Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT02360475
Collaborator
(none)
507
12
4
15.1
42.3
2.8
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of different formulations of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant women aged 18 to 45 years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
507 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
An Observer-blind Study to Assess the Safety, Reactogenicity and Immunogenicity of Different Formulations of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women
Actual Study Start Date
:
Mar 20, 2015
Actual Primary Completion Date
:
Jul 2, 2015
Actual Study Completion Date
:
Jun 21, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RSV vaccine formulation 1 Group Subjects in this group will receive a single dose of formulation 1 of the RSV vaccine |
Biological: RSV vaccine GSK3003895A (formulation 1)
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
|
| Experimental: RSV vaccine formulation 2 Group Subjects in this group will receive a single dose of formulation 2 of RSV vaccine |
Biological: RSV vaccine GSK3003898A (formulation 2)
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
|
| Experimental: RSV vaccine formulation 3 Group Subjects in this group will receive a single dose of formulation 3 of RSV vaccine |
Biological: RSV vaccine GSK3003899A (formulation 3)
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
|
| Active Comparator: Boostrix Group Subjects in this group will receive a single dose of Boostrix |
Biological: Boostrix
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With Solicited Local Symptoms [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 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm).
- Number of Subjects With Solicited General Symptoms [During the 7-day (Days 0-6) post-vaccination period]
Assessed solicited general symptoms (symp.) were headache, fever [defined as oral temperature (temp.) equal to or above 37.5 degrees Celsius (°C)], fatigue, gastrointestinal (Gastro.) symptoms [nausea, vomiting, diarrhoea and/or abdominal pain]. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 (G3) symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
- Number of Subjects With Unsolicited Adverse Events (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.
- Number of Subjects With Serious Adverse Events (SAEs) [From vaccination at Day 0, up to Day 30 post-vaccination]
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
- Titres of RSV-A Neutralizing Antibodies [At Day 0 pre-vaccination]
RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).
- Titres of RSV-A Neutralizing Antibodies [At Day 30 post-vaccination]
RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).
Secondary Outcome Measures
- Titres of RSV-A Neutralizing Antibodies [At Day 60 post-vaccination]
RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60).
- Titres of RSV-A Neutralizing Antibodies [At Day 90 post-vaccination]
RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60).
- Concentrations of Palivizumab Competing Antibodies (PCA) [At Day 0 pre-vaccination]
Palivizumab competing antibody concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).
- Concentrations of PCA [At Day 30 post-vaccination]
PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).
- Concentrations of PCA [At Day 60 post-vaccination]
PCA concentrations, expressed as Geometric Mean Concentrations (GMCs).The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).
- Concentrations of PCA [At Day 90 post-vaccination]
PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).
- Number of Subjects With SAEs [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.
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 performing 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.
-
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 during the study period.
Exclusion Criteria:
-
Use of any investigational or non-registered product other than the study vaccine within 30 days prior to study vaccination, or planned use during the study period.
-
Concurrently participating in 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.
-
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
-
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 reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
-
History of severe allergic reaction after a previous dose of any tetanus toxoid, diphtheria toxoid, or pertussis antigen-containing vaccine or to any component of Boostrix.
-
History of encephalopathy of unknown aetiology occurring within 7 days following a previous vaccination with pertussis-containing vaccine.
-
History of any neurological disorders or seizures
-
History of transient thrombocytopenia or neurological complications following a previous vaccination against diphtheria and/ or tetanus.
-
Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to study vaccination, or planned administration during the study period. Inhaled and topical steroids are allowed.
-
Administration of immunoglobulins and/ or any blood products within the 3 months prior to study vaccination, or planned administration during the study period.
-
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
-
Family history of congenital or hereditary immunodeficiency.
-
History of or current autoimmune disease.
-
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
-
Malignancy within previous 5 years or lymphoproliferative disorder.
-
Current alcohol and/or drug abuse.
-
Acute disease and/ or fever at the time of enrolment.
-
Hypersensitivity to latex.
-
Pregnant or lactating female.
-
Planned move to a location that will prohibit participating in the trial until study end.
-
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 | Mesa | Arizona | United States | 85213 |
| 2 | GSK Investigational Site | San Diego | California | United States | 92108 |
| 3 | GSK Investigational Site | Lenexa | Kansas | United States | 66219 |
| 4 | GSK Investigational Site | Lexington | Kentucky | United States | 40509 |
| 5 | GSK Investigational Site | Milford | Massachusetts | United States | 01757 |
| 6 | GSK Investigational Site | Syracuse | New York | United States | 13210 |
| 7 | GSK Investigational Site | Austin | Texas | United States | 78705 |
| 8 | GSK Investigational Site | Melbourne | Victoria | Australia | 3004 |
| 9 | GSK Investigational Site | Hradec Kralove | Czechia | ||
| 10 | GSK Investigational Site | Wuerzburg | Bayern | Germany | 97070 |
| 11 | GSK Investigational Site | Dippoldiswalde | Sachsen | Germany | 01744 |
| 12 | GSK Investigational Site | Luebeck | Schleswig-Holstein | Germany | 23554 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02360475
Other Study ID Numbers:
- 201510
- 2014-002688-14
First Posted:
Feb 10, 2015
Last Update Posted:
Jul 3, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group |
|---|---|---|---|---|
| Arm/Group Description | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
| Period Title: Overall Study | ||||
| STARTED | 126 | 124 | 125 | 125 |
| COMPLETED | 122 | 111 | 117 | 120 |
| NOT COMPLETED | 4 | 13 | 8 | 5 |
Baseline Characteristics
| Arm/Group Title | GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Total of all reporting groups |
| Overall Participants | 126 | 124 | 125 | 125 | 500 |
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
29.2
(7.5)
|
29.5
(8.2)
|
29.1
(7.4)
|
29.2
(7.9)
|
29.25
(7.73)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
126
100%
|
124
100%
|
125
100%
|
125
100%
|
500
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||
| African Heritage / African American |
5
4%
|
7
5.6%
|
9
7.2%
|
9
7.2%
|
30
6%
|
| Asian - Central/South Asian Heritage |
0
0%
|
0
0%
|
3
2.4%
|
0
0%
|
3
0.6%
|
| Asian - East Asian Heritage |
1
0.8%
|
0
0%
|
3
2.4%
|
0
0%
|
4
0.8%
|
| Asian - Japanese Heritage |
1
0.8%
|
0
0%
|
0
0%
|
0
0%
|
1
0.2%
|
| Asian - South East Asian Heritage |
1
0.8%
|
1
0.8%
|
6
4.8%
|
4
3.2%
|
12
2.4%
|
| Native Hawaiian or Other Pacific Islander |
1
0.8%
|
0
0%
|
0
0%
|
0
0%
|
1
0.2%
|
| White-Arabic / North African Heritage |
2
1.6%
|
1
0.8%
|
2
1.6%
|
2
1.6%
|
7
1.4%
|
| White-Caucasian/European Heritage |
112
88.9%
|
114
91.9%
|
97
77.6%
|
108
86.4%
|
431
86.2%
|
| Other |
3
2.4%
|
1
0.8%
|
5
4%
|
2
1.6%
|
11
2.2%
|
Outcome Measures
| Title | Number of Subjects With Solicited Local Symptoms |
|---|---|
| Description | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm). |
| 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 subjects with study vaccines administration documented and with the symptoms sheet filled in. |
| Arm/Group Title | GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group |
|---|---|---|---|---|
| Arm/Group Description | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
| Measure Participants | 124 | 119 | 124 | 124 |
| Any Pain |
62
49.2%
|
68
54.8%
|
104
83.2%
|
104
83.2%
|
| Grade 3 Pain |
1
0.8%
|
2
1.6%
|
9
7.2%
|
3
2.4%
|
| Any Redness |
6
4.8%
|
3
2.4%
|
8
6.4%
|
6
4.8%
|
| Grade 3 Redness |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any Swelling |
7
5.6%
|
6
4.8%
|
12
9.6%
|
5
4%
|
| Grade 3 Swelling |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Subjects With Solicited General Symptoms |
|---|---|
| Description | Assessed solicited general symptoms (symp.) were headache, fever [defined as oral temperature (temp.) equal to or above 37.5 degrees Celsius (°C)], fatigue, gastrointestinal (Gastro.) symptoms [nausea, vomiting, diarrhoea and/or abdominal pain]. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 (G3) symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| 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 subjects with study vaccines administration documented and with the symptoms sheet filled in. |
| Arm/Group Title | GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group |
|---|---|---|---|---|
| Arm/Group Description | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
| Measure Participants | 124 | 119 | 124 | 124 |
| Any Fatigue |
53
42.1%
|
50
40.3%
|
56
44.8%
|
45
36%
|
| G3 Fatigue |
8
6.3%
|
1
0.8%
|
4
3.2%
|
2
1.6%
|
| Related Fatigue |
44
34.9%
|
41
33.1%
|
50
40%
|
39
31.2%
|
| Any Gastro. symp. |
16
12.7%
|
19
15.3%
|
23
18.4%
|
20
16%
|
| G3 Gastro. symp. |
1
0.8%
|
2
1.6%
|
1
0.8%
|
0
0%
|
| Related Gastro. symp. |
9
7.1%
|
14
11.3%
|
21
16.8%
|
17
13.6%
|
| Any Headache |
47
37.3%
|
44
35.5%
|
53
42.4%
|
39
31.2%
|
| G3 Headache |
3
2.4%
|
2
1.6%
|
5
4%
|
3
2.4%
|
| Related Headache |
37
29.4%
|
33
26.6%
|
39
31.2%
|
33
26.4%
|
| Any Temp. |
7
5.6%
|
9
7.3%
|
12
9.6%
|
7
5.6%
|
| G3 Temp. |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Related Temp. |
5
4%
|
8
6.5%
|
11
8.8%
|
6
4.8%
|
| Title | Number of Subjects With Unsolicited Adverse Events (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 subjects with study vaccines administration documented. |
| Arm/Group Title | GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group |
|---|---|---|---|---|
| Arm/Group Description | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
| Measure Participants | 126 | 124 | 125 | 125 |
| Count of Participants [Participants] |
35
27.8%
|
38
30.6%
|
34
27.2%
|
37
29.6%
|
| Title | Number of Subjects With Serious Adverse Events (SAEs) |
|---|---|
| Description | Serious adverse events (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 vaccination at Day 0, up to Day 30 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented. |
| Arm/Group Title | GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group |
|---|---|---|---|---|
| Arm/Group Description | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
| Measure Participants | 126 | 124 | 125 | 125 |
| Count of Participants [Participants] |
1
0.8%
|
1
0.8%
|
0
0%
|
0
0%
|
| Title | Titres of RSV-A Neutralizing Antibodies |
|---|---|
| Description | RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60). |
| Time Frame | At Day 0 pre-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch. |
| Arm/Group Title | GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group |
|---|---|---|---|---|
| Arm/Group Description | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
| Measure Participants | 117 | 117 | 118 | 118 |
| Geometric Mean (95% Confidence Interval) [Titres] |
397.1
|
326.3
|
444.2
|
423.7
|
| Title | Titres of RSV-A Neutralizing Antibodies |
|---|---|
| Description | RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60). |
| Time Frame | At Day 30 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch. |
| Arm/Group Title | GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group |
|---|---|---|---|---|
| Arm/Group Description | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
| Measure Participants | 117 | 117 | 118 | 118 |
| Geometric Mean (95% Confidence Interval) [Titres] |
1237.0
|
1278.7
|
1442.5
|
387.1
|
| Title | Titres of RSV-A Neutralizing Antibodies |
|---|---|
| Description | RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60). |
| Time Frame | At Day 60 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch. |
| Arm/Group Title | GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group |
|---|---|---|---|---|
| Arm/Group Description | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
| Measure Participants | 109 | 111 | 108 | 111 |
| Geometric Mean (95% Confidence Interval) [Titres] |
947.2
|
882.9
|
1055.7
|
358.8
|
| Title | Titres of RSV-A Neutralizing Antibodies |
|---|---|
| Description | RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60). |
| Time Frame | At Day 90 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch. |
| Arm/Group Title | GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group |
|---|---|---|---|---|
| Arm/Group Description | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
| Measure Participants | 112 | 111 | 110 | 111 |
| Geometric Mean (95% Confidence Interval) [Titres] |
837.7
|
774.5
|
897.5
|
358.3
|
| Title | Concentrations of Palivizumab Competing Antibodies (PCA) |
|---|---|
| Description | Palivizumab competing antibody concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL). |
| Time Frame | At Day 0 pre-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch. |
| Arm/Group Title | GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group |
|---|---|---|---|---|
| Arm/Group Description | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
| Measure Participants | 110 | 107 | 105 | 110 |
| Geometric Mean (95% Confidence Interval) [µg/mL] |
5.4
|
5.2
|
4.6
|
5.7
|
| Title | Concentrations of PCA |
|---|---|
| Description | PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL). |
| Time Frame | At Day 30 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch. |
| Arm/Group Title | GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group |
|---|---|---|---|---|
| Arm/Group Description | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
| Measure Participants | 115 | 116 | 116 | 109 |
| Geometric Mean (95% Confidence Interval) [µg/mL] |
79.9
|
88.6
|
97.2
|
6.1
|
| Title | Concentrations of PCA |
|---|---|
| Description | PCA concentrations, expressed as Geometric Mean Concentrations (GMCs).The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL). |
| Time Frame | At Day 60 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch. |
| Arm/Group Title | GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group |
|---|---|---|---|---|
| Arm/Group Description | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
| Measure Participants | 109 | 111 | 108 | 111 |
| Geometric Mean (95% Confidence Interval) [µg/mL] |
65.9
|
68.4
|
74.1
|
5.8
|
| Title | Concentrations of PCA |
|---|---|
| Description | PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL). |
| Time Frame | At Day 90 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch. |
| Arm/Group Title | GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group |
|---|---|---|---|---|
| Arm/Group Description | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
| Measure Participants | 112 | 111 | 110 | 109 |
| Geometric Mean (95% Confidence Interval) [µg/mL] |
60.4
|
62.5
|
66.1
|
7.5
|
| Title | Number of Subjects With 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 | 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 subjects with study vaccines administration documented. |
| Arm/Group Title | GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group |
|---|---|---|---|---|
| Arm/Group Description | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
| Measure Participants | 126 | 124 | 125 | 125 |
| Count of Participants [Participants] |
3
2.4%
|
3
2.4%
|
6
4.8%
|
2
1.6%
|
Adverse Events
| Time Frame | Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group | ||||
| Arm/Group Description | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | ||||
All Cause Mortality |
||||||||
| GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/126 (0%) | 0/124 (0%) | 0/125 (0%) | 0/125 (0%) | ||||
Serious Adverse Events |
||||||||
| GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/126 (2.4%) | 3/124 (2.4%) | 6/125 (4.8%) | 2/125 (1.6%) | ||||
| Gastrointestinal disorders | ||||||||
| Colitis | 0/126 (0%) | 0 | 0/124 (0%) | 0 | 1/125 (0.8%) | 1 | 0/125 (0%) | 0 |
| Umbilical hernia | 0/126 (0%) | 0 | 0/124 (0%) | 0 | 1/125 (0.8%) | 1 | 0/125 (0%) | 0 |
| Infections and infestations | ||||||||
| Pneumonia bacterial | 0/126 (0%) | 0 | 0/124 (0%) | 0 | 0/125 (0%) | 0 | 1/125 (0.8%) | 1 |
| Erysipelas | 0/126 (0%) | 0 | 0/124 (0%) | 0 | 1/125 (0.8%) | 1 | 0/125 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Multiple injuries | 0/126 (0%) | 0 | 0/124 (0%) | 0 | 0/125 (0%) | 0 | 1/125 (0.8%) | 1 |
| Musculoskeletal injury | 0/126 (0%) | 0 | 1/124 (0.8%) | 1 | 0/125 (0%) | 0 | 0/125 (0%) | 0 |
| Fibula fracture | 0/126 (0%) | 0 | 0/124 (0%) | 0 | 1/125 (0.8%) | 1 | 0/125 (0%) | 0 |
| Incisional hernia | 0/126 (0%) | 0 | 0/124 (0%) | 0 | 1/125 (0.8%) | 1 | 0/125 (0%) | 0 |
| Tibia fracture | 0/126 (0%) | 0 | 0/124 (0%) | 0 | 1/125 (0.8%) | 1 | 0/125 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Jaw cyst | 1/126 (0.8%) | 1 | 0/124 (0%) | 0 | 0/125 (0%) | 0 | 0/125 (0%) | 0 |
| Nervous system disorders | ||||||||
| Transient ischaemic attack | 0/126 (0%) | 0 | 1/124 (0.8%) | 1 | 0/125 (0%) | 0 | 0/125 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||||||
| Abortion spontaneous | 0/126 (0%) | 0 | 1/124 (0.8%) | 1 | 1/125 (0.8%) | 1 | 0/125 (0%) | 0 |
| Psychiatric disorders | ||||||||
| Suicide attempt | 1/126 (0.8%) | 1 | 0/124 (0%) | 0 | 0/125 (0%) | 0 | 0/125 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 0/126 (0%) | 0 | 0/124 (0%) | 0 | 1/125 (0.8%) | 1 | 0/125 (0%) | 0 |
| Obliterative bronchiolitis | 1/126 (0.8%) | 1 | 0/124 (0%) | 0 | 0/125 (0%) | 0 | 0/125 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| GSK3003891A 30 Non-adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 60 Adjuvanted Group | Boostrix Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 93/126 (73.8%) | 88/124 (71%) | 112/125 (89.6%) | 109/125 (87.2%) | ||||
| Gastrointestinal disorders | ||||||||
| Gastrointestinal disorder | 16/126 (12.7%) | 16 | 19/124 (15.3%) | 19 | 23/125 (18.4%) | 23 | 20/125 (16%) | 20 |
| General disorders | ||||||||
| Fatigue | 53/126 (42.1%) | 53 | 50/124 (40.3%) | 50 | 56/125 (44.8%) | 57 | 45/125 (36%) | 46 |
| Pain | 62/126 (49.2%) | 62 | 68/124 (54.8%) | 69 | 104/125 (83.2%) | 105 | 104/125 (83.2%) | 104 |
| Pyrexia | 7/126 (5.6%) | 7 | 10/124 (8.1%) | 10 | 12/125 (9.6%) | 12 | 8/125 (6.4%) | 8 |
| Swelling | 7/126 (5.6%) | 7 | 6/124 (4.8%) | 6 | 12/125 (9.6%) | 12 | 5/125 (4%) | 5 |
| Infections and infestations | ||||||||
| Upper respiratory tract infection | 2/126 (1.6%) | 2 | 7/124 (5.6%) | 7 | 3/125 (2.4%) | 3 | 6/125 (4.8%) | 6 |
| Nervous system disorders | ||||||||
| Headache | 49/126 (38.9%) | 53 | 45/124 (36.3%) | 47 | 56/125 (44.8%) | 59 | 41/125 (32.8%) | 43 |
| Skin and subcutaneous tissue disorders | ||||||||
| Erythema | 6/126 (4.8%) | 6 | 3/124 (2.4%) | 3 | 8/125 (6.4%) | 8 | 6/125 (4.8%) | 6 |
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 |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02360475
Other Study ID Numbers:
- 201510
- 2014-002688-14
First Posted:
Feb 10, 2015
Last Update Posted:
Jul 3, 2018
Last Verified:
May 1, 2018