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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001135-12 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK3003891A vaccine formulation 1 Group | Experimental | Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0. |
|
| GSK3003891A vaccine formulation 2 Group | Experimental | Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
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| GSK3003891A vaccine formulation 3 Group | Experimental | Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
|
| Control Group | Placebo Comparator | Subjects in this group received a single placebo injection at Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSV Vaccine (GSK3003891A) formulation 1 | Biological | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | During the 7-day (Days 0-6) post-vaccination period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject prior to performance of any study specific procedure.
Non-pregnant female between, and including, 18 and 45 years of age at the time of study vaccination.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Female subjects of non-childbearing potential may be enrolled in the study
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Use of any investigational or non-registered product other than the study vaccines within 30 days prior to study vaccination, or planned use during the study period.
Concurrently participating in the active phase of another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Chronic administration of immunosuppressants or other immune-modifying drugs, as well as administration of long-acting immune-modifying drugs, within 6 months prior to study vaccination, or planned administration until 90 days post-vaccination. For corticosteroids, this will mean prednisone ≥ 10 mg/day, or equivalent. Inhaled and topical steroids are allowed.
Administration of immunoglobulins and/or any blood products during the period starting 3 months before the study vaccination, or planned administration until 90 days post-vaccination.
Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before or after study vaccination.
Previous experimental vaccination against RSV.
History of any neurological disorders or seizures.
Family history of congenital or hereditary immunodeficiency.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
History of or current autoimmune disease
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by physical examination and/or Medical History.
Lymphoproliferative disorder or malignancy within previous 5 years.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
Hypersensitivity to latex.
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
Current alcohol and/or drug abuse.
Acute disease and/or fever at the time of enrolment.
Body mass index (BMI) > 40 kg/m².
Pregnant or lactating female.
Planned move to a location that will prohibit participating in the trial until study conclusion.
Any other condition that the investigator judges may interfere with study procedures or findings.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ghent | 9000 | Belgium | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31951765 | Derived | Steff AM, Cadieux-Dion C, de Lannoy G, Prato MK, Czeszak X, Andre B, Ingels DC, Louckx M, Dewe W, Picciolato M, Maleux K, Fissette L, Dieussaert I. Hamster neogenin, a host-cell protein contained in a respiratory syncytial virus candidate vaccine, induces antibody responses in rabbits but not in clinical trial participants. Hum Vaccin Immunother. 2020 Jun 2;16(6):1327-1337. doi: 10.1080/21645515.2019.1693749. Epub 2020 Jan 17. | |
| 31418022 |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Out of 406 subjects initially enrolled in the study, 6 subjects had numbers allocated but did not receive any study vaccine dose, hence only 400 subjects were included in the Total Vaccinated Cohort.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK3003891A Vaccine Formulation 1 Group | Subjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0. |
| FG001 | GSK3003891A Vaccine Formulation 2 Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 21, 2017 | Aug 28, 2018 |
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| RSV Vaccine (GSK3003891A) formulation 2 | Biological | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm. |
|
| RSV Vaccine (GSK3003891A) formulation 3 | Biological | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm. |
|
| Placebo (Formulation buffer S9b) | Drug | A single dose of placebo is administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm. |
|
| 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). | 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). | 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). | 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). | At Day 30 |
| 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. | 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. | 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. | 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]. | 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]. | 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]. | 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]. | 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]. | 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. | 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. | 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. | 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. | 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. | From Day 0 up to study end, at Day 360 |
| Tallinn |
| 10117 |
| Estonia |
| GSK Investigational Site | Tartu | 50106 | Estonia |
| GSK Investigational Site | Clermont-Ferrand | 63003 | France |
| GSK Investigational Site | Paris | 75679 | France |
| GSK Investigational Site | Würzburg | Bavaria | 97070 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30159 | Germany |
| GSK Investigational Site | Goch | North Rhine-Westphalia | 47574 | Germany |
| Derived |
| Schwarz TF, McPhee RA, Launay O, Leroux-Roels G, Talli J, Picciolato M, Gao F, Cai R, Nguyen TL, Dieussaert I, Miller JM, Schmidt AC. Immunogenicity and Safety of 3 Formulations of a Respiratory Syncytial Virus Candidate Vaccine in Nonpregnant Women: A Phase 2, Randomized Trial. J Infect Dis. 2019 Oct 22;220(11):1816-1825. doi: 10.1093/infdis/jiz395. |
Subjects in this group received a single 60 µg dose injection of the investigational GSK3003891A vaccine at Day 0.
| FG002 | GSK3003891A Vaccine Formulation 3 Group | Subjects in this group received a single 120 µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| FG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK3003891A Vaccine Formulation 1 Group | Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| BG001 | GSK3003891A Vaccine Formulation 2 Group | Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| BG002 | GSK3003891A Vaccine Formulation 3 Group | Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| BG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period |
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| Primary | 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). | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptom sheets filled in. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period |
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| Primary | 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). | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period |
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| Primary | 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). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 30, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay at Day 0. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 0 |
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| Primary | 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). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 30, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay at Day 30. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 30 |
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| Primary | 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). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 30, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay at Day 0. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Day 0 |
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| Primary | 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). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 30, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay at Day 30. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Day 30 |
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| Secondary | 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. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptom sheets filled in. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period |
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| Secondary | 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. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptom sheets filled in. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period |
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| Secondary | 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. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | During the 30-day (Days 0-29) post-vaccination period |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | From Day 0 up to study end, at Day 360 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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]. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 7. | Posted | Count of Participants | Participants | At Day 7 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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]. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 30. | Posted | Count of Participants | Participants | At Day 30 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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]. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 60. | Posted | Count of Participants | Participants | At Day 60 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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]. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 90. | Posted | Count of Participants | Participants | At Day 90 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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]. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, during the considered period. | Posted | Count of Participants | Participants | From Day 7 up to Day 90 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 90, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay up to Day 90. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 60 and Day 90 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 90, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay up to Day 90. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 0, Day 30, Day 60 and Day 90 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 90, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay up to Day 90. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Day 60 and Day 90 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | This immunogenicity analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom immunogenicity results were available for this assay up to Day 30. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | At Day 0 and Day 30 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | From Day 0 up to study end, at Day 360 |
|
Solicited and unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (Day 0-Day 360).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK3003891A Vaccine Formulation 1 Group | Subjects in this group received a single 30µg dose injection of the investigational GSK3003891A vaccine at Day 0. | 0 | 100 | 1 | 100 | 88 | 100 |
| EG001 | GSK3003891A Vaccine Formulation 2 Group | Subjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0. | 0 | 99 | 3 | 99 | 86 | 99 |
| EG002 | GSK3003891A Vaccine Formulation 3 Group | Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. | 0 | 99 | 2 | 99 | 83 | 99 |
| EG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. | 0 | 102 | 2 | 102 | 76 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Biliary colic | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastric disorder | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Infective keratitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Salpingo-oophoritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Post procedural inflammation | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Facial neuralgia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Intercostal neuralgia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Retained placenta or membranes | Pregnancy, puerperium and perinatal conditions | MedDRA 21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Menstrual disorder | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Polymenorrhoea | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Premenstrual pain | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | shm60684@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2018 | Aug 28, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D022261 | Respiratory Syncytial Virus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
| Asian - Central/South Asian Heritage |
|
| Asian - East Asian Heritage |
|
| Asian - South East Asian Heritage |
|
| White - Arabic/North African Heritage |
|
| White - Caucasian/European Heritage |
|
| Unspecified |
|
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
Subjects in this group received a single 120 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0. |
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
Subjects in this group received a single 120 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0. |
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
| GSK3003891A Vaccine Formulation 3 Group |
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
|
|
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
| OG002 |
| GSK3003891A Vaccine Formulation 3 Group |
Subjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0. |
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
| OG003 | Control Group | Subjects in this group received a single placebo injection at Day 0. |
|
|
| Control Group |
Subjects in this group received a single placebo injection at Day 0. |
|
|
Subjects in this group received a single placebo injection at Day 0.
|
|
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