A Phase 2 interventional study of RSV Vaccine (GSK3003891A) formulation 1 and RSV Vaccine (GSK3003891A) formulation 2 in Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline. Completed at 8 sites in 4 countries. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-02.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
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.
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.
293 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 45 are open to participants now.
This study's enrollment of 406 is above the median of 90 across 213 interventional studies indexed under Respiratory Syncytial Virus Infections.
Browse Respiratory Syncytial Virus Infections studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Acute disease and/or fever at the time of enrolment.
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
Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Biological: RSV Vaccine (GSK3003891A) formulation 2
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Biological: RSV Vaccine (GSK3003891A) formulation 3
Subjects in this group received a single placebo injection at Day 0.
Drug: Placebo (Formulation buffer S9b)
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
A single dose of placebo is administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
Number of Subjects With Any Grade 2 and Grade 3 General Adverse Events (AEs) - Solicited and Unsolicited
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
Number of Subjects With Grade 2 and Grade 3 Fever
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
Number of Subjects With Related Serious Adverse Events (SAEs)
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
Neutralizing Antibody Titers Against RSV-A Subtype
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
Neutralizing Antibody Titers Against RSV-A Subtype
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
Palivizumab Competing Antibody (PCA) Concentrations
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
Pavilizumab Competing Antibody (PCA) Concentrations
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
Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs
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
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
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
Number of Subjects With Any Unsolicited AEs
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
Number of Subjects With Any SAEs
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
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
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
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
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
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
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
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities
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
Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading
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
Neutralizing Antibody Titers Against RSV-A Subtype
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
Neutralizing Antibody Titers Against RSV-B Subtype
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
Palivizumab Competing Antibody (PCA) Concentrations
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
Antibody Concentrations Against Neogenin (NEO) Residual Host Cell Protein
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
Number of Subjects With Any Medically Attended (MA) Respiratory Tract Infections (RTIs) Associated With RSV
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
| Milestone | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Started | 100 | 99 | 99 | 102 |
| Completed | 100 | 96 | 97 | 99 |
| Not completed | 0 | 3 | 2 | 3 |
| Withdrew: Serious adverse events | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 | 2 | 0 |
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).
| Participants | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Number of Subjects With Any Grade 2 and Grade 3 General Adverse Events (AEs) - Solicited and Unsolicited | 32 | 30 | 24 | 27 |
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).
| Participants | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Grade 2 Fever | 0 | 2 | 1 | 0 |
| Grade 3 Fever | 0 | 1 | 0 | 0 |
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).
| Participants | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Number of Subjects With Related Serious Adverse Events (SAEs) | 0 | 0 | 0 | 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).
| Titers | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Neutralizing Antibody Titers Against RSV-A Subtype | 228.8 (193.1 to 271.0) | 249.5 (213.9 to 290.9) | 285.7 (244.5 to 333.9) | 247.1 (211.2 to 289.1) |
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).
| Titers | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Neutralizing Antibody Titers Against RSV-A Subtype | 858.2 (724.7 to 1016.3) | 1114.8 (971.9 to 1278.8) | 1245.5 (1070.3 to 1449.2) | 271.6 (228.0 to 323.5) |
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).
| µg/mL | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Palivizumab Competing Antibody (PCA) Concentrations | 5.7 (5.3 to 6.2) | 5.6 (5.2 to 6.1) | 5.8 (5.3 to 6.3) | 6.0 (5.5 to 6.6) |
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).
| µg/mL | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Pavilizumab Competing Antibody (PCA) Concentrations | 66.8 (59.0 to 75.8) | 81.2 (72.5 to 90.9) | 83.7 (73.5 to 95.5) | 6.1 (5.5 to 6.8) |
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.
| Participants | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Any Pain | 52 | 52 | 51 | 11 |
| Grade 2 Pain | 5 | 5 | 10 | 1 |
| Grade 3 Pain | 1 | 0 | 1 | 0 |
| Medically-attended Pain | 0 | 0 | 0 | 0 |
| Any Redness (mm) | 6 | 10 | 8 | 1 |
| Grade 2 Redness (mm) | 2 | 2 | 1 | 0 |
| Grade 3 Redness | 0 | 0 | 0 | 0 |
| Medically-attended Redness (mm) | 0 | 0 | 0 | 0 |
| Any Swelling (mm) | 4 | 6 | 7 | 0 |
| Grade 2 Swelling (mm) | 1 | 0 | 0 | 0 |
| Grade 3 Swelling (mm) | 0 | 1 | 0 | 0 |
| Medically-attended Swelling (mm) | 0 | 0 | 0 | 0 |
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.
| Participants | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Any Fatigue | 47 | 43 | 45 | 42 |
| Grade 2 Fatigue | 9 | 14 | 8 | 12 |
| Grade 3 Fatigue | 3 | 3 | 2 | 1 |
| Related Fatigue | 37 | 29 | 36 | 33 |
| Medically-attended Fatigue | 0 | 1 | 1 | 0 |
| Any Gastrointestinal symptoms | 20 | 23 | 14 | 11 |
| Grade 2 Gastrointestinal symptoms | 4 | 3 | 1 | 1 |
| Grade 3 Gastrointestinal symptoms | 1 | 2 | 0 | 1 |
| Related Gastrointestinal symptoms | 13 | 17 | 10 | 7 |
| Medically-attended Gastrointestinal symptoms | 0 | 0 | 0 | 0 |
| Any Headache | 47 | 42 | 41 | 37 |
| Grade 2 Headache | 11 | 11 | 12 | 10 |
| Grade 3 Headache | 3 | 2 | 1 | 3 |
| Related Headache | 30 | 27 | 33 | 29 |
| Medically-attended Headache | 0 | 1 | 1 | 0 |
| Any Temperature/(Oral) (°C) | 8 | 8 | 6 | 4 |
| Related Temperature/(Oral) (°C) | 5 | 1 | 6 | 2 |
| Medically-attended Temperature/(Oral) (°C) | 0 | 3 | 1 | 0 |
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.
| Participants | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Number of Subjects With Any Unsolicited AEs | 55 | 52 | 46 | 49 |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Participants | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Number of Subjects With Any SAEs | 1 | 3 | 2 | 2 |
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) \[e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 7\].
| Participants | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| ALT, Below — Below | — | — | — | — |
| ALT, Below — Within | — | — | — | — |
| ALT, Below — Above | — | — | — | — |
| ALT, Within — Below | 0 | 0 | 0 | 0 |
| ALT, Within — Within | 99 | 97 | 99 | 102 |
| ALT, Within — Above | 0 | 0 | 0 | 0 |
| ALT, Above — Below | 0 | 0 | — | — |
| ALT, Above — Within | 1 | 1 | — | — |
| ALT, Above — Above | 0 | 0 | — | — |
| AST, Below — Below | — | — | — | — |
| AST, Below — Within | — | — | — | — |
| AST, Below — Above | — | — | — | — |
| AST, Within — Below | 0 | 0 | 0 | 0 |
| AST, Within — Within | 99 | 97 | 98 | 100 |
| AST, Within — Above | 0 | 0 | 1 | 0 |
| AST, Above — Below | 0 | 0 | — | 0 |
| AST, Above — Within | 1 | 1 | — | 1 |
| AST, Above — Above | 0 | 0 | — | 0 |
| Creatinine, Below — Below | 2 | 3 | 2 | 0 |
| Creatinine, Below — Within | 4 | 2 | 0 | 2 |
| Creatinine, Below — Above | 0 | 0 | 0 | 0 |
| Creatinine, Within — Below | 1 | 2 | 4 | 0 |
| Creatinine, Within — Within | 92 | 90 | 93 | 99 |
| Creatinine, Within — Above | 0 | 0 | 0 | 0 |
| Creatinine, Above — Below | 0 | 0 | — | 0 |
| Creatinine, Above — Within | 0 | 1 | — | 0 |
| Creatinine, Above — Above | 1 | 0 | — | 1 |
| Eosinophils, Unknown — Below | 0 | 0 | 0 | 0 |
| Eosinophils, Unknown — Within | 1 | 1 | 1 | 1 |
| Eosinophils, Unknown — Above | 0 | 0 | 0 | 0 |
| Eosinophils, Below — Below | 5 | 5 | 3 | 6 |
| Eosinophils, Below — Within | 7 | 3 | 7 | 2 |
| Eosinophils, Below — Above | 0 | 0 | 0 | 0 |
| Eosinophils, Within — Below | 3 | 2 | 4 | 5 |
| Eosinophils, Within — Within | 77 | 84 | 79 | 81 |
| Eosinophils, Within — Above | 1 | 0 | 0 | 3 |
| Eosinophils, Above — Below | 0 | — | — | — |
| Eosinophils, Above — Within | 1 | — | — | — |
| Eosinophils, Above — Above | 1 | — | — | — |
| Hemoglobin, Unknown — Below | 0 | — | — | 0 |
| Hemoglobin, Unknown — Within | 1 | — | — | 1 |
| Hemoglobin, Unknown — Above | 0 | — | — | 0 |
| Hemoglobin, Below — Below | 12 | 7 | 7 | 7 |
| Hemoglobin, Below — Within | 8 | 4 | 1 | 4 |
| Hemoglobin, Below — Above | 0 | 0 | 0 | 0 |
| Hemoglobin, Within — Below | 4 | 1 | 7 | 2 |
| Hemoglobin, Within — Within | 74 | 84 | 84 | 88 |
| Hemoglobin, Within — Above | 1 | 0 | 0 | 0 |
| Hemoglobin, Above — Below | — | 0 | — | — |
| Hemoglobin, Above — Within | — | 1 | — | — |
| Hemoglobin, Above — Above | — | 1 | — | — |
| Lymphocytes, Unknown — Below | 0 | 0 | 0 | 0 |
| Lymphocytes, Unknown — Within | 1 | 1 | 1 | 1 |
| Lymphocytes, Unknown — Above | 0 | 0 | 0 | 0 |
| Lymphocytes, Below — Below | 0 | — | — | 1 |
| Lymphocytes, Below — Within | 1 | — | — | 0 |
| Lymphocytes, Below — Above | 0 | — | — | 0 |
| Lymphocytes, Within — Below | 1 | 0 | 0 | 0 |
| Lymphocytes, Within — Within | 92 | 93 | 92 | 94 |
| Lymphocytes, Within — Above | 0 | 0 | 1 | 2 |
| Lymphocytes, Above — Below | 0 | 0 | — | — |
| Lymphocytes, Above — Within | 1 | 1 | — | — |
| Lymphocytes, Above — Above | 0 | 0 | — | — |
| Neutrophils, Unknown — Below | 0 | 0 | 1 | 0 |
| Neutrophils, Unknown — Within | 1 | 1 | 0 | 1 |
| Neutrophils, Unknown — Above | 0 | 0 | 0 | 0 |
| Neutrophils, Below — Below | 2 | 0 | — | 1 |
| Neutrophils, Below — Within | 2 | 1 | — | 2 |
| Neutrophils, Below — Above | 0 | 0 | — | 0 |
| Neutrophils, Within — Below | 2 | 6 | 4 | 8 |
| Neutrophils, Within — Within | 88 | 81 | 86 | 82 |
| Neutrophils, Within — Above | 1 | 2 | 0 | 3 |
| Neutrophils, Above — Below | — | 0 | 0 | 0 |
| Neutrophils, Above — Within | — | 4 | 3 | 1 |
| Neutrophils, Above — Above | — | 0 | 0 | 0 |
| Platelet count, Unknown — Below | 0 | 0 | — | 0 |
| Platelet count, Unknown — Within | 2 | 2 | — | 1 |
| Platelet count, Unknown — Above | 0 | 0 | — | 0 |
| Platelet count, Below — Below | — | — | — | — |
| Platelet count, Below — Within | — | — | — | — |
| Platelet count, Below — Above | — | — | — | — |
| Platelet count, Within — Below | 1 | 1 | 0 | 0 |
| Platelet count, Within — Within | 93 | 95 | 99 | 100 |
| Platelet count, Within — Above | 1 | 0 | 0 | 0 |
| Platelet count, Above — Below | 0 | — | — | 0 |
| Platelet count, Above — Within | 1 | — | — | 1 |
| Platelet count, Above — Above | 0 | — | — | 0 |
| WBC, Unknown — Below | 0 | — | — | 0 |
| WBC, Unknown — Within | 1 | — | — | 1 |
| WBC, Unknown — Above | 0 | — | — | 0 |
| WBC, Below — Below | 2 | — | 0 | 2 |
| WBC, Below — Within | 1 | — | 1 | 3 |
| WBC, Below — Above | 0 | — | 0 | 0 |
| WBC, Within — Below | 4 | 4 | 1 | 4 |
| WBC, Within — Within | 90 | 87 | 92 | 87 |
| WBC, Within — Above | 1 | 2 | 1 | 3 |
| WBC, Above — Below | — | 0 | 0 | 0 |
| WBC, Above — Within | — | 3 | 3 | 1 |
| WBC, Above — Above | — | 1 | 0 | 0 |
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) \[e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 30\].
| Participants | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| ALT, Below — Below | — | — | — | — |
| ALT, Below — Within | — | — | — | — |
| ALT, Below — Above | — | — | — | — |
| ALT, Within — Below | 0 | 0 | 0 | 0 |
| ALT, Within — Within | 93 | 97 | 96 | 101 |
| ALT, Within — Above | 3 | 0 | 3 | 1 |
| ALT, Above — Below | 0 | 0 | — | — |
| ALT, Above — Within | 1 | 0 | — | — |
| ALT, Above — Above | 0 | 1 | — | — |
| AST, Below — Below | — | — | — | — |
| AST, Below — Within | — | — | — | — |
| AST, Below — Above | — | — | — | — |
| AST, Within — Below | 0 | 0 | 0 | 0 |
| AST, Within — Within | 94 | 97 | 97 | 100 |
| AST, Within — Above | 2 | 0 | 2 | 1 |
| AST, Above — Below | 0 | 0 | — | 0 |
| AST, Above — Within | 1 | 0 | — | 1 |
| AST, Above — Above | 0 | 1 | — | 0 |
| Creatinine, Below — Below | 1 | 2 | 2 | 2 |
| Creatinine, Below — Within | 5 | 3 | 0 | 0 |
| Creatinine, Below — Above | 0 | 0 | 0 | 0 |
| Creatinine, Within — Below | 1 | 0 | 3 | 2 |
| Creatinine, Within — Within | 89 | 91 | 93 | 97 |
| Creatinine, Within — Above | 0 | 1 | 1 | 0 |
| Creatinine, Above — Below | 0 | 0 | — | 0 |
| Creatinine, Above — Within | 1 | 0 | — | 1 |
| Creatinine, Above — Above | 0 | 1 | — | 0 |
| Eosinophils, Unknown — Below | 0 | 1 | 0 | 0 |
| Eosinophils, Unknown — Within | 1 | 0 | 1 | 1 |
| Eosinophils, Unknown — Above | 0 | 0 | 0 | 0 |
| Eosinophils, Below — Below | 5 | 4 | 4 | 4 |
| Eosinophils, Below — Within | 7 | 4 | 7 | 4 |
| Eosinophils, Below — Above | 0 | 0 | 0 | 0 |
| Eosinophils, Within — Below | 3 | 6 | 8 | 7 |
| Eosinophils, Within — Within | 80 | 82 | 75 | 83 |
| Eosinophils, Within — Above | 1 | 0 | 3 | 0 |
| Eosinophils, Above — Below | 0 | — | — | — |
| Eosinophils, Above — Within | 1 | — | — | — |
| Eosinophils, Above — Above | 1 | — | — | — |
| Hemoglobin, Unknown — Below | 0 | — | — | 0 |
| Hemoglobin, Unknown — Within | 1 | — | — | 1 |
| Hemoglobin, Unknown — Above | 0 | — | — | 0 |
| Hemoglobin, Below — Below | 13 | 6 | 6 | 7 |
| Hemoglobin, Below — Within | 7 | 5 | 2 | 4 |
| Hemoglobin, Below — Above | 0 | 0 | 0 | 0 |
| Hemoglobin, Within — Below | 2 | 4 | 5 | 3 |
| Hemoglobin, Within — Within | 76 | 79 | 86 | 87 |
| Hemoglobin, Within — Above | 0 | 1 | 0 | 0 |
| Hemoglobin, Above — Below | — | 0 | — | — |
| Hemoglobin, Above — Within | — | 1 | — | — |
| Hemoglobin, Above — Above | — | 1 | — | — |
| Lymphocytes, Unknown — Below | 0 | 0 | 0 | 0 |
| Lymphocytes, Unknown — Within | 1 | 1 | 1 | 1 |
| Lymphocytes, Unknown — Above | 0 | 0 | 0 | 0 |
| Lymphocytes, Below — Below | 0 | — | — | 1 |
| Lymphocytes, Below — Within | 1 | — | — | 0 |
| Lymphocytes, Below — Above | 0 | — | — | 0 |
| Lymphocytes, Within — Below | 1 | 0 | 0 | 0 |
| Lymphocytes, Within — Within | 94 | 94 | 97 | 95 |
| Lymphocytes, Within — Above | 1 | 1 | 0 | 2 |
| Lymphocytes, Above — Below | 0 | 0 | — | — |
| Lymphocytes, Above — Within | 1 | 1 | — | — |
| Lymphocytes, Above — Above | 0 | 0 | — | — |
| Neutrophils, Unknown — Below | 0 | 0 | 0 | 0 |
| Neutrophils, Unknown — Within | 1 | 1 | 1 | 1 |
| Neutrophils, Unknown — Above | 0 | 0 | 0 | 0 |
| Neutrophils, Below — Below | 1 | 0 | — | 0 |
| Neutrophils, Below — Within | 3 | 1 | — | 3 |
| Neutrophils, Below — Above | 0 | 0 | — | 0 |
| Neutrophils, Within — Below | 4 | 1 | 1 | 3 |
| Neutrophils, Within — Within | 88 | 88 | 92 | 88 |
| Neutrophils, Within — Above | 2 | 2 | 1 | 3 |
| Neutrophils, Above — Below | — | 0 | 0 | 0 |
| Neutrophils, Above — Within | — | 3 | 3 | 1 |
| Neutrophils, Above — Above | — | 1 | 0 | 0 |
| Platelet count, Unknown — Below | 0 | 0 | — | 0 |
| Platelet count, Unknown — Within | 2 | 2 | — | 1 |
| Platelet count, Unknown — Above | 0 | 0 | — | 0 |
| Platelet count, Below — Below | — | — | — | — |
| Platelet count, Below — Within | — | — | — | — |
| Platelet count, Below — Above | — | — | — | — |
| Platelet count, Within — Below | 0 | 0 | 0 | 0 |
| Platelet count, Within — Within | 92 | 94 | 99 | 99 |
| Platelet count, Within — Above | 2 | 1 | 0 | 1 |
| Platelet count, Above — Below | 0 | — | — | 0 |
| Platelet count, Above — Within | 1 | — | — | 1 |
| Platelet count, Above — Above | 0 | — | — | 0 |
| WBC, Unknown — Below | 0 | — | — | 0 |
| WBC, Unknown — Within | 1 | — | — | 1 |
| WBC, Unknown — Above | 0 | — | — | 0 |
| WBC, Below — Below | 2 | — | 1 | 0 |
| WBC, Below — Within | 1 | — | 1 | 4 |
| WBC, Below — Above | 0 | — | 0 | 0 |
| WBC, Within — Below | 3 | 1 | 3 | 0 |
| WBC, Within — Within | 90 | 89 | 90 | 90 |
| WBC, Within — Above | 2 | 3 | 1 | 5 |
| WBC, Above — Below | — | 0 | 0 | 0 |
| WBC, Above — Within | — | 2 | 2 | 1 |
| WBC, Above — Above | — | 2 | 1 | 0 |
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) \[e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 60\].
| Participants | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| ALT, Below — Below | — | — | — | — |
| ALT, Below — Within | — | — | — | — |
| ALT, Below — Above | — | — | — | — |
| ALT, Within — Below | 0 | 0 | 0 | 0 |
| ALT, Within — Within | 98 | 95 | 98 | 101 |
| ALT, Within — Above | 0 | 0 | 0 | 0 |
| ALT, Above — Below | 0 | 0 | — | — |
| ALT, Above — Within | 1 | 1 | — | — |
| ALT, Above — Above | 0 | 0 | — | — |
| AST, Below — Below | — | — | — | — |
| AST, Below — Within | — | — | — | — |
| AST, Below — Above | — | — | — | — |
| AST, Within — Below | 0 | 0 | 0 | 0 |
| AST, Within — Within | 98 | 95 | 97 | 100 |
| AST, Within — Above | 0 | 0 | 1 | 0 |
| AST, Above — Below | 0 | 0 | — | 0 |
| AST, Above — Within | 1 | 1 | — | 1 |
| AST, Above — Above | 0 | 0 | — | 0 |
| Creatinine, Below — Below | 0 | 3 | 2 | 2 |
| Creatinine, Below — Within | 6 | 2 | 0 | 0 |
| Creatinine, Below — Above | 0 | 0 | 0 | 0 |
| Creatinine, Within — Below | 2 | 3 | 3 | 6 |
| Creatinine, Within — Within | 89 | 87 | 93 | 91 |
| Creatinine, Within — Above | 1 | 0 | 0 | 1 |
| Creatinine, Above — Below | 0 | 0 | — | 0 |
| Creatinine, Above — Within | 1 | 1 | — | 1 |
| Creatinine, Above — Above | 0 | 0 | — | 0 |
| Eosinophils, Unknown — Below | 0 | — | 0 | 0 |
| Eosinophils, Unknown — Within | 1 | — | 1 | 1 |
| Eosinophils, Unknown — Above | 0 | — | 0 | 0 |
| Eosinophils, Below — Below | 5 | 2 | 4 | 5 |
| Eosinophils, Below — Within | 7 | 6 | 6 | 4 |
| Eosinophils, Below — Above | 0 | 0 | 0 | 0 |
| Eosinophils, Within — Below | 6 | 4 | 5 | 7 |
| Eosinophils, Within — Within | 77 | 82 | 77 | 81 |
| Eosinophils, Within — Above | 2 | 1 | 3 | 3 |
| Eosinophils, Above — Below | 0 | — | — | — |
| Eosinophils, Above — Within | 0 | — | — | — |
| Eosinophils, Above — Above | 2 | — | — | — |
| Hemoglobin, Unknown — Below | 0 | — | — | 0 |
| Hemoglobin, Unknown — Within | 1 | — | — | 1 |
| Hemoglobin, Unknown — Above | 0 | — | — | 0 |
| Hemoglobin, Below — Below | 13 | 6 | 5 | 8 |
| Hemoglobin, Below — Within | 7 | 5 | 3 | 3 |
| Hemoglobin, Below — Above | 0 | 0 | 0 | 0 |
| Hemoglobin, Within — Below | 5 | 4 | 6 | 7 |
| Hemoglobin, Within — Within | 74 | 78 | 84 | 81 |
| Hemoglobin, Within — Above | 0 | 0 | 0 | 1 |
| Hemoglobin, Above — Below | — | 0 | — | — |
| Hemoglobin, Above — Within | — | 1 | — | — |
| Hemoglobin, Above — Above | — | 1 | — | — |
| Lymphocytes, Unknown — Below | 0 | — | 0 | 0 |
| Lymphocytes, Unknown — Within | 1 | — | 1 | 1 |
| Lymphocytes, Unknown — Above | 0 | — | 0 | 0 |
| Lymphocytes, Below — Below | 0 | — | — | 0 |
| Lymphocytes, Below — Within | 1 | — | — | 1 |
| Lymphocytes, Below — Above | 0 | — | — | 0 |
| Lymphocytes, Within — Below | 1 | 0 | 1 | 0 |
| Lymphocytes, Within — Within | 96 | 94 | 93 | 96 |
| Lymphocytes, Within — Above | 0 | 0 | 1 | 3 |
| Lymphocytes, Above — Below | 0 | 0 | — | — |
| Lymphocytes, Above — Within | 1 | 1 | — | — |
| Lymphocytes, Above — Above | 0 | 0 | — | — |
| Neutrophils, Unknown — Below | 0 | — | 0 | 0 |
| Neutrophils, Unknown — Within | 1 | — | 1 | 1 |
| Neutrophils, Unknown — Above | 0 | — | 0 | 0 |
| Neutrophils, Below — Below | 0 | 0 | — | 1 |
| Neutrophils, Below — Within | 4 | 1 | — | 2 |
| Neutrophils, Below — Above | 0 | 0 | — | 0 |
| Neutrophils, Within — Below | 4 | 4 | 4 | 4 |
| Neutrophils, Within — Within | 89 | 84 | 88 | 89 |
| Neutrophils, Within — Above | 2 | 2 | 0 | 3 |
| Neutrophils, Above — Below | — | 0 | 0 | 0 |
| Neutrophils, Above — Within | — | 4 | 3 | 1 |
| Neutrophils, Above — Above | — | 0 | 0 | 0 |
| Platelet count, Unknown — Below | 0 | 0 | — | 0 |
| Platelet count, Unknown — Within | 2 | 2 | — | 1 |
| Platelet count, Unknown — Above | 0 | 0 | — | 0 |
| Platelet count, Below — Below | — | — | — | — |
| Platelet count, Below — Within | — | — | — | — |
| Platelet count, Below — Above | — | — | — | — |
| Platelet count, Within — Below | 0 | 0 | 1 | 0 |
| Platelet count, Within — Within | 93 | 92 | 97 | 98 |
| Platelet count, Within — Above | 1 | 1 | 0 | 1 |
| Platelet count, Above — Below | 0 | — | — | 0 |
| Platelet count, Above — Within | 1 | — | — | 1 |
| Platelet count, Above — Above | 0 | — | — | 0 |
| WBC, Unknown — Below | 0 | — | — | 0 |
| WBC, Unknown — Within | 1 | — | — | 1 |
| WBC, Unknown — Above | 0 | — | — | 0 |
| WBC, Below — Below | 1 | — | 2 | 3 |
| WBC, Below — Within | 2 | — | 0 | 2 |
| WBC, Below — Above | 0 | — | 0 | 0 |
| WBC, Within — Below | 2 | 1 | 2 | 1 |
| WBC, Within — Within | 92 | 86 | 90 | 87 |
| WBC, Within — Above | 2 | 4 | 1 | 6 |
| WBC, Above — Below | — | 0 | 0 | 0 |
| WBC, Above — Within | — | 3 | 2 | 1 |
| WBC, Above — Above | — | 1 | 1 | 0 |
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) \[e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 90\].
| Participants | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| ALT, Below — Below | — | — | — | — |
| ALT, Below — Within | — | — | — | — |
| ALT, Below — Above | — | — | — | — |
| ALT, Within — Below | 0 | 0 | 0 | 0 |
| ALT, Within — Within | 98 | 95 | 97 | 99 |
| ALT, Within — Above | 1 | 0 | 0 | 0 |
| ALT, Above — Below | 0 | 0 | — | — |
| ALT, Above — Within | 1 | 1 | — | — |
| ALT, Above — Above | 0 | 0 | — | — |
| AST, Below — Below | — | — | — | — |
| AST, Below — Within | — | — | — | — |
| AST, Below — Above | — | — | — | — |
| AST, Within — Below | 0 | 0 | 0 | 0 |
| AST, Within — Within | 99 | 95 | 97 | 98 |
| AST, Within — Above | 0 | 0 | 0 | 0 |
| AST, Above — Below | 0 | 0 | — | 0 |
| AST, Above — Within | 1 | 1 | — | 1 |
| AST, Above — Above | 0 | 0 | — | 0 |
| Creatinine, Below — Below | 1 | 2 | 2 | 2 |
| Creatinine, Below — Within | 5 | 3 | 0 | 0 |
| Creatinine, Below — Above | 0 | 0 | 0 | 0 |
| Creatinine, Within — Below | 3 | 2 | 4 | 3 |
| Creatinine, Within — Within | 90 | 88 | 91 | 92 |
| Creatinine, Within — Above | 0 | 0 | 0 | 1 |
| Creatinine, Above — Below | 0 | 0 | — | 0 |
| Creatinine, Above — Within | 1 | 0 | — | 1 |
| Creatinine, Above — Above | 0 | 1 | — | 0 |
| Eosinophils, Unknown — Below | 0 | 0 | 0 | 0 |
| Eosinophils, Unknown — Within | 1 | 1 | 1 | 1 |
| Eosinophils, Unknown — Above | 0 | 0 | 0 | 0 |
| Eosinophils, Below — Below | 6 | 2 | 4 | 4 |
| Eosinophils, Below — Within | 6 | 6 | 7 | 5 |
| Eosinophils, Below — Above | 0 | 0 | 0 | 0 |
| Eosinophils, Within — Below | 6 | 5 | 8 | 9 |
| Eosinophils, Within — Within | 76 | 81 | 70 | 80 |
| Eosinophils, Within — Above | 2 | 1 | 2 | 0 |
| Eosinophils, Above — Below | 0 | — | — | — |
| Eosinophils, Above — Within | 2 | — | — | — |
| Eosinophils, Above — Above | 0 | — | — | — |
| Hemoglobin, Unknown — Below | 0 | — | — | 0 |
| Hemoglobin, Unknown — Within | 1 | — | — | 1 |
| Hemoglobin, Unknown — Above | 0 | — | — | 0 |
| Hemoglobin, Below — Below | 11 | 5 | 6 | 7 |
| Hemoglobin, Below — Within | 9 | 6 | 1 | 4 |
| Hemoglobin, Below — Above | 0 | 0 | 0 | 0 |
| Hemoglobin, Within — Below | 4 | 3 | 4 | 5 |
| Hemoglobin, Within — Within | 75 | 81 | 84 | 82 |
| Hemoglobin, Within — Above | 0 | 0 | 1 | 0 |
| Hemoglobin, Above — Below | — | 0 | — | — |
| Hemoglobin, Above — Within | — | 1 | — | — |
| Hemoglobin, Above — Above | — | 1 | — | — |
| Lymphocytes, Unknown — Below | 0 | 0 | 0 | 0 |
| Lymphocytes, Unknown — Within | 1 | 1 | 1 | 1 |
| Lymphocytes, Unknown — Above | 0 | 0 | 0 | 0 |
| Lymphocytes, Below — Below | 0 | — | — | 1 |
| Lymphocytes, Below — Within | 1 | — | — | 0 |
| Lymphocytes, Below — Above | 0 | — | — | 0 |
| Lymphocytes, Within — Below | 1 | 0 | 1 | 1 |
| Lymphocytes, Within — Within | 95 | 93 | 90 | 95 |
| Lymphocytes, Within — Above | 0 | 1 | 0 | 1 |
| Lymphocytes, Above — Below | 0 | 0 | — | — |
| Lymphocytes, Above — Within | 1 | 0 | — | — |
| Lymphocytes, Above — Above | 0 | 1 | — | — |
| Neutrophils, Unknown — Below | 0 | 0 | 0 | 0 |
| Neutrophils, Unknown — Within | 1 | 1 | 1 | 1 |
| Neutrophils, Unknown — Above | 0 | 0 | 0 | 0 |
| Neutrophils, Below — Below | 2 | 0 | — | 1 |
| Neutrophils, Below — Within | 2 | 1 | — | 2 |
| Neutrophils, Below — Above | 0 | 0 | — | 0 |
| Neutrophils, Within — Below | 3 | 5 | 2 | 1 |
| Neutrophils, Within — Within | 89 | 83 | 86 | 91 |
| Neutrophils, Within — Above | 2 | 2 | 0 | 2 |
| Neutrophils, Above — Below | — | 0 | 0 | 0 |
| Neutrophils, Above — Within | — | 4 | 3 | 0 |
| Neutrophils, Above — Above | — | 0 | 0 | 1 |
| Platelet count, Unknown — Below | 1 | 0 | — | 0 |
| Platelet count, Unknown — Within | 2 | 2 | — | 1 |
| Platelet count, Unknown — Above | 0 | 0 | — | 0 |
| Platelet count, Below — Below | — | — | — | — |
| Platelet count, Below — Within | — | — | — | — |
| Platelet count, Below — Above | — | — | — | — |
| Platelet count, Within — Below | 0 | 1 | 0 | 0 |
| Platelet count, Within — Within | 91 | 91 | 95 | 95 |
| Platelet count, Within — Above | 3 | 2 | 1 | 0 |
| Platelet count, Above — Below | 0 | — | — | 0 |
| Platelet count, Above — Within | 1 | — | — | 1 |
| Platelet count, Above — Above | 0 | — | — | 0 |
| WBC, Unknown — Below | 0 | — | — | 0 |
| WBC, Unknown — Within | 1 | — | — | 1 |
| WBC, Unknown — Above | 0 | — | — | 0 |
| WBC, Below — Below | 1 | — | 1 | 1 |
| WBC, Below — Within | 2 | — | 1 | 4 |
| WBC, Below — Above | 0 | — | 0 | 0 |
| WBC, Within — Below | 2 | 1 | 1 | 0 |
| WBC, Within — Within | 91 | 89 | 89 | 89 |
| WBC, Within — Above | 3 | 3 | 1 | 3 |
| WBC, Above — Below | — | 0 | 0 | 0 |
| WBC, Above — Within | — | 3 | 3 | 0 |
| WBC, Above — Above | — | 1 | 0 | 1 |
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) \[e.g. ALT Grade 0 - Unknown = ALT Grade 0 at baseline versus Unknown grade from Day 7 up to Day 90\].
| Participants | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| ALT, Grade 0 — Unknown | 0 | 0 | 0 | 0 |
| ALT, Grade 0 — Grade 0 | 96 | 97 | 96 | 101 |
| ALT, Grade 0 — Grade 1 | 2 | 0 | 3 | 1 |
| ALT, Grade 0 — Grade 2 | 0 | 0 | 0 | 0 |
| ALT, Grade 0 — Grade 3 | 1 | 0 | 0 | 0 |
| ALT, Grade 0 — Grade 4 | 0 | 0 | 0 | 0 |
| ALT, Grade 1 — Unknown | 0 | — | — | — |
| ALT, Grade 1 — Grade 0 | 1 | — | — | — |
| ALT, Grade 1 — Grade 1 | 0 | — | — | — |
| ALT, Grade 1 — Grade 2 | 0 | — | — | — |
| ALT, Grade 1 — Grade 3 | 0 | — | — | — |
| ALT, Grade 1 — Grade 4 | 0 | — | — | — |
| ALT, Grade 2 — Unknown | — | 0 | — | — |
| ALT, Grade 2 — Grade 0 | — | 0 | — | — |
| ALT, Grade 2 — Grade 1 | — | 0 | — | — |
| ALT, Grade 2 — Grade 2 | — | 1 | — | — |
| ALT, Grade 2 — Grade 3 | — | 0 | — | — |
| ALT, Grade 2 — Grade 4 | — | 0 | — | — |
| AST, Grade 0 — Unknown | 0 | 0 | 0 | 0 |
| AST, Grade 0 — Grade 0 | 98 | 97 | 97 | 101 |
| AST, Grade 0 — Grade 1 | 0 | 0 | 2 | 0 |
| AST, Grade 0 — Grade 2 | 1 | 0 | 0 | 0 |
| AST, Grade 0 — Grade 3 | 0 | 0 | 0 | 0 |
| AST, Grade 0 — Grade 4 | 1 | 0 | 0 | 0 |
| AST, Grade 1 — Unknown | — | 0 | — | 0 |
| AST, Grade 1 — Grade 0 | — | 0 | — | 1 |
| AST, Grade 1 — Grade 1 | — | 0 | — | 0 |
| AST, Grade 1 — Grade 2 | — | 1 | — | 0 |
| AST, Grade 1 — Grade 3 | — | 0 | — | 0 |
| AST, Grade 1 — Grade 4 | — | 0 | — | 0 |
| Creatinine, Grade 0 — Unknown | 0 | 0 | 0 | 0 |
| Creatinine, Grade 0 — Grade 0 | 100 | 98 | 99 | 102 |
| Creatinine, Grade 0 — Grade 1 | 0 | 0 | 0 | 0 |
| Creatinine, Grade 0 — Grade 2 | 0 | 0 | 0 | 0 |
| Creatinine, Grade 0 — Grade 3 | 0 | 0 | 0 | 0 |
| Creatinine, Grade 0 — Grade 4 | 0 | 0 | 0 | 0 |
| Eosinophils increase, Unknown — Unknown | 0 | 0 | 0 | 0 |
| Eosinophils increase, Unknown — Grade 0 | 1 | 1 | 1 | 1 |
| Eosinophils increase, Unknown — Grade 1 | 0 | 0 | 0 | 0 |
| Eosinophils increase, Unknown — Grade 2 | 0 | 0 | 0 | 0 |
| Eosinophils increase, Unknown — Grade 3 | 0 | 0 | 0 | 0 |
| Eosinophils increase, Unknown — Grade 4 | 0 | 0 | 0 | 0 |
| Eosinophils increase, Grade 0 — Unknown | 0 | 0 | 0 | 0 |
| Eosinophils increase, Grade 0 — Grade 0 | 94 | 96 | 95 | 99 |
| Eosinophils increase, Grade 0 — Grade 1 | 3 | 1 | 3 | 2 |
| Eosinophils increase, Grade 0 — Grade 2 | 0 | 0 | 0 | 0 |
| Eosinophils increase, Grade 0 — Grade 3 | 0 | 0 | 0 | 0 |
| Eosinophils increase, Grade 0 — Grade 4 | 0 | 0 | 0 | 0 |
| Eosinophils increase, Grade 1 — Unknown | 0 | — | — | — |
| Eosinophils increase, Grade 1 — Grade 0 | 0 | — | — | — |
| Eosinophils increase, Grade 1 — Grade 1 | 1 | — | — | — |
| Eosinophils increase, Grade 1 — Grade 2 | 0 | — | — | — |
| Eosinophils increase, Grade 1 — Grade 3 | 0 | — | — | — |
| Eosinophils increase, Grade 1 — Grade 4 | 0 | — | — | — |
| Eosinophils increase, Grade 2 — Unknown | 0 | — | — | — |
| Eosinophils increase, Grade 2 — Grade 0 | 0 | — | — | — |
| Eosinophils increase, Grade 2 — Grade 1 | 0 | — | — | — |
| Eosinophils increase, Grade 2 — Grade 2 | 1 | — | — | — |
| Eosinophils increase, Grade 2 — Grade 3 | 0 | — | — | — |
| Eosinophils increase, Grade 2 — Grade 4 | 0 | — | — | — |
| Hemoglobin decrease, Unknown — Unknown | 0 | — | — | 0 |
| Hemoglobin decrease, Unknown — Grade 0 | 1 | — | — | 1 |
| Hemoglobin decrease, Unknown — Grade 1 | 0 | — | — | 0 |
| Hemoglobin decrease, Unknown — Grade 2 | 0 | — | — | 0 |
| Hemoglobin decrease, Unknown — Grade 3 | 0 | — | — | 0 |
| Hemoglobin decrease, Unknown — Grade 4 | 0 | — | — | 0 |
| Hemoglobin decrease, Grade 0 — Unknown | 0 | 0 | 0 | 0 |
| Hemoglobin decrease, Grade 0 — Grade 0 | 61 | 74 | 73 | 74 |
| Hemoglobin decrease, Grade 0 — Grade 1 | 14 | 12 | 15 | 13 |
| Hemoglobin decrease, Grade 0 — Grade 2 | 2 | 0 | 0 | 1 |
| Hemoglobin decrease, Grade 0 — Grade 3 | 1 | 0 | 0 | 0 |
| Hemoglobin decrease, Grade 0 — Grade 4 | 0 | 0 | 0 | 0 |
| Hemoglobin decrease, Grade 1 — Unknown | 0 | 0 | 0 | 0 |
| Hemoglobin decrease, Grade 1 — Grade 0 | 3 | 2 | 2 | 0 |
| Hemoglobin decrease, Grade 1 — Grade 1 | 11 | 9 | 5 | 10 |
| Hemoglobin decrease, Grade 1 — Grade 2 | 5 | 1 | 2 | 2 |
| Hemoglobin decrease, Grade 1 — Grade 3 | 0 | 0 | 0 | 0 |
| Hemoglobin decrease, Grade 1 — Grade 4 | 0 | 0 | 0 | 0 |
| Hemoglobin decrease, Grade 2 — Unknown | 0 | — | 0 | 0 |
| Hemoglobin decrease, Grade 2 — Grade 0 | 0 | — | 0 | 0 |
| Hemoglobin decrease, Grade 2 — Grade 1 | 0 | — | 1 | 0 |
| Hemoglobin decrease, Grade 2 — Grade 2 | 1 | — | 1 | 1 |
| Hemoglobin decrease, Grade 2 — Grade 3 | 0 | — | 0 | 0 |
| Hemoglobin decrease, Grade 2 — Grade 4 | 0 | — | 0 | 0 |
| Hemoglobin decrease, Grade 3 — Unknown | 0 | — | — | — |
| Hemoglobin decrease, Grade 3 — Grade 0 | 0 | — | — | — |
| Hemoglobin decrease, Grade 3 — Grade 1 | 0 | — | — | — |
| Hemoglobin decrease, Grade 3 — Grade 2 | 1 | — | — | — |
| Hemoglobin decrease, Grade 3 — Grade 3 | 0 | — | — | — |
| Hemoglobin decrease, Grade 3 — Grade 4 | 0 | — | — | — |
| Lymphocytes decrease, Unknown — Unknown | 0 | 0 | 0 | 0 |
| Lymphocytes decrease, Unknown — Grade 0 | 1 | 1 | 1 | 1 |
| Lymphocytes decrease, Unknown — Grade 1 | 0 | 0 | 0 | 0 |
| Lymphocytes decrease, Unknown — Grade 2 | 0 | 0 | 0 | 0 |
| Lymphocytes decrease, Unknown — Grade 3 | 0 | 0 | 0 | 0 |
| Lymphocytes decrease, Unknown — Grade 4 | 0 | 0 | 0 | 0 |
| Lymphocytes decrease, Grade 0 — Unknown | 0 | 0 | 0 | 0 |
| Lymphocytes decrease, Grade 0 — Grade 0 | 90 | 97 | 93 | 99 |
| Lymphocytes decrease, Grade 0 — Grade 1 | 5 | 0 | 4 | 1 |
| Lymphocytes decrease, Grade 0 — Grade 2 | 1 | 0 | 0 | 0 |
| Lymphocytes decrease, Grade 0 — Grade 3 | 0 | 0 | 0 | 0 |
| Lymphocytes decrease, Grade 0 — Grade 4 | 0 | 0 | 0 | 0 |
| Lymphocytes decrease, Grade 1 — Unknown | 0 | — | 0 | — |
| Lymphocytes decrease, Grade 1 — Grade 0 | 1 | — | 1 | — |
| Lymphocytes decrease, Grade 1 — Grade 1 | 1 | — | 0 | — |
| Lymphocytes decrease, Grade 1 — Grade 2 | 0 | — | 0 | — |
| Lymphocytes decrease, Grade 1 — Grade 3 | 0 | — | 0 | — |
| Lymphocytes decrease, Grade 1 — Grade 4 | 0 | — | 0 | — |
| Lymphocytes decrease, Grade 2 — Unknown | 0 | — | — | 0 |
| Lymphocytes decrease, Grade 2 — Grade 0 | 0 | — | — | 0 |
| Lymphocytes decrease, Grade 2 — Grade 1 | 1 | — | — | 1 |
| Lymphocytes decrease, Grade 2 — Grade 2 | 0 | — | — | 0 |
| Lymphocytes decrease, Grade 2 — Grade 3 | 0 | — | — | 0 |
| Lymphocytes decrease, Grade 2 — Grade 4 | 0 | — | — | 0 |
| Neutrophils decrease, Unknown — Unknown | 0 | 0 | 0 | 0 |
| Neutrophils decrease, Unknown — Grade 0 | 1 | 1 | 0 | 1 |
| Neutrophils decrease, Unknown — Grade 1 | 0 | 0 | 1 | 0 |
| Neutrophils decrease, Unknown — Grade 2 | 0 | 0 | 0 | 0 |
| Neutrophils decrease, Unknown — Grade 3 | 0 | 0 | 0 | 0 |
| Neutrophils decrease, Unknown — Grade 4 | 0 | 0 | 0 | 0 |
| Neutrophils decrease, Grade 0 — Unknown | 0 | 0 | 0 | 0 |
| Neutrophils decrease, Grade 0 — Grade 0 | 80 | 70 | 82 | 82 |
| Neutrophils decrease, Grade 0 — Grade 1 | 10 | 20 | 11 | 8 |
| Neutrophils decrease, Grade 0 — Grade 2 | 3 | 5 | 2 | 5 |
| Neutrophils decrease, Grade 0 — Grade 3 | 1 | 0 | 0 | 0 |
| Neutrophils decrease, Grade 0 — Grade 4 | 0 | 0 | 0 | 0 |
| Neutrophils decrease, Grade 1 — Unknown | 0 | 0 | 0 | 0 |
| Neutrophils decrease, Grade 1 — Grade 0 | 0 | 1 | 3 | 2 |
| Neutrophils decrease, Grade 1 — Grade 1 | 1 | 0 | 0 | 1 |
| Neutrophils decrease, Grade 1 — Grade 2 | 1 | 0 | 0 | 1 |
| Neutrophils decrease, Grade 1 — Grade 3 | 0 | 0 | 0 | 0 |
| Neutrophils decrease, Grade 1 — Grade 4 | 0 | 0 | 0 | 0 |
| Neutrophils decrease, Grade 2 — Unknown | 0 | 0 | — | 0 |
| Neutrophils decrease, Grade 2 — Grade 0 | 0 | 0 | — | 0 |
| Neutrophils decrease, Grade 2 — Grade 1 | 1 | 1 | — | 1 |
| Neutrophils decrease, Grade 2 — Grade 2 | 2 | 0 | — | 1 |
| Neutrophils decrease, Grade 2 — Grade 3 | 0 | 0 | — | 0 |
| Neutrophils decrease, Grade 2 — Grade 4 | 0 | 0 | — | 0 |
| Platelet count decrease, Unknown — Unknown | 1 | 0 | — | 0 |
| Platelet count decrease, Unknown — Grade 0 | 2 | 2 | — | 1 |
| Platelet count decrease, Unknown — Grade 1 | 0 | 0 | — | 0 |
| Platelet count decrease, Unknown — Grade 2 | 0 | 0 | — | 0 |
| Platelet count decrease, Unknown — Grade 3 | 1 | 0 | — | 0 |
| Platelet count decrease, Unknown — Grade 4 | 0 | 0 | — | 0 |
| Platelet count decrease, Grade 0 — Unknown | 0 | 0 | 0 | 0 |
| Platelet count decrease, Grade 0 — Grade 0 | 94 | 94 | 97 | 100 |
| Platelet count decrease, Grade 0 — Grade 1 | 1 | 1 | 1 | 1 |
| Platelet count decrease, Grade 0 — Grade 2 | 1 | 0 | 1 | 0 |
| Platelet count decrease, Grade 0 — Grade 3 | 0 | 0 | 0 | 0 |
| Platelet count decrease, Grade 0 — Grade 4 | 0 | 0 | 0 | 0 |
| Platelet count decrease, Grade 1 — Unknown | — | 0 | — | — |
| Platelet count decrease, Grade 1 — Grade 0 | — | 0 | — | — |
| Platelet count decrease, Grade 1 — Grade 1 | — | 1 | — | — |
| Platelet count decrease, Grade 1 — Grade 2 | — | 0 | — | — |
| Platelet count decrease, Grade 1 — Grade 3 | — | 0 | — | — |
| Platelet count decrease, Grade 1 — Grade 4 | — | 0 | — | — |
| WBC decrease, Unknown — Unknown | 0 | — | — | 0 |
| WBC decrease, Unknown — Grade 0 | 1 | — | — | 1 |
| WBC decrease, Unknown — Grade 1 | 0 | — | — | 0 |
| WBC decrease, Unknown — Grade 2 | 0 | — | — | 0 |
| WBC decrease, Unknown — Grade 3 | 0 | — | — | 0 |
| WBC decrease, Unknown — Grade 4 | 0 | — | — | 0 |
| WBC decrease, Grade 0 — Unknown | 0 | 0 | 0 | 0 |
| WBC decrease, Grade 0 — Grade 0 | 92 | 95 | 94 | 94 |
| WBC decrease, Grade 0 — Grade 1 | 6 | 3 | 4 | 4 |
| WBC decrease, Grade 0 — Grade 2 | 0 | 0 | 0 | 0 |
| WBC decrease, Grade 0 — Grade 3 | 0 | 0 | 0 | 0 |
| WBC decrease, Grade 0 — Grade 4 | 0 | 0 | 0 | 0 |
| WBC decrease, Grade 1 — Unknown | 0 | — | 0 | 0 |
| WBC decrease, Grade 1 — Grade 0 | 0 | — | 0 | 0 |
| WBC decrease, Grade 1 — Grade 1 | 1 | — | 0 | 3 |
| WBC decrease, Grade 1 — Grade 2 | 0 | — | 1 | 0 |
| WBC decrease, Grade 1 — Grade 3 | 0 | — | 0 | 0 |
| WBC decrease, Grade 1 — Grade 4 | 0 | — | 0 | 0 |
| WBC increase, Unknown — Unknown | 0 | — | — | 0 |
| WBC increase, Unknown — Grade 0 | 1 | — | — | 1 |
| WBC increase, Unknown — Grade 1 | 0 | — | — | 0 |
| WBC increase, Unknown — Grade 2 | 0 | — | — | 0 |
| WBC increase, Unknown — Grade 3 | 0 | — | — | 0 |
| WBC increase, Unknown — Grade 4 | 0 | — | — | 0 |
| WBC increase, Grade 0 — Unknown | 0 | 0 | 0 | 0 |
| WBC increase, Grade 0 — Grade 0 | 95 | 85 | 91 | 88 |
| WBC increase, Grade 0 — Grade 1 | 3 | 9 | 5 | 11 |
| WBC increase, Grade 0 — Grade 2 | 1 | 0 | 0 | 0 |
| WBC increase, Grade 0 — Grade 3 | 0 | 0 | 0 | 0 |
| WBC increase, Grade 0 — Grade 4 | 0 | 0 | 0 | 0 |
| WBC increase, Grade 1 — Unknown | — | 0 | 0 | 0 |
| WBC increase, Grade 1 — Grade 0 | — | 1 | 1 | 1 |
| WBC increase, Grade 1 — Grade 1 | — | 3 | 1 | 0 |
| WBC increase, Grade 1 — Grade 2 | — | 0 | 0 | 1 |
| WBC increase, Grade 1 — Grade 3 | — | 0 | 0 | 0 |
| WBC increase, Grade 1 — Grade 4 | — | 0 | 0 | 0 |
| WBC increase, Grade 2 — Unknown | — | — | 0 | — |
| WBC increase, Grade 2 — Grade 0 | — | — | 0 | — |
| WBC increase, Grade 2 — Grade 1 | — | — | 1 | — |
| WBC increase, Grade 2 — Grade 2 | — | — | 0 | — |
| WBC increase, Grade 2 — Grade 3 | — | — | 0 | — |
| WBC increase, Grade 2 — Grade 4 | — | — | 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 ≥ 8 ED60.
| Titers | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Anti-RSV.A, Day 60 | 715.4 (615.8 to 831.1) | 831.9 (733.0 to 944.1) | 965.1 (827.7 to 1125.4) | 311.6 (269.0 to 360.8) |
| Anti-RSV.A, Day 90 | 566.5 (494.9 to 648.4) | 732.1 (640.2 to 837.2) | 902.8 (776.4 to 1049.9) | 319.6 (274.2 to 372.4) |
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.
| Titers | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Anti-RSV.B, Day 0 | 385.6 (318.4 to 466.9) | 392.1 (334.3 to 460.0) | 410.6 (346.5 to 486.5) | 340.2 (289.0 to 400.4) |
| Anti-RSV.B, Day 30 | 909.1 (778.5 to 1061.6) | 1004.1 (886.5 to 1137.4) | 1131.7 (987.3 to 1297.2) | 357.7 (309.0 to 414.0) |
| Anti-RSV.B, Day 60 | 752.1 (646.7 to 874.6) | 847.1 (746.8 to 960.9) | 923.6 (813.2 to 1048.8) | 409.6 (359.2 to 467.1) |
| Anti-RSV.B, Day 90 | 667.8 (572.8 to 778.7) | 804.9 (699.4 to 926.3) | 848.6 (731.4 to 984.7) | 423.2 (359.2 to 498.6) |
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.
| µg/mL | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| PCA, Day 60 | 55.2 (48.8 to 62.5) | 69.0 (62.4 to 76.4) | 66.7 (58.7 to 75.8) | 6.4 (5.8 to 7.1) |
| PCA, Day 90 | 47.6 (42.3 to 53.5) | 57.9 (51.4 to 65.1) | 57.0 (50.0 to 64.9) | 7.4 (6.5 to 8.6) |
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.
| ng/mL | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Anti-NEO, Day 0 | 32.9 (29.2 to 37.1) | 32.0 (28.7 to 35.7) | 33.5 (29.3 to 38.3) | 34.5 (30.0 to 39.5) |
| Anti-NEO, Day 30 | 32.9 (29.5 to 36.7) | 31.5 (28.4 to 34.9) | 33.1 (29.3 to 37.4) | 34.7 (30.2 to 39.9) |
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.
| Participants | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Number of Subjects With Any Medically Attended (MA) Respiratory Tract Infections (RTIs) Associated With RSV | 21 | 11 | 10 | 9 |
Collected over Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSK3003891A Vaccine Formulation 1 Group | 0/100 (0%) | 1/100 (1%) | 88/100 (88%) |
| GSK3003891A Vaccine Formulation 2 Group | 0/99 (0%) | 3/99 (3%) | 86/99 (86.9%) |
| GSK3003891A Vaccine Formulation 3 Group | 0/99 (0%) | 2/99 (2%) | 83/99 (83.8%) |
| Control Group | 0/102 (0%) | 2/102 (2%) | 76/102 (74.5%) |
| Event | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| Campylobacter gastroenteritisInfections and infestations | 0/100 | 0/99 | 1/99 | 0/102 |
| Soft tissue infectionInfections and infestations | 0/100 | 1/99 | 0/99 | 0/102 |
| Lung adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/100 | 1/99 | 0/99 | 0/102 |
| Pancreatic carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/100 | 1/99 | 0/99 | 0/102 |
| HemiparesisNervous system disorders | 0/100 | 0/99 | 1/99 | 0/102 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/100 | 1/99 | 0/99 | 0/102 |
| Biliary colicHepatobiliary disorders | 1/100 | 0/99 | 0/99 | 0/102 |
| Peritonsillar abscessInfections and infestations | 0/100 | 0/99 | 0/99 | 1/102 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 0/100 | 0/99 | 0/99 | 1/102 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 0/100 | 0/99 | 0/99 | 1/102 |
| Event | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group |
|---|---|---|---|---|
| HeadacheNervous system disorders | 54/100 | 47/99 | 47/99 | 47/102 |
| PainGeneral disorders | 52/100 | 52/99 | 51/99 | 11/102 |
| FatigueGeneral disorders | 47/100 | 43/99 | 45/99 | 42/102 |
| Gastrointestinal disorderGastrointestinal disorders | 22/100 | 24/99 | 14/99 | 11/102 |
| RhinitisInfections and infestations | 13/100 | 3/99 | 7/99 | 6/102 |
| ErythemaSkin and subcutaneous tissue disorders | 6/100 | 10/99 | 8/99 | 1/102 |
| Upper respiratory tract infectionInfections and infestations | 3/100 | 9/99 | 8/99 | 1/102 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 9/100 | 4/99 | 4/99 | 5/102 |
| PyrexiaGeneral disorders | 8/100 | 8/99 | 6/99 | 4/102 |
| SwellingGeneral disorders | 4/100 | 6/99 | 7/99 | 0/102 |
| Age, Continuous(Years) | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group | Total |
|---|---|---|---|---|---|
| Mean | 30.2 ± 6.7 | 29.1 ± 7.2 | 29.6 ± 7.1 | 29.9 ± 6.9 | 29.7 ± 7.0 |
| Sex: Female, Male(Participants) | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group | Total |
|---|---|---|---|---|---|
| Female | 100 | 99 | 99 | 102 | 400 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | GSK3003891A Vaccine Formulation 1 Group | GSK3003891A Vaccine Formulation 2 Group | GSK3003891A Vaccine Formulation 3 Group | Control Group | Total |
|---|---|---|---|---|---|
| Geographic Ancestry — African Heritage/African American | 1 | 0 | 2 | 1 | 4 |
| Geographic Ancestry — Asian - Central/South Asian Heritage | 1 | 1 | 0 | 0 | 2 |
| Geographic Ancestry — Asian - East Asian Heritage | 0 | 0 | 1 | 0 | 1 |
| Geographic Ancestry — Asian - South East Asian Heritage | 0 | 0 | 0 | 1 | 1 |
| Geographic Ancestry — White - Arabic/North African Heritage | 0 | 1 | 2 | 1 | 4 |
| Geographic Ancestry — White - Caucasian/European Heritage | 96 | 97 | 93 | 98 | 384 |
| Geographic Ancestry — Unspecified | 2 | 0 | 1 | 1 | 4 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Respiratory Syncytial Virus Infections→
GlaxoSmithKline