| Primary | Number of Subjects With Abnormal Biochemical Laboratory Values. | Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CRE]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0. | The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Day 7 | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | | OG001 | Boostrix Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrixâ„¢ vaccine, intramuscularly in the deltoid region of the arm, at Day 0 |
| | | Title | Denominators | Categories |
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| ALT, Within-Bellow | - ParticipantsOG00049
- ParticipantsOG00151
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| Primary | Number of Subjects With Abnormal Biochemical Laboratory Values. | Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CRE]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0. | The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Day 30 | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | | OG001 | Boostrix Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrixâ„¢ vaccine, intramuscularly in the deltoid region of the arm, at Day 0 |
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| Primary | Number of Subjects With Abnormal Haematological Laboratory Values. | Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC. | The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Day 7 | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | | OG001 | Boostrix Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrixâ„¢ vaccine, intramuscularly in the deltoid region of the arm, at Day 0 |
| |
| Primary | Number of Subjects With Abnormal Haematological Laboratory Values. | Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC. | The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Day 30 | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | | OG001 | Boostrix Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrixâ„¢ vaccine, intramuscularly in the deltoid region of the arm, at Day 0 |
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| Primary | Number of Subjects With Abnormal Haematological Laboratory Values. | Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT | The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Day 7 | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | | OG001 | Boostrix Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrixâ„¢ vaccine, intramuscularly in the deltoid region of the arm, at Day 0 |
| |
| Primary | Number of Subjects With Abnormal Haematological Laboratory Values. | Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT. | The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Day 30 | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | | OG001 | Boostrix Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrixâ„¢ vaccine, intramuscularly in the deltoid region of the arm, at Day 0 |
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| Primary | Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading | Among biochemical parameters tested were ALT, AST and CRE, graded by FDA toxicity grading for biochemistry parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Day 7 up to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | | OG001 | Boostrix Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrixâ„¢ vaccine, intramuscularly in the deltoid region of the arm, at Day 0 |
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| Primary | Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading | Among haematological parameters tested were EOS, decreased Hgb and LYM graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented | Posted | | Count of Participants | | Participants | | From Day 7 up to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | | OG001 | Boostrix Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrixâ„¢ vaccine, intramuscularly in the deltoid region of the arm, at Day 0 |
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| Primary | Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading | Among haematological parameters tested were NEU, PLT, decreased WBC and increased WBC/I, graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Day 7 up to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | | OG001 | Boostrix Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrixâ„¢ vaccine, intramuscularly in the deltoid region of the arm, at Day 0 |
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| Primary | Number of Subjects With Haematology Change From Baseline by Maximum Grade | Assessed laboratory parameter changed from baseline was haemoglobin (Hgb). FDA grading for Hgb (change from baseline) was not applicable a baseline. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Day 7 up to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | | OG001 | Boostrix Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrixâ„¢ vaccine, intramuscularly in the deltoid region of the arm, at Day 0 |
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| Primary | Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimetres (mm) of injection site. All solicited local symptoms are considered as related to the vaccination. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented. | Posted | | Count of Participants | | Participants | | During a 7-day follow-up period (from Day 0 to Day 6) after vaccination | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | | OG001 | Boostrix Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrixâ„¢ vaccine, intramuscularly in the deltoid region of the arm, at Day 0 |
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| Primary | Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were fatigue, temperature (defined as oral temperature equal to or above [≥] 37.5 degrees Celsius [°C] for oral, axillary or tympanic route), gastrointestinal symptoms (gastro) including nausea, vomiting, diarrhoea and/or abdominal pain; and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented. | Posted | | Count of Participants | | Participants | | During a 7-day follow-up period (from Day 0 to Day 6) after vaccination | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | | OG001 | Boostrix Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrixâ„¢ vaccine, intramuscularly in the deltoid region of the arm, at Day 0 |
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| Primary | Number of Subjects With Unsolicited Adverse Events (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 out-side 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 (TVC), which included all subjects with study vaccine administration documented. | Posted | | Count of Participants | | Participants | | During a 30-day follow-up period (from Day 0 to Day 29) after vaccination | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | | OG001 | Boostrix Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrixâ„¢ vaccine, intramuscularly in the deltoid region of the arm, at Day 0 |
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| Primary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented. | Posted | | Count of Participants | | Participants | | From vaccination (Day 0) up to study end (Day 30) | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | | OG001 | Boostrix Group | Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrixâ„¢ vaccine, intramuscularly in the deltoid region of the arm, at Day 0 |
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