| 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 = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented and with the symptoms sheet filled in. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A 30 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG001 | GSK3003891A 60 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG002 | GSK3003891A 60 Adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG003 | Boostrix Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
| | Units | Counts |
|---|
| Participants | - OG000124
- OG001119
- OG002124
- OG003
|
| | Title | Denominators | Categories |
|---|
| Any Pain | | | Title | Measurements |
|---|
| - OG00062
- OG00168
- OG002104
- OG003
|
|
| |
| Primary | Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms (symp.) were headache, fever [defined as oral temperature (temp.) equal to or above 37.5 degrees Celsius (°C)], fatigue, gastrointestinal (Gastro.) symptoms [nausea, vomiting, diarrhoea and/or abdominal pain]. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 (G3) symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented and with the symptoms sheet filled in. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A 30 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG001 | GSK3003891A 60 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
|
| 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 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 subjects with study vaccines administration documented. | Posted | | Count of Participants | | Participants | | During the 30-Day (Days 0-29) post-vaccination period | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A 30 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG001 | GSK3003891A 60 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
|
| 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, which included all subjects with study vaccines administration documented. | Posted | | Count of Participants | | Participants | | From vaccination at Day 0, up to Day 30 post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A 30 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG001 | GSK3003891A 60 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG002 | GSK3003891A 60 Adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
|
| Primary | Titres of RSV-A Neutralizing Antibodies | RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At Day 0 pre-vaccination | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A 30 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG001 | GSK3003891A 60 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG002 |
|
| Primary | Titres of RSV-A Neutralizing Antibodies | RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At Day 30 post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A 30 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG001 | GSK3003891A 60 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG002 |
|
| Secondary | Titres of RSV-A Neutralizing Antibodies | RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At Day 60 post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A 30 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG001 | GSK3003891A 60 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG002 | GSK3003891A 60 Adjuvanted Group |
|
| Secondary | Titres of RSV-A Neutralizing Antibodies | RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch. | Posted | | Geometric Mean | 95% Confidence Interval | Titres | | At Day 90 post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A 30 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG001 | GSK3003891A 60 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG002 | GSK3003891A 60 Adjuvanted Group |
|
| Secondary | Concentrations of Palivizumab Competing Antibodies (PCA) | Palivizumab competing antibody concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Day 0 pre-vaccination | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A 30 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG001 | GSK3003891A 60 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG002 | GSK3003891A 60 Adjuvanted Group |
|
| Secondary | Concentrations of PCA | PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Day 30 post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A 30 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG001 | GSK3003891A 60 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG002 | GSK3003891A 60 Adjuvanted Group | |
|
| Secondary | Concentrations of PCA | PCA concentrations, expressed as Geometric Mean Concentrations (GMCs).The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Day 60 post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A 30 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG001 | GSK3003891A 60 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG002 | GSK3003891A 60 Adjuvanted Group | |
|
| Secondary | Concentrations of PCA | PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Day 90 post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A 30 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG001 | GSK3003891A 60 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG002 | GSK3003891A 60 Adjuvanted Group | |
|
| Secondary | Number of Subjects With 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 subjects with study vaccines administration documented. | Posted | | Count of Participants | | Participants | | Up to study end at Day 360 | | | | ID | Title | Description |
|---|
| OG000 | GSK3003891A 30 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG001 | GSK3003891A 60 Non-adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | | OG002 | GSK3003891A 60 Adjuvanted Group | Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. |
|