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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000357-26 | EudraCT Number |
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The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA). In addition, this study will evaluate immunogenicity, safety and reactogenicity from co-administration of RSV MAT vaccine and GSK's quadrivalent seasonal influenza (Flu D-QIV) vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSV lot1 Group | Experimental | Participants randomized to the RSV lot1 Group received one dose of RSV MAT Lot 1 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. |
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| RSV lot2 Group | Experimental | Participants randomized to the RSV lot2 Group received one dose of RSV MAT Lot 2 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. |
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| RSV lot3 Group | Experimental | Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. |
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| RSV+Flu pooled Group | Experimental | Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSVPreF3(120 μg) | Combination Product | A single dose of RSVPreF3(120 μg) combined with Sodium Chloride (NaCl) was administrated intramuscular (IM). There were used 3 different lots of RSVPreF3(120 μg), one for each individual group (RSV lot1 Group, RSV lot2 Group and RSV lot3 Group) considered under RSV pooled Group. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Solicited Administration Site Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group | Assessed solicited administration site events include pain, erythema and swelling. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | From Day 1 to Day 7 (including Day 7) |
| Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group | Assessed solicited systemic events include fatigue, headache, gastrointestinal (GI) symptoms (nausea, vomiting, diarrhea, abdominal pain) and fever. The preferred location for measuring temperature was the oral cavity. Fever was defined as temperature equal to or above (≥) 38.0 °C/ 100.4°F. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | From Day 1 to Day 7 (including Day 7) |
| Percentage of Participants Reporting Unsolicited Adverse Events (AEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group | 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 is reported as an unsolicited adverse event. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| RSV A Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31 | Serological assays for the determilnation of antibodies against RSV A were performed by neutralization assay. RSV A neutralizing antibody titers were expressed as geometric mean titers (GMTs), in serum dilution inducing 60% inhibition in plaque forming units (ED60). This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV A neutralizing antibody. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine. |
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Inclusion Criteria:
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study specific procedure.
Healthy female participants; as established by medical history and clinical examination, aged 18 to 49 years at the time of the first study intervention administration.
No local condition precluding injection in both left and right deltoid muscles.
Exclusion Criteria:
Medical conditions
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions;
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination;
Current autoimmune disorder, for which the participant has received immune-modifying therapy within 6 months, before study vaccination;
Hypersensitivity to latex;
Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities or any other clinical conditions, as determined by physical examination or medical history that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study;
Significant or uncontrolled psychiatric illness;
Recurrent history or uncontrolled neurological disorders or seizures;
Documented HIV-positive participant;
Body mass index > 40 kg/m^2;
Any clinically significant* hematological parameter and/or biochemical laboratory abnormality.
*The investigator should use his/her clinical judgment to decide which abnormalities are clinically significant.
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
Prior/Concomitant therapy
Prior/Concurrent clinical study experience Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product;
Other exclusions
Only healthy non-pregnant women 18-49 YOA are included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | West Palm Beach | Florida | 33409 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38970327 | Derived | Chime N, Anspach B, Jain V, Laajalahti O, Ollinger T, Yaplee D, Kim JH. Phase 3 Study Assessing Lot-to-Lot Consistency of Respiratory Syncytial Virus Prefusion Protein F3 Vaccine and Its Immune Response, Safety, and Reactogenicity When Co-administered With Quadrivalent Influenza Vaccine. J Infect Dis. 2025 Feb 4;231(1):e144-e153. doi: 10.1093/infdis/jiae342. |
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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, key secondary endpoints and safety data 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.
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As pre-specified in statistical plan, data reported in Participant Flow, Baseline Characteristics and Adverse Events were presented for individual RSV lot groups, pooled RSV+Flu group (since minimal differences were expected between participants who received different RSV lots of the vaccine) and Flu+Placebo Group. As pre-specified in protocol, immunogenicity outcome measures presented data for the pooled RSV and RSV+Flu groups, and individual RSV lot groups were used for lot-to-lot analyses.
Out of 1586 participants enrolled,47 participants did not receive vaccination as they did not meet the eligibility criteria or they were lost to follow up, therefore only 1539 participants were included in the Exposed Set and started the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | RSV lot1 Group | Participants randomized to the RSV lot1 Group received one dose of RSV MAT Lot 1 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. |
| FG001 | RSV lot2 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 | May 26, 2022 | Jun 2, 2023 |
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Observer-blind (lot-to-lot consistency) & single-blind (immunogenicity, safety and reactogenicity)
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| Flu+Placebo Group | Active Comparator | Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group. |
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| Flu Quadrivalent influenza vaccine (15 μg HA) | Combination Product | A single dose of Flu Quadrivalent influenza (15 μg HA) vaccine was administrated intramuscular (IM). |
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| Placebo | Combination Product | One dose of placebo, administered intramuscularly in the deltoid region of the right arm, at Day 1. |
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| From Day 1 to Day 30 (including Day 30) |
| Percentage of Participants Reporting Serious Adverse Events (SAEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results i+F2n abnormal pregnancy outcomes. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | From Day 1 to Day 30 (including Day 30) |
| Percentage of Participants Reporting SAEs in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in abnormal pregnancy outcomes.This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | From first vaccination up to study end (Day 1 to Day 181) |
| RSV MAT Immunoglobulin G (IgG) Enzyme-Linked Immunosorbent Assay (ELISA) Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 31 | Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EU/mL). As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze RSV MAT IgG ELISA concentrations, in order to demonstrate the lot-to-lot consistency of the vaccine lots. | At Day 31 |
| Flu D-QIV Haemagglutinin Inhibition (HI) Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31 | Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | At Day 31 |
| At Day 1 and Day 31 |
| Seroconversion Rate (SCR) to Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31 | The SCR was defined as the percentage of participants with: a Day 1 (pre-vaccination) serum anti-HI titer <1:10 and a Day 31 (post-vaccination) serum anti-HI titer ≥1:40, or a Day 1 (pre-vaccination) serum anti-HI titer ≥ 1:10 and a fold increase (post/pre) ≥ 4 at Day 31. The 3 influenza strains assessed were: A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019 and B/Phuket/3073/2013. This objective analyzed the seroconversion rate to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | At Day 31 |
| RSV B Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31 | Serological assays for the determination of antibodies against RSV B were performed by neutralization assay. RSV B neutralizing antibody titers were expressed as GMTs, in ED60. This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV B neutralizing antibody. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine. | At Day 1 and Day 31 |
| RSV MAT IgG Concentrations for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31 | Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as GMCs, in EU/mL. This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV MAT IgG concentrations. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine. | At Day 1 and Day 31 |
| Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 | Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221;B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | At Day 1 and Day 31 |
| Seroprotection Rate (SPR) to Flu D-QIV HI Antibody Titers for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 | SPR was measured by the percentage of participants achieving an HI antibody titer ≥1:40. This objective analyzed the seroprotection rate to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | At Day 1 and Day 31 |
| RSV A Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31 | Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. RSV A neutralizing antibody titers were expressed as GMTs, in ED60. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the humoral immune response of RSV A neutralizing antibody titers, in order to demonstrate the lot-to-lot consistency of the vaccine lots. | At Day 1 and Day 31 |
| RSV B Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31 | Serological assays for the determination of antibodies against RSV B were performed by neutralization assay. RSV B neutralizing antibody titers were expressed as GMTs, in ED60. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the humoral immune response of RSV B neutralizing antibody titers, in order to demonstrate the lot-to-lot consistency of the vaccine lots. | At Day 1 and Day 31 |
| RSV MAT IgG Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31 | Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as GMCs, in EU/mL. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the RSV MAT IgG concentration, in order to demonstrate the lot-to-lot consistency of the vaccine lots. | At Day 1 and Day 31 |
| Stockbridge |
| Georgia |
| 30281 |
| United States |
| GSK Investigational Site | Peoria | Illinois | 61614 | United States |
| GSK Investigational Site | Springfield | Missouri | 65802 | United States |
| GSK Investigational Site | Seattle | Washington | 98105 | United States |
| GSK Investigational Site | Surrey | British Columbia | V3S 2N6 | Canada |
| GSK Investigational Site | Vancouver | British Columbia | V6Z 2T1 | Canada |
| GSK Investigational Site | Truro | Nova Scotia | B2N 1L2 | Canada |
| GSK Investigational Site | London | Ontario | N5W 6A2 | Canada |
| GSK Investigational Site | Sarnia | Ontario | N7T 4X3 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| GSK Investigational Site | Mirabel | Quebec | J7J 2K8 | Canada |
| GSK Investigational Site | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| GSK Investigational Site | Québec | Quebec | G1W 4R4 | Canada |
| GSK Investigational Site | Saint-Charles-Borromée | Quebec | J6E 2B4 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1L 0H8 | Canada |
| GSK Investigational Site | Espoo | 02230 | Finland |
| GSK Investigational Site | Helsinki | 00100 | Finland |
| GSK Investigational Site | Helsinki | 00930 | Finland |
| GSK Investigational Site | Jarvenpaa | 04400 | Finland |
| GSK Investigational Site | Kokkola | 67100 | Finland |
| GSK Investigational Site | Pori | 28100 | Finland |
| GSK Investigational Site | Seinäjoki | 60100 | Finland |
| GSK Investigational Site | Tampere | 33100 | Finland |
| GSK Investigational Site | Turku | 20520 | Finland |
| GSK Investigational Site | Gyeonggi-do | 15355 | South Korea |
| GSK Investigational Site | Seoul | 07441 | South Korea |
| GSK Investigational Site | Seoul | 08308 | South Korea |
| GSK Investigational Site | Alcorcón/Madrid | 28922 | Spain |
| GSK Investigational Site | Madrid | 28006 | Spain |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | Madrid | 28041 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Majadahonda (Madrid) | 28222 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15706 | Spain |
| GSK Investigational Site | Valencia | 46015 | Spain |
Participants randomized to the RSV lot2 Group received one dose of RSV MAT Lot 2 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. |
| FG002 | RSV lot3 Group | Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. |
| FG003 | RSV+Flu Pooled Group | Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines. |
| FG004 | Flu+Placebo Group | Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | RSV lot1 Group | Participants randomized to the RSV lot1 Group received one dose of RSV MAT Lot 1 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. |
| BG001 | RSV lot2 Group | Participants randomized to the RSV lot2 Group received one dose of RSV MAT Lot 2 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. |
| BG002 | RSV lot3 Group | Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. |
| BG003 | RSV+Flu Pooled Group | Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines. |
| BG004 | Flu+Placebo Group | Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| 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 | |||||||||||||||||||||||||||
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| Primary | Percentage of Participants Reporting Solicited Administration Site Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group | Assessed solicited administration site events include pain, erythema and swelling. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | Analysis was performed on the Solicited Safety Set (SSS), which includes all participants who received at least 1 dose of the study intervention (Exposed Set [ES]) and who have solicited safety data. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 to Day 7 (including Day 7) |
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| Primary | Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group | Assessed solicited systemic events include fatigue, headache, gastrointestinal (GI) symptoms (nausea, vomiting, diarrhea, abdominal pain) and fever. The preferred location for measuring temperature was the oral cavity. Fever was defined as temperature equal to or above (≥) 38.0 °C/ 100.4°F. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | Analysis was performed on the Solicited Safety Set (SSS), which includes all participants who received at least 1 dose of the study intervention (Exposed Set [ES]) and who have solicited safety data. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 to Day 7 (including Day 7) |
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| Primary | Percentage of Participants Reporting Unsolicited Adverse Events (AEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group | 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 is reported as an unsolicited adverse event. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | Analysis was performed on the ES (Exposed Set), which includes all participants who received at least 1 dose of the study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 to Day 30 (including Day 30) |
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| Primary | Percentage of Participants Reporting Serious Adverse Events (SAEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results i+F2n abnormal pregnancy outcomes. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | Analysis was performed on the ES, which includes all participants who received at least 1 dose of the study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 to Day 30 (including Day 30) |
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| Primary | Percentage of Participants Reporting SAEs in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in abnormal pregnancy outcomes.This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | Analysis is performed on the ES, which includes all participants who received at least 1 dose of the study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | From first vaccination up to study end (Day 1 to Day 181) |
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| Primary | RSV MAT Immunoglobulin G (IgG) Enzyme-Linked Immunosorbent Assay (ELISA) Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 31 | Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EU/mL). As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze RSV MAT IgG ELISA concentrations, in order to demonstrate the lot-to-lot consistency of the vaccine lots. | Analysis was performed on the Per Protocol Set (PPS), only on the participants who received only 1 dose of RSV MAT vaccine (from RSV MAT vaccine Lot 1, Lot 2 or Lot 3), and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | At Day 31 |
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| Primary | Flu D-QIV Haemagglutinin Inhibition (HI) Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31 | Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | Analysis was performed on the Per Protocol Set (PPS), only on the participants who received 1 dose of Flu D-QIV vaccine and optionally other study treatment, and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 31 |
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| Secondary | RSV A Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31 | Serological assays for the determilnation of antibodies against RSV A were performed by neutralization assay. RSV A neutralizing antibody titers were expressed as geometric mean titers (GMTs), in serum dilution inducing 60% inhibition in plaque forming units (ED60). This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV A neutralizing antibody. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine. | Analysis was performed on the Per Protocol Set (PPS), only on the participants who received 1 dose of RSV MAT vaccine (from one of the 3 lots used) and optionally other study treatment, and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 1 and Day 31 |
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| Secondary | Seroconversion Rate (SCR) to Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31 | The SCR was defined as the percentage of participants with: a Day 1 (pre-vaccination) serum anti-HI titer <1:10 and a Day 31 (post-vaccination) serum anti-HI titer ≥1:40, or a Day 1 (pre-vaccination) serum anti-HI titer ≥ 1:10 and a fold increase (post/pre) ≥ 4 at Day 31. The 3 influenza strains assessed were: A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019 and B/Phuket/3073/2013. This objective analyzed the seroconversion rate to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | Analysis was performed on the Per Protocol Set (PPS), only on the participants who received 1 dose of Flu D-QIV vaccine and optionally other study treatment, and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 31 |
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| Secondary | RSV B Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31 | Serological assays for the determination of antibodies against RSV B were performed by neutralization assay. RSV B neutralizing antibody titers were expressed as GMTs, in ED60. This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV B neutralizing antibody. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine. | Analysis was performed on the Per Protocol Set (PPS), only on the participants who received 1 dose of RSV MAT vaccine (from one of the 3 lots used) and optionally other study treatment, and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 1 and Day 31 |
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| Secondary | RSV MAT IgG Concentrations for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31 | Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as GMCs, in EU/mL. This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV MAT IgG concentrations. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine. | Analysis was performed on the Per Protocol Set (PPS), only on the participants who received 1 dose of RSV MAT vaccine (from one of the 3 lots used) and optionally other study treatment, and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | At Day 1 and Day 31 |
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| Secondary | Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 | Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221;B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | Analysis was performed on the Per Protocol Set (PPS), only on the participants who received 1 dose of Flu D-QIV vaccine and optionally other study treatment, and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 1 and Day 31 |
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| Secondary | Seroprotection Rate (SPR) to Flu D-QIV HI Antibody Titers for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 | SPR was measured by the percentage of participants achieving an HI antibody titer ≥1:40. This objective analyzed the seroprotection rate to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine. | Analysis was performed on the Per Protocol Set (PPS), only on the participants who received 1 dose of Flu D-QIV vaccine and optionally other study treatment, and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 1 and Day 31 |
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| Secondary | RSV A Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31 | Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. RSV A neutralizing antibody titers were expressed as GMTs, in ED60. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the humoral immune response of RSV A neutralizing antibody titers, in order to demonstrate the lot-to-lot consistency of the vaccine lots. | Analysis was performed on the Per Protocol Set (PPS), only on the participants who received only 1 dose of RSV MAT vaccine (from RSV MAT vaccine Lot 1, Lot 2 or Lot 3), and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 1 and Day 31 |
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| Secondary | RSV B Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31 | Serological assays for the determination of antibodies against RSV B were performed by neutralization assay. RSV B neutralizing antibody titers were expressed as GMTs, in ED60. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the humoral immune response of RSV B neutralizing antibody titers, in order to demonstrate the lot-to-lot consistency of the vaccine lots. | Analysis was performed on the Per Protocol Set (PPS), only on the participants who received only 1 dose of RSV MAT vaccine (from RSV MAT vaccine Lot 1, Lot 2 or Lot 3), and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 1 and Day 31 |
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| Secondary | RSV MAT IgG Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31 | Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as GMCs, in EU/mL. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the RSV MAT IgG concentration, in order to demonstrate the lot-to-lot consistency of the vaccine lots. | Analysis was performed on the Per Protocol Set (PPS), only on the participants who received only 1 dose of RSV MAT vaccine (from RSV MAT vaccine Lot 1, Lot 2 or Lot 3), and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | At Day 1 and Day 31 |
|
Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included.
As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
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 | RSV lot1 Group | Participants randomized to the RSV lot1 Group received one dose of RSV MAT Lot 1 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. | 0 | 220 | 2 | 220 | 182 | 220 |
| EG001 | RSV lot2 Group | Participants randomized to the RSV lot2 Group received one dose of RSV MAT Lot 2 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. | 0 | 223 | 1 | 223 | 193 | 223 |
| EG002 | RSV lot3 Group | Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. | 0 | 218 | 2 | 218 | 194 | 218 |
| EG003 | RSV+Flu Pooled Group | Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines. | 0 | 438 | 4 | 438 | 409 | 438 |
| EG004 | Flu+Placebo Group | Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group. | 0 | 440 | 4 | 440 | 396 | 440 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint ankylosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Greater trochanteric pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Optic neuropathy | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Administration site pain | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Administration site swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Administration site erythema | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site lymphadenopathy | General disorders | MedDRA | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Chills | General disorders | MedDRA | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
| |
| Administration site warmth | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site extravasation | General disorders | MedDRA | Systematic Assessment |
| |
| Vaccination site haematoma | General disorders | MedDRA | Systematic Assessment |
| |
| Vaccination site rash | General disorders | MedDRA | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA | Systematic Assessment |
| |
| Temperature regulation disorder | General disorders | MedDRA | Systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Idiopathic intracranial hypertension | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness exertional | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhoids thrombosed | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasal herpes | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Eczema impetiginous | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Vulvovaginitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bacterial vulvovaginitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Aphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary calcification | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle contracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Axillary mass | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| External ear inflammation | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Excessive cerumen production | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Eustachian tube disorder | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fascial rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Menstrual disorder | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Eye symptom | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eczema eyelids | Eye disorders | MedDRA | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Smear cervix abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| High risk sexual behaviour | Social circumstances | MedDRA | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Immunisation reaction | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Supernumerary teeth | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | 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 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2022 | Jun 2, 2023 | SAP_001.pdf |
Not provided
| 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
| Male |
|
| ASIAN |
|
| BLACK OR AFRICAN AMERICAN |
|
| NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER |
|
| OTHER |
|
| WHITE |
|
|
| Swelling |
|
| RSV+Flu Pooled Group |
Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines. |
| OG002 | Flu+Placebo Group | Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group. |
|
|
Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181).
The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.
| OG002 | Flu+Placebo Group | Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group. |
|
|
Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines. |
| OG002 | Flu+Placebo Group | Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group. |
|
|
Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines. |
| OG002 | Flu+Placebo Group | Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group. |
|
|
| OG002 | RSV lot3 Group | Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. |
|
|
|
| OG001 | Flu+Placebo Group | Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group. |
|
|
|
| OG001 | RSV+Flu Pooled Group | Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines. |
|
|
|
| OG001 | Flu+Placebo Group | Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group. |
|
|
|
| RSV+Flu Pooled Group |
Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines. |
|
|
| RSV+Flu Pooled Group |
Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines. |
|
|
| OG001 | Flu+Placebo Group | Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group. |
|
|
Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group. |
|
|
| OG002 | RSV lot3 Group | Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. |
|
|
| OG002 | RSV lot3 Group | Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. |
|
|
| OG002 | RSV lot3 Group | Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. |
|
|