| Primary | Number of Subjects With Any Solicited Local Adverse Events (AEs) During a 7-day Follow-up Period After the First Vaccination (Administered at Day 1) | Assessed solicited local AEs are erythema, pain and swelling at injection site. Any = occurrence of the adverse event regardless of intensity grade. Any redness and swelling = adverse event reported with a surface diameter greater than 0 millimeters. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, active comparators pooled and placebo groups separately to compare the expected adverse events observed from routine pediatric vaccines (active comparators) with the investigational RSV vaccine. Placebo was not pooled with active comparators as no significant difference was expected in AEs when placebo was pooled with active comparators. As pre-specified in the protocol, the choice of active comparator or placebo was based on each participating country's standard of care. | Analysis was performed on the Exposed set, which included all subjects with at least 1 study vaccine administration documented and diary card completed after first vaccination. | Posted | | Count of Participants | | Participants | | During a 7-day follow-up period after the first vaccination (administered at Day 1) | | | | ID | Title | Description |
|---|
| OG000 | RSV1D Pooled Group | Subjects received the interventions as follows:
- Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
- Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
| | OG001 | RSV2D Pooled Group | Subjects received the interventions as follows:
- Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
- Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.
| | OG002 | Placebo Group | Subjects received 2 doses of Placebo alone (administered at Days 1 and 31). | | OG003 | Active Comparators Pooled Group | Subjects received either one of interventions schedule as follows:
- 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).
- 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).
- 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).
- 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .
|
| | Units | Counts |
|---|
| Participants | - OG00065
- OG00171
- OG00222
- OG003
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| | Title | Denominators | Categories |
|---|
| Any Erythema | | |
| |
| Primary | Number of Subjects With Any Solicited Local Adverse Events (AEs) During a 7-day Follow-up Period After the Second Vaccination (Administered at Day 31) | Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, active comparators pooled and placebo groups separately to compare the expected adverse events observed from routine pediatric vaccines (active comparators) with the investigational RSV vaccine. Placebo was not pooled with active comparators as no significant difference was expected in AEs when placebo was pooled with active comparators. As pre-specified in the protocol, the choice of active comparator or placebo was based on each participating country's standard of care. | Analysis was performed on Exposed set, which included all subjects with at least 1 study vaccine administration documented and diary card completed after second vaccination. | Posted | | Count of Participants | | Participants | | During a 7-day follow-up period after the second vaccination (administered at Day 31) | | | | ID | Title | Description |
|---|
| OG000 | RSV1D Pooled Group | Subjects received the interventions as follows:
- Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
- Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
|
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| Primary | Number of Subjects With Any Solicited General AEs During a 7-day Follow-up Period After the First Vaccination (Administered at Day 1) | Assessed solicited general adverse events are drowsiness, fever [defined as temperature equal to or above (>=) 38.degrees Celsius (C)/100.4 Fahrenheit (F) by any route], irritability/fussiness and loss of appetite. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, each of the active comparators and placebo groups separately as the study interest was to investigate solicited AEs during the follow-up period of RSV vaccine administration, compared to placebo and routine pediatric vaccines, especially comparing to the rates of Bexsero-related fever. As pre-specified in the protocol, the choice of active comparator or placebo was based on each participating country's standard of care. | Analysis was performed on the Exposed set, which included all subjects with at least 1 study vaccine administration documented and diary card completed after first vaccination. | Posted | | Count of Participants | | Participants | | During a 7-day follow-up period after the first vaccination (administered at Day 1) | | | | ID | Title | Description |
|---|
| OG000 | RSV1D Pooled Group | Subjects received the interventions as follows:
- Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
- Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
|
|
| Primary | Number of Subjects With Any Solicited General AEs During a 7-day Follow-up Period After the Second Vaccination (Administered at Day 31) | Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, each of the active comparators and placebo groups separately as the study interest was to investigate solicited AEs during the follow-up period of RSV vaccine administration, compared to placebo and routine pediatric vaccines, especially comparing to the rates of Bexsero-related fever. As pre-specified in the protocol, the choice of active comparator or placebo was based on each participating country's standard of care. | Analysis was performed on the Exposed set, which included all subjects with at least 1 study vaccine administration documented and diary card completed after second vaccination. | Posted | | Count of Participants | | Participants | | During a 7-day follow-up period after the second vaccination (administered at Day 31) | | | | ID | Title | Description |
|---|
| OG000 | RSV1D Pooled Group | Subjects received the interventions as follows:
- Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
- Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
|
|
| Primary | 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. Unsolicited AEs are 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 study vaccination. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups. | The analysis was performed on the Exposed set, which included all subjects with at least one study vaccine administration documented. Study interest was to check unsolicited AEs only during the follow-up period of study RSV vaccine. | Posted | | Count of Participants | | Participants | | During a 30-day follow-up period across the 2 vaccinations administered at Day 1 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | RSV1D Pooled Group | Subjects received the interventions as follows:
- Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
- Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
|
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| Primary | Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61 | Assessed serious adverse events (SAEs) include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of theindividual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups. | The analysis was performed on the Exposed set, which included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Day 1 up to Day 61 | | | | ID | Title | Description |
|---|
| OG000 | RSV1D Pooled Group | Subjects received the interventions as follows:
- Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
- Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
|
|
| Primary | Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Special Interest) | Any episode of spontaneous or excessive bleeding if occurring after vaccination was to be fully investigated with a full range of hematological tests to identify the underlying cause and reported as an AE of special interest. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups. | The analysis was performed on the Exposed set, which included all subjects with at least one study vaccine administration documented. Study interest was to check episode of spontaneous or excessive bleeding (AE of special interest) only during the follow-up period of study RSV vaccine. | Posted | | Count of Participants | | Participants | | During a 30-day follow-up period across the 2 vaccinations administered at Day 1 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | RSV1D Pooled Group | Subjects received the interventions as follows:
- Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
- Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
|
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| Secondary | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI), Severe RSV-LRTI and Very Severe RSV-LRTI (According to Standardized Case Definitions) | According to standardized case definitions,RSV-RTI is a subject having runny nose/blocked nose/ cough & confirmed RSV infection.RSV-LRTI is a subject having history of cough/ difficulty breathing[based on history reported by parents] & blood oxygen saturation (SpO2) lower than(<)95 percent (%)/ respiratory rate (RR) increase & confirmed RSV infection Severe RSV-LRTI-Cases meeting RSV-LRTI case definition & an SpO2<93 %/lower chest wall in-drawing. Very severe RSV-LRTI-Cases meeting RSV-LRTI case definition & an SpO2<90%/inability to feed/failure to respond/unconscious.Analysis of this outcome measure was reported for RSV1D pooled, RSV2D pooled & comparator_placebo pooled groups as data was collected based on different standard of care provided at participating countries rather than randomization to each of the groups.Per the pre-specified analysis plan,data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups | The analysis was performed on the Exposed set, which included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year) | | | | ID | Title | Description |
|---|
| OG000 | RSV1D Pooled Group | Subjects received the interventions as follows:
- Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
- Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
|
|
| Secondary | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI and Very Severe RSV-LRTI (According to Standardized Case Definitions) | Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups. | The analysis was performed on the Exposed set, which included all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | From first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years) | | | | ID | Title | Description |
|---|
| OG000 | RSV1D Pooled Group | Subjects received the interventions as follows:
- Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
- Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
| |
|
| Secondary | Number of Subjects With SAEs From First Vaccination (Day 1) up to the End of the Second RSV Transmission Season (up to 2 Years) | Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the 15 groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups. | The analysis was performed on the Exposed set, which includes all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | From first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years) | | | | ID | Title | Description |
|---|
| OG000 | RSV1D Pooled Group | Subjects received the interventions as follows:
- Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
- Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
| |
|
| Secondary | Number of Subjects With RSV-LRTI (AE of Special Interest) From First Vaccination (Day 1) up to the End of the First RSV Transmission Season (up to 1 Year) | Subjects experiencing an LRTI associated with RSV infection were reported as AE of special interest. To identify RSV-LRTI for the purpose of AE of specific interest, the diagnosis was based on the investigators' clinical judgment taking into account the clinical history, the examination, relevant medical investigations and locally-available diagnostic test for RSV. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups. | The analysis was performed on the Exposed set, which includes all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year) | | | | ID | Title | Description |
|---|
| OG000 | RSV1D Pooled Group | Subjects received the interventions as follows:
- Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
- Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
|
|
| Secondary | Number of Subjects With RSV-LRTI (AE of Special Interest) From First Vaccination (Day 1) up to the End of the Second RSV Transmission Season (up to 2 Years) | Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups. | The analysis was performed on the Exposed set, which includes all subjects with at least one study vaccine administration documented. | Posted | | Count of Participants | | Participants | | From first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years) | | | | ID | Title | Description |
|---|
| OG000 | RSV1D Pooled Group | Subjects received the interventions as follows:
- Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
- Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
|
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| Secondary | Number of RSV Infected Subjects With a Negative RSV Exposure Status (at Screening Based on In-stream Baseline Serological Testing) With Very Severe RSV-LRTI (According to Standardized Case Definition) | Very severe RSV LRTI are cases meeting the case definition of RSV-LRTI AND a SpO2 <90%, OR inability to feed, OR failure to respond/unconscious. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups. | The analysis was performed on the Exposed set with a negative RSV exposure status, which included all vaccinated subjects assessed as RSV unexposed at screening based on in-stream baseline serological testing. | Posted | | Count of Participants | | Participants | | From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year) | | | | ID | Title | Description |
|---|
| OG000 | RSV1D Pooled Group | Subjects received the interventions as follows:
- Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
- Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
|
|
| Secondary | Anti-RSV-A Neutralizing Antibody Titers | Humoral response to the investigational RSV vaccine was measured in terms of anti-RSV-A neutralizing antibody titers and expressed as geometric mean titers (GMTs) in Estimated Dilution 60 (ED60) titers. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups. | The analysis was performed on the Per-protocol set for analysis of immunogenicity, which included all subjects with at least one study vaccine administration documented, who complied with eligibility criteria, study procedures up to the end of the study and had immunogenicity results for the specified assay and time point. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At pre-vaccination (Screening), Day 31, Day 61 and at the end of the first RSV transmission season (EOS1) (up to 1 year) | | | | ID | Title | Description |
|---|
| OG000 | RSV1D Pooled Group | Subjects received the interventions as follows:
- Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
- Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
|
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| Secondary | Anti-RSV-F Antibody Concentrations | Humoral response to the investigational RSV vaccine was measured in terms of anti-RSV-F antibody concentrations and expressed as geometric mean concentrations (GMCs) in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL). Analysis of this outcome measure was reported for the RSV1D pooled, RSV2D pooled, and comparator_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups. | The analysis was performed on the Per-protocol set for analysis of immunogenicity, which included all subjects with at least one study vaccine administration documented, who complied with eligibility criteria, study procedures up to the end of the study and had immunogenicity results for the specified assay and time point. | Posted | | Geometric Mean | 95% Confidence Interval | EU/mL | | At pre-vaccination (Screening), Day 31, Day 61 and at the end of the first RSV transmission season (EOS1) (up to 1 year) | | | | ID | Title | Description |
|---|
| OG000 | RSV1D Pooled Group | Subjects received the interventions as follows:
- Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
- Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
|
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