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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503951-81-00 | Other Identifier | EU CT number |
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The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSV_IC_1 group | Experimental | Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). |
|
| RSV_IC_2 group | Experimental | IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days). |
|
| RSV_HA group | Active Comparator | Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSVPreF3 OA Investigational Vaccine | Biological | 0.5 mililiter dose was administered intramuscularly as 1 dose to RSV_IC_1 and RSV_HA groups, and 2 doses to RSV_IC_2 group. |
| Measure | Description | Time Frame |
|---|---|---|
| RSV-A Serum Neutralizing Titers Expressed As Mean Geometric Increase (MGI) Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group | MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-A post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3). | At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days) |
| RSV-B Serum Neutralizing Titers Expressed As MGI Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group | MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-B post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3). | At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days) |
| Measure | Description | Time Frame |
|---|---|---|
| RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | Neutralizing titers were calculated as GMT and expressed in titers (Estimated Dilution 60 [ED60]). | At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 in a subset of participants (Visit 1+ 7-14 days), Visit 3 (Visit 1+ 30-60 days), Visit 4 (Visit 3+ 30-42 days), Visit 5 (last dose+ 180-210 days) and Visit 6 (last dose+ 350-380 days) |
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Inclusion Criteria:
Specific inclusion criteria for renal/lung transplant patients:
Specific inclusion criteria for renal transplant (RTx) patients:
• Participant with stable renal function, stability defined as less than 20% variability between last two results of eGFR or in the opinion of the investigator after investigator review of more than the last two results of eGFRs and based on medical history.
Specific inclusion criteria for lung transplant (LTx) patients:
• Participant with stable lung function, with stability defined as the stability in the FEV1 compared to post-transplant baseline FEV1 and based on medical history of the last 3 months, in the opinion of the investigator.
Specific inclusion criteria for healthy participants:
Exclusion Criteria:
Medical conditions:
Prior/Concomitant therapy:
Prior/Concurrent clinical study experience:
• Concurrently participating in another active clinical study
Other exclusion criteria:
Specific exclusion criteria for renal/lung transplant patients:
Specific exclusion criteria for RTx patients:
Specific exclusion criteria for LTx patients:
Specific exclusion criteria for healthy participants:
Any confirmed/suspected immunosuppressive/immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.
Unstable serious chronic illness.
Chronic administration of immune-modifying drugs (>14 days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the end of the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85013 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41199924 | Derived | Vyse A, Hockey C, Wright H, Ellsbury G. Could more adults than just those aged 75-79 years potentially benefit from vaccination against RSV: insights from UK data. J Pharm Policy Pract. 2025 Nov 4;18(1):2576618. doi: 10.1080/20523211.2025.2576618. eCollection 2025. |
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Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated 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.
386 participants were enrolled in the study, received at least 1 dose of the study intervention and were included in the Exposed set.
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| ID | Title | Description |
|---|---|---|
| FG000 | RSV_IC_1 Group | Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). |
| FG001 | RSV_IC_2 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 | Oct 11, 2023 | Jun 25, 2025 |
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This study is an open label study.
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| RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups | Group GMT was assessed for RSV_HA group over pooled RSV_IC group (combined RSV_IC_1 and RSV_IC_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_HA and Pooled RSV_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan. | At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days) |
| RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups | Group GMT of RSV_IC_2 over RSV_IC_1 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_1 and RSV_IC_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan. | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) |
| RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups | Group GMT of RSV_HA over RSV_IC_1 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_1 and RSV_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan. | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) |
| RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups | Group GMT of RSV_HA over RSV_IC_2 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_2 and RSV_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan. | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) |
| RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups | Group GMT was assessed for RSV_HA group over pooled RSV_IC group (combined RSV_IC_1 and RSV_IC_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_HA and Pooled RSV_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan. | At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days) |
| RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups | Group GMT ratio of RSV_IC_2 over RSV_IC_1 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_1 and RSV_IC_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan. | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) |
| RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups | Group GMT of RSV_HA over RSV_IC_1 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_1 and RSV_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan. | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) |
| RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups | Group GMT of RSV_HA over RSV_IC_2 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_2 and RSV_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan. | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) |
| RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | MGI was assessed at Visit 2 (in a subset of participants) over Visit 1 and Visit 3 over Visit 1 in RSV_HA and pooled RSV_IC (combined RSV_IC_1 and RSV_IC_2 groups), and at Visit 4, Visit 5 and Visit 6 over Visit 1 in RSV_IC_1, RSV_IC_2, RSV_HA groups. | At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days), Visit 3 (Visit 1 + 30-60 days), Visit 4 (Visit 3 + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days), each compared to Visit 1 (Day 1) |
| Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells | CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific cluster of differentiation CD4+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV_IC_1 and RSV_IC_2 groups) and healthy participants (from RSV_HA group). | At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days), Visit 4 (Visit 3 + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) |
| CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells | CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV_IC_1 and RSV_IC_2 groups) and healthy participants (from RSV_HA group). | At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days), Visit 4 (Visit 3 + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) |
| Number Of Participants Reporting Any Solicited Administration Site Events | Assessed solicited administration site events included pain, erythema (redness) and swelling, at the injection site. Any = occurrence of the symptom regardless of intensity grade. | Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group) |
| Number Of Participants Reporting Any Solicited Systemic Events | Assessed solicited systemic events included fever (pyrexia), myalgia, arthralgia, headache, and fatigue. Fever is defined as body temperature greater or equal to (≥) 38 degrees Celsius (ºC). Any = occurrence of the symptom regardless of intensity grade. | Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group) |
| Number Of Participants Reporting Any Unsolicited Adverse Events (AEs) At Any Dose Administration | An unsolicited AE is an AE that was not included in the list of solicited events. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention. | Within 30 days (i.e., the day of vaccination and 29 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group) |
| Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs | A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of intensity grade or relation to study intervention. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of intensity grade or relation to study intervention. | From Visit 1 (Day 1) up to Visit 6 (last dose + 350-380 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group) |
| Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention | pIMDs are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any pIMDs = occurrence of the pIMDs regardless of intensity grade or relation to study intervention. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination. | From Visit 1 (Day 1) up to Visit 6 (last dose + 350-380 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group) |
| Number Of Participants With Any AEs Of Special Interest (AESIs) Specific To Renal And Lung Solid Organ Transplant (SOT) Participants | AESIs include the acute rejection of transplant (specific to renal and lung SOT participants). Analysis was performed only on participants that received transplant in RSV_IC_1 and RSV_IC_2 groups. | From Visit 1 (Day 1) up to Visit 6 (last dose + 350-380 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group) |
| Chicago |
| Illinois |
| 60612 |
| United States |
| GSK Investigational Site | Lexington | Kentucky | 40536 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55455 | United States |
| GSK Investigational Site | St Louis | Missouri | 63110 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68198-2456 | United States |
| GSK Investigational Site | New York | New York | 10032 | United States |
| GSK Investigational Site | New York | New York | 10065 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| GSK Investigational Site | Temple | Texas | 76502 | United States |
| GSK Investigational Site | Camperdown | New South Wales | 2050 | Australia |
| GSK Investigational Site | Birtinya | Queensland | 4556 | Australia |
| GSK Investigational Site | Herston | Queensland | 4029 | Australia |
| GSK Investigational Site | Adelaide | South Australia | 5000 | Australia |
| GSK Investigational Site | Edmonton | Alberta | T6G 2B7 | Canada |
| GSK Investigational Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| GSK Investigational Site | London | Ontario | N6A 5A5 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 2N2 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1J 2G2 | Canada |
| GSK Investigational Site | Giessen | 35392 | Germany |
| GSK Investigational Site | Milan | 20122 | Italy |
| GSK Investigational Site | Milan | 20132 | Italy |
| GSK Investigational Site | Palermo | 90127 | Italy |
| GSK Investigational Site | Pavia | 27100 | Italy |
| GSK Investigational Site | Siena | 53100 | Italy |
| GSK Investigational Site | Aichi | 466-8650 | Japan |
| GSK Investigational Site | Aichi | 470-1192 | Japan |
| GSK Investigational Site | Fukuoka | 814-0180 | Japan |
| GSK Investigational Site | Hyōgo | 662-0918 | Japan |
| GSK Investigational Site | Kumamoto | 861-8520 | Japan |
| GSK Investigational Site | Okayama | 700-8558 | Japan |
| GSK Investigational Site | Tokyo | 160-0017 | Japan |
| GSK Investigational Site | Tokyo | 193-0998 | Japan |
| GSK Investigational Site | Seoul | 03722 | South Korea |
| GSK Investigational Site | Seoul | 110-774 | South Korea |
| GSK Investigational Site | Seoul | 138-736 | South Korea |
| GSK Investigational Site | A Coruña | 15006 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Barcelona | 08907 | Spain |
| GSK Investigational Site | Córdoba | 14004 | Spain |
| GSK Investigational Site | Madrid | 28007 | Spain |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28041 | Spain |
| GSK Investigational Site | Madrid | 28222 | Spain |
| GSK Investigational Site | Santander | 39011 | Spain |
IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).
| FG002 | RSV_HA Group | Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). |
| COMPLETED |
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| NOT COMPLETED |
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Exposed set included all participants that received at least one study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | RSV_IC_1 Group | Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). |
| BG001 | RSV_IC_2 Group | IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days). |
| BG002 | RSV_HA Group | Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | YEARS |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | RSV-A Serum Neutralizing Titers Expressed As Mean Geometric Increase (MGI) Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group | MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-A post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3). | Analysis was performed on Per protocol Set (PPS) for humoral immunogenicity, which included all participants who received the study intervention administration as per protocol, had immunogenicity results pre and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity, without prohibited concomitant medication/vaccination. Only participants with data available for the RSV-A MGI at the specified timepoint were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days) |
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| Primary | RSV-B Serum Neutralizing Titers Expressed As MGI Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group | MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-B post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3). | Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-B MGI at the specified timepoint were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days) |
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| Secondary | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | Neutralizing titers were calculated as GMT and expressed in titers (Estimated Dilution 60 [ED60]). | Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-A and RSV-B GMTs at the specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers (ED60) | At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 in a subset of participants (Visit 1+ 7-14 days), Visit 3 (Visit 1+ 30-60 days), Visit 4 (Visit 3+ 30-42 days), Visit 5 (last dose+ 180-210 days) and Visit 6 (last dose+ 350-380 days) |
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| Secondary | RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups | Group GMT was assessed for RSV_HA group over pooled RSV_IC group (combined RSV_IC_1 and RSV_IC_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_HA and Pooled RSV_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan. | Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-A group GMT for the specified groups at the specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers (ED60) | At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days) |
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| Secondary | RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups | Group GMT of RSV_IC_2 over RSV_IC_1 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_1 and RSV_IC_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan. | Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-A group GMT for the specified groups at the specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers (ED60) | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) |
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| Secondary | RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups | Group GMT of RSV_HA over RSV_IC_1 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_1 and RSV_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan. | Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-A group GMT for the specified groups at the specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers (ED60) | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) |
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| Secondary | RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups | Group GMT of RSV_HA over RSV_IC_2 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_2 and RSV_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan. | Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-A group GMT for the specified groups at the specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers (ED60) | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) |
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| Secondary | RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups | Group GMT was assessed for RSV_HA group over pooled RSV_IC group (combined RSV_IC_1 and RSV_IC_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_HA and Pooled RSV_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan. | Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-B group GMT for the specified groups at the specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers (ED60) | At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days) |
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| Secondary | RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups | Group GMT ratio of RSV_IC_2 over RSV_IC_1 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_1 and RSV_IC_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan. | Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-B group GMT for the specified groups at the specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers (ED60) | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) |
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| Secondary | RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups | Group GMT of RSV_HA over RSV_IC_1 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_1 and RSV_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan. | Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-B group GMT for the specified groups at the specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers (ED60) | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) |
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| Secondary | RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups | Group GMT of RSV_HA over RSV_IC_2 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_2 and RSV_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan. | Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-B group GMT for the specified groups at the specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers (ED60) | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) |
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| Secondary | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | MGI was assessed at Visit 2 (in a subset of participants) over Visit 1 and Visit 3 over Visit 1 in RSV_HA and pooled RSV_IC (combined RSV_IC_1 and RSV_IC_2 groups), and at Visit 4, Visit 5 and Visit 6 over Visit 1 in RSV_IC_1, RSV_IC_2, RSV_HA groups. | Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-A and RSV-B MGI for the specified groups at the specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days), Visit 3 (Visit 1 + 30-60 days), Visit 4 (Visit 3 + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days), each compared to Visit 1 (Day 1) |
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| Secondary | Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells | CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific cluster of differentiation CD4+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV_IC_1 and RSV_IC_2 groups) and healthy participants (from RSV_HA group). | Analysis was performed on the PPS for cell mediated immunity (CMI) [CMI subset], which included all participants who received the study intervention administration, had cell mediated immunogenicity results pre and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity, without prohibited concomitant medication/vaccination. Only participants with data available for CD4+ T cells at the specified timepoints were included in analysis. | Posted | Geometric Mean | Standard Deviation | Specific CD4+ Tcells/million CD4+ Tcells | At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days), Visit 4 (Visit 3 + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) |
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| Secondary | CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells | CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV_IC_1 and RSV_IC_2 groups) and healthy participants (from RSV_HA group). | Analysis was performed on PPS for CMI [CMI subset]. Only participants with data available for CD8+ T cells for the specified groups at the specified timepoints were included in this analysis. | Posted | Geometric Mean | Standard Deviation | Specific CD8+ Tcells/million CD8+ Tcells | At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days), Visit 4 (Visit 3 + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) |
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| Secondary | Number Of Participants Reporting Any Solicited Administration Site Events | Assessed solicited administration site events included pain, erythema (redness) and swelling, at the injection site. Any = occurrence of the symptom regardless of intensity grade. | Analysis was performed on the Exposed set (ES) which included all participants who received the study intervention administration. Only participants with solicited administration site events at the specified time periods were included in this analysis. | Posted | Count of Participants | Participants | Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group) |
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| Secondary | Number Of Participants Reporting Any Solicited Systemic Events | Assessed solicited systemic events included fever (pyrexia), myalgia, arthralgia, headache, and fatigue. Fever is defined as body temperature greater or equal to (≥) 38 degrees Celsius (ºC). Any = occurrence of the symptom regardless of intensity grade. | Analysis was performed on the ES. Only participants with solicited systemic events at the specified time periods were included in this analysis. | Posted | Count of Participants | Participants | Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group) |
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| Secondary | Number Of Participants Reporting Any Unsolicited Adverse Events (AEs) At Any Dose Administration | An unsolicited AE is an AE that was not included in the list of solicited events. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention. | Analysis was performed on the ES. Only participants with unsolicited AEs at the specified timepoints were included in the analysis. | Posted | Count of Participants | Participants | Within 30 days (i.e., the day of vaccination and 29 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group) |
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| Secondary | Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs | A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of intensity grade or relation to study intervention. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of intensity grade or relation to study intervention. | Analysis was performed on the ES. | Posted | Count of Participants | Participants | From Visit 1 (Day 1) up to Visit 6 (last dose + 350-380 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group) |
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| Secondary | Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention | pIMDs are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any pIMDs = occurrence of the pIMDs regardless of intensity grade or relation to study intervention. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination. | Analysis was performed on the ES. | Posted | Count of Participants | Participants | From Visit 1 (Day 1) up to Visit 6 (last dose + 350-380 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group) |
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| Secondary | Number Of Participants With Any AEs Of Special Interest (AESIs) Specific To Renal And Lung Solid Organ Transplant (SOT) Participants | AESIs include the acute rejection of transplant (specific to renal and lung SOT participants). Analysis was performed only on participants that received transplant in RSV_IC_1 and RSV_IC_2 groups. | Analysis was performed on the ES. Only SOT participants that had data available at the specified timepoints were included in the analysis. | Posted | Count of Participants | Participants | From Visit 1 (Day 1) up to Visit 6 (last dose + 350-380 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group) |
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Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RSV_IC_1 Group | Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). | 3 | 131 | 29 | 131 | 106 | 131 |
| EG001 | RSV_IC_2 Group | IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days). | 3 | 130 | 37 | 130 | 120 | 130 |
| EG002 | RSV_HA Group | Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). | 0 | 125 | 4 | 125 | 111 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Gastroenteritis Escherichia coli | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Systematic Assessment |
| |
| Oropharyngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Systematic Assessment |
| |
| Lung adenocarcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome with excess blasts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Candida pneumonia | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Cystitis escherichia | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Escherichia pyelonephritis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| HCoV-NL63 infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Actinomycosis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Hepatic cyst infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Histoplasmosis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Klebsiella urinary tract infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Nocardiosis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Norovirus infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Pantoea agglomerans infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pancreatitis ( | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Clear cell endometrial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Systematic Assessment |
| |
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Myelopathy | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Optic ischaemic neuropathy | Eye disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Lymph gland infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Herpes simplex reactivation | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Stenotrophomonas maltophilia pneumonia | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Administration site pruritus | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Administration site pain | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Vaccination site bruising | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Brain fog | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Intestinal mucosal hypertrophy | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Nipple pain | Reproductive system and breast disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Small intestine adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Systematic Assessment |
| |
| Asthenopia | Eye disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Ear congestion | Ear and labyrinth disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pseudallescheria infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Administration site erythema | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Administration site swelling | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Scleroderma | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Systematic Assessment |
| |
| Hypertensive nephropathy | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Fungal disease carrier | Infections and infestations | MedDRA v28.0 | 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 | Jun 26, 2025 | May 15, 2026 | SAP_002.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 |
|
| American Indian Or Alaska Native |
|
| Asian |
|
| Black Or African American |
|
| Not Reported |
|
| Multiple |
|
| Unknown |
|
|
|
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units |
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| Counts |
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| Participants |
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| Units |
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| Participants |
|
|
|
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
| OG003 | Pooled RSV_IC Group | IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV_IC_1 and RSV_IC_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days). |
|
|
| OG001 |
| RSV_IC_2 Group |
IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days). |
| OG002 | RSV_HA Group | Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). |
|
|
| OG002 | RSV_HA Group | Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). |
|
|
|
|
|
|
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
|
| RSV_HA Group |
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). |
|
|
|
|
| Participants |
|
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