	97	93	99
Lymphocytes decrease, G0-G1 [N=96;97;97;100]	5	0	4	1
Lymphocytes decrease, G0-G2 [N=96;97;97;100]	1	0	0	0
Lymphocytes decrease, G0-G3 [N=96;97;97;100]	0	0	0	0
Lymphocytes decrease, G0-G4 [N=96;97;97;100]	0	0	0	0
Lymphocytes decrease, G1-U [N=2;0;1;0]	0	0	0	0
Lymphocytes decrease, G1-G0 [N=2;0;1;0]	1	0	1	0
Lymphocytes decrease, G1-G1 [N=2;0;1;0]	1	0	0	0
Lymphocytes decrease, G1-G2 [N=2;0;1;0]	0	0	0	0
Lymphocytes decrease, G1-G3 [N=2;0;1;0]	0	0	0	0
Lymphocytes decrease, G1-G4 [N=2;0;1;0]	0	0	0	0
Lymphocytes decrease, G2-U [N=1;0;0;1]	0	0	0	0
Lymphocytes decrease, G2-G0 [N=1;0;0;1]	0	0	0	0
Lymphocytes decrease, G2-G1 [N=1;0;0;1]	1	0	0	1
Lymphocytes decrease, G2-G2 [N=1;0;0;1]	0	0	0	0
Lymphocytes decrease, G2-G3 [N=1;0;0;1]	0	0	0	0
Lymphocytes decrease, G2-G4 [N=1;0;0;1]	0	0	0	0
Neutrophils decrease, U-U [N=1;1;1;1]	0	0	0	0
Neutrophils decrease, U-G0 [N=1;1;1;1]	1	1	0	1
Neutrophils decrease, U-G1 [N=1;1;1;1]	0	0	1	0
Neutrophils decrease, U-G2 [N=1;1;1;1]	0	0	0	0
Neutrophils decrease, U-G3 [N=1;1;1;1]	0	0	0	0
Neutrophils decrease, U-G4 [N=1;1;1;1]	0	0	0	0
Neutrophils decrease, G0-U [N=94;95;95;95]	0	0	0	0
Neutrophils decrease, G0-G0 [N=94;95;95;95]	80	70	82	82
Neutrophils decrease, G0-G1 [N=94;95;95;95]	10	20	11	8
Neutrophils decrease, G0-G2 [N=94;95;95;95]	3	5	2	5
Neutrophils decrease, G0-G3 [N=94;95;95;95]	1	0	0	0
Neutrophils decrease, G0-G4 [N=94;95;95;95]	0	0	0	0
Neutrophils decrease, G1-U [N=2;1;3;4]	0	0	0	0
Neutrophils decrease, G1-G0 [N=2;1;3;4]	0	1	3	2
Neutrophils decrease, G1-G1 [N=2;1;3;4]	1	0	0	1
Neutrophils decrease, G1-G2 [N=2;1;3;4]	1	0	0	1
Neutrophils decrease, G1-G3 [N=2;1;3;4]	0	0	0	0
Neutrophils decrease, G1-G4 [N=2;1;3;4]	0	0	0	0
Neutrophils decrease, G2-U [N=3;1;0;2]	0	0	0	0
Neutrophils decrease, G2-G0 [N=3;1;0;2]	0	0	0	0
Neutrophils decrease, G2-G1 [N=3;1;0;2]	1	1	0	1
Neutrophils decrease, G2-G2 [N=3;1;0;2]	2	0	0	1
Neutrophils decrease, G2-G3 [N=3;1;0;2]	0	0	0	0
Neutrophils decrease, G2-G4 [N=3;1;0;2]	0	0	0	0
Platelet count decrease, U-U [N=4;2;0;1]	1	0	0	0
Platelet count decrease, U-G0 [N=4;2;0;1]	2	2	0	1
Platelet count decrease, U-G1 [N=4;2;0;1]	0	0	0	0
Platelet count decrease, U-G2 [N=4;2;0;1]	0	0	0	0
Platelet count decrease, U-G3 [N=4;2;0;1]	1	0	0	0
Platelet count decrease, U-G4 [N=4;2;0;1]	0	0	0	0
Platelet count decrease, G0-U [N=96;95;99;101]	0	0	0	0
Platelet count decrease, G0-G0 [N=96;95;99;101]	94	94	97	100
Platelet count decrease, G0-G1 [N=96;95;99;101]	1	1	1	1
Platelet count decrease, G0-G2 [N=96;95;99;101]	1	0	1	0
Platelet count decrease, G0-G3 [N=96;95;99;101]	0	0	0	0
Platelet count decrease, G0-G4 [N=96;95;99;101]	0	0	0	0
Platelet count decrease, G1-U [N=0;1;0;0]	0	0	0	0
Platelet count decrease, G1-G0 [N=0;1;0;0]	0	0	0	0
Platelet count decrease, G1-G1 [N=0;1;0;0]	0	1	0	0
Platelet count decrease, G1-G2 [N=0;1;0;0]	0	0	0	0
Platelet count decrease, G1-G3 [N=0;1;0;0]	0	0	0	0
Platelet count decrease, G1-G4 [N=0;1;0;0]	0	0	0	0
WBC decrease, U-U [N=1;0;0;1]	0	0	0	0
WBC decrease, U-G0 [N=1;0;0;1]	1	0	0	1
WBC decrease, U-G1 [N=1;0;0;1]	0	0	0	0
WBC decrease, U-G2 [N=1;0;0;1]	0	0	0	0
WBC decrease, U-G3 [N=1;0;0;1]	0	0	0	0
WBC decrease, U-G4 [N=1;0;0;1]	0	0	0	0
WBC decrease, G0-U [N=98;98;98;98]	0	0	0	0
WBC decrease, G0-G0 [N=98;98;98;98]	92	95	94	94
WBC decrease, G0-G1 [N=98;98;98;98]	6	3	4	4
WBC decrease, G0-G2 [N=98;98;98;98]	0	0	0	0
WBC decrease, G0-G3 [N=98;98;98;98]	0	0	0	0
WBC decrease, G0-G4 [N=98;98;98;98]	0	0	0	0
WBC decrease, G1-U [N=1;0;1;3]	0	0	0	0
WBC decrease, G1-G0 [N=1;0;1;3]	0	0	0	0
WBC decrease, G1-G1 [N=1;0;1;3]	1	0	0	3
WBC decrease, G1-G2 [N=1;0;1;3]	0	0	1	0
WBC decrease, G1-G3 [N=1;0;1;3]	0	0	0	0
WBC decrease, G1-G4 [N=1;0;1;3]	0	0	0	0
WBC increase, U-U [N=1;0;0;1]	0	0	0	0
WBC increase, U-G0 [N=1;0;0;1]	1	0	0	1
WBC increase, U-G1 [N=1;0;0;1]	0	0	0	0
WBC increase, U-G2 [N=1;0;0;1]	0	0	0	0
WBC increase, U-G3 [N=1;0;0;1]	0	0	0	0
WBC increase, U-G4 [N=1;0;0;1]	0	0	0	0
WBC increase, G0-U [N=99;94;96;99]	0	0	0	0
WBC increase, G0-G0 [N=99;94;96;99]	95	85	91	88
WBC increase, G0-G1 [N=99;94;96;99]	3	9	5	11
WBC increase, G0-G2 [N=99;94;96;99]	1	0	0	0
WBC increase, G0-G3 [N=99;94;96;99]	0	0	0	0
WBC increase, G0-G4 [N=99;94;96;99]	0	0	0	0
WBC increase, G1-U [N=0;4;2;2]	0	0	0	0
WBC increase, G1-G0 [N=0;4;2;2]	0	1	1	1
WBC increase, G1-G1 [N=0;4;2;2]	0	3	1	0
WBC increase, G1-G2 [N=0;4;2;2]	0	0	0	1
WBC increase, G1-G3 [N=0;4;2;2]	0	0	0	0
WBC increase, G1-G4 [N=0;4;2;2]	0	0	0	0
WBC increase, G2-U [N=0;0;1;0]	0	0	0	0
WBC increase, G2-G0 [N=0;0;1;0]	0	0	0	0
WBC increase, G2-G1 [N=0;0;1;0]	0	0	1	0
WBC increase, G2-G2 [N=0;0;1;0]	0	0	0	0
WBC increase, G2-G3 [N=0;0;1;0]	0	0	0	0
WBC increase, G2-G4 [N=0;0;1;0]	0	0	0	0

No statistical analyses for this end point

Secondary: Neutralizing antibody titers against RSV-A subtype

Top of page

End point title

Neutralizing antibody titers against RSV-A subtype

End point description

End point type

Secondary

End point timeframe

At Day 60 and Day 90

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	98	92	96	96
Units: Titers
geometric mean (confidence interval 95%)
Anti-RSV.A, Day 30 [N=98;92;96;96]	715.4 (615.8 to 831.1)	831.9 (733.0 to 944.1)	965.1 (827.7 to 1125.4)	311.6 (269.0 to 360.8)
Anti-RSV.A, Day 90 [N=98;92;95;95]	566.5 (494.9 to 648.4)	732.1 (640.2 to 837.2)	902.8 (776.4 to 1049.9)	319.6 (274.2 to 372.4)

No statistical analyses for this end point

Secondary: Neutralizing antibody titers against RSV-B subtype

Top of page

End point title

Neutralizing antibody titers against RSV-B subtype

End point description

RSV-B is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value ≥ 6 ED60.

End point type

Secondary

End point timeframe

At Day 0, Day 30, Day 60 and Day 90

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	98	95	98	100
Units: Titers
geometric mean (confidence interval 95%)
Anti-RSV.B, Day 0 [N=98;95;98;100]	385.6 (318.4 to 466.9)	392.1 (334.3 to 460.0)	410.6 (346.5 to 486.5)	340.2 (289.0 to 400.4)
Anti-RSV.B, Day 30 [N=98;94;98;100]	909.1 (778.5 to 1061.6)	1004.1 (886.5 to 1137.4)	1131.7 (987.3 to 1297.2)	357.7 (309.0 to 414.0)
Anti-RSV.B, Day 60 [N=98;92;96;96]	752.1 (646.7 to 874.6)	847.1 (746.8 to 960.9)	923.6 (813.2 to 1048.8)	409.6 (359.2 to 467.1)
Anti-RSV.B, Day 90 [N=98;92;95;95]	667.8 (572.8 to 778.7)	804.9 (699.4 to 926.3)	848.6 (731.4 to 984.7)	423.2 (359.2 to 498.6)

No statistical analyses for this end point

Secondary: Palivizumab competing antibody (PCA) concentrations

Top of page

End point title

Palivizumab competing antibody (PCA) concentrations

End point description

End point type

Secondary

End point timeframe

At Day 60 and Day 90

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	98	92	96	96
Units: µg/mL
geometric mean (confidence interval 95%)
PCA, Day 60 [N=98;92;96;96]	55.2 (48.8 to 62.5)	69.0 (62.4 to 76.4)	66.7 (58.7 to 75.8)	6.4 (5.8 to 7.1)
PCA, Day 90 [N=98;92;94;95]	47.6 (42.3 to 53.5)	57.9 (51.4 to 65.1)	57.0 (50.0 to 64.9)	7.4 (6.5 to 8.6)

No statistical analyses for this end point

Secondary: Antibody concentrations against neogenin (NEO) residual host cell protein

Top of page

End point title

Antibody concentrations against neogenin (NEO) residual host cell protein

End point description

Anti-neogenin (anti-NEO) antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in nanograms per milliliter (ng/mL), for a seropositivity cut-off value ≥ 55 ng/mL.

End point type

Secondary

End point timeframe

At Day 0 and Day 30

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	100	99	99	102
Units: ng/mL
geometric mean (confidence interval 95%)
Anti-NEO, Day 0 [N=100;99;97;102]	32.9 (29.2 to 37.1)	32.0 (28.7 to 35.7)	33.5 (29.3 to 38.3)	34.5 (30.0 to 39.5)
Anti-NEO, Day 30 [N=100;98;99;102]	32.9 (29.5 to 36.7)	31.5 (28.4 to 34.9)	33.1 (29.3 to 37.4)	34.7 (30.2 to 39.9)

No statistical analyses for this end point

Secondary: Number of subjects with any medically attended (MA) respiratory tract infections (RTIs) associated with RSV

Top of page

End point title

Number of subjects with any medically attended (MA) respiratory tract infections (RTIs) associated with RSV

End point description

MA-RSV-RTIs were defined as a visit to a health care provider for respiratory symptoms including but not limited to cough, sputum production, difficulty breathing.

End point type

Secondary

End point timeframe

From Day 0 up to study end, at Day 360

End point values	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Number of subjects analysed	100	99	99	102
Units: Participants
Participants	21	11	10	9

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

GSK3003891A vaccine formulation 1 Group

Reporting group description

Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0.

Reporting group title

GSK3003891A vaccine formulation 2 Group

Reporting group description

Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.

Reporting group title

GSK3003891A vaccine formulation 3 Group

Reporting group description

Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.

Reporting group title

Control Group

Reporting group description

Subjects in this group received a single placebo injection at Day 0.

Serious adverse events	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 100 (1.00%)	3 / 99 (3.03%)	2 / 99 (2.02%)	2 / 102 (1.96%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pancreatic carcinoma
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Hemiparesis
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Biliary colic
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pneumothorax
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Campylobacter gastroenteritis
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Peritonsillar abscess
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Soft tissue infection
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	GSK3003891A vaccine formulation 1 Group	GSK3003891A vaccine formulation 2 Group	GSK3003891A vaccine formulation 3 Group	Control Group
Total subjects affected by non serious adverse events
subjects affected / exposed	88 / 100 (88.00%)	86 / 99 (86.87%)	83 / 99 (83.84%)	76 / 102 (74.51%)
Pregnancy, puerperium and perinatal conditions
Retained placenta or membranes
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	0	0	0	1
General disorders and administration site conditions
Asthenia
subjects affected / exposed	2 / 100 (2.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	2	2	0	0
Axillary pain
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	3 / 99 (3.03%)	0 / 102 (0.00%)
occurrences all number	0	0	3	0
Chills
subjects affected / exposed	1 / 100 (1.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	1	0	0
Fatigue
subjects affected / exposed	47 / 100 (47.00%)	43 / 99 (43.43%)	45 / 99 (45.45%)	42 / 102 (41.18%)
occurrences all number	48	43	46	42
Feeling cold
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	0	0	0	1
Gait disturbance
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	0	0	1	0
Influenza like illness
subjects affected / exposed	1 / 100 (1.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	1	1	0	1
Injection site haematoma
subjects affected / exposed	0 / 100 (0.00%)	2 / 99 (2.02%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	2	0	0
Injection site haemorrhage
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	3 / 99 (3.03%)	0 / 102 (0.00%)
occurrences all number	1	0	3	0
Injection site pruritus
subjects affected / exposed	2 / 100 (2.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	2	1	0	1
Malaise
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	1	0	0
Pain
subjects affected / exposed	52 / 100 (52.00%)	52 / 99 (52.53%)	51 / 99 (51.52%)	11 / 102 (10.78%)
occurrences all number	53	52	51	12
Pyrexia
subjects affected / exposed	8 / 100 (8.00%)	8 / 99 (8.08%)	6 / 99 (6.06%)	4 / 102 (3.92%)
occurrences all number	8	8	6	4
Swelling
subjects affected / exposed	4 / 100 (4.00%)	6 / 99 (6.06%)	7 / 99 (7.07%)	0 / 102 (0.00%)
occurrences all number	4	6	7	0
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	2 / 100 (2.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	2	1	0	1
Menstrual disorder
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Ovarian cyst
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	1	0	0
Polymenorrhoea
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	0	0	1	0
Premenstrual pain
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	0	0	1	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	5 / 100 (5.00%)	2 / 99 (2.02%)	5 / 99 (5.05%)	5 / 102 (4.90%)
occurrences all number	5	2	5	5
Epistaxis
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	2	0	0
Nasal congestion
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Oropharyngeal pain
subjects affected / exposed	9 / 100 (9.00%)	4 / 99 (4.04%)	4 / 99 (4.04%)	5 / 102 (4.90%)
occurrences all number	13	4	4	5
Pneumothorax
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	0	0	0	1
Productive cough
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	1	0	0
Pulmonary mass
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	0	0	0	1
Respiratory disorder
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	0	0	1	0
Rhinitis allergic
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Rhinorrhoea
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	1	0	0
Psychiatric disorders
Insomnia
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Sleep disorder
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	1	0	0
Investigations
Haemoglobin decreased
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	0	0	1	0
Hepatic enzyme increased
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	1	0	0
Platelet count decreased
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
White blood cell count decreased
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Injury, poisoning and procedural complications
Bone contusion
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Contusion
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	1	0	0
Ligament sprain
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	1	0	0	1
Meniscus injury
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Muscle strain
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Post procedural inflammation
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Tooth fracture
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	0	0	1	0
Vaccination complication
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	0	0	0	1
Nervous system disorders
Carpal tunnel syndrome
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	1	0	0
Cervicobrachial syndrome
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	1	0	1	0
Dizziness
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	1	0	0	1
Facial neuralgia
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	1	0	0
Headache
subjects affected / exposed	54 / 100 (54.00%)	47 / 99 (47.47%)	47 / 99 (47.47%)	47 / 102 (46.08%)
occurrences all number	61	56	55	53
Hypoaesthesia
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	0	0	0	1
Intercostal neuralgia
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	0	0	0	1
Migraine
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	1 / 99 (1.01%)	1 / 102 (0.98%)
occurrences all number	0	1	2	1
Syncope
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Blood and lymphatic system disorders
Iron deficiency anaemia
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Lymphadenopathy
subjects affected / exposed	0 / 100 (0.00%)	2 / 99 (2.02%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	0	2	1	0
Neutropenia
subjects affected / exposed	1 / 100 (1.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	2 / 102 (1.96%)
occurrences all number	1	1	0	2
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	1	0	0
Vertigo
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	3 / 99 (3.03%)	0 / 102 (0.00%)
occurrences all number	0	0	4	0
Eye disorders
Blepharospasm
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	1	0	0
Vision blurred
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	0	0	1	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	1	0	1	0
Abdominal pain upper
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Constipation
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	0	0	1	0
Diarrhoea
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	2 / 102 (1.96%)
occurrences all number	0	0	0	2
Dyspepsia
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Gastric disorder
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Gastrointestinal disorder
subjects affected / exposed	22 / 100 (22.00%)	24 / 99 (24.24%)	14 / 99 (14.14%)	11 / 102 (10.78%)
occurrences all number	22	24	14	11
Nausea
subjects affected / exposed	2 / 100 (2.00%)	0 / 99 (0.00%)	2 / 99 (2.02%)	1 / 102 (0.98%)
occurrences all number	2	0	3	1
Toothache
subjects affected / exposed	0 / 100 (0.00%)	2 / 99 (2.02%)	0 / 99 (0.00%)	2 / 102 (1.96%)
occurrences all number	0	2	0	2
Vomiting
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	0	0	1	0
Dermatitis
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	0	0	0	1
Erythema
subjects affected / exposed	6 / 100 (6.00%)	10 / 99 (10.10%)	8 / 99 (8.08%)	1 / 102 (0.98%)
occurrences all number	6	10	8	1
Pruritus
subjects affected / exposed	2 / 100 (2.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	2	0	1	0
Rash
subjects affected / exposed	2 / 100 (2.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	2	0	1	0
Rash vesicular
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	0	0	1	0
Renal and urinary disorders
Dysuria
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	0	0	1	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	1	0	0
Back pain
subjects affected / exposed	4 / 100 (4.00%)	2 / 99 (2.02%)	1 / 99 (1.01%)	4 / 102 (3.92%)
occurrences all number	4	3	1	4
Bone pain
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Musculoskeletal stiffness
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	0	0	0	1
Myalgia
subjects affected / exposed	1 / 100 (1.00%)	1 / 99 (1.01%)	2 / 99 (2.02%)	0 / 102 (0.00%)
occurrences all number	1	1	2	0
Neck pain
subjects affected / exposed	1 / 100 (1.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	2	0	0
Pain in extremity
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Tendonitis
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	1 / 102 (0.98%)
occurrences all number	0	0	1	1
Infections and infestations
Bronchitis
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	0	0	1	0
Cystitis
subjects affected / exposed	1 / 100 (1.00%)	3 / 99 (3.03%)	1 / 99 (1.01%)	1 / 102 (0.98%)
occurrences all number	1	4	1	1
Gastroenteritis
subjects affected / exposed	3 / 100 (3.00%)	1 / 99 (1.01%)	1 / 99 (1.01%)	1 / 102 (0.98%)
occurrences all number	3	1	1	1
Gastroenteritis viral
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	1	0	0
Genital herpes
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Gingivitis
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	0	0	0	1
Herpes simplex
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	0	0	1	0
Infection
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Infective keratitis
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	1	0	0
Influenza
subjects affected / exposed	1 / 100 (1.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	2 / 102 (1.96%)
occurrences all number	1	1	0	2
Nasopharyngitis
subjects affected / exposed	6 / 100 (6.00%)	3 / 99 (3.03%)	4 / 99 (4.04%)	4 / 102 (3.92%)
occurrences all number	7	3	4	5
Oral herpes
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	1 / 99 (1.01%)	1 / 102 (0.98%)
occurrences all number	2	0	1	1
Pharyngitis
subjects affected / exposed	1 / 100 (1.00%)	1 / 99 (1.01%)	1 / 99 (1.01%)	0 / 102 (0.00%)
occurrences all number	1	1	1	0
Pulpitis dental
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	0	0	0	1
Rhinitis
subjects affected / exposed	13 / 100 (13.00%)	3 / 99 (3.03%)	7 / 99 (7.07%)	6 / 102 (5.88%)
occurrences all number	14	4	7	6
Salpingo-oophoritis
subjects affected / exposed	1 / 100 (1.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0	0
Sinusitis
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	2 / 102 (1.96%)
occurrences all number	0	0	0	2
Skin bacterial infection
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	1	0	0
Tonsillitis
subjects affected / exposed	0 / 100 (0.00%)	1 / 99 (1.01%)	0 / 99 (0.00%)	0 / 102 (0.00%)
occurrences all number	0	1	0	0
Upper respiratory tract infection
subjects affected / exposed	3 / 100 (3.00%)	9 / 99 (9.09%)	8 / 99 (8.08%)	1 / 102 (0.98%)
occurrences all number	3	10	8	1
Urinary tract infection
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	0	0	0	1
Vulvovaginal candidiasis
subjects affected / exposed	0 / 100 (0.00%)	0 / 99 (0.00%)	0 / 99 (0.00%)	1 / 102 (0.98%)
occurrences all number	0	0	0	1

More information

Top of page

Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase II, randomised, observer-blind, controlled, multi-country study to rank different formulations of GSK Biologicals’ investigational RSV vaccine (GSK3003891A), based on immunogenicity, reactogenicity and safety, when administered to healthy women, aged 18-45 years.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of subjects with any Grade 2 and Grade 3 general Adverse Events (AEs) - solicited and unsolicited

Primary: Number of subjects with any Grade 2 and Grade 3 general Adverse Events (AEs) - solicited and unsolicited

Primary: Number of subjects with Grade 2 and Grade 3 fever

Primary: Number of subjects with Grade 2 and Grade 3 fever

Primary: Number of subjects with related serious adverse events (SAEs)

Primary: Number of subjects with related serious adverse events (SAEs)

Primary: Neutralizing antibody titers against RSV-A subtype

Primary: Neutralizing antibody titers against RSV-A subtype

Primary: Neutralizing antibody titers against RSV-A subtype

Primary: Neutralizing antibody titers against RSV-A subtype

Primary: Palivizumab competing antibody (PCA) concentrations

Primary: Palivizumab competing antibody (PCA) concentrations

Primary: Pavilizumab competing antibody (PCA) concentrations

Primary: Pavilizumab competing antibody (PCA) concentrations

Secondary: Number of subjects with any, Grade 2, Grade 3 and medically attended solicited local AEs

Secondary: Number of subjects with any, Grade 2, Grade 3 and medically attended solicited local AEs

Secondary: Number of subjects with any, Grade 2, Grade 3, related and medically attended solicited general AEs

Secondary: Number of subjects with any, Grade 2, Grade 3, related and medically attended solicited general AEs

Secondary: Number of subjects with any unsolicited AEs

Secondary: Number of subjects with any unsolicited AEs

Secondary: Number of subjects with any SAEs

Secondary: Number of subjects with any SAEs

Secondary: Number of subjects with any biochemical and hematological laboratory abnormalities

Secondary: Number of subjects with any biochemical and hematological laboratory abnormalities

Secondary: Number of subjects with any biochemical and hematological laboratory abnormalities

Secondary: Number of subjects with any biochemical and hematological laboratory abnormalities

Secondary: Number of subjects with any biochemical and hematological laboratory abnormalities

Secondary: Number of subjects with any biochemical and hematological laboratory abnormalities

Secondary: Number of subjects with any biochemical and hematological laboratory abnormalities

Secondary: Number of subjects with any biochemical and hematological laboratory abnormalities

Secondary: Number of subjects with any biochemical and hematological laboratory abnormalities, by maximum grading

Secondary: Number of subjects with any biochemical and hematological laboratory abnormalities, by maximum grading

Secondary: Neutralizing antibody titers against RSV-A subtype

Secondary: Neutralizing antibody titers against RSV-A subtype

Secondary: Neutralizing antibody titers against RSV-B subtype

Secondary: Neutralizing antibody titers against RSV-B subtype

Secondary: Palivizumab competing antibody (PCA) concentrations

Secondary: Palivizumab competing antibody (PCA) concentrations

Secondary: Antibody concentrations against neogenin (NEO) residual host cell protein

Secondary: Antibody concentrations against neogenin (NEO) residual host cell protein

Secondary: Number of subjects with any medically attended (MA) respiratory tract infections (RTIs) associated with RSV

Secondary: Number of subjects with any medically attended (MA) respiratory tract infections (RTIs) associated with RSV

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase II, randomised, observer-blind, controlled, multi-country study to rank different formulations of GSK Biologicals’ investigational RSV vaccine (GSK3003891A), based on immunogenicity, reactogenicity and safety, when administered to healthy women, aged 18-45 years.