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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509455-13-00 | Other Identifier | EU CTR Number |
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The purpose of the current study is to evaluate the immune response of the RSVPreF3 OA investigational vaccine in older adults (OA) at least (>=) 60 years of age (YOA) in China compared to OA in the same age range to be enrolled from overseas countries that participated in the RSV OA=ADJ-006 (NCT04886596) study, since the vaccine efficacy against lower respiratory tract disease (LRTD) has been demonstrated following a single dose of the RSVPreF3 OA investigational vaccine in the global efficacy study RSV OA=ADJ-006. In addition, the safety (in all participants) , reactogenicity and occurrence of RSV-associated acute respiratory illness (ARI) (in study participants in China only) after administration of the vaccine are also assessed in the current study. No ARI surveillance will be conducted for the overseas participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSV OA vaccine Group (Overseas) | Experimental | Overseas older adults (OA) participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6). |
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| RSV OA vaccine Group (China) | Experimental | Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later). |
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| Placebo Group (China) | Experimental | Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSVPreF3 OA investigational vaccine | Biological | One dose of the RSVPreF3 OA investigational vaccine is administered intramuscularly at Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| RSV-A Neutralizing Titers Expressed as Adjusted Geometric Mean Titers (GMTs) at 1 Month Post RSVPreF3 OA Vaccination | RSV-A neutralizing titers were determined by neutralization assay and the results were expressed as GMTs. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model includes treatment group as fixed effect, and the pre-dose log10-transformed titers as a covariate. | At Day 31 |
| Percentage of Participants With Seroresponse for RSV-A Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination | Seroresponse was defined as at least a 4 fold (≥4) increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration). | At Day 31 compared to baseline (Day 1) |
| RSV-B Neutralizing Titers Expressed as Adjusted GMTs at 1 Month Post RSVPreF3 OA Vaccination | RSV-B neutralizing titers were determined by neutralization assay and the results were expressed as GMTs. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model includes treatment group as fixed effect, and the pre-dose log10-transformed titers as a covariate. | At Day 31 |
| Percentage of Participants With Seroresponse for RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination | At Day 31 compared to baseline (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| RSV-A Neutralizing Titers Expressed as Unadjusted GMTs at Baseline and 1 Month Post RSVPreF3 OA Vaccination | Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. Unadjusted GMT is a descriptive statistic calculated directly from the observed titer values at pre-vaccination and at 1-month post-vaccination timepoints for all participants in the analysis set, without any statistical modelling or adjustment for covariates. |
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Inclusion Criteria:
Exclusion Criteria:
Medical Conditions:
Prior/Concomitant Therapy:
Prior/Concurrent Clinical Study Experience:
• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
Other Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Shanghai | Putuo | 200065 | China | ||
| GSK Investigational Site |
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://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.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.
Analysis presented includes data up to Primary Completion. Additional results will be provided within one year of study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | RSV OA Vaccine Group (Overseas) | Overseas older adults (OA) participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6). |
| FG001 | RSV OA Vaccine Group (China) |
| 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 | Feb 15, 2024 | Apr 24, 2026 |
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Data from study participants in China is collected in an observer-blind manner. The study is open labelled for overseas participants.
| Placebo (Saline solution) | Drug | One dose of placebo is administered intramuscularly at Day 1. |
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| At Day 1 (baseline) and Day 31 (1 month post RSVPreF3 OA vaccination) |
| RSV-B Neutralizing Titers Expressed as Unadjusted GMTs at Baseline and 1 Month Post RSVPreF3 OA Vaccination | Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. Unadjusted GMT is a descriptive statistic calculated directly from the observed titer values at pre-vaccination and at 1-month post-vaccination timepoints for all participants in the analysis set, without any statistical modelling or adjustment for covariates. | At Day 1 (baseline) and Day 31 (1 month post RSVPreF3 OA vaccination) |
| RSV-A and RSV-B Neutralizing Titers Expressed as Unadjusted GMTs at 6 Months Post RSVPreF3 OA Vaccination | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | At Day 181 (6 months post RSVPreF3 OA vaccination) |
| Percentage of Participants With Seroresponse for RSV-A and RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination | At Day 31 compared to baseline (Day 1) |
| Percentage of Participants With Seroresponse for RSV-A and RSV-B Neutralizing Titers at 6 Months Post RSVPreF3 OA Vaccination | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | At Day 181 compared to baseline (Day 1) |
| RSV-A and RSV-B Neutralizing Titers Expressed as Adjusted GMTs at 1 Month Post RSVPreF3 OA Vaccination Between RSV OA Overseas (RSV OA=ADJ-006 Study) vs RSV OA Vaccine Group (China) Group | This outcome measure compares the adjusted GMTs for RSV-A and RSV-B for the RSV OA vaccine Group (China) to the selected immunogenicity subset of the global efficacy study RSV OA=ADJ-006 [RSV OA Overseas (RSV OA=ADJ-006 study) group]. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model includes treatment group as fixed effect, and the pre-dose log10-transformed titers as a covariate. | At Day 31 |
| Percentage of Participants With Seroresponse for RSV-A and RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination Between RSV OA Overseas (RSV OA=ADJ-006 Study) vs RSV OA Vaccine Group (China) Group | This outcome measure compares the seroresponse for RSV-A and RSV-B neutralizing titers in the RSV OA vaccine Group (China) group to the selected immunogenicity subset of the global efficacy study RSV OA=ADJ-006 [RSV OA Overseas (RSV OA=ADJ-006 study) group]. | At Day 31 compared to baseline (Day 1) |
| Number of Participants With Real Time Polymerase Chain Reaction (RT-PCR) Confirmed RSV-A/B Associated Acute Respiratory Illness (ARI) and Lower Respiratory Tract Disease (LRTD) Cases | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | From Day 15 and up to study end (6 months post dose [dose administered at Day 1]) |
| Duration of Episodes for RSV-confirmed ARI and LRTD Cases | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | From Day 15 and up to study end (6 months post dose [dose administered at Day 1]) |
| Number of Episodes of Each of the Symptoms/Signs Associated to RSV-confirmed ARI Cases | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | From Day 15 and up to study end (6 months post dose [dose administered at Day 1]) |
| Number of Episodes of Each of the Symptoms/Signs Associated With RSV-confirmed LRTD Cases | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | From Day 15 and up to study end (6 months post dose [dose administered at Day 1]) |
| Number of Participants With RSV-confirmed ARI and LRTD Episodes by Severity | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | From Day 15 and up to study end (6 months post dose [dose administered at Day 1]) |
| Number of Participants With RSV-confirmed ARI and LRTD Cases by Frailty Status | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | From Day 15 and up to study end (6 months post dose [dose administered at Day 1]) |
| Number of Participants Reporting Any Solicited Administration Site Adverse Events | Assessed solicited administration site adverse events were pain, redness (erythema) and swelling at administration site. Any = occurrence of the symptom regardless of intensity grade. | Day 1 (baseline) to Day 7 |
| Number of Participants Reporting Any Solicited Systemic Adverse Events | Assessed solicited systemic adverse events were fever (pyrexia), headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness). Fever was defined as body temperature greater or equal to (≥) 38 degrees Celsius (ºC). Any = occurrence of the symptom regardless of intensity grade. | Day 1 (baseline) to Day 7 |
| Number of Participants Reporting Any Unsolicited Adverse Events (AEs) | 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 included both serious and non-serious AEs. Any = occurrence of the symptom regardless of intensity grade. | Day 1 (baseline) to Day 30 |
| Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs up to Data Lock Point of Primary Analysis | An SAE is defined as any untoward medical occurrence that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes. Any SAE = occurrence of the SAE regardless of the intensity grade or relation to study vaccination. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination. | Day 1 (baseline) up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days) |
| Number of Participants Reporting Any SAEs, Related SAEs and Fatal SAEs up to End of Study | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | Throughout the study period (up to 6 months post dose [administered at Day 1 (baseline)]) |
| Number of Participants Reporting Any Potential Immune-mediated Disease (pIMDs) and Related pIMDs up to Data Lock Point for Primary Analysis | pIMDs are a subset of Adverse Events of Specific Interest (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 the intensity grade or relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination. | Day 1 (baseline) up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days) |
| Number of Participants Reporting Any pIMDs and Related pIMDs up to End of Study | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | Throughout the study period (up to 6 months post dose [administered at Day 1 (baseline)]) |
| Shanghai |
| Putuo |
| China |
| GSK Investigational Site | Shanghai | Shanghai Municipality | China |
| GSK Investigational Site | Shanghai | 200136 | China |
| GSK Investigational Site | Shanghai | 201620 | China |
| GSK Investigational Site | Shanghai | 201901 | China |
| GSK Investigational Site | Shanghai | China |
| GSK Investigational Site | Espoo | 02230 | Finland |
| GSK Investigational Site | Helsinki | 00290 | Finland |
| GSK Investigational Site | Kokkola | 67100 | Finland |
| GSK Investigational Site | Oulu | 90220 | Finland |
| GSK Investigational Site | Seinäjoki | 60100 | Finland |
| GSK Investigational Site | Tampere | 33100 | Finland |
| GSK Investigational Site | Turku | 20520 | Finland |
| GSK Investigational Site | Tokyo | 160-0017 | Japan |
| GSK Investigational Site | Elblag | 82-300 | Poland |
| GSK Investigational Site | Katowice | 40-282 | Poland |
| GSK Investigational Site | Katowice | 40-600 | Poland |
| GSK Investigational Site | Krakow | 31-501 | Poland |
| GSK Investigational Site | Lodz | 91-363 | Poland |
| GSK Investigational Site | Lublin | 20-362 | Poland |
| GSK Investigational Site | Sochaczew | 96-500 | Poland |
| GSK Investigational Site | Warsaw | 00-215 | Poland |
| GSK Investigational Site | Wroclaw | 50-088 | Poland |
| GSK Investigational Site | Guri-si | 471-701 | South Korea |
| GSK Investigational Site | Incheon | 400-711 | South Korea |
| GSK Investigational Site | Seoul | 152-703 | South Korea |
| GSK Investigational Site | Ávila | 05071 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Burgos | 09006 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Salamanca | 37007 | Spain |
| GSK Investigational Site | Valladolid | 47003 | Spain |
| GSK Investigational Site | Belfast | BT7 2EB | United Kingdom |
| GSK Investigational Site | Blackpool | FY3 7EN | United Kingdom |
| GSK Investigational Site | Bristol | BS37 4AX | United Kingdom |
| GSK Investigational Site | Cambridgeshire | CB7 5JD | United Kingdom |
| GSK Investigational Site | Eynsham | OX29 4QB | United Kingdom |
| GSK Investigational Site | Hounslow | TW3 3EL | United Kingdom |
| GSK Investigational Site | Witney | OX28 6JS | United Kingdom |
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
| FG002 | Placebo Group (China) | Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | RSV OA Vaccine Group (Overseas) | Overseas older adults (OA) participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6). |
| BG001 | RSV OA Vaccine Group (China) | Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later). |
| BG002 | Placebo Group (China) | Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later). |
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | RSV-A Neutralizing Titers Expressed as Adjusted Geometric Mean Titers (GMTs) at 1 Month Post RSVPreF3 OA Vaccination | RSV-A neutralizing titers were determined by neutralization assay and the results were expressed as GMTs. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model includes treatment group as fixed effect, and the pre-dose log10-transformed titers as a covariate. | Analysis performed on Per Protocol Set(PPS)-all eligible participants who received study intervention,had immunogenicity results pre&post dose,complied with blood draw intervals,without intercurrent conditions that may interfere with immunogenicity & without prohibited concomitant medication.As pre-specified in Protocol,analysis was performed only on RSV OA vaccine (China) & RSV OA vaccine (Oversea) groups.Participants with adjusted RSV-A GMTs data available at specified timepoint were reported. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 31 |
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| Primary | Percentage of Participants With Seroresponse for RSV-A Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination | Seroresponse was defined as at least a 4 fold (≥4) increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration). | Analysis was performed on the PPS. As pre-specified in the Protocol, the analysis was performed only on the RSV OA vaccine Group (China) and RSV OA vaccine Group (Overseas). Participants with data available for seroresponse for RSV-A at the specified timepoint were reported in this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 31 compared to baseline (Day 1) |
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| Primary | RSV-B Neutralizing Titers Expressed as Adjusted GMTs at 1 Month Post RSVPreF3 OA Vaccination | RSV-B neutralizing titers were determined by neutralization assay and the results were expressed as GMTs. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model includes treatment group as fixed effect, and the pre-dose log10-transformed titers as a covariate. | Analysis was performed on the PPS. As pre-specified in the Protocol, the analysis was performed only on the RSV OA vaccine Group (China) and RSV OA vaccine Group (Overseas). Participants with adjusted RSV-B GMTs data available at the specified timepoint were reported in this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 31 |
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| Primary | Percentage of Participants With Seroresponse for RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination | Analysis was performed on the PPS. As pre-specified in the Protocol, the analysis was performed only on the RSV OA vaccine Group (China) and RSV OA vaccine Group (Overseas). Participants with data available for seroresponse for RSV-B at the specified timepoint were reported in this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 31 compared to baseline (Day 1) |
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| Secondary | RSV-A Neutralizing Titers Expressed as Unadjusted GMTs at Baseline and 1 Month Post RSVPreF3 OA Vaccination | Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. Unadjusted GMT is a descriptive statistic calculated directly from the observed titer values at pre-vaccination and at 1-month post-vaccination timepoints for all participants in the analysis set, without any statistical modelling or adjustment for covariates. | Analysis was performed on the PPS. As pre-specified in the Protocol, the analysis was performed only on the RSV OA vaccine Group (China) and RSV OA vaccine Group (Overseas). Participants with unadjusted RSV-A GMT data available at the specified timepoints (Day 1 and Day 31) were reported in this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 1 (baseline) and Day 31 (1 month post RSVPreF3 OA vaccination) |
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| Secondary | RSV-B Neutralizing Titers Expressed as Unadjusted GMTs at Baseline and 1 Month Post RSVPreF3 OA Vaccination | Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. Unadjusted GMT is a descriptive statistic calculated directly from the observed titer values at pre-vaccination and at 1-month post-vaccination timepoints for all participants in the analysis set, without any statistical modelling or adjustment for covariates. | Analysis was performed on the PPS. As pre-specified in the Protocol, the analysis was performed only on the RSV OA vaccine Group (China) and RSV OA vaccine Group (Overseas). Participants with unadjusted RSV-B GMT data available at the specified timepoints (Day 1 and Day 31) were reported in this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 1 (baseline) and Day 31 (1 month post RSVPreF3 OA vaccination) |
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| Secondary | RSV-A and RSV-B Neutralizing Titers Expressed as Unadjusted GMTs at 6 Months Post RSVPreF3 OA Vaccination | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | Not Posted | At Day 181 (6 months post RSVPreF3 OA vaccination) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Seroresponse for RSV-A and RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination | Analysis was performed on the PPS. As pre-specified in the Protocol, the analysis was performed only on the RSV OA vaccine Group (China) and RSV OA vaccine Group (Overseas). Participants with data available for seroresponse for RSV-A and RSV-B at the specified timepoint were reported in this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 31 compared to baseline (Day 1) |
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| Secondary | Percentage of Participants With Seroresponse for RSV-A and RSV-B Neutralizing Titers at 6 Months Post RSVPreF3 OA Vaccination | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | Not Posted | At Day 181 compared to baseline (Day 1) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | RSV-A and RSV-B Neutralizing Titers Expressed as Adjusted GMTs at 1 Month Post RSVPreF3 OA Vaccination Between RSV OA Overseas (RSV OA=ADJ-006 Study) vs RSV OA Vaccine Group (China) Group | This outcome measure compares the adjusted GMTs for RSV-A and RSV-B for the RSV OA vaccine Group (China) to the selected immunogenicity subset of the global efficacy study RSV OA=ADJ-006 [RSV OA Overseas (RSV OA=ADJ-006 study) group]. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model includes treatment group as fixed effect, and the pre-dose log10-transformed titers as a covariate. | Analysis was performed on the PPS. Only participants from RSV OA vaccine Group (China) and the immunogenicity subset of the global RSV OA=ADJ-006 study [RSV OA Overseas (RSV OA=ADJ-006 study)] with data available for adjusted RSV-A and RSV-B GMTs at the specified timepoint (Day 31) were reported in this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 31 |
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| Secondary | Percentage of Participants With Seroresponse for RSV-A and RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination Between RSV OA Overseas (RSV OA=ADJ-006 Study) vs RSV OA Vaccine Group (China) Group | This outcome measure compares the seroresponse for RSV-A and RSV-B neutralizing titers in the RSV OA vaccine Group (China) group to the selected immunogenicity subset of the global efficacy study RSV OA=ADJ-006 [RSV OA Overseas (RSV OA=ADJ-006 study) group]. | Analysis was performed on the PPS. Only participants from RSV OA vaccine Group (China) and the immunogenicity subset of the global RSV OA=ADJ-006 study [RSV OA Overseas (RSV OA=ADJ-006 study)] with data available for seroresponse for RSV-A and RSV-B at the specified timepoints (Day 1 and Day 31) were reported in this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 31 compared to baseline (Day 1) |
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| Secondary | Number of Participants With Real Time Polymerase Chain Reaction (RT-PCR) Confirmed RSV-A/B Associated Acute Respiratory Illness (ARI) and Lower Respiratory Tract Disease (LRTD) Cases | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | Not Posted | From Day 15 and up to study end (6 months post dose [dose administered at Day 1]) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Episodes for RSV-confirmed ARI and LRTD Cases | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | Not Posted | From Day 15 and up to study end (6 months post dose [dose administered at Day 1]) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Episodes of Each of the Symptoms/Signs Associated to RSV-confirmed ARI Cases | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | Not Posted | From Day 15 and up to study end (6 months post dose [dose administered at Day 1]) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Episodes of Each of the Symptoms/Signs Associated With RSV-confirmed LRTD Cases | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | Not Posted | From Day 15 and up to study end (6 months post dose [dose administered at Day 1]) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With RSV-confirmed ARI and LRTD Episodes by Severity | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | Not Posted | Jul 2026 | From Day 15 and up to study end (6 months post dose [dose administered at Day 1]) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With RSV-confirmed ARI and LRTD Cases by Frailty Status | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | Not Posted | Jul 2026 | From Day 15 and up to study end (6 months post dose [dose administered at Day 1]) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Any Solicited Administration Site Adverse Events | Assessed solicited administration site adverse events were pain, redness (erythema) and swelling at administration site. Any = occurrence of the symptom regardless of intensity grade. | Analysis was performed on the ES. As pre-specified in Protocol, data for this outcome measure were collected only for the Chinese groups (RSV OA vaccine Group [China] and Placebo Group [China]), from which only those participants with data available for solicited administration site adverse events at the specified time period were reported in this outcome measure. | Posted | Count of Participants | Participants | Day 1 (baseline) to Day 7 |
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| Secondary | Number of Participants Reporting Any Solicited Systemic Adverse Events | Assessed solicited systemic adverse events were fever (pyrexia), headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness). Fever was 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. As pre-specified in Protocol, data for this outcome measure were collected only for the Chinese groups (RSV OA vaccine Group [China] and Placebo Group [China]), from which only those participants with data available for solicited systemic adverse events at the specified time period were reported in this outcome measure. | Posted | Count of Participants | Participants | Day 1 (baseline) to Day 7 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Any Unsolicited Adverse Events (AEs) | 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 included both serious and non-serious AEs. Any = occurrence of the symptom regardless of intensity grade. | Analysis was performed on the ES. As pre-specified in Protocol, data for this outcome measure was presented only for the Chinese participants (RSV OA vaccine Group [China] and Placebo Group [China]), from which only those participants with data available for the specified analysis at the specified time period were reported in this outcome measure. | Posted | Count of Participants | Participants | Day 1 (baseline) to Day 30 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs up to Data Lock Point of Primary Analysis | An SAE is defined as any untoward medical occurrence that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes. Any SAE = occurrence of the SAE regardless of the intensity grade or relation to study vaccination. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination. | Analysis was performed on the ES. Only those participants with data available for SAEs at the specified time period were reported in this outcome measure. | Posted | Count of Participants | Participants | Day 1 (baseline) up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Any SAEs, Related SAEs and Fatal SAEs up to End of Study | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | Not Posted | Throughout the study period (up to 6 months post dose [administered at Day 1 (baseline)]) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Any Potential Immune-mediated Disease (pIMDs) and Related pIMDs up to Data Lock Point for Primary Analysis | pIMDs are a subset of Adverse Events of Specific Interest (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 the intensity grade or relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination. | Analysis was performed on the ES. Only those participants with data available for pIMDs at the specified time period were reported in this outcome measure. | Posted | Count of Participants | Participants | Day 1 (baseline) up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Any pIMDs and Related pIMDs up to End of Study | Data not available at the time of initial results posting, will be updated at the final results disclosure stage. | Not Posted | Throughout the study period (up to 6 months post dose [administered at Day 1 (baseline)]) | Participants |
Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days min.: 28 days, max.: 338 days) [blocked]
Not provided
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 OA Vaccine Group (Overseas) | Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6). | 2 | 820 | 28 | 820 | 2 | 820 |
| EG001 | RSV OA Vaccine Group (China) | Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later). | 2 | 1,199 | 53 | 1,199 | 641 | 1,199 |
| EG002 | Placebo Group (China) | Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later). | 0 | 601 | 38 | 601 | 107 | 601 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Cor pulmonale | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Sinus arrest | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hypertensive heart disease | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pulmonary bullae rupture | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Intestinal mass | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Salivary gland mass | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Cerebral artery occlusion | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Persistent postural-perceptual dizziness | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Facial spasm | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pelvic organ prolapse | Reproductive system and breast disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Uterine disorder | Reproductive system and breast disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Gastric cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Systematic Assessment |
| |
| Colorectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Type 3 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Focal segmental glomerulosclerosis | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Acute cholecystitis necrotic | Hepatobiliary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Adenomatous polyposis coli | Congenital, familial and genetic disorders | MedDRA v28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Administration site pain | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Vaccination site pruritus | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Vaccination site swelling | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Myringitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Subungual abscess | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | 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 |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Angular cheilitis | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Dysbiosis | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Uterine mass | Reproductive system and breast disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Tumour marker increased | Investigations | MedDRA v28.0 | Systematic Assessment |
| |
| Influenza A virus test positive | Investigations | MedDRA v28.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Ear inflammation | Ear and labyrinth disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | 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 | Aug 6, 2025 | Apr 24, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
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| White |
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| American Indian or Alaskan Native |
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| Black or African American |
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NI was to be demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio between RSV OA vaccine Group (Overseas) over RSV OA vaccine Group (China) at 1 month post RSVPreF3 OA vaccine administration was less than or equal to (≤) 1.5. |
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| OG002 | Placebo Group (China) | Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later). |
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| Placebo Group (China) |
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later). |
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