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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001356-34 | EudraCT Number |
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The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Co-Ad Group | Experimental | Participants received one dose of FLU-HD 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-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSVPreF3 OA investigational vaccine | Biological | RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs) | RSV-A neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60). | At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) |
| Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs | HI titers were assessed 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 strains. | At 1 month after the FLU vaccine dose (Day 31 for both groups) |
| RSV-B Neutralizing Titers Expressed as Group GMTs | RSV-B neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60). | At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) |
| Measure | Description | Time Frame |
|---|---|---|
| HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains | SCR for HI titers was 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
Note: In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is recommended and/or organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
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 intervention (drug/invasive medical device).
Other exclusions
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35205 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38981954 | Background | Buynak R, Cannon K, DeAtkine D, Kirby J, Usdan L, Bhavsar A, Gerard C, Kuznetsova A, Jayadev A, Amare H, Valenciano S, Meyer N. Randomized, Open-Label Phase 3 Study Evaluating Immunogenicity, Safety, and Reactogenicity of RSVPreF3 OA Coadministered with FLU-QIV-HD in Adults Aged >/= 65. Infect Dis Ther. 2024 Aug;13(8):1789-1805. doi: 10.1007/s40121-024-00985-4. Epub 2024 Jun 26. |
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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 Flu High-Dose vaccine (FLU-HD [FLU]), in adults aged 65 years old or above.
1029 participants received at least one dose of the 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-HD 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 19, 2022 | Mar 6, 2024 |
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| FLU HD vaccine | Biological | FLU HD vaccine administered intramuscularly in the deltoid region of the dominant arm (Co-Ad Group) or the non-dominant arm (Control Group). |
|
| At 1 month after the FLU vaccine dose (Day 31 for both groups) |
| RSV-A Neutralizing 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 Neutralizing 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) |
| HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT | HI titers were assessed 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 strains. HI antibodies were expressed as GMTs, in titers. | At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups) |
| HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains | SPR for HI titers was defined as the percentage of participants with a serum HI titer >= 1:40. The assessed Flu strains were: 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 and 1 month after FLU vaccine dose administration (Day 31 for both groups) |
| HI 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. | At 1 month after the FLU vaccine dose administration (Day 31 for both groups) |
| Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration | The solicited administration site events after vaccination included erythema, pain and swelling. | Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31) |
| Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration | The solicited systemic events after vaccination include arthralgia, fatigue, fever, headache and myalgia. | Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31) |
| 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 diary. Unsolicited events must have been 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 after vaccine administration (the day of vaccination and 29 subsequent days after vaccination) |
| Percentage of Participants Reporting Serious Adverse Events (SAEs) | 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. | From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group) |
| Percentage of Participants Reporting 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 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group) |
| Tempe |
| Arizona |
| 85281 |
| United States |
| GSK Investigational Site | Canoga Park | California | 91303 | United States |
| GSK Investigational Site | Colton | California | 92324 | United States |
| GSK Investigational Site | Sacramento | California | 95864 | United States |
| GSK Investigational Site | San Diego | California | 92103-6204 | United States |
| GSK Investigational Site | Walnut Creek | California | 94598 | United States |
| GSK Investigational Site | Aurora | Colorado | 80012 | United States |
| GSK Investigational Site | Coral Gables | Florida | 33134 | United States |
| GSK Investigational Site | Fort Myers | Florida | 33912 | United States |
| GSK Investigational Site | Hialeah | Florida | 33012 | United States |
| GSK Investigational Site | Immokalee | Florida | 34142 | United States |
| GSK Investigational Site | Miami | Florida | 33016 | United States |
| GSK Investigational Site | Miami | Florida | 33184 | United States |
| GSK Investigational Site | Orlando | Florida | 32801 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33409 | United States |
| GSK Investigational Site | Sandy Springs | Georgia | 30328 | United States |
| GSK Investigational Site | Savannah | Georgia | 31406 | United States |
| GSK Investigational Site | Chicago | Illinois | 60640 | United States |
| GSK Investigational Site | Evansville | Indiana | 47714 | United States |
| GSK Investigational Site | Mishawaka | Indiana | 46544 | United States |
| GSK Investigational Site | Valparaiso | Indiana | 46383 | United States |
| GSK Investigational Site | Ames | Iowa | 50010 | United States |
| GSK Investigational Site | El Dorado | Kansas | 67042 | United States |
| GSK Investigational Site | Methuen | Massachusetts | 01844 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55402 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Grand Island | Nebraska | 68803 | United States |
| GSK Investigational Site | Papillion | Nebraska | 68046 | United States |
| GSK Investigational Site | North Las Vegas | Nevada | 89030 | United States |
| GSK Investigational Site | Warren Township | New Jersey | 07059 | United States |
| GSK Investigational Site | Hickory | North Carolina | 28601 | United States |
| GSK Investigational Site | Rocky Mount | North Carolina | 27804 | United States |
| GSK Investigational Site | Wilmington | North Carolina | 28401 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45236 | United States |
| GSK Investigational Site | Edmond | Oklahoma | 73013 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15243 | United States |
| GSK Investigational Site | Columbia | South Carolina | 21045 | United States |
| GSK Investigational Site | North Charleston | South Carolina | 29405 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Jefferson City | Tennessee | 37760 | United States |
| GSK Investigational Site | Memphis | Tennessee | 38119 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37912 | United States |
| GSK Investigational Site | Austin | Texas | 78745 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | San Antonio | Texas | 78237 | United States |
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
| COMPLETED |
|
| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Co-Ad Group | Participants received one dose of FLU-HD 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-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end. |
| 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 | RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs) | RSV-A neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60). | Analysis was performed on Per Protocol Set (PPS) for RSV analysis which included eligible participants who: received RSVPreF3 OA vaccine dose in Control group and all study doses in Co-Ad group, had pre and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post-RSVPreF3 OA vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) |
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| Primary | Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs | HI titers were assessed 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 strains. | Analysis was performed on PPS for FLU analysis which included eligible participants who: received FLU vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, 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-B Neutralizing Titers Expressed as Group GMTs | RSV-B neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60). | Analysis was performed on PPS for RSV analysis which included eligible participants who: received RSVPreF3 OA vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post- RSVPreF3 OA vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad 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 titers was 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 PPS for FLU analysis which included eligible participants who: received FLU vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, 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 Neutralizing 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 PPS for RSV analysis which included eligible participants who: received RSVPreF3 OA vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post- RSVPreF3 OA vaccine dose, 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 Neutralizing 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 PPS for RSV analysis which included eligible participants who: received RSVPreF3 OA vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post- RSVPreF3 OA vaccine dose, 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 | HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT | HI titers were assessed 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 strains. HI antibodies were expressed as GMTs, in titers. | Analysis was performed on PPS for FLU analysis which included eligible participants who: received FLU vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups) |
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| Secondary | HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains | SPR for HI titers was defined as the percentage of participants with a serum HI titer >= 1:40. The assessed Flu strains were: 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 PPS for FLU analysis which included eligible participants who: received FLU vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups) |
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| Secondary | HI 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. | Analysis was performed on PPS for FLU analysis which included eligible participants who: received FLU vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At 1 month after the FLU vaccine dose administration (Day 31 for both groups) |
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| Secondary | Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration | The solicited administration site events after vaccination included erythema, pain and swelling. | Analysis was performed on Modified Safety Set, which included participants who received a study intervention, with the electronic diary completed post-each vaccination by the participant or authorized caregiver, and for whom solicited administration event data was available for the 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31) |
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| Secondary | Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration | The solicited systemic events after vaccination include arthralgia, fatigue, fever, headache and myalgia. | Analysis was performed on Modified Safety Set, which included participants who received a study intervention, with the electronic diary completed post-each vaccination by the participant or authorized caregiver, and for whom solicited administration event data was available for the 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31) |
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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 diary. Unsolicited events must have been 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 a study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 30 days after vaccine administration (the day of vaccination and 29 subsequent days after vaccination) |
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| Secondary | Percentage of Participants Reporting Serious Adverse Events (SAEs) | 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. | Analysis was performed on Exposed set which included participants who received a study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group) |
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| Secondary | Percentage of Participants Reporting 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 a study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group) |
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Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected 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.
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 | Co-Ad Group | Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study. | 1 | 516 | 12 | 516 | 339 | 516 |
| EG001 | Control Group | Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end. | 0 | 513 | 15 | 513 | 319 | 513 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Diverticulitis intestinal haemorrhagic | Infections and infestations | v26.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | v26.0 | Systematic Assessment |
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| Influenza | Infections and infestations | v26.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | v26.0 | Systematic Assessment |
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| Pneumonia respiratory syncytial viral | Infections and infestations | v26.0 | Systematic Assessment |
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| Spinal cord infection | Infections and infestations | v26.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | v26.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | v26.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | v26.0 | Systematic Assessment |
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| Arteriosclerosis coronary artery | Cardiac disorders | v26.0 | Systematic Assessment |
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| Sinus node dysfunction | Cardiac disorders | v26.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Intraventricular haemorrhage | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Thalamus haemorrhage | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
| |
| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
| |
| Lymphadenopathy mediastinal | Blood and lymphatic system disorders | v26.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | v26.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | v26.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | v26.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular 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 swelling | General disorders | v26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | v26.0 | Systematic Assessment |
| |
| Chills | General disorders | v26.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | v26.0 | Systematic Assessment |
| |
| Pain | General disorders | v26.0 | Systematic Assessment |
| |
| Administration site erythema | General disorders | v26.0 | Systematic Assessment |
| |
| Administration site pain | General disorders | v26.0 | Systematic Assessment |
| |
| Administration site pruritus | General disorders | v26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | v26.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | v26.0 | Systematic Assessment |
| |
| Injection site paraesthesia | General 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 |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Bone swelling | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Parosmia | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Radiculitis brachial | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | v26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Conjunctivitis viral | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Lyme disease | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | v26.0 | Systematic Assessment |
| |
| Tooth abscess | 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 |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Nasal pruritus | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Respiratory symptom | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Diaphragmatic hernia | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | v26.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Animal scratch | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | v26.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth 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 |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | v26.0 | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | v26.0 | Systematic Assessment |
| |
| Cor pulmonale acute | Cardiac disorders | v26.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | v26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | v26.0 | Systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | v26.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | v26.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | v26.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | v26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | v26.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | v26.0 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | v26.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | v26.0 | Systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | v26.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | v26.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | v26.0 | Systematic Assessment |
| |
| Endometrial thickening | Reproductive system and breast disorders | v26.0 | Systematic Assessment |
| |
| Multiple allergies | Immune system disorders | v26.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 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 20, 2022 | Mar 6, 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
| Male |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other, Not Specified |
|
The non-inferiority is demonstrated if the Upper Limit (UL) of the 2-sided 95% Confidence Interval (CI) of the GMT ratio (Control group divided by Co-Ad group) for RSVPreF3 OA vaccine is less than or equal (<=)1.5. |
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