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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000623-21 | EudraCT Number |
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The aim of this study is to assess the immunogenicity, safety and reactogenicity of the RSV PreFusion protein 3 older adult (RSVPreF3 OA) investigational vaccine when co-administered with an adjuvanted quadrivalent influenza (FLU aQIV) vaccine, in adults aged 65 years of age (YOA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Co-Ad Group | Experimental | Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study. |
|
| Control Group | Active Comparator | Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSVPreF3 OA vaccine | Biological | One dose of RSVPreF3 OA vaccine administered intramuscularly. |
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| Measure | Description | Time Frame |
|---|---|---|
| Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 FLU Vaccine Strains Expressed as Group Geometric Mean Titers (GMTs) at 1 Month After FLU Vaccine Dose | HI antibodies assessed were antibodies against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata flu strains. | At 1 month after the FLU vaccine dose (Day 31 for both groups) |
| RSV-A Neutralizing Antibody Titers Expressed as GMTs | RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dilution 60 (ED60). | At 1 month after the RSVPreF3 OA dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) |
| RSV-B Neutralizing Antibody Titers Expressed as GMTs | RSV B neutralizing antibodies are given as GMTs and expressed as Estimated Dilution 60 (ED60). | At 1 month after the RSVPreF3 OA dose (Day 31 for the CoAd Group and Day 61 for the Control Group) |
| Measure | Description | Time Frame |
|---|---|---|
| HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains | SCR for HI antibody is defined as the percentage of participants who have either a HI predose titer less than (<) 1:10 and a post-dose titer greater than or equal to (>=) 1:40, or a pre-dose titer >= 1:10 and at least a 4-fold increase in post-dose titer. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata. |
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Inclusion Criteria:
Exclusion Criteria:
Medical conditions
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 (drug or invasive medical device).
Other exclusions
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Edegem | 2650 | Belgium | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39099085 | Background | Clark R, Davies S, Labrador J, Loubet P, Natalini Martinez S, Morinigo HM, Nicolas JF, Vera MP, Ramet M, Rebollo-Rodrigo MH, Sanz-Munoz I, Dezutter N, Germain S, David MP, Jayadev A, Amare Hailemariam H, Kotb S, Meyer N. Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion F Protein Vaccine when Co-administered with Adjuvanted Seasonal Quadrivalent Influenza Vaccine in Older Adults: A Phase 3 Randomized Trial. Clin Infect Dis. 2024 Oct 15;79(4):1088-1098. doi: 10.1093/cid/ciae365. |
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GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
This study assessed the immunogenicity, safety and reactogenicity of the RSVPre3 OA vaccine when co-administered with an adjuvanted quadrivalent influenza (FLU-aQIV [FLU]) vaccine, in adults aged 65 years old or above.
All 1045 enrolled participants were randomized to Co-Ad and Control Groups and received at least 1 dose of study intervention and were included in the exposed set.
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| ID | Title | Description |
|---|---|---|
| FG000 | Co-Ad Group | Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study. |
| FG001 | Control 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 | Dec 16, 2022 | Feb 16, 2024 |
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| FLU vaccine | Biological | One dose of FLU vaccine administered intramuscularly. |
|
|
| At 1 month after the FLU vaccine dose (Day 31 for both groups) |
| RSV-A Neutralization Antibody Titers Expressed as Mean Geometric Increase (MGI) | MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer. | At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group) |
| RSV-B Neutralization Antibody Titers Expressed as MGI | MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer. | At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group) |
| Titers for HI Antibodies Against 4 FLU Vaccine Strains | HI antibodies assessed were antibodies against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata flu strains. HI antibodies were expressed as GMT, in titers. | At Day 1 (Baseline) and Day 31 |
| HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains | SPR for HI antibody was defined as the percentage of participants with a serum HI titer >= 1:40. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata. | At Day 1 (Baseline) and Day 31 |
| HI Antibody Titers for 4 FLU Vaccine Strains Expressed as MGI | MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata. | At 1 month after the FLU dose (Day 31 for both groups) compared to pre-vaccination (Day 1 for both groups) |
| Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration | The solicited administration site events after vaccination include erythema, pain and swelling. | Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for CoAd Group and at Day 1 and Day 31 for Control group) |
| Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration | The solicited systemic events after vaccination include fever, headache, fatigue, myalgia and arthralgia. | Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 and Day 31 for C-oAd Group and at Day 1 and Day 31 for Control group) |
| Percentage of Participants Reporting Unsolicited Adverse Events (AEs) | An unsolicited AEs is an AE that is not included in a list of solicited events using a Participant Electronic Diary. Unsolicited events must be spontaneously communicated by a participant who signs the informed consent. Unsolicited AEs include both serious, non-serious AEs and potential immune-mediated diseases (pIMDs). | Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administration |
| Percentage of Participants Reporting at Least One Serious Adverse Event (SAEs) | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. | From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group) |
| Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMDs) | pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. The investigator must exercise his/her medical/scientific judgment to determine whether other diseases have an autoimmune origin (i.e., pathophysiology involving systemic or organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD. | From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group) |
| Erpent |
| 5101 |
| Belgium |
| GSK Investigational Site | Genk | 3600 | Belgium |
| GSK Investigational Site | Ieper | 8900 | Belgium |
| GSK Investigational Site | Espoo | 02230 | Finland |
| GSK Investigational Site | Helsinki | 00100 | Finland |
| GSK Investigational Site | Kokkola | 67100 | Finland |
| GSK Investigational Site | Oulu | 90220 | Finland |
| GSK Investigational Site | Seinäjoki | 60100 | Finland |
| GSK Investigational Site | Tampere | 33100 | Finland |
| GSK Investigational Site | Angers | 49000 | France |
| GSK Investigational Site | Clermont-Ferrand | 63003 | France |
| GSK Investigational Site | Limoges | 87042 | France |
| GSK Investigational Site | Lyon | 69317 | France |
| GSK Investigational Site | Montpellier | 34295 | France |
| GSK Investigational Site | Nîmes | 30029 | France |
| GSK Investigational Site | Paris | 75679 | France |
| GSK Investigational Site | Pierre-Bénite | 69495 | France |
| GSK Investigational Site | Marbella - Málaga | Andalusia | 29603 | Spain |
| GSK Investigational Site | Benalmádena, Málaga | 29630 | Spain |
| GSK Investigational Site | Boadilla Del Monte (Madrid) | 28660 | Spain |
| GSK Investigational Site | Burgos | 09006 | Spain |
| GSK Investigational Site | Centelles | 08540 | Spain |
| GSK Investigational Site | La Roca Del Valles (Barcelona) | 08430 | Spain |
| GSK Investigational Site | Madrid | 28006 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Salamanca | 37007 | Spain |
| GSK Investigational Site | Santander (Cantabria) | 39008 | Spain |
| GSK Investigational Site | Valladolid | 47005 | Spain |
| GSK Investigational Site | Vic | 28500 | Spain |
| GSK Investigational Site | Soham | Cambridgeshire | CB7 5JD | United Kingdom |
| GSK Investigational Site | Bollington | Cheshire | SK10 5JH | United Kingdom |
| GSK Investigational Site | Chippenham | Wiltshire | SN15 2SB | United Kingdom |
| GSK Investigational Site | Blackpool | FY3 7EN | United Kingdom |
| GSK Investigational Site | Bristol | BS37 4AX | United Kingdom |
| GSK Investigational Site | Chippenham | SN14 6GT | United Kingdom |
| GSK Investigational Site | Peterborough | PE8 6PL | United Kingdom |
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Co-Ad Group | Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study. |
| BG001 | Control Group | Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 FLU Vaccine Strains Expressed as Group Geometric Mean Titers (GMTs) at 1 Month After FLU Vaccine Dose | HI antibodies assessed were antibodies against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata flu strains. | Analysis was performed on Per Protocol Set for FLU analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At 1 month after the FLU vaccine dose (Day 31 for both groups) |
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| Primary | RSV-A Neutralizing Antibody Titers Expressed as GMTs | RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dilution 60 (ED60). | Analysis was performed on Per Protocol Set for RSV OA analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-RSVPreF3 OA vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At 1 month after the RSVPreF3 OA dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) |
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| Primary | RSV-B Neutralizing Antibody Titers Expressed as GMTs | RSV B neutralizing antibodies are given as GMTs and expressed as Estimated Dilution 60 (ED60). | Analysis was performed on Per Protocol Set for RSV OA analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-RSVPreF3 OA vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At 1 month after the RSVPreF3 OA dose (Day 31 for the CoAd Group and Day 61 for the Control Group) |
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| Secondary | HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains | SCR for HI antibody is defined as the percentage of participants who have either a HI predose titer less than (<) 1:10 and a post-dose titer greater than or equal to (>=) 1:40, or a pre-dose titer >= 1:10 and at least a 4-fold increase in post-dose titer. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata. | Analysis was performed on Per Protocol Set for FLU analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1 month after the FLU vaccine dose (Day 31 for both groups) |
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| Secondary | RSV-A Neutralization Antibody Titers Expressed as Mean Geometric Increase (MGI) | MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer. | Analysis was performed on Per Protocol Set for RSV OA analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-RSVPreF3 OA vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group) |
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| Secondary | RSV-B Neutralization Antibody Titers Expressed as MGI | MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer. | Analysis was performed on Per Protocol Set for RSV OA analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-RSVPreF3 OA vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group) |
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| Secondary | Titers for HI Antibodies Against 4 FLU Vaccine Strains | HI antibodies assessed were antibodies against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata flu strains. HI antibodies were expressed as GMT, in titers. | Analysis was performed on Per Protocol Set for FLU analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 1 (Baseline) and Day 31 |
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| Secondary | HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains | SPR for HI antibody was defined as the percentage of participants with a serum HI titer >= 1:40. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata. | Analysis was performed on Per Protocol Set for FLU analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 1 (Baseline) and Day 31 |
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| Secondary | HI Antibody Titers for 4 FLU Vaccine Strains Expressed as MGI | MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata. | Analysis was performed on Per Protocol Set for FLU analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At 1 month after the FLU dose (Day 31 for both groups) compared to pre-vaccination (Day 1 for both groups) |
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| Secondary | Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration | The solicited administration site events after vaccination include erythema, pain and swelling. | Analysis was performed on Exposed set which included participants who received a study intervention and with the electronic diary completed post-each vaccination and for whom solicited administration event data was available for specific visit. The Control group received FLU vaccination at Day 1 and RSVPreF3 OA vaccination at Day 31; Co-Ad group received co-administered vaccine (RSVPreF3 OA + FLU) on Day 1. Analysis per group is based on the study intervention administered on specific visit. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for CoAd Group and at Day 1 and Day 31 for Control group) |
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| Secondary | Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration | The solicited systemic events after vaccination include fever, headache, fatigue, myalgia and arthralgia. | Analysis was performed on Exposed set which included participants who received a study intervention and with the electronic diary completed post-each vaccination and for whom solicited administration event data was available for specific visit. The Control group received FLU vaccination at Day 1 and RSVPreF3 OA vaccination at Day 31; Co-Ad group received co-administered vaccine (RSVPreF3 OA + FLU) on Day 1. Analysis per group is based on the study intervention administered on specific visit. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 and Day 31 for C-oAd Group and at Day 1 and Day 31 for Control group) |
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| Secondary | Percentage of Participants Reporting Unsolicited Adverse Events (AEs) | An unsolicited AEs is an AE that is not included in a list of solicited events using a Participant Electronic Diary. Unsolicited events must be spontaneously communicated by a participant who signs the informed consent. Unsolicited AEs include both serious, non-serious AEs and potential immune-mediated diseases (pIMDs). | Analysis was performed on Exposed set which included participants who received at least a study intervention and had data for the assessed timepoint and analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administration |
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| Secondary | Percentage of Participants Reporting at Least One Serious Adverse Event (SAEs) | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. | Analysis was performed on Exposed set which included participants who received at least a study intervention and had data for the assessed timepoint and analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group) |
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| Secondary | Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMDs) | pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. The investigator must exercise his/her medical/scientific judgment to determine whether other diseases have an autoimmune origin (i.e., pathophysiology involving systemic or organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD. | Analysis was performed on Exposed set which included participants who received at least a study intervention and had data for the assessed timepoint and analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group) |
|
Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Co-Ad Group | Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study. | 0 | 523 | 21 | 523 | 427 | 523 |
| EG001 | Control Group | Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study. | 6 | 522 | 36 | 522 | 428 | 522 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | v26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | v26.0 | Systematic Assessment |
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| Respiratory syncytial virus infection | Infections and infestations | v26.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Bacterial disease carrier | Infections and infestations | v26.0 | Systematic Assessment |
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| Complicated appendicitis | Infections and infestations | v26.0 | Systematic Assessment |
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| Erysipelas | Infections and infestations | v26.0 | Systematic Assessment |
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| Infected skin ulcer | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Infective exacerbation of bronchiectasis | Infections and infestations | v26.0 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Retroperitoneal abscess | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Superinfection | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | v26.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | v26.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | v26.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | v26.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | v26.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | v26.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | v26.0 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | v26.0 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | v26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
| |
| Ocular melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
| |
| Oesophageal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
| |
| Small intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Posterior capsule rupture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Wound necrosis | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | v26.0 | Systematic Assessment |
| |
| Giant cell arteritis | Vascular disorders | v26.0 | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | v26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | v26.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | v26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | v26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | v26.0 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | v26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | v26.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | v26.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | v26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | v26.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | v26.0 | Systematic Assessment |
| |
| Administration site erythema | General disorders | v26.0 | Systematic Assessment |
| |
| Administration site pain | General disorders | v26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | v26.0 | Systematic Assessment |
| |
| Chills | General disorders | v26.0 | Systematic Assessment |
| |
| Inflammation | General disorders | v26.0 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | v26.0 | Systematic Assessment |
| |
| Malaise | General disorders | v26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | v26.0 | Systematic Assessment |
| |
| Pain | General disorders | v26.0 | Systematic Assessment |
| |
| Vessel puncture site swelling | General disorders | v26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | v26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Abscess oral | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Infected bite | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Immunisation reaction | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Muscle contusion | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | v26.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | v26.0 | Systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | v26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | v26.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | v26.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | v26.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | v26.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | v26.0 | Systematic Assessment |
| |
| Neovascular age-related macular degeneration | Eye disorders | v26.0 | Systematic Assessment |
| |
| Hypochromic anaemia | Blood and lymphatic system disorders | v26.0 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | v26.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | v26.0 | Systematic Assessment |
| |
| Occult blood positive | Investigations | v26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | v26.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | v26.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | v26.0 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | v26.0 | 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 | Dec 21, 2022 | Feb 16, 2024 | SAP_001.pdf |
| 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
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Multiple |
|
| Other - Unspecified |
|
| Flu A/Victoria/2570/2019 H1N1 |
|
|
| Flu B/Austria/1359417/2021 Victoria |
|
|
| Flu B/Phuket/3073/2013 Yamagata |
|
|
The non-inferiority is demonstrated if the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is less than or equal (<=) 1.5. |
| To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Victoria/2570/2019 H1N1 influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups). | GMT Ratio | 1.04 | 2-Sided | 0.95 | 0.91 | 1.18 | The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is <=1.5. |
| To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Austria/1359417/2021 influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups). | GMT Ratio | 0.97 | 2-Sided | 0.95 | 0.90 | 1.06 | The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is <=1.5. |
| To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the Flu vaccine administered alone, in terms of HI GMTs against the Flu B/Phuket/3073/2013 Yamagata influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups). | GMT Ratio | 1.04 | 2-Sided | 0.95 | 0.95 | 1.13 | The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is <=1.5. |
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