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A Study to Rank Different Dosages of Antigen of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A), Based on Their Immune Response and Safety, When Administered to Healthy Adult Women

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT02956837
Collaborator
(none)
406
Enrollment
8
Locations
4
Arms
14.9
Actual Duration (Months)
50.8
Patients Per Site
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to rank different RSV vaccine dosages of antigen (or formulations) based on safety/reactogenicity and immune response data. The formulations eliciting strong immune responses while maintaining an acceptable safety profile will be considered for further evaluation, including in studies vaccinating pregnant women.

Condition or Disease Intervention/Treatment Phase
  • Biological: RSV Vaccine (GSK3003891A) formulation 1
  • Biological: RSV Vaccine (GSK3003891A) formulation 2
  • Biological: RSV Vaccine (GSK3003891A) formulation 3
  • Drug: Placebo (Formulation buffer S9b)
 Phase 2

Detailed Description

The purpose of the RSV F-021 study that will be conducted in an observer-blind manner during Epoch 1 and single blinded during Epoch 2, is to rank the 3 different doses of the non-adjuvanted investigational RSV PreF-vaccine (30, 60 and 120 μg) based on safety/reactogenicity and immunogenicity data up to 1 month post-vaccination (Day 30). Non-pregnant women aged 18-45 years will be randomized in a 1:1:1:1 ratio to receive one of three dose levels (30, 60, 120 μg) of the RSV PreF vaccine or placebo. The doses eliciting strong immune responses while maintaining an acceptable safety profile will be considered for further evaluation, including in studies vaccinating pregnant women. This will allow evaluation of a wider antigen dose range to determine if there is a dose response relationship in terms of antibody response at the higher dose range that was not present at the lower range.

Since in RSV F-021 the 120ug dosage of the PreF-based investigational RSV vaccine will be tested for the first time in humans, appropriate safety monitoring is planned for this study, including pausing enrolment when the first 25% of subjects from each study group have been vaccinated until review of day 7 post-vaccination safety data by an unblinded GSK internal Safety Review Committee (iSRC) has been completed. The enrolment/vaccination of the remaining subjects can only start following the favourable outcome of this iSRC safety review.

In addition to study visits at Day 0, Day 7 and Day 30 to evaluate primary objective of the study, additional study visits are planned at Day 60 and 90 for further investigation of the immunogenicity and safety/reactogenicity profile of the formulations. A follow-up period has been set up in which the subjects will be contacted at Day 180, 270 and 360. During these contacts, the investigator (or delegate) will ask the subject if she has experienced any serious adverse events and/or any AEs leading to study withdrawal since Day 90/last contact (as applicable), as well as if she has become pregnant during the post-vaccination period. The investigator (or delegate) will also ask the subject about concomitant vaccinations/products/medications that she has received since Day 90/last contact (as applicable) and whether the she had a respiratory tract infection that needed medical attention. Contact should be preferably performed via telephone, or alternatively, if phone contact is not possible, through email/other means where the information can be fully collected.

Healthy, non-pregnant women aged 18 - 45 years will be enrolled in this study:

Women aged 18 - 45 years are selected to match the vaccine's target population, i.e. pregnant women, as closely as possible (gender, age).

Non-pregnant women are selected to avoid unnecessarily exposing a vulnerable population (pregnant women and the foetuses/children) to a higher dose of the vaccine that has not previously been studied in non-pregnant women.

Study Design

Study Type:
Interventional
Actual Enrollment :
406 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
An Observer-blind Study to Rank Different Formulations of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A) Administered to Healthy Women
Actual Study Start Date :
Nov 10, 2016
Actual Primary Completion Date :
Aug 30, 2017
Actual Study Completion Date :
Feb 5, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: GSK3003891A vaccine formulation 1 Group

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

Biological: RSV Vaccine (GSK3003891A) formulation 1
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
Experimental: GSK3003891A vaccine formulation 2 Group

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

Biological: RSV Vaccine (GSK3003891A) formulation 2
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
Experimental: GSK3003891A vaccine formulation 3 Group

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

Biological: RSV Vaccine (GSK3003891A) formulation 3
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
Placebo Comparator: Control Group

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

Drug: Placebo (Formulation buffer S9b)
A single dose of placebo is administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.

Outcome Measures

Primary Outcome Measures

  1. Number of Subjects With Any Grade 2 and Grade 3 General Adverse Events (AEs) - Solicited and Unsolicited [During the 7-day (Days 0-6) post-vaccination period]

    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).

  2. Number of Subjects With Grade 2 and Grade 3 Fever [During the 7-day (Days 0-6) post-vaccination period]

    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).

  3. Number of Subjects With Related Serious Adverse Events (SAEs) [During the 7-day (Days 0-6) post-vaccination period]

    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).

  4. Neutralizing Antibody Titers Against RSV-A Subtype [At Day 0]

    RSV-A is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value greater than or equal to (≥) 8 ED60 (Estimated Dilution 60). This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).

  5. Neutralizing Antibody Titers Against RSV-A Subtype [At Day 30]

    RSV-A is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value ≥ 8 ED60 (Estimated Dilution 60). This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).

  6. Palivizumab Competing Antibody (PCA) Concentrations [At Day 0]

    PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off ≥ 9.6 µg/mL. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).

  7. Pavilizumab Competing Antibody (PCA) Concentrations [At Day 30]

    PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off ≥ 9.6 µg/mL. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).

Secondary Outcome Measures

  1. Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs [During the 7-day (Days 0-6) post-vaccination period]

    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.

  2. Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs [During the 7-day (Days 0-6) post-vaccination period]

    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.

  3. Number of Subjects With Any Unsolicited AEs [During the 30-day (Days 0-29) post-vaccination period]

    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.

  4. Number of Subjects With Any SAEs [From Day 0 up to study end, at Day 360]

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

  5. Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities [At Day 7]

    Biochemical parameters assessed included alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine. Hematological parameters assessed included eosinophils, hemoglobin level, lymphocytes, neutrophils, platelet count and White Blood Cells [WBC]. Abnormal laboratory values at Day 7 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 7].

  6. Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities [At Day 30]

    Biochemical parameters assessed included alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine. Hematological parameters assessed included eosinophils, hemoglobin level, lymphocytes, neutrophils, platelet count and White Blood Cells [WBC]. Abnormal laboratory values at Day 30 were Below, Within and Above normal ranges, as compared to the baseline values of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 30].

  7. Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities [At Day 60]

    Biochemical parameters assessed included alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine. Hematological parameters assessed included eosinophils, hemoglobin level, lymphocytes, neutrophils, platelet count and White Blood Cells [WBC]. Abnormal laboratory values at Day 60 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 60].

  8. Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities [At Day 90]

    Biochemical parameters assessed included alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine. Hematological parameters assessed included eosinophils, hemoglobin level, lymphocytes, neutrophils, platelet count and White Blood Cells [WBC]. Abnormal laboratory values at Day 90 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 90].

  9. Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading [From Day 7 up to Day 90]

    The biochemical and hematological parameters analyzed were ALT, AST, creatinine, eosinophils increase, hemoglobin decrease, lymphocytes decrease, neutrophils decrease, platelet count decrease, WBC decrease and WBC increase, which were graded by FDA Toxicity Grading Scale. Assessed grades over the Day 7- Day 90 period were Unknown, Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening), as compared to the baseline status of the same parameters, at Day 0 (Unknown, Grade 1, Grade 2, Grade 3) [e.g. ALT Grade 0 - Unknown = ALT Grade 0 at baseline versus Unknown grade from Day 7 up to Day 90].

  10. Neutralizing Antibody Titers Against RSV-A Subtype [At Day 60 and Day 90]

    RSV-A is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value ≥ 8 ED60.

  11. Neutralizing Antibody Titers Against RSV-B Subtype [At Day 0, Day 30, Day 60 and Day 90]

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

  12. Palivizumab Competing Antibody (PCA) Concentrations [At Day 60 and Day 90]

    PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off value ≥ 9.6 µg/mL.

  13. Antibody Concentrations Against Neogenin (NEO) Residual Host Cell Protein [At Day 0 and Day 30]

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

  14. Number of Subjects With Any Medically Attended (MA) Respiratory Tract Infections (RTIs) Associated With RSV [From Day 0 up to study end, at Day 360]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

  • Written informed consent obtained from the subject prior to performance of any study specific procedure.

  • Non-pregnant female between, and including, 18 and 45 years of age at the time of study vaccination.

  • Healthy subjects as established by medical history and clinical examination before entering into the study.

  • Female subjects of non-childbearing potential may be enrolled in the study

  • Non-childbearing potential is defined as pre-menarche, hysterectomy, ovariectomy or post-menopause.

  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

  • Has practiced adequate contraception for 30 days prior to study vaccination, and

  • Has a negative pregnancy test on the day of study vaccination, and

  • Has agreed to continue adequate contraception up to 90 days after vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccines within 30 days prior to study vaccination, or planned use during the study period.

  • Concurrently participating in the active phase of another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.

  • Chronic administration of immunosuppressants or other immune-modifying drugs, as well as administration of long-acting immune-modifying drugs, within 6 months prior to study vaccination, or planned administration until 90 days post-vaccination. For corticosteroids, this will mean prednisone ≥ 10 mg/day, or equivalent. Inhaled and topical steroids are allowed.

  • Administration of immunoglobulins and/or any blood products during the period starting 3 months before the study vaccination, or planned administration until 90 days post-vaccination.

  • Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before or after study vaccination.

  • Previous experimental vaccination against RSV.

  • History of any neurological disorders or seizures.

  • Family history of congenital or hereditary immunodeficiency.

  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination

  • History of or current autoimmune disease

  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by physical examination and/or Medical History.

  • Lymphoproliferative disorder or malignancy within previous 5 years.

  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.

  • Hypersensitivity to latex.

  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.

  • Current alcohol and/or drug abuse.

  • Acute disease and/or fever at the time of enrolment.

  • Fever is defined as temperature ≥37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route.

  • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.

  • For subjects with acute disease and/or fever at the time of enrolment, Visit 1/Day 0 will be rescheduled within the allowed recruitment period.

  • Body mass index (BMI) > 40 kg/m².

  • Pregnant or lactating female.

  • Planned move to a location that will prohibit participating in the trial until study conclusion.

  • Any other condition that the investigator judges may interfere with study procedures or findings.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Gent Belgium 9000
2 GSK Investigational Site Tallinn Estonia 10117
3 GSK Investigational Site Tartu Estonia 50106
4 GSK Investigational Site Clermont-Ferrand France 63003
5 GSK Investigational Site Paris France 75679
6 GSK Investigational Site Wuerzburg Bayern Germany 97070
7 GSK Investigational Site Hannover Niedersachsen Germany 30159
8 GSK Investigational Site Goch Nordrhein-Westfalen Germany 47574

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02956837
Other Study ID Numbers:
  • 204812
  • 2016-001135-12
First Posted:
Nov 6, 2016
Last Update Posted:
Jul 2, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Vaccines
Respiratory Syncytial Viruses
Safety
Reactogenicity
Ranking of Formulations
Immunogenicity
Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Vaccines

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail Out of 406 subjects initially enrolled in the study, 6 subjects had numbers allocated but did not receive any study vaccine dose, hence only 400 subjects were included in the Total Vaccinated Cohort.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60 µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120 µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Period Title: Overall Study
STARTED 100 99 99 102
COMPLETED 100 96 97 99
NOT COMPLETED 0 3 2 3

Baseline Characteristics

Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group Total
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0. Total of all reporting groups
Overall Participants 100 99 99 102 400
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
30.2
(6.7)
29.1
(7.2)
29.6
(7.1)
29.9
(6.9)
29.7
(7.0)
Sex: Female, Male (Count of Participants)
Female
100
100%
99
100%
99
100%
102
100%
400
100%
Male
0
0%
0
0%
0
0%
0
0%
0
0%
Race/Ethnicity, Customized (Count of Participants)
African Heritage/African American
1
1%
0
0%
2
2%
1
1%
4
1%
Asian - Central/South Asian Heritage
1
1%
1
1%
0
0%
0
0%
2
0.5%
Asian - East Asian Heritage
0
0%
0
0%
1
1%
0
0%
1
0.3%
Asian - South East Asian Heritage
0
0%
0
0%
0
0%
1
1%
1
0.3%
White - Arabic/North African Heritage
0
0%
1
1%
2
2%
1
1%
4
1%
White - Caucasian/European Heritage
96
96%
97
98%
93
93.9%
98
96.1%
384
96%
Unspecified
2
2%
0
0%
1
1%
1
1%
4
1%

Outcome Measures

1. Primary Outcome
Title Number of Subjects With Any Grade 2 and Grade 3 General Adverse Events (AEs) - Solicited and Unsolicited
Description Assessed solicited general AEs were fatigue, gastrointestinal symptoms [nausea, vomiting, diarrhea and/or abdominal pain], fever and headache. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.Grade 2 symptoms = occurrence of symptoms discomforting enough to interfere with daily activities. Grade 3 symptoms = symptoms that prevented normal activities. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Time Frame During the 7-day (Days 0-6) post-vaccination period

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 100 99 99 102
Count of Participants [Participants]
32
32%
30
30.3%
24
24.2%
27
26.5%
2. Primary Outcome
Title Number of Subjects With Grade 2 and Grade 3 Fever
Description Grade 2 Fever was defined as oral temperature above (>) 38.5 degrees Celsius (°C) to less than or equal to (≤) 39.5°C. Grade 3 Fever was defined as oral temperature > 39.5°C. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Time Frame During the 7-day (Days 0-6) post-vaccination period

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptom sheets filled in.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 100 98 99 102
Grade 2 Fever
0
0%
2
2%
1
1%
0
0%
Grade 3 Fever
0
0%
1
1%
0
0%
0
0%
3. Primary Outcome
Title Number of Subjects With Related Serious Adverse Events (SAEs)
Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAEs = SAEs assessed by the investigator as related to the vaccination. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Time Frame During the 7-day (Days 0-6) post-vaccination period

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 100 99 99 102
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
4. Primary Outcome
Title Neutralizing Antibody Titers Against RSV-A Subtype
Description RSV-A is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value greater than or equal to (≥) 8 ED60 (Estimated Dilution 60). This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Time Frame At Day 0

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 30, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay at Day 0.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 98 95 98 100
Geometric Mean (95% Confidence Interval) [Titers]
228.8
249.5
285.7
247.1
5. Primary Outcome
Title Neutralizing Antibody Titers Against RSV-A Subtype
Description RSV-A is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value ≥ 8 ED60 (Estimated Dilution 60). This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Time Frame At Day 30

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 30, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay at Day 30.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 98 94 98 100
Geometric Mean (95% Confidence Interval) [Titers]
858.2
1114.8
1245.5
271.6
6. Primary Outcome
Title Palivizumab Competing Antibody (PCA) Concentrations
Description PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off ≥ 9.6 µg/mL. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Time Frame At Day 0

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 30, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay at Day 0.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 98 94 96 100
Geometric Mean (95% Confidence Interval) [µg/mL]
5.7
5.6
5.8
6.0
7. Primary Outcome
Title Pavilizumab Competing Antibody (PCA) Concentrations
Description PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off ≥ 9.6 µg/mL. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).
Time Frame At Day 30

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 30, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay at Day 30.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 98 94 98 100
Geometric Mean (95% Confidence Interval) [µg/mL]
66.8
81.2
83.7
6.1
8. Secondary Outcome
Title Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs
Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 2 pain = painful when limb was moved and that interfered with every day activities.Grade 3 pain = significant pain at rest, pain that prevented normal every day activity. Grade 2 redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) and up to (and including) 100 mm of injection site.Grade 3 redness/swelling = redness/swelling > 100 mm of injection site. Medically attended symptoms = occurrence of symptoms that required medical advice.
Time Frame During the 7-day (Days 0-6) post-vaccination period

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptom sheets filled in.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 100 98 99 102
Any Pain
52
52%
52
52.5%
51
51.5%
11
10.8%
Grade 2 Pain
5
5%
5
5.1%
10
10.1%
1
1%
Grade 3 Pain
1
1%
0
0%
1
1%
0
0%
Medically-attended Pain
0
0%
0
0%
0
0%
0
0%
Any Redness (mm)
6
6%
10
10.1%
8
8.1%
1
1%
Grade 2 Redness (mm)
2
2%
2
2%
1
1%
0
0%
Grade 3 Redness
0
0%
0
0%
0
0%
0
0%
Medically-attended Redness (mm)
0
0%
0
0%
0
0%
0
0%
Any Swelling (mm)
4
4%
6
6.1%
7
7.1%
0
0%
Grade 2 Swelling (mm)
1
1%
0
0%
0
0%
0
0%
Grade 3 Swelling (mm)
0
0%
1
1%
0
0%
0
0%
Medically-attended Swelling (mm)
0
0%
0
0%
0
0%
0
0%
9. Secondary Outcome
Title Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
Description Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (which include nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 2 symptoms = occurrence of symptoms discomforting enough to interfere with daily activities. Grade 3 symptoms = symptoms that prevented normal activities.Related = symptom assessed by the investigator as related to the vaccination. Medically attended symptom = occurrence of symptom that required medical advice.
Time Frame During the 7-day (Days 0-6) post-vaccination period

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptom sheets filled in.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 100 98 99 102
Any Fatigue
47
47%
43
43.4%
45
45.5%
42
41.2%
Grade 2 Fatigue
9
9%
14
14.1%
8
8.1%
12
11.8%
Grade 3 Fatigue
3
3%
3
3%
2
2%
1
1%
Related Fatigue
37
37%
29
29.3%
36
36.4%
33
32.4%
Medically-attended Fatigue
0
0%
1
1%
1
1%
0
0%
Any Gastrointestinal symptoms
20
20%
23
23.2%
14
14.1%
11
10.8%
Grade 2 Gastrointestinal symptoms
4
4%
3
3%
1
1%
1
1%
Grade 3 Gastrointestinal symptoms
1
1%
2
2%
0
0%
1
1%
Related Gastrointestinal symptoms
13
13%
17
17.2%
10
10.1%
7
6.9%
Medically-attended Gastrointestinal symptoms
0
0%
0
0%
0
0%
0
0%
Any Headache
47
47%
42
42.4%
41
41.4%
37
36.3%
Grade 2 Headache
11
11%
11
11.1%
12
12.1%
10
9.8%
Grade 3 Headache
3
3%
2
2%
1
1%
3
2.9%
Related Headache
30
30%
27
27.3%
33
33.3%
29
28.4%
Medically-attended Headache
0
0%
1
1%
1
1%
0
0%
Any Temperature/(Oral) (°C)
8
8%
8
8.1%
6
6.1%
4
3.9%
Related Temperature/(Oral) (°C)
5
5%
1
1%
6
6.1%
2
2%
Medically-attended Temperature/(Oral) (°C)
0
0%
3
3%
1
1%
0
0%
10. Secondary Outcome
Title Number of Subjects With Any Unsolicited AEs
Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame During the 30-day (Days 0-29) post-vaccination period

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 100 99 99 102
Count of Participants [Participants]
55
55%
52
52.5%
46
46.5%
49
48%
11. Secondary Outcome
Title Number of Subjects With Any SAEs
Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame From Day 0 up to study end, at Day 360

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 100 99 99 102
Count of Participants [Participants]
1
1%
3
3%
2
2%
2
2%
12. Secondary Outcome
Title Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Description Biochemical parameters assessed included alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine. Hematological parameters assessed included eosinophils, hemoglobin level, lymphocytes, neutrophils, platelet count and White Blood Cells [WBC]. Abnormal laboratory values at Day 7 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 7].
Time Frame At Day 7

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 7.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 100 98 99 102
Below
Within
Above
Below
0
0%
0
0%
0
0%
0
0%
Within
99
99%
97
98%
99
100%
102
100%
Above
0
0%
0
0%
0
0%
0
0%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
Within
Above
Below
0
0%
0
0%
0
0%
0
0%
Within
99
99%
97
98%
98
99%
100
98%
Above
0
0%
0
0%
1
1%
0
0%
Below
0
0%
0
0%
0
0%
Within
1
1%
1
1%
1
1%
Above
0
0%
0
0%
0
0%
Below
2
2%
3
3%
2
2%
0
0%
Within
4
4%
2
2%
0
0%
2
2%
Above
0
0%
0
0%
0
0%
0
0%
Below
1
1%
2
2%
4
4%
0
0%
Within
92
92%
90
90.9%
93
93.9%
99
97.1%
Above
0
0%
0
0%
0
0%
0
0%
Below
0
0%
0
0%
0
0%
Within
0
0%
1
1%
0
0%
Above
1
1%
0
0%
1
1%
Below
0
0%
0
0%
0
0%
0
0%
Within
1
1%
1
1%
1
1%
1
1%
Above
0
0%
0
0%
0
0%
0
0%
Below
5
5%
5
5.1%
3
3%
6
5.9%
Within
7
7%
3
3%
7
7.1%
2
2%
Above
0
0%
0
0%
0
0%
0
0%
Below
3
3%
2
2%
4
4%
5
4.9%
Within
77
77%
84
84.8%
79
79.8%
81
79.4%
Above
1
1%
0
0%
0
0%
3
2.9%
Below
0
0%
Within
1
1%
Above
1
1%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
12
12%
7
7.1%
7
7.1%
7
6.9%
Within
8
8%
4
4%
1
1%
4
3.9%
Above
0
0%
0
0%
0
0%
0
0%
Below
4
4%
1
1%
7
7.1%
2
2%
Within
74
74%
84
84.8%
84
84.8%
88
86.3%
Above
1
1%
0
0%
0
0%
0
0%
Below
0
0%
Within
1
1%
Above
1
1%
Below
0
0%
0
0%
0
0%
0
0%
Within
1
1%
1
1%
1
1%
1
1%
Above
0
0%
0
0%
0
0%
0
0%
Below
0
0%
1
1%
Within
1
1%
0
0%
Above
0
0%
0
0%
Below
1
1%
0
0%
0
0%
0
0%
Within
92
92%
93
93.9%
92
92.9%
94
92.2%
Above
0
0%
0
0%
1
1%
2
2%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
0
0%
0
0%
1
1%
0
0%
Within
1
1%
1
1%
0
0%
1
1%
Above
0
0%
0
0%
0
0%
0
0%
Below
2
2%
0
0%
1
1%
Within
2
2%
1
1%
2
2%
Above
0
0%
0
0%
0
0%
Below
2
2%
6
6.1%
4
4%
8
7.8%
Within
88
88%
81
81.8%
86
86.9%
82
80.4%
Above
1
1%
2
2%
0
0%
3
2.9%
Below
0
0%
0
0%
0
0%
Within
4
4%
3
3%
1
1%
Above
0
0%
0
0%
0
0%
Below
0
0%
0
0%
0
0%
Within
2
2%
2
2%
1
1%
Above
0
0%
0
0%
0
0%
Below
Within
Above
Below
1
1%
1
1%
0
0%
0
0%
Within
93
93%
95
96%
99
100%
100
98%
Above
1
1%
0
0%
0
0%
0
0%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
2
2%
0
0%
2
2%
Within
1
1%
1
1%
3
3%
Above
0
0%
0
0%
0
0%
Below
4
4%
4
4%
1
1%
4
3.9%
Within
90
90%
87
87.9%
92
92.9%
87
85.3%
Above
1
1%
2
2%
1
1%
3
2.9%
Below
0
0%
0
0%
0
0%
Within
3
3%
3
3%
1
1%
Above
1
1%
0
0%
0
0%
13. Secondary Outcome
Title Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Description Biochemical parameters assessed included alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine. Hematological parameters assessed included eosinophils, hemoglobin level, lymphocytes, neutrophils, platelet count and White Blood Cells [WBC]. Abnormal laboratory values at Day 30 were Below, Within and Above normal ranges, as compared to the baseline values of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 30].
Time Frame At Day 30

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 30.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 99 98 99 102
Below
Within
Above
Below
0
0%
0
0%
0
0%
0
0%
Within
93
93%
97
98%
96
97%
101
99%
Above
3
3%
0
0%
3
3%
1
1%
Below
0
0%
0
0%
Within
1
1%
0
0%
Above
0
0%
1
1%
Below
Within
Above
Below
0
0%
0
0%
0
0%
0
0%
Within
94
94%
97
98%
97
98%
100
98%
Above
2
2%
0
0%
2
2%
1
1%
Below
0
0%
0
0%
0
0%
Within
1
1%
0
0%
1
1%
Above
0
0%
1
1%
0
0%
Below
1
1%
2
2%
2
2%
2
2%
Within
5
5%
3
3%
0
0%
0
0%
Above
0
0%
0
0%
0
0%
0
0%
Below
1
1%
0
0%
3
3%
2
2%
Within
89
89%
91
91.9%
93
93.9%
97
95.1%
Above
0
0%
1
1%
1
1%
0
0%
Below
0
0%
0
0%
0
0%
Within
1
1%
0
0%
1
1%
Above
0
0%
1
1%
0
0%
Below
0
0%
1
1%
0
0%
0
0%
Within
1
1%
0
0%
1
1%
1
1%
Above
0
0%
0
0%
0
0%
0
0%
Below
5
5%
4
4%
4
4%
4
3.9%
Within
7
7%
4
4%
7
7.1%
4
3.9%
Above
0
0%
0
0%
0
0%
0
0%
Below
3
3%
6
6.1%
8
8.1%
7
6.9%
Within
80
80%
82
82.8%
75
75.8%
83
81.4%
Above
1
1%
0
0%
3
3%
0
0%
Below
0
0%
Within
1
1%
Above
1
1%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
13
13%
6
6.1%
6
6.1%
7
6.9%
Within
7
7%
5
5.1%
2
2%
4
3.9%
Above
0
0%
0
0%
0
0%
0
0%
Below
2
2%
4
4%
5
5.1%
3
2.9%
Within
76
76%
79
79.8%
86
86.9%
87
85.3%
Above
0
0%
1
1%
0
0%
0
0%
Below
0
0%
Within
1
1%
Above
1
1%
Below
0
0%
0
0%
0
0%
0
0%
Within
1
1%
1
1%
1
1%
1
1%
Above
0
0%
0
0%
0
0%
0
0%
Below
0
0%
1
1%
Within
1
1%
0
0%
Above
0
0%
0
0%
Below
1
1%
0
0%
0
0%
0
0%
Within
94
94%
94
94.9%
97
98%
95
93.1%
Above
1
1%
1
1%
0
0%
2
2%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
0
0%
0
0%
0
0%
0
0%
Within
1
1%
1
1%
1
1%
1
1%
Above
0
0%
0
0%
0
0%
0
0%
Below
1
1%
0
0%
0
0%
Within
3
3%
1
1%
3
3%
Above
0
0%
0
0%
0
0%
Below
4
4%
1
1%
1
1%
3
2.9%
Within
88
88%
88
88.9%
92
92.9%
88
86.3%
Above
2
2%
2
2%
1
1%
3
2.9%
Below
0
0%
0
0%
0
0%
Within
3
3%
3
3%
1
1%
Above
1
1%
0
0%
0
0%
Below
0
0%
0
0%
0
0%
Within
2
2%
2
2%
1
1%
Above
0
0%
0
0%
0
0%
Below
Within
Above
Below
0
0%
0
0%
0
0%
0
0%
Within
92
92%
94
94.9%
99
100%
99
97.1%
Above
2
2%
1
1%
0
0%
1
1%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
2
2%
1
1%
0
0%
Within
1
1%
1
1%
4
4%
Above
0
0%
0
0%
0
0%
Below
3
3%
1
1%
3
3%
0
0%
Within
90
90%
89
89.9%
90
90.9%
90
88.2%
Above
2
2%
3
3%
1
1%
5
4.9%
Below
0
0%
0
0%
0
0%
Within
2
2%
2
2%
1
1%
Above
2
2%
1
1%
0
0%
14. Secondary Outcome
Title Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Description Biochemical parameters assessed included alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine. Hematological parameters assessed included eosinophils, hemoglobin level, lymphocytes, neutrophils, platelet count and White Blood Cells [WBC]. Abnormal laboratory values at Day 60 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 60].
Time Frame At Day 60

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 60.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 100 96 98 101
Below
Within
Above
Below
0
0%
0
0%
0
0%
0
0%
Within
98
98%
95
96%
98
99%
101
99%
Above
0
0%
0
0%
0
0%
0
0%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
Within
Above
Below
0
0%
0
0%
0
0%
0
0%
Within
98
98%
95
96%
97
98%
100
98%
Above
0
0%
0
0%
1
1%
0
0%
Below
0
0%
0
0%
0
0%
Within
1
1%
1
1%
1
1%
Above
0
0%
0
0%
0
0%
Below
0
0%
3
3%
2
2%
2
2%
Within
6
6%
2
2%
0
0%
0
0%
Above
0
0%
0
0%
0
0%
0
0%
Below
2
2%
3
3%
3
3%
6
5.9%
Within
89
89%
87
87.9%
93
93.9%
91
89.2%
Above
1
1%
0
0%
0
0%
1
1%
Below
0
0%
0
0%
0
0%
Within
1
1%
1
1%
1
1%
Above
0
0%
0
0%
0
0%
Below
0
0%
0
0%
0
0%
Within
1
1%
1
1%
1
1%
Above
0
0%
0
0%
0
0%
Below
5
5%
2
2%
4
4%
5
4.9%
Within
7
7%
6
6.1%
6
6.1%
4
3.9%
Above
0
0%
0
0%
0
0%
0
0%
Below
6
6%
4
4%
5
5.1%
7
6.9%
Within
77
77%
82
82.8%
77
77.8%
81
79.4%
Above
2
2%
1
1%
3
3%
3
2.9%
Below
0
0%
Within
0
0%
Above
2
2%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
13
13%
6
6.1%
5
5.1%
8
7.8%
Within
7
7%
5
5.1%
3
3%
3
2.9%
Above
0
0%
0
0%
0
0%
0
0%
Below
5
5%
4
4%
6
6.1%
7
6.9%
Within
74
74%
78
78.8%
84
84.8%
81
79.4%
Above
0
0%
0
0%
0
0%
1
1%
Below
0
0%
Within
1
1%
Above
1
1%
Below
0
0%
0
0%
0
0%
Within
1
1%
1
1%
1
1%
Above
0
0%
0
0%
0
0%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
1
1%
0
0%
1
1%
0
0%
Within
96
96%
94
94.9%
93
93.9%
96
94.1%
Above
0
0%
0
0%
1
1%
3
2.9%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
0
0%
0
0%
0
0%
Within
1
1%
1
1%
1
1%
Above
0
0%
0
0%
0
0%
Below
0
0%
0
0%
1
1%
Within
4
4%
1
1%
2
2%
Above
0
0%
0
0%
0
0%
Below
4
4%
4
4%
4
4%
4
3.9%
Within
89
89%
84
84.8%
88
88.9%
89
87.3%
Above
2
2%
2
2%
0
0%
3
2.9%
Below
0
0%
0
0%
0
0%
Within
4
4%
3
3%
1
1%
Above
0
0%
0
0%
0
0%
Below
0
0%
0
0%
0
0%
Within
2
2%
2
2%
1
1%
Above
0
0%
0
0%
0
0%
Below
Within
Above
Below
0
0%
0
0%
1
1%
0
0%
Within
93
93%
92
92.9%
97
98%
98
96.1%
Above
1
1%
1
1%
0
0%
1
1%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
1
1%
2
2%
3
3%
Within
2
2%
0
0%
2
2%
Above
0
0%
0
0%
0
0%
Below
2
2%
1
1%
2
2%
1
1%
Within
92
92%
86
86.9%
90
90.9%
87
85.3%
Above
2
2%
4
4%
1
1%
6
5.9%
Below
0
0%
0
0%
0
0%
Within
3
3%
2
2%
1
1%
Above
1
1%
1
1%
0
0%
15. Secondary Outcome
Title Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
Description Biochemical parameters assessed included alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine. Hematological parameters assessed included eosinophils, hemoglobin level, lymphocytes, neutrophils, platelet count and White Blood Cells [WBC]. Abnormal laboratory values at Day 90 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 90].
Time Frame At Day 90

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 90.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 100 97 97 99
Below
Within
Above
Below
0
0%
0
0%
0
0%
0
0%
Within
98
98%
95
96%
97
98%
99
97.1%
Above
1
1%
0
0%
0
0%
0
0%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
Within
Above
Below
0
0%
0
0%
0
0%
0
0%
Within
99
99%
95
96%
97
98%
98
96.1%
Above
0
0%
0
0%
0
0%
0
0%
Below
0
0%
0
0%
0
0%
Within
1
1%
1
1%
1
1%
Above
0
0%
0
0%
0
0%
Below
1
1%
2
2%
2
2%
2
2%
Within
5
5%
3
3%
0
0%
0
0%
Above
0
0%
0
0%
0
0%
0
0%
Below
3
3%
2
2%
4
4%
3
2.9%
Within
90
90%
88
88.9%
91
91.9%
92
90.2%
Above
0
0%
0
0%
0
0%
1
1%
Below
0
0%
0
0%
0
0%
Within
1
1%
0
0%
1
1%
Above
0
0%
1
1%
0
0%
Below
0
0%
0
0%
0
0%
0
0%
Within
1
1%
1
1%
1
1%
1
1%
Above
0
0%
0
0%
0
0%
0
0%
Below
6
6%
2
2%
4
4%
4
3.9%
Within
6
6%
6
6.1%
7
7.1%
5
4.9%
Above
0
0%
0
0%
0
0%
0
0%
Below
6
6%
5
5.1%
8
8.1%
9
8.8%
Within
76
76%
81
81.8%
70
70.7%
80
78.4%
Above
2
2%
1
1%
2
2%
0
0%
Below
0
0%
Within
2
2%
Above
0
0%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
11
11%
5
5.1%
6
6.1%
7
6.9%
Within
9
9%
6
6.1%
1
1%
4
3.9%
Above
0
0%
0
0%
0
0%
0
0%
Below
4
4%
3
3%
4
4%
5
4.9%
Within
75
75%
81
81.8%
84
84.8%
82
80.4%
Above
0
0%
0
0%
1
1%
0
0%
Below
0
0%
Within
1
1%
Above
1
1%
Below
0
0%
0
0%
0
0%
0
0%
Within
1
1%
1
1%
1
1%
1
1%
Above
0
0%
0
0%
0
0%
0
0%
Below
0
0%
1
1%
Within
1
1%
0
0%
Above
0
0%
0
0%
Below
1
1%
0
0%
1
1%
1
1%
Within
95
95%
93
93.9%
90
90.9%
95
93.1%
Above
0
0%
1
1%
0
0%
1
1%
Below
0
0%
0
0%
Within
1
1%
0
0%
Above
0
0%
1
1%
Below
0
0%
0
0%
0
0%
0
0%
Within
1
1%
1
1%
1
1%
1
1%
Above
0
0%
0
0%
0
0%
0
0%
Below
2
2%
0
0%
1
1%
Within
2
2%
1
1%
2
2%
Above
0
0%
0
0%
0
0%
Below
3
3%
5
5.1%
2
2%
1
1%
Within
89
89%
83
83.8%
86
86.9%
91
89.2%
Above
2
2%
2
2%
0
0%
2
2%
Below
0
0%
0
0%
0
0%
Within
4
4%
3
3%
0
0%
Above
0
0%
0
0%
1
1%
Below
1
1%
0
0%
0
0%
Within
2
2%
2
2%
1
1%
Above
0
0%
0
0%
0
0%
Below
Within
Above
Below
0
0%
1
1%
0
0%
0
0%
Within
91
91%
91
91.9%
95
96%
95
93.1%
Above
3
3%
2
2%
1
1%
0
0%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
0
0%
0
0%
Within
1
1%
1
1%
Above
0
0%
0
0%
Below
1
1%
1
1%
1
1%
Within
2
2%
1
1%
4
4%
Above
0
0%
0
0%
0
0%
Below
2
2%
1
1%
1
1%
0
0%
Within
91
91%
89
89.9%
89
89.9%
89
87.3%
Above
3
3%
3
3%
1
1%
3
2.9%
Below
0
0%
0
0%
0
0%
Within
3
3%
3
3%
0
0%
Above
1
1%
0
0%
1
1%
16. Secondary Outcome
Title Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
Description The biochemical and hematological parameters analyzed were ALT, AST, creatinine, eosinophils increase, hemoglobin decrease, lymphocytes decrease, neutrophils decrease, platelet count decrease, WBC decrease and WBC increase, which were graded by FDA Toxicity Grading Scale. Assessed grades over the Day 7- Day 90 period were Unknown, Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening), as compared to the baseline status of the same parameters, at Day 0 (Unknown, Grade 1, Grade 2, Grade 3) [e.g. ALT Grade 0 - Unknown = ALT Grade 0 at baseline versus Unknown grade from Day 7 up to Day 90].
Time Frame From Day 7 up to Day 90

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, during the considered period.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 100 98 99 102
Unknown
0
0%
0
0%
0
0%
0
0%
Grade 0
96
96%
97
98%
96
97%
101
99%
Grade 1
2
2%
0
0%
3
3%
1
1%
Grade 2
0
0%
0
0%
0
0%
0
0%
Grade 3
1
1%
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
0
0%
Unknown
0
0%
Grade 0
1
1%
Grade 1
0
0%
Grade 2
0
0%
Grade 3
0
0%
Grade 4
0
0%
Unknown
0
0%
Grade 0
0
0%
Grade 1
0
0%
Grade 2
1
1%
Grade 3
0
0%
Grade 4
0
0%
Unknown
0
0%
0
0%
0
0%
0
0%
Grade 0
98
98%
97
98%
97
98%
101
99%
Grade 1
0
0%
0
0%
2
2%
0
0%
Grade 2
1
1%
0
0%
0
0%
0
0%
Grade 3
0
0%
0
0%
0
0%
0
0%
Grade 4
1
1%
0
0%
0
0%
0
0%
Unknown
0
0%
0
0%
Grade 0
0
0%
1
1%
Grade 1
0
0%
0
0%
Grade 2
1
1%
0
0%
Grade 3
0
0%
0
0%
Grade 4
0
0%
0
0%
Unknown
0
0%
0
0%
0
0%
0
0%
Grade 0
100
100%
98
99%
99
100%
102
100%
Grade 1
0
0%
0
0%
0
0%
0
0%
Grade 2
0
0%
0
0%
0
0%
0
0%
Grade 3
0
0%
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
0
0%
Unknown
0
0%
0
0%
0
0%
0
0%
Grade 0
1
1%
1
1%
1
1%
1
1%
Grade 1
0
0%
0
0%
0
0%
0
0%
Grade 2
0
0%
0
0%
0
0%
0
0%
Grade 3
0
0%
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
0
0%
Unknown
0
0%
0
0%
0
0%
0
0%
Grade 0
94
94%
96
97%
95
96%
99
97.1%
Grade 1
3
3%
1
1%
3
3%
2
2%
Grade 2
0
0%
0
0%
0
0%
0
0%
Grade 3
0
0%
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
0
0%
Unknown
0
0%
Grade 0
0
0%
Grade 1
1
1%
Grade 2
0
0%
Grade 3
0
0%
Grade 4
0
0%
Unknown
0
0%
Grade 0
0
0%
Grade 1
0
0%
Grade 2
1
1%
Grade 3
0
0%
Grade 4
0
0%
Unknown
0
0%
0
0%
Grade 0
1
1%
1
1%
Grade 1
0
0%
0
0%
Grade 2
0
0%
0
0%
Grade 3
0
0%
0
0%
Grade 4
0
0%
0
0%
Unknown
0
0%
0
0%
0
0%
0
0%
Grade 0
61
61%
74
74.7%
73
73.7%
74
72.5%
Grade 1
14
14%
12
12.1%
15
15.2%
13
12.7%
Grade 2
2
2%
0
0%
0
0%
1
1%
Grade 3
1
1%
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
0
0%
Unknown
0
0%
0
0%
0
0%
0
0%
Grade 0
3
3%
2
2%
2
2%
0
0%
Grade 1
11
11%
9
9.1%
5
5.1%
10
9.8%
Grade 2
5
5%
1
1%
2
2%
2
2%
Grade 3
0
0%
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
0
0%
Unknown
0
0%
0
0%
0
0%
Grade 0
0
0%
0
0%
0
0%
Grade 1
0
0%
1
1%
0
0%
Grade 2
1
1%
1
1%
1
1%
Grade 3
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
Unknown
0
0%
Grade 0
0
0%
Grade 1
0
0%
Grade 2
1
1%
Grade 3
0
0%
Grade 4
0
0%
Unknown
0
0%
0
0%
0
0%
0
0%
Grade 0
1
1%
1
1%
1
1%
1
1%
Grade 1
0
0%
0
0%
0
0%
0
0%
Grade 2
0
0%
0
0%
0
0%
0
0%
Grade 3
0
0%
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
0
0%
Unknown
0
0%
0
0%
0
0%
0
0%
Grade 0
90
90%
97
98%
93
93.9%
99
97.1%
Grade 1
5
5%
0
0%
4
4%
1
1%
Grade 2
1
1%
0
0%
0
0%
0
0%
Grade 3
0
0%
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
0
0%
Unknown
0
0%
0
0%
Grade 0
1
1%
1
1%
Grade 1
1
1%
0
0%
Grade 2
0
0%
0
0%
Grade 3
0
0%
0
0%
Grade 4
0
0%
0
0%
Unknown
0
0%
0
0%
Grade 0
0
0%
0
0%
Grade 1
1
1%
1
1%
Grade 2
0
0%
0
0%
Grade 3
0
0%
0
0%
Grade 4
0
0%
0
0%
Unknown
0
0%
0
0%
0
0%
0
0%
Grade 0
1
1%
1
1%
0
0%
1
1%
Grade 1
0
0%
0
0%
1
1%
0
0%
Grade 2
0
0%
0
0%
0
0%
0
0%
Grade 3
0
0%
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
0
0%
Unknown
0
0%
0
0%
0
0%
0
0%
Grade 0
80
80%
70
70.7%
82
82.8%
82
80.4%
Grade 1
10
10%
20
20.2%
11
11.1%
8
7.8%
Grade 2
3
3%
5
5.1%
2
2%
5
4.9%
Grade 3
1
1%
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
0
0%
Unknown
0
0%
0
0%
0
0%
0
0%
Grade 0
0
0%
1
1%
3
3%
2
2%
Grade 1
1
1%
0
0%
0
0%
1
1%
Grade 2
1
1%
0
0%
0
0%
1
1%
Grade 3
0
0%
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
0
0%
Unknown
0
0%
0
0%
0
0%
Grade 0
0
0%
0
0%
0
0%
Grade 1
1
1%
1
1%
1
1%
Grade 2
2
2%
0
0%
1
1%
Grade 3
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
Unknown
1
1%
0
0%
0
0%
Grade 0
2
2%
2
2%
1
1%
Grade 1
0
0%
0
0%
0
0%
Grade 2
0
0%
0
0%
0
0%
Grade 3
1
1%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
Unknown
0
0%
0
0%
0
0%
0
0%
Grade 0
94
94%
94
94.9%
97
98%
100
98%
Grade 1
1
1%
1
1%
1
1%
1
1%
Grade 2
1
1%
0
0%
1
1%
0
0%
Grade 3
0
0%
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
0
0%
Unknown
0
0%
Grade 0
0
0%
Grade 1
1
1%
Grade 2
0
0%
Grade 3
0
0%
Grade 4
0
0%
Unknown
0
0%
0
0%
Grade 0
1
1%
1
1%
Grade 1
0
0%
0
0%
Grade 2
0
0%
0
0%
Grade 3
0
0%
0
0%
Grade 4
0
0%
0
0%
Unknown
0
0%
0
0%
0
0%
0
0%
Grade 0
92
92%
95
96%
94
94.9%
94
92.2%
Grade 1
6
6%
3
3%
4
4%
4
3.9%
Grade 2
0
0%
0
0%
0
0%
0
0%
Grade 3
0
0%
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
0
0%
Unknown
0
0%
0
0%
0
0%
Grade 0
0
0%
0
0%
0
0%
Grade 1
1
1%
0
0%
3
3%
Grade 2
0
0%
1
1%
0
0%
Grade 3
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
Unknown
0
0%
0
0%
Grade 0
1
1%
1
1%
Grade 1
0
0%
0
0%
Grade 2
0
0%
0
0%
Grade 3
0
0%
0
0%
Grade 4
0
0%
0
0%
Unknown
0
0%
0
0%
0
0%
0
0%
Grade 0
95
95%
85
85.9%
91
91.9%
88
86.3%
Grade 1
3
3%
9
9.1%
5
5.1%
11
10.8%
Grade 2
1
1%
0
0%
0
0%
0
0%
Grade 3
0
0%
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
0
0%
Unknown
0
0%
0
0%
0
0%
Grade 0
1
1%
1
1%
1
1%
Grade 1
3
3%
1
1%
0
0%
Grade 2
0
0%
0
0%
1
1%
Grade 3
0
0%
0
0%
0
0%
Grade 4
0
0%
0
0%
0
0%
Unknown
0
0%
Grade 0
0
0%
Grade 1
1
1%
Grade 2
0
0%
Grade 3
0
0%
Grade 4
0
0%
17. Secondary Outcome
Title Neutralizing Antibody Titers Against RSV-A Subtype
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.
Time Frame At Day 60 and Day 90

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 90, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay up to Day 90.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 98 92 96 96
Anti-RSV.A, Day 60
715.4
831.9
965.1
311.6
Anti-RSV.A, Day 90
566.5
732.1
902.8
319.6
18. Secondary Outcome
Title Neutralizing Antibody Titers Against RSV-B Subtype
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.
Time Frame At Day 0, Day 30, Day 60 and Day 90

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 90, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay up to Day 90.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 98 95 98 100
Anti-RSV.B, Day 0
385.6
392.1
410.6
340.2
Anti-RSV.B, Day 30
909.1
1004.1
1131.7
357.7
Anti-RSV.B, Day 60
752.1
847.1
923.6
409.6
Anti-RSV.B, Day 90
667.8
804.9
848.6
423.2
19. Secondary Outcome
Title Palivizumab Competing Antibody (PCA) Concentrations
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 value ≥ 9.6 µg/mL.
Time Frame At Day 60 and Day 90

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 90, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay up to Day 90.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 98 92 96 96
PCA, Day 60
55.2
69.0
66.7
6.4
PCA, Day 90
47.6
57.9
57.0
7.4
20. Secondary Outcome
Title Antibody Concentrations Against Neogenin (NEO) Residual Host Cell Protein
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.
Time Frame At Day 0 and Day 30

Outcome Measure Data

Analysis Population Description
This immunogenicity analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom immunogenicity results were available for this assay up to Day 30.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 100 99 99 102
Anti-NEO, Day 0
32.9
32.0
33.5
34.5
Anti-NEO, Day 30
32.9
31.5
33.1
34.7
21. Secondary Outcome
Title Number of Subjects With Any Medically Attended (MA) Respiratory Tract Infections (RTIs) Associated With RSV
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.
Time Frame From Day 0 up to study end, at Day 360

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
Measure Participants 100 99 99 102
Count of Participants [Participants]
21
21%
11
11.1%
10
10.1%
9
8.8%

Adverse Events

Time Frame Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
Adverse Event Reporting Description
Arm/Group Title GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Arm/Group Description Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. Subjects in this group received a single placebo injection at Day 0.
All Cause Mortality
GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/100 (0%) 0/99 (0%) 0/99 (0%) 0/102 (0%)
Serious Adverse Events
GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/100 (1%) 3/99 (3%) 2/99 (2%) 2/102 (2%)
Hepatobiliary disorders
Biliary colic 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Infections and infestations
Campylobacter gastroenteritis 0/100 (0%) 0 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Peritonsillar abscess 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Soft tissue infection 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Pancreatic carcinoma 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Nervous system disorders
Hemiparesis 0/100 (0%) 0 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Respiratory, thoracic and mediastinal disorders
Pneumothorax 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Other (Not Including Serious) Adverse Events
GSK3003891A Vaccine Formulation 1 Group GSK3003891A Vaccine Formulation 2 Group GSK3003891A Vaccine Formulation 3 Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 88/100 (88%) 86/99 (86.9%) 83/99 (83.8%) 76/102 (74.5%)
Blood and lymphatic system disorders
Iron deficiency anaemia 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Lymphadenopathy 0/100 (0%) 0 2/99 (2%) 2 1/99 (1%) 1 0/102 (0%) 0
Neutropenia 1/100 (1%) 1 1/99 (1%) 1 0/99 (0%) 0 2/102 (2%) 2
Ear and labyrinth disorders
Ear pain 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Vertigo 0/100 (0%) 0 0/99 (0%) 0 3/99 (3%) 4 0/102 (0%) 0
Eye disorders
Blepharospasm 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Vision blurred 0/100 (0%) 0 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Gastrointestinal disorders
Abdominal pain 1/100 (1%) 1 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Abdominal pain upper 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Constipation 0/100 (0%) 0 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Diarrhoea 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 2/102 (2%) 2
Dyspepsia 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Gastric disorder 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Gastrointestinal disorder 22/100 (22%) 22 24/99 (24.2%) 24 14/99 (14.1%) 14 11/102 (10.8%) 11
Nausea 2/100 (2%) 2 0/99 (0%) 0 2/99 (2%) 3 1/102 (1%) 1
Toothache 0/100 (0%) 0 2/99 (2%) 2 0/99 (0%) 0 2/102 (2%) 2
Vomiting 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
General disorders
Asthenia 2/100 (2%) 2 1/99 (1%) 2 0/99 (0%) 0 0/102 (0%) 0
Axillary pain 0/100 (0%) 0 0/99 (0%) 0 3/99 (3%) 3 0/102 (0%) 0
Chills 1/100 (1%) 1 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Fatigue 47/100 (47%) 48 43/99 (43.4%) 43 45/99 (45.5%) 46 42/102 (41.2%) 42
Feeling cold 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Gait disturbance 0/100 (0%) 0 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Influenza like illness 1/100 (1%) 1 1/99 (1%) 1 0/99 (0%) 0 1/102 (1%) 1
Injection site haematoma 0/100 (0%) 0 2/99 (2%) 2 0/99 (0%) 0 0/102 (0%) 0
Injection site haemorrhage 1/100 (1%) 1 0/99 (0%) 0 3/99 (3%) 3 0/102 (0%) 0
Injection site pruritus 2/100 (2%) 2 1/99 (1%) 1 0/99 (0%) 0 1/102 (1%) 1
Malaise 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Pain 52/100 (52%) 53 52/99 (52.5%) 52 51/99 (51.5%) 51 11/102 (10.8%) 12
Pyrexia 8/100 (8%) 8 8/99 (8.1%) 8 6/99 (6.1%) 6 4/102 (3.9%) 4
Swelling 4/100 (4%) 4 6/99 (6.1%) 6 7/99 (7.1%) 7 0/102 (0%) 0
Infections and infestations
Bronchitis 0/100 (0%) 0 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Cystitis 1/100 (1%) 1 3/99 (3%) 4 1/99 (1%) 1 1/102 (1%) 1
Gastroenteritis 3/100 (3%) 3 1/99 (1%) 1 1/99 (1%) 1 1/102 (1%) 1
Gastroenteritis viral 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Genital herpes 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Gingivitis 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Herpes simplex 0/100 (0%) 0 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Infection 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Infective keratitis 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Influenza 1/100 (1%) 1 1/99 (1%) 1 0/99 (0%) 0 2/102 (2%) 2
Nasopharyngitis 6/100 (6%) 7 3/99 (3%) 3 4/99 (4%) 4 4/102 (3.9%) 5
Oral herpes 1/100 (1%) 2 0/99 (0%) 0 1/99 (1%) 1 1/102 (1%) 1
Pharyngitis 1/100 (1%) 1 1/99 (1%) 1 1/99 (1%) 1 0/102 (0%) 0
Pulpitis dental 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Rhinitis 13/100 (13%) 14 3/99 (3%) 4 7/99 (7.1%) 7 6/102 (5.9%) 6
Salpingo-oophoritis 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Sinusitis 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 2/102 (2%) 2
Skin bacterial infection 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Tonsillitis 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Upper respiratory tract infection 3/100 (3%) 3 9/99 (9.1%) 10 8/99 (8.1%) 8 1/102 (1%) 1
Urinary tract infection 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Vulvovaginal candidiasis 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Injury, poisoning and procedural complications
Bone contusion 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Contusion 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Ligament sprain 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Meniscus injury 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Muscle strain 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Post procedural inflammation 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Tooth fracture 0/100 (0%) 0 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Vaccination complication 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Investigations
Haemoglobin decreased 0/100 (0%) 0 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Hepatic enzyme increased 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Platelet count decreased 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
White blood cell count decreased 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Musculoskeletal and connective tissue disorders
Arthralgia 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Back pain 4/100 (4%) 4 2/99 (2%) 3 1/99 (1%) 1 4/102 (3.9%) 4
Bone pain 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Musculoskeletal stiffness 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Myalgia 1/100 (1%) 1 1/99 (1%) 1 2/99 (2%) 2 0/102 (0%) 0
Neck pain 1/100 (1%) 1 1/99 (1%) 2 0/99 (0%) 0 0/102 (0%) 0
Pain in extremity 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Tendonitis 0/100 (0%) 0 0/99 (0%) 0 1/99 (1%) 1 1/102 (1%) 1
Nervous system disorders
Carpal tunnel syndrome 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Cervicobrachial syndrome 1/100 (1%) 1 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Dizziness 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Facial neuralgia 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Headache 54/100 (54%) 61 47/99 (47.5%) 56 47/99 (47.5%) 55 47/102 (46.1%) 53
Hypoaesthesia 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Intercostal neuralgia 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Migraine 0/100 (0%) 0 1/99 (1%) 1 1/99 (1%) 2 1/102 (1%) 1
Syncope 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Pregnancy, puerperium and perinatal conditions
Retained placenta or membranes 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Psychiatric disorders
Insomnia 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Sleep disorder 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Renal and urinary disorders
Dysuria 0/100 (0%) 0 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Reproductive system and breast disorders
Dysmenorrhoea 2/100 (2%) 2 1/99 (1%) 1 0/99 (0%) 0 1/102 (1%) 1
Menstrual disorder 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Ovarian cyst 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Polymenorrhoea 0/100 (0%) 0 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Premenstrual pain 0/100 (0%) 0 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Respiratory, thoracic and mediastinal disorders
Cough 5/100 (5%) 5 2/99 (2%) 2 5/99 (5.1%) 5 5/102 (4.9%) 5
Epistaxis 0/100 (0%) 0 1/99 (1%) 2 0/99 (0%) 0 0/102 (0%) 0
Nasal congestion 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Oropharyngeal pain 9/100 (9%) 13 4/99 (4%) 4 4/99 (4%) 4 5/102 (4.9%) 5
Pneumothorax 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Productive cough 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Pulmonary mass 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Respiratory disorder 0/100 (0%) 0 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Rhinitis allergic 1/100 (1%) 1 0/99 (0%) 0 0/99 (0%) 0 0/102 (0%) 0
Rhinorrhoea 0/100 (0%) 0 1/99 (1%) 1 0/99 (0%) 0 0/102 (0%) 0
Skin and subcutaneous tissue disorders
Acne 0/100 (0%) 0 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Dermatitis 0/100 (0%) 0 0/99 (0%) 0 0/99 (0%) 0 1/102 (1%) 1
Erythema 6/100 (6%) 6 10/99 (10.1%) 10 8/99 (8.1%) 8 1/102 (1%) 1
Pruritus 2/100 (2%) 2 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Rash 2/100 (2%) 2 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0
Rash vesicular 0/100 (0%) 0 0/99 (0%) 0 1/99 (1%) 1 0/102 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

Name/Title GSK Response Center
Organization GlaxoSmithKline
Phone 866-435-7343
Email shm60684@gsk.com
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02956837
Other Study ID Numbers:
  • 204812
  • 2016-001135-12
First Posted:
Nov 6, 2016
Last Update Posted:
Jul 2, 2019
Last Verified:
Jun 1, 2019