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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 seasonal quadrivalent influenza vaccine (FLU-QIV) in adults aged 60 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 1 dose of RSV_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end. |
|
| Control Group | Active Comparator | Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV_PreF3 OA investigational vaccine at Day 31 and were followed up 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 Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMTs) | The serum neutralization assay is a functional assay that measures the ability of serum antibodies to neutralize RSV-A entry and replication in a host cell line. The serum neutralizing antibody titer is expressed in ED60 (Estimated Dilution 60) and corresponds to the inverse of the interpolated serum dilution that yields a 60% reduction of the signal compared to a control without serum. | At 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group) |
| Hemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs | HI antibody titers were assessed for each of the Flu vaccine strains, namely Flu A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). The serum HI antibody titers are expressed in 1/Dilution (DIL) where DIL corresponds to the highest dilution that shows complete HI. | 1 month after the FLU vaccine dose (at Day 31) |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary: HI Seroconversion Status for Each of the Flu Vaccine Strains Expressed as Seroconversion Rate (SCR) | SCR for HI antibody response was defined as the percentage of vaccinees who have either a HI pre-dose titer < 1:10 and a post-dose titer >= 1:40 or a pre-dose titer >= 1:10 and at least a four-fold increase in post-dose titer. HI antibody titers were assessed for each of the Flu vaccine strains, namely Flu A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). |
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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 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 | Auckland | 1010 | New Zealand | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38189778 | Background | Chandler R, Montenegro N, Llorach C, Aguirre LN, Germain S, Kuriyakose SO, Lambert A, Descamps D, Olivier A, Hulstrom V. Immunogenicity, Reactogenicity, and Safety of AS01E-adjuvanted RSV Prefusion F Protein-based Candidate Vaccine (RSVPreF3 OA) When Co-administered With a Seasonal Quadrivalent Influenza Vaccine in Older Adults: Results of a Phase 3, Open-Label, Randomized Controlled Trial. Clin Infect Dis. 2024 Jan 8:ciad786. doi: 10.1093/cid/ciad786. Online ahead of print. |
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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.
Out of 976 participants enrolled in the study, 86 participants were not assigned to any study group and 5 participants did not receive any study treatment.
885 participants were vaccinated and included in the Exposed Set.
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| ID | Title | Description |
|---|---|---|
| FG000 | Co-Ad Group | Participants received 1 dose of RSV_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end. |
| 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 | Nov 27, 2020 | Sep 20, 2022 |
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| FLU-QIV | Biological | FLU-QIV administered intramuscularly in the deltoid region of the dominant (Co-Ad Group) arm or the non-dominant (Control Group) arm. |
|
| 1 month after the FLU vaccine dose (at Day 31) |
| 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. | 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group) |
| RSV-B Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMT) | The serum neutralization assay is a functional assay that measures the ability of serum antibodies to neutralize RSV-B entry and replication in a host cell line. The serum neutralizing antibody titer is expressed in ED60 (Estimated Dilution 60) and corresponds to the inverse of the interpolated serum dilution that yields a 60% reduction of the signal compared to a control without serum. | 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the 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. | 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group) |
| HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs | HI antibody titers were assessed for each of the Flu vaccine strains, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). The serum HI antibody titers are expressed in 1/DIL where DIL corresponds to the highest dilution that shows complete HI. | At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31) |
| HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR) | SPR for HI antibody response was defined as percentage of vaccinees with a serum HI titer >= 1:40 that usually is accepted as indicating protection. HI antibody titers were assessed for each of the Flu vaccine strains, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). | At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31) |
| HI Antibody Titers for Each of the 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. HI antibody were assessed for each of the FLUvaccine strain, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). | 1 month after the FLU vaccine dose (at Day 31) |
| Percentage of Participants With Solicited Administration Site Events | Solicited administration site adverse events(AEs) assessed were erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. | Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination |
| Percentage of Participants With Solicited Systemic Events | Solicited systemic events assessed were arthralgia, fatigue, fever [defined as temperature equal to or above (>=) 38 degrees Celsius (C)/100.4 degrees Fahrenheit (F)], headache and myalgia. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. | Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination |
| Percentage of Participants Reporting at Least One Unsolicited Adverse Event | An unsolicited AEs is any AE reported in addition to those solicited during the clinical study and that was not included in a list of solicited events using a Participant Diary. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Unsolicited AEs include serious, non-serious AEs and potential immune-mediated diseases (pIMDs). Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | Within 30 days (the day of vaccination and 29 subsequent days) after each vaccination |
| Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) | 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. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. | From Day 1 up to study end (6 months after last vaccination) |
| Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMD) | 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. | From Day 1 up to study end (6 months after last vaccination) |
| Auckland |
| 1701 |
| New Zealand |
| GSK Investigational Site | Christchurch | 8011 | New Zealand |
| GSK Investigational Site | Havelock North | 4130 | New Zealand |
| GSK Investigational Site | Paraparaumu | 5032 | New Zealand |
| GSK Investigational Site | Tauranga | 3001 | New Zealand |
| GSK Investigational Site | Wellington | 6242 | New Zealand |
| GSK Investigational Site | Panama City | 0801 | Panama |
| GSK Investigational Site | Panama City | 1001 | Panama |
| GSK Investigational Site | Panama City | 7002 | Panama |
| GSK Investigational Site | Panama City | 7099 | Panama |
| GSK Investigational Site | Panama City | 7219 | Panama |
| GSK Investigational Site | Boksburg | Gauteng | 1459 | South Africa |
| GSK Investigational Site | Middelburg | Mpumalanga | 1055 | South Africa |
Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Co-Ad Group | Participants received 1 dose of RSV_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end. |
| BG001 | Control Group | Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV_PreF3 OA investigational vaccine at Day 31 and were followed up 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 |
|
| 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 Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMTs) | The serum neutralization assay is a functional assay that measures the ability of serum antibodies to neutralize RSV-A entry and replication in a host cell line. The serum neutralizing antibody titer is expressed in ED60 (Estimated Dilution 60) and corresponds to the inverse of the interpolated serum dilution that yields a 60% reduction of the signal compared to a control without serum. | The analysis was performed on the Per Protocol set (PPS) which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers (ED 60) | At 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group) |
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| Primary | Hemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs | HI antibody titers were assessed for each of the Flu vaccine strains, namely Flu A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). The serum HI antibody titers are expressed in 1/Dilution (DIL) where DIL corresponds to the highest dilution that shows complete HI. | The analysis was performed on the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/DIL) | 1 month after the FLU vaccine dose (at Day 31) |
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| Secondary | Secondary: HI Seroconversion Status for Each of the Flu Vaccine Strains Expressed as Seroconversion Rate (SCR) | SCR for HI antibody response was defined as the percentage of vaccinees who have either a HI pre-dose titer < 1:10 and a post-dose titer >= 1:40 or a pre-dose titer >= 1:10 and at least a four-fold increase in post-dose titer. HI antibody titers were assessed for each of the Flu vaccine strains, namely Flu A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). | The analysis was performed on the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 month after the FLU vaccine dose (at Day 31) |
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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. | The analysis was performed on the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group) |
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| Secondary | RSV-B Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMT) | The serum neutralization assay is a functional assay that measures the ability of serum antibodies to neutralize RSV-B entry and replication in a host cell line. The serum neutralizing antibody titer is expressed in ED60 (Estimated Dilution 60) and corresponds to the inverse of the interpolated serum dilution that yields a 60% reduction of the signal compared to a control without serum. | The analysis was performed on the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers (ED 60) | 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the 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. | The analysis was performed on a subset of the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group) |
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| Secondary | HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs | HI antibody titers were assessed for each of the Flu vaccine strains, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). The serum HI antibody titers are expressed in 1/DIL where DIL corresponds to the highest dilution that shows complete HI. | The analysis was performed on the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/DIL) | At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31) |
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| Secondary | HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR) | SPR for HI antibody response was defined as percentage of vaccinees with a serum HI titer >= 1:40 that usually is accepted as indicating protection. HI antibody titers were assessed for each of the Flu vaccine strains, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). | The analysis was performed on the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. | Posted | Number | 95% Confidence Interval | Percentage of participants | At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31) |
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| Secondary | HI Antibody Titers for Each of the 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. HI antibody were assessed for each of the FLUvaccine strain, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). | The analysis was performed on the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | 1 month after the FLU vaccine dose (at Day 31) |
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| Secondary | Percentage of Participants With Solicited Administration Site Events | Solicited administration site adverse events(AEs) assessed were erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. | The analysis was performed on the Exposed set, which included All participants who received a study intervention. Analysis per group is based on the study intervention administered. RSV vaccine was administered at day 1 for the control group and at day 31 for the Co-Ad group. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination |
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| Secondary | Percentage of Participants With Solicited Systemic Events | Solicited systemic events assessed were arthralgia, fatigue, fever [defined as temperature equal to or above (>=) 38 degrees Celsius (C)/100.4 degrees Fahrenheit (F)], headache and myalgia. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. | The analysis was performed on the Exposed set, which included All participants who received a study intervention. Analysis per group is based on the study intervention administered. The Co-Ad group only received vaccination at Day 1. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination |
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| Secondary | Percentage of Participants Reporting at Least One Unsolicited Adverse Event | An unsolicited AEs is any AE reported in addition to those solicited during the clinical study and that was not included in a list of solicited events using a Participant Diary. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Unsolicited AEs include serious, non-serious AEs and potential immune-mediated diseases (pIMDs). Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Exposed set, which included All participants who received a study intervention. Analysis per group is based on the study intervention administered. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 30 days (the day of vaccination and 29 subsequent days) after each vaccination |
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| Secondary | Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) | 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. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. | The analysis was performed on the Exposed set, which included All participants who received a study intervention. Analysis per group is based on the study intervention administered. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Day 1 up to study end (6 months after last vaccination) |
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| Secondary | Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMD) | 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 analysis was performed on the Exposed set, which included All participants who received a study intervention. Analysis per group is based on the study intervention administered. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 up to study end (6 months after last vaccination) |
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Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
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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 1 dose of RSV_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end. | 4 | 442 | 15 | 442 | 290 | 442 |
| EG001 | Control Group | Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end. | 8 | 443 | 20 | 443 | 276 | 443 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
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| Eye pain | Eye disorders | Systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Diverticulitis | Infections and infestations | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | Systematic Assessment |
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| Suspected COVID-19 | Infections and infestations | Systematic Assessment |
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| Wound infection | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pathological fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Diffuse large B-cell lymphoma stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Dementia | Nervous system disorders | Systematic Assessment |
| ||
| Acute disseminated encephalomyelitis | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Injection site erythema | General disorders | Systematic Assessment |
| ||
| Injection site swelling | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Injection site bruising | General disorders | Systematic Assessment |
| ||
| Injection site pruritus | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Influenza like illness | General disorders | Systematic Assessment |
| ||
| Administration site swelling | General disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Feeling cold | General disorders | Systematic Assessment |
| ||
| Injection site discolouration | General disorders | Systematic Assessment |
| ||
| Malaise | General disorders | Systematic Assessment |
| ||
| Peripheral swelling | General disorders | Systematic Assessment |
| ||
| Thirst | General disorders | Systematic Assessment |
| ||
| Vaccination site bruising | General disorders | Systematic Assessment |
| ||
| Vaccination site pain | General disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Costochondritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Tremor | Nervous system disorders | Systematic Assessment |
| ||
| Hypokinesia | Nervous system disorders | Systematic Assessment |
| ||
| Migraine | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Viral upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection viral | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Tooth abscess | Infections and infestations | Systematic Assessment |
| ||
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | Systematic Assessment |
| ||
| Lower respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Nail infection | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Tooth infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Cystitis | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
| ||
| Gingivitis | Infections and infestations | Systematic Assessment |
| ||
| Helicobacter infection | Infections and infestations | Systematic Assessment |
| ||
| Oral herpes | Infections and infestations | Systematic Assessment |
| ||
| Paronychia | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Postoperative wound infection | Infections and infestations | Systematic Assessment |
| ||
| Rhinitis | Infections and infestations | Systematic Assessment |
| ||
| Skin candida | Infections and infestations | Systematic Assessment |
| ||
| Suspected COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sinonasal obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sinus pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain lower | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dental caries | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Proctalgia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Limb injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Animal bite | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Ankle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Foot fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Meniscus injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Muscle strain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Skin abrasion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Skin laceration | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Spinal column injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Tendon injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Tooth fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Actinic keratosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Night sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hot flush | Vascular disorders | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Gout | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Glucose tolerance impaired | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Lymphadenitis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Meniere's disease | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
| ||
| Lacrimation increased | Eye disorders | Systematic Assessment |
| ||
| Faecal volume increased | Investigations | Systematic Assessment |
| ||
| Benign prostatic hyperplasia | Reproductive system and breast disorders | 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 | Apr 16, 2021 | Sep 20, 2022 | 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 |
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| Black Or African American |
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| Maori |
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| Mixed Race |
|
| Native Hawaiian Or Other Pacific Islander |
|
| Other, Not Specified |
|
| White |
|
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