| Primary | Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose of Vaccination | Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling is scored with a diameter larger than (>) 20 millimeters (mm). | The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after first dose of vaccination administered at Day 1 | | | | ID | Title | Description |
|---|
| OG000 | RSV_PreF3_AS01B Group | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. | | OG001 | Placebo Group | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
| | | Title | Denominators | Categories |
|---|
| Erythema | | | | Pain | | |
| |
| Primary | Number of Subjects With Solicited Local AEs After Second Dose of Vaccination | Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling was scored with a diameter larger than (>) 20 millimeters (mm). | The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after second dose of vaccination administered at Day 61 | | | | ID | Title | Description |
|---|
| OG000 | RSV_PreF3_AS01B Group | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. | | OG001 | Placebo Group | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
| |
| Primary | Number of Subjects With Solicited General AEs After First Dose of Vaccination | Assessed solicited general AEs solicited were: arthralgia; fatigue; fever (any temperature greater than or equal to 38.0 °C - the preferred location for measuring temperature being the oral cavity); gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain); headache; myalgia and shivering. | The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after first dose of vaccination administered at Day 1 | | | | ID | Title | Description |
|---|
| OG000 | RSV_PreF3_AS01B Group | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. | | OG001 | Placebo Group | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
| |
| Primary | Number of Subjects With Solicited General AEs After Second Dose of Vaccination | Assessed solicited general AEs solicited are: arthralgia; fatigue; fever (any temperature greater than or equal to 38.0 °C - the preferred location for measuring temperature being the oral cavity); gastrointestinal symptoms including (nausea, vomiting, diarrhea and/or abdominal pain); headache; myalgia and shivering. | The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after second dose of vaccination administered at Day 61 | | | | ID | Title | Description |
|---|
| OG000 | RSV_PreF3_AS01B Group | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. | | OG001 | Placebo Group | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
| |
| Primary | Number of Subjects With Unsolicited AEs After Any Vaccination | An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. | The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after any vaccination (across doses) | | | | ID | Title | Description |
|---|
| OG000 | RSV_PreF3_AS01B Group | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. | | OG001 | Placebo Group | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
| |
| Primary | Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 | Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 1 (pre-vaccination dose 1=baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as below, within or above the normal ranges. | The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 7 days after the first vaccine dose (i.e. at Day 8 versus Day 1) | | | | ID | Title | Description |
|---|
| OG000 | RSV_PreF3_AS01B Group | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. | | OG001 | Placebo Group | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
|
| Primary | Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 | Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 61 (pre-vaccination dose 2=baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as below, within or above the normal ranges. | The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | At 7 days after the second vaccine dose (i.e at Day 68 versus Day 61) | | | | ID | Title | Description |
|---|
| OG000 | RSV_PreF3_AS01B Group | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. | | OG001 | Placebo Group | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
|
| Primary | Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After First Dose of Vaccination | A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy. | The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | During a 30-day follow-up period (i.e., on the day of vaccination at Day 1, and 29 subsequent days) after first vaccination | | | | ID | Title | Description |
|---|
| OG000 | RSV_PreF3_AS01B Group | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. | | OG001 | Placebo Group | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
| |
| Primary | Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After Second Dose of Vaccination | A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy. | The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | During a 30-day follow-up period (i.e., on the day of vaccination at Day 61, and 29 subsequent days) after second vaccination | | | | ID | Title | Description |
|---|
| OG000 | RSV_PreF3_AS01B Group | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. | | OG001 | Placebo Group | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
| |
| Primary | Number of Subjects With Any Serious Adverse Events (SAEs) up to 30 Days After the Second Vaccination | A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. | The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Day 1 up to 30 days after the second vaccination (Day 91) | | | | ID | Title | Description |
|---|
| OG000 | RSV_PreF3_AS01B Group | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. | | OG001 | Placebo Group | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
| |
| Primary | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days After the Second Vaccination | pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology | The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Day 1 up to 30 days after the second vaccination (Day 91) | | | | ID | Title | Description |
|---|
| OG000 | RSV_PreF3_AS01B Group | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. | | OG001 | Placebo Group | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
| |
| Secondary | Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of Neutralizing Antibody Titers Against RSV- Serotype A | Serological assays for the determination of functional antibodies against RSV-A were performed by neutralization assay. Anti RSV-A neutralizing antibody titers are given as geometric mean titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60). The cut-off of the assay is 18 ED60. | The analysis was performed on the Per Protocol Set (PPS) that included all subjects who received at least 1 dose of the study treatment to which they were randomized and had post-vaccination data, minus subjects with protocol deviations that led to exclusion. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91) | | | | ID | Title | Description |
|---|
| OG000 | RSV_PreF3_AS01B Group | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. | | OG001 | Placebo Group | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
|
| Secondary | Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations | The detection and the quantification of total IgG antibodies directed against RSVPreF3 in human serum samples are based on an indirect enzyme-linked immunosorbent assay (ELISA). Anti RSVPreF3 antibody concentration is given in geometric mean concentration (GMC) and is expressed in ELISA Laboratory Units per milliliter (ELU/mL). The assay cut-off is 25 ELU/mL. | The analysis was performed on the PPS that included all subjects who received at least 1 dose of the study treatment to which they were randomized and had post-vaccination data, minus subjects with protocol deviations that led to exclusion. | Posted | | Geometric Mean | 95% Confidence Interval | ELU/mL | | At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91) | | | | ID | Title | Description |
|---|
| OG000 | RSV_PreF3_AS01B Group | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. | | OG001 | Placebo Group | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
|
| Secondary | Number of Subjects With Any SAEs, up the End of Follow-up Study Period (Month 14) | A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. | The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Day 1 up to the end of follow-up period (Month 14) | | | | ID | Title | Description |
|---|
| OG000 | RSV_PreF3_AS01B Group | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. | | OG001 | Placebo Group | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
| |
| Secondary | Number of Subjects Reporting pIMDs up to the End of Follow-up Study Period (Month 14) | pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. | The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Day 1 up to the end of follow-up period (Month 14) | | | | ID | Title | Description |
|---|
| OG000 | RSV_PreF3_AS01B Group | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. | | OG001 | Placebo Group | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
| |
| Secondary | Number of Subjects With Respiratory Tract Infection (RTI) Episodes Reported During RTI Surveillance | The number of RTI cases is provided by group. Reported categories are "RSV+ RTI" (= RTI episode tested as RSV positive by quantitative reverse transcription polymerase chain reaction (qRT-PCR) on nasal/throat swab collected at assessment visit) and "RSV- RTI" (= RTI episode tested as RSV negative by qRT-PCR on nasal/throat swab collected at assessment visit). | The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the RSV seasons from Day 1 to Month 14 | | | | ID | Title | Description |
|---|
| OG000 | RSV_PreF3_AS01B Group | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. | | OG001 | Placebo Group | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
| |