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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-510196-59-00 | Other Identifier | EU CTR Number |
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This study is assessing the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Co-Ad Group | Experimental | Participants received a single dose of RSVPreF3 OA vaccine and a single dose of COVID-19 mRNA vaccine at Day 1, in different arms. |
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| Control Group | Active Comparator | Participants received a single dose of COVID-19 mRNA vaccine at Day 1, followed by a single dose of RSVPreF3 OA vaccine at Day 31. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSVPreF3 OA investigational vaccine | Biological | 1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1 to participants in the Co-ad Group and on Day 31 to participants in the Control Group. |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Geometric Mean Titers (GMT) of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination | RSV-A neutralizing titers were provided as group GMTs and expressed as estimated dilution 60 (ED60) titers. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model adjusted for baseline differences (in the pre-dose titers) includes treatment group and age category (age at vaccination: 50-59, 60-69 or ≥70 years) as fixed effects, and the pre-dose log10-transformed titers as a covariate. | At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) |
| Adjusted GMTs of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination | RSV-B neutralizing titers were provided as group GMTs and expressed as estimated dilution 60 (ED60) titers. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model adjusted for baseline differences (in the pre-dose titers) includes treatment group and age category (age at vaccination: 50-59, 60-69 or ≥70 years) as fixed effects, and the pre-dose log10-transformed titers as a covariate. | At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) |
| Adjusted GMTs of SARS-CoV-2 Omicron XBB.1.5 Neutralizing Titers at 1 Month After the COVID-19 mRNA Vaccination | SARS-CoV-2 Omicron XBB.1.5 neutralizing titers against the pseudovirus bearing S protein were provided as group GMTs and expressed as titers. The neutralizing titer was calculated as the reciprocal serum dilution corresponding to the 50% signal reduction (NT50). Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model adjusted for baseline differences (in the pre-dose titers) includes treatment group and age category (age at vaccination: 50-59, 60-69 or ≥70 years) as fixed effects, and the pre-dose log10-transformed titers as a covariate. | At 1 month post-COVID-19 mRNA vaccine dose administration (at Day 31 for both groups) |
| Measure | Description | Time Frame |
|---|---|---|
| RSV-A Neutralizing Titers Expressed as GMT at 1 Month After RSVPreF3 OA Vaccination | Neutralizing titers for RSV-A were measured with neutralizing assay and the results were expressed as GMT. GMT is a descriptive statistic calculated directly from the observed titer values at the 1-month post-vaccination timepoint for all participants in the analysis set, without any statistical modelling or adjustment for covariates. |
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Inclusion Criteria:
• Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
Note: In case of physical incapacity that would preclude the self-completion of the diary cards, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home). However, at no time will the site staff or caregiver evaluate the participant's health status while answering diaries or make decisions on behalf of the participant.
A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
• Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
Participants who have received previously a SARS-CoV-2 vaccine, being administered at least 3 months prior to study vaccination.
Female participants of non-childbearing potential may be enrolled in the study. Non childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and post-menopause.
Female participants of childbearing potential may be enrolled in the study if the participant.
Exclusion Criteria:
Medical Conditions
Prior/Concomitant Therapy Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions and ending 30 days after the last vaccine administration, or their planned use during the study period.
Planned administration of a vaccine in the period starting 30 days before the first dose and ending 30 days after the last dose of study intervention(s) administration*, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after the study vaccination.
*If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by 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 Sponsor is notified.
Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the last blood sampling visit.
Up to 3 months prior to the study intervention administration:
Up to 6 months prior to study intervention administration: long-acting immune modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies and antitumoral medication.
Administration of any SARS-CoV-2 vaccine during the 3 months preceding the study COVID-19 mRNA vaccine administration.
Previous vaccination with licensed or investigational RSV vaccine. 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 Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Coral Gables | Florida | 33134 | United States | ||
| GSK Investigational Site |
GSK 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/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.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 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 841 enrolled participants, 833 participants were randomized in a 1:1 ratio to either Co-Ad Group or Control Group at Day 1 and started the study. These participants were included in the Exposed Set.
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| ID | Title | Description |
|---|---|---|
| FG000 | Co-Ad Group | Participants received a single dose of RSVPreF3 OA vaccine and a single dose of COVID-19 mRNA vaccine at Day 1, in different arms. |
| FG001 | Control Group | Participants received a single dose of COVID-19 mRNA vaccine at Day 1, followed by a single dose of RSVPreF3 OA vaccine at Day 31. |
| 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 | Jan 9, 2024 | Oct 31, 2025 |
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This is an open-label study.
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| COVID-19 mRNA vaccine | Biological | 1 dose of COVID-19 mRNA vaccine is administered intramuscularly on Day 1 to participants in the Co-ad and Control Groups. |
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| At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) |
| Mean Geometric Increase (MGI) of RSV-A Neutralizing Titers at 1 Month After RSVPreF3 OA Vaccination | The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. | At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) compared to pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group) |
| RSV-A Neutralizing Titers Expressed as Seroresponse Rate (SRR) at 1 Month After RSVPreF3 OA Vaccination | The SRR was defined as the percentage of participants having a fold increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to (>=) 4. | At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) compared to pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group) |
| Percentage of Participants Having RSV-A Neutralizing Titers Greater or Equal to the Assay Cut-off Value at Pre-vaccination and at 1 Month After RSVPreF3 OA Vaccination | Percentage of participants with RSV-A neutralizing titers >= to the assay cut-off value (i.e. lower limit of quantification [LLOQ]) are presented. | At pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group) and at 1 month post-RSVPreF3 OA vaccine dose administration (Day 31 for Co-Ad Group and Day 61 for Control Group) |
| RSV-B Neutralizing Titers Expressed as GMT at 1 Month After RSVPreF3 OA Vaccination | Neutralizing titers for RSV-B were measured with neutralizing assay and the results were expressed as GMT. GMT is a descriptive statistic calculated directly from the observed titer values at the 1-month post-vaccination timepoint for all participants in the analysis set, without any statistical modelling or adjustment for covariates. | At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) |
| MGI of RSV-B Neutralizing Titers at 1 Month After RSVPreF3 OA Vaccination | The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. | At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) compared to pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group) |
| RSV-B Neutralizing Titers Expressed as SRR at 1 Month After RSVPreF3 OA Vaccination | The SRR was defined as the percentage of participants having a fold increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration) >= 4. | At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) compared to pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group) |
| Percentage of Participants Having RSV-B Neutralizing Titers Greater or Equal to Assay Cut-off Value at Pre-vaccination and at 1 Month After RSVPreF3 OA Vaccination | Percentage of participants with RSV-B neutralizing titers >= to the assay cut-off value (i.e. LLOQ) are presented. | At pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group) and at 1 month post-RSVPreF3 OA vaccine dose administration (Day 31 for Co-Ad Group and Day 61 for Control Group) |
| SARS-CoV-2 Omicron XBB.1.5 Neutralizing Titers Expressed as GMT at 1 Month After COVID-19 mRNA Vaccination | The SARS-CoV-2 Omicron XBB.1.5 neutralizing titers against the pseudovirus bearing S protein were measured with neutralizing assay and the results were expressed as GMT. GMT is a descriptive statistic calculated directly from the observed titer values at the 1-month post-vaccination timepoint for all participants in the analysis set, without any statistical modelling or adjustment for covariates. | At 1 month post-COVID-19 mRNA vaccine dose administration (Day 31 for both groups) |
| MGI of SARS-CoV-2 Omicron XBB.1.5 Neutralizing Titers at 1 Month After COVID-19 mRNA Vaccination | The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. | At 1 month post-COVID-19 mRNA vaccine dose administration (Day 31 for both groups) compared to pre-vaccination (at Day 1 for both groups) |
| Percentage of Participants Having SARS-CoV-2 Omicron XBB.1.5 Neutralizing Titers Greater Than or Equal to Assay Cut-off Value at Pre-vaccination and at 1 Month After COVID-19 mRNA Vaccination | Percentage of participants with SARS-CoV-2 Omicron XBB.1.5 neutralizing titers >= to the assay cut-off value (i.e. LLOQ) are presented. | At pre-vaccination (Day 1 for both groups) and at 1 month post-COVID-19 mRNA vaccine dose administration (Day 31 for both groups) |
| Number of Participants Reporting Each Solicited Administration Site Event, for Each Type of Vaccine Administered | The solicited administration site events after vaccination included pain, erythema/redness, and swelling. Any = occurrence of the events regardless of the intensity grade. | Within 4 days (the day of administration and 3 subsequent days) after each type of vaccine (RSVPreF3 OA vaccine administered at Day 1 for Co-Ad Group and at Day 31 for Control Group, COVID-19 mRNA vaccine administered at Day 1 for both groups) |
| Number of Participants Reporting Each Solicited Systemic Event, for Each Day of Dose Administered | The solicited systemic events after vaccination included arthralgia, fatigue, fever (pyrexia), headache and myalgia. Fever was defined as body temperature equal or greater than 38 degrees Celsius (°C). Any = occurrence of the events regardless of the intensity grade. | Within 4 days (the day of dose administered and 3 subsequent days) after each dose (administered at Day 1 for Co-Ad Group and at Days 1 and 31 for Control Group) |
| Number of Participants Reporting Unsolicited Adverse Events (AEs), for Each Day of Dose Administered | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study vaccine, which does not necessarily have a causal relationship with study vaccine. An unsolicited AE was an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs must had been communicated by participant/participant's caregiver(s) who had signed the informed consent. Unsolicited AEs included both serious and non-serious AEs. Any = occurrence of the events regardless of the intensity grade or relation to study dose administration. | Within 30 days (the day of vaccination and 29 subsequent days) after each dose (dose administered at Day 1 for Co-Ad Group and at Days 1 and 31 for Control Group) |
| Number of Participants Reporting Any Serious Adverse Events (SAEs) | An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Any = occurrence of the events regardless of the intensity grade or relation to study dose administration. | Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-Ad Group and Day 31 for Control Group]) |
| Number of Participants Reporting Any Potential Immune-mediated Diseases (pIMDs) | The pIMD was defined as a subset of adverse events of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any = occurrence of the events regardless of the intensity grade or relation to study dose administration. | Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-Ad Group and Day 31 for Control Group]) |
| Savannah |
| Georgia |
| 31406 |
| United States |
| GSK Investigational Site | Evansville | Indiana | 47714 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68134 | United States |
| GSK Investigational Site | Rochester | New York | 14609 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | North Charleston | South Carolina | 29405 | United States |
| GSK Investigational Site | Newport News | Virginia | 23606 | United States |
| GSK Investigational Site | Antwerp | 2000 | Belgium |
| GSK Investigational Site | Edegem | 2650 | Belgium |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Kluisbergen | 9690 | Belgium |
| GSK Investigational Site | Mechelen | 2800 | Belgium |
| GSK Investigational Site | Breda | 4818 CK | Netherlands |
| GSK Investigational Site | Enschede | 7512 KZ | Netherlands |
| GSK Investigational Site | Utrecht | 3584 BA | Netherlands |
| GSK Investigational Site | Zutphen | 7207 AE | Netherlands |
| GSK Investigational Site | A Coruña | 15006 | Spain |
| GSK Investigational Site | Barcelona | 08023 | Spain |
| GSK Investigational Site | Barcelona | 08907 | Spain |
| GSK Investigational Site | Boadilla Del Monte Madrid | 28660 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28041 | Spain |
| GSK Investigational Site | Madrid | 28222 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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Exposed set included all participants that received at least one study administration dose.
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| ID | Title | Description |
|---|---|---|
| BG000 | Co-Ad Group | Participants received a single dose of RSVPreF3 OA vaccine and a single dose of COVID-19 mRNA vaccine at Day 1, in different arms. |
| BG001 | Control Group | Participants received a single dose of COVID-19 mRNA vaccine at Day 1, followed by a single dose of RSVPreF3 OA vaccine at Day 31. |
| BG002 | 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 | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | YEARS |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | American Indian or Alaska Native and Asian are considered as minority races in this study and are presented together as "Other Races". | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Adjusted Geometric Mean Titers (GMT) of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination | RSV-A neutralizing titers were provided as group GMTs and expressed as estimated dilution 60 (ED60) titers. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model adjusted for baseline differences (in the pre-dose titers) includes treatment group and age category (age at vaccination: 50-59, 60-69 or ≥70 years) as fixed effects, and the pre-dose log10-transformed titers as a covariate. | Per protocol set (PPS) for RSVPreF3 OA included participants who: received RSVPreF3 OA, had immunogenicity results for RSV titers, complied with the blood draw interval, without intercurrent medical conditions, without prohibited concomitant medication/vaccination, did not meet criteria for elimination. Only participants included in both pre-vaccination and 1-month post vaccination timepoints and with results for adjusted GMTs for RSV-A at 1-month post dose were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) |
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| Primary | Adjusted GMTs of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination | RSV-B neutralizing titers were provided as group GMTs and expressed as estimated dilution 60 (ED60) titers. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model adjusted for baseline differences (in the pre-dose titers) includes treatment group and age category (age at vaccination: 50-59, 60-69 or ≥70 years) as fixed effects, and the pre-dose log10-transformed titers as a covariate. | Analysis was performed on PPS for RSVPreF3 OA. Only participants included in both pre-vaccination and 1-month post vaccination timepoints and with results for adjusted GMTs for RSV-B at 1-month post dose were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) |
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| Primary | Adjusted GMTs of SARS-CoV-2 Omicron XBB.1.5 Neutralizing Titers at 1 Month After the COVID-19 mRNA Vaccination | SARS-CoV-2 Omicron XBB.1.5 neutralizing titers against the pseudovirus bearing S protein were provided as group GMTs and expressed as titers. The neutralizing titer was calculated as the reciprocal serum dilution corresponding to the 50% signal reduction (NT50). Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model adjusted for baseline differences (in the pre-dose titers) includes treatment group and age category (age at vaccination: 50-59, 60-69 or ≥70 years) as fixed effects, and the pre-dose log10-transformed titers as a covariate. | The PPS for COVID-19 mRNA included participants who:received COVID-19 mRNA, had immunogenicity results for SARS-CoV-2 titers, complied with the blood draw interval, without intercurrent medical conditions, without prohibited concomitant medication/vaccination, did not meet criteria for elimination. Only participants included in both pre-vaccination and 1-month post vaccination timepoints and with results for adjusted GMTs for SARS-CoV-2 titers at 1-month post dose were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At 1 month post-COVID-19 mRNA vaccine dose administration (at Day 31 for both groups) |
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| Secondary | RSV-A Neutralizing Titers Expressed as GMT at 1 Month After RSVPreF3 OA Vaccination | Neutralizing titers for RSV-A were measured with neutralizing assay and the results were expressed as GMT. GMT is a descriptive statistic calculated directly from the observed titer values at the 1-month post-vaccination timepoint for all participants in the analysis set, without any statistical modelling or adjustment for covariates. | Analysis was performed on PPS for RSVPreF3 OA. Only participants included in 1-month post vaccination timepoint and with data available for RSV-A titers at the specified timepoint were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) |
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| Secondary | Mean Geometric Increase (MGI) of RSV-A Neutralizing Titers at 1 Month After RSVPreF3 OA Vaccination | The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. | Analysis was performed on PPS for RSVPreF3 OA. Only participants with data available for RSV-A titers at the specified timepoints were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) compared to pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group) |
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| Secondary | RSV-A Neutralizing Titers Expressed as Seroresponse Rate (SRR) at 1 Month After RSVPreF3 OA Vaccination | The SRR was defined as the percentage of participants having a fold increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to (>=) 4. | Analysis was performed on PPS for RSVPreF3 OA. Only participants with data available for RSV-A titers at the specified timepoints were included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) compared to pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group) |
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| Secondary | Percentage of Participants Having RSV-A Neutralizing Titers Greater or Equal to the Assay Cut-off Value at Pre-vaccination and at 1 Month After RSVPreF3 OA Vaccination | Percentage of participants with RSV-A neutralizing titers >= to the assay cut-off value (i.e. lower limit of quantification [LLOQ]) are presented. | Analysis was performed on PPS for RSVPreF3 OA. Only participants with data available for RSV-A titers at the specified timepoints were included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | At pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group) and at 1 month post-RSVPreF3 OA vaccine dose administration (Day 31 for Co-Ad Group and Day 61 for Control Group) |
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| Secondary | RSV-B Neutralizing Titers Expressed as GMT at 1 Month After RSVPreF3 OA Vaccination | Neutralizing titers for RSV-B were measured with neutralizing assay and the results were expressed as GMT. GMT is a descriptive statistic calculated directly from the observed titer values at the 1-month post-vaccination timepoint for all participants in the analysis set, without any statistical modelling or adjustment for covariates. | Analysis was performed on PPS for RSVPreF3 OA. Only participants included in 1-month post vaccination timepoint and with data available for RSV-B titers at the specified timepoint were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) |
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| Secondary | MGI of RSV-B Neutralizing Titers at 1 Month After RSVPreF3 OA Vaccination | The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. | Analysis was performed on PPS for RSVPreF3 OA. Only participants with data available for RSV-B titers at the specified timepoints were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) compared to pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group) |
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| Secondary | RSV-B Neutralizing Titers Expressed as SRR at 1 Month After RSVPreF3 OA Vaccination | The SRR was defined as the percentage of participants having a fold increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration) >= 4. | Analysis was performed on PPS for RSVPreF3 OA. Only participants with data available for RSV-B titers at the specified timepoints were included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) compared to pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group) |
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| Secondary | Percentage of Participants Having RSV-B Neutralizing Titers Greater or Equal to Assay Cut-off Value at Pre-vaccination and at 1 Month After RSVPreF3 OA Vaccination | Percentage of participants with RSV-B neutralizing titers >= to the assay cut-off value (i.e. LLOQ) are presented. | Analysis was performed on PPS for RSVPreF3 OA. Only participants with data available for RSV-B titers at the specified timepoints were included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | At pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group) and at 1 month post-RSVPreF3 OA vaccine dose administration (Day 31 for Co-Ad Group and Day 61 for Control Group) |
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| Secondary | SARS-CoV-2 Omicron XBB.1.5 Neutralizing Titers Expressed as GMT at 1 Month After COVID-19 mRNA Vaccination | The SARS-CoV-2 Omicron XBB.1.5 neutralizing titers against the pseudovirus bearing S protein were measured with neutralizing assay and the results were expressed as GMT. GMT is a descriptive statistic calculated directly from the observed titer values at the 1-month post-vaccination timepoint for all participants in the analysis set, without any statistical modelling or adjustment for covariates. | Analysis was performed on PPS for COVID-19 mRNA. Only participants included in 1-month post vaccination timepoint and with data available for SARS-CoV-2 titers at the specified timepoint were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At 1 month post-COVID-19 mRNA vaccine dose administration (Day 31 for both groups) |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | MGI of SARS-CoV-2 Omicron XBB.1.5 Neutralizing Titers at 1 Month After COVID-19 mRNA Vaccination | The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. | Analysis was performed on PPS for COVID-19 mRNA. Only participants with data available for SARS-CoV-2 Omicron XBB.1.5 neutralizing titers against the pseudovirus bearing S protein at the specified timepoints were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At 1 month post-COVID-19 mRNA vaccine dose administration (Day 31 for both groups) compared to pre-vaccination (at Day 1 for both groups) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Having SARS-CoV-2 Omicron XBB.1.5 Neutralizing Titers Greater Than or Equal to Assay Cut-off Value at Pre-vaccination and at 1 Month After COVID-19 mRNA Vaccination | Percentage of participants with SARS-CoV-2 Omicron XBB.1.5 neutralizing titers >= to the assay cut-off value (i.e. LLOQ) are presented. | Analysis was performed on PPS for COVID-19 mRNA. Only participants with data available for SARS-CoV-2 Omicron XBB.1.5 neutralizing titers against the pseudovirus bearing S protein at the specified timepoints were included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | At pre-vaccination (Day 1 for both groups) and at 1 month post-COVID-19 mRNA vaccine dose administration (Day 31 for both groups) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Each Solicited Administration Site Event, for Each Type of Vaccine Administered | The solicited administration site events after vaccination included pain, erythema/redness, and swelling. Any = occurrence of the events regardless of the intensity grade. | Exposed set included all participants in the enrolled set who received at least 1 study intervention. Only those participants with solicited administration site AEs were included in this analysis. Analysis was reported based on each type of vaccine administered (RSVPreF3 OA vaccine and COVID-19 mRNA vaccine). | Posted | Count of Participants | Participants | Within 4 days (the day of administration and 3 subsequent days) after each type of vaccine (RSVPreF3 OA vaccine administered at Day 1 for Co-Ad Group and at Day 31 for Control Group, COVID-19 mRNA vaccine administered at Day 1 for both groups) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Each Solicited Systemic Event, for Each Day of Dose Administered | The solicited systemic events after vaccination included arthralgia, fatigue, fever (pyrexia), headache and myalgia. Fever was defined as body temperature equal or greater than 38 degrees Celsius (°C). Any = occurrence of the events regardless of the intensity grade. | Analysis was performed on the Exposed set. Only those participants with solicited systemic AEs were included in this analysis. Analysis was reported based on the day of study dose administration. | Posted | Count of Participants | Participants | Within 4 days (the day of dose administered and 3 subsequent days) after each dose (administered at Day 1 for Co-Ad Group and at Days 1 and 31 for Control Group) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Unsolicited Adverse Events (AEs), for Each Day of Dose Administered | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study vaccine, which does not necessarily have a causal relationship with study vaccine. An unsolicited AE was an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs must had been communicated by participant/participant's caregiver(s) who had signed the informed consent. Unsolicited AEs included both serious and non-serious AEs. Any = occurrence of the events regardless of the intensity grade or relation to study dose administration. | Analysis was performed on Exposed set. | Posted | Count of Participants | Participants | Within 30 days (the day of vaccination and 29 subsequent days) after each dose (dose administered at Day 1 for Co-Ad Group and at Days 1 and 31 for Control Group) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Any Serious Adverse Events (SAEs) | An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Any = occurrence of the events regardless of the intensity grade or relation to study dose administration. | Analysis was performed on Exposed set. | Posted | Count of Participants | Participants | Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-Ad Group and Day 31 for Control Group]) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Any Potential Immune-mediated Diseases (pIMDs) | The pIMD was defined as a subset of adverse events of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any = occurrence of the events regardless of the intensity grade or relation to study dose administration. | Analysis was performed on Exposed set. | Posted | Count of Participants | Participants | Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-Ad Group and Day 31 for Control Group]) |
|
|
Solicited AEs were collected within 4 days post each vaccination. Unsolicited AEs were collected within 30 days post each vaccination. All cause mortality, SAEs and pIMDs were collected throughout the study period (from Day 1 up to 6 months post-last administration [last dose given at Day 1 for Co-ad Group and Day 31 for Control Group]).
Solicited and unsolicited events were reported per participant, after any vaccination, for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan. All events presented in the All-cause mortality, SAE and Other (not including Serious) AEs are reported for the Exposed set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Co-Ad Group | Participants received a single dose of RSVPreF3 OA vaccine and a single dose of COVID-19 mRNA vaccine at Day 1, in different arms. | 0 | 417 | 16 | 417 | 365 | 417 |
| EG001 | Control Group | Participants received a single dose of COVID-19 mRNA vaccine at Day 1, followed by a single dose of RSVPreF3 OA vaccine at Day 31. | 0 | 416 | 14 | 416 | 337 | 416 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v.27.1 | Systematic Assessment |
| |
| Endometrial cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v.27.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v.27.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v.27.1 | Systematic Assessment |
| |
| Lung adenocarcinoma stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v.27.1 | Systematic Assessment |
| |
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA v.27.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA v.27.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v.27.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Alcohol use disorder | Psychiatric disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v.27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Administration site pain | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Administration site erythema | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Administration site swelling | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Administration site pruritus | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Application site warmth | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Facial discomfort | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Administration site rash | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Vaccination site bruising | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Vessel puncture site haemorrhage | General disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Temporomandibular pain and dysfunction syndrome | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Muscle contracture | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Mycoplasma infection | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA v.27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Vasomotor rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v.27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v.27.1 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA v.27.1 | Systematic Assessment |
| |
| Avulsion fracture | Injury, poisoning and procedural complications | MedDRA v.27.1 | Systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA v.27.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v.27.1 | Systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA v.27.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA v.27.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v.27.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v.27.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA v.27.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA v.27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Solar dermatitis | Skin and subcutaneous tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Skin warm | Skin and subcutaneous tissue disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Generalised anxiety disorder | Psychiatric disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Colorectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v.27.1 | Systematic Assessment |
| |
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v.27.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Thyroglossal cyst | Congenital, familial and genetic disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v.27.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v.27.1 | Systematic Assessment |
| |
| Menopause | Social circumstances | MedDRA v.27.1 | 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 | Mar 24, 2025 | Oct 31, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000722934 | CVnCoV COVID-19 vaccine |
Not provided
Not provided
Not provided
| Male |
|
| White |
|
| Black or African American |
|
| Multiple |
|
| Not reported |
|
Non-inferiority (NI) was to be demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the GMT ratio between the Control Group (at Day 61) versus Co-Ad Group (at Day 31) for RSV-A neutralizing titers 1-month after the RSVPreF3 OA vaccine dose was less than or equal to (≤) 1.5. |
| Units | Counts |
|---|
| Participants |
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Participants received a single dose of COVID-19 mRNA vaccine at Day 1, followed by a single dose of RSVPreF3 OA vaccine at Day 31. |
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