Respiratory Syncytial Virus InfectionsPhase 3NCT06551181
A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older
A Phase 3 study testing RSVPreF3 OA investigational vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 40 sites in 7 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- RSVPreF3 OA investigational vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,620 participants
- Where
- 40 sitesin 7 countries
- Study dates
- 5 Aug 2024to 15 Sep 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male or female of ≥60 YOA at the time of study intervention administration, who live in the community dwelling (CD participants).
- 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, attend regular phone calls/study site visits, perform self-swabbing (study participants in China only), ability to access and utilize a phone or other electronic communications).
- Participants who are medically stable in the opinion of the investigator at the time of vaccination. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.
- Written or witnessed informed consent obtained from the participant (participant must be able to understand the informed consent) prior to performance of any study specific procedure.
Who cannot join
- Medical Conditions:
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
- Any clinical conditions for which serum samples would be prohibited for transfer to local central lab for testing. These clinical conditions include hepatitis B, hepatitis C, HIV and Syphilis based on medical history and physical examination (all participants) and laboratory screening tests (overseas participants).
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).
- Any history of dementia or any medical condition that moderately or severely impairs cognition.
- Recurrent history or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g. completion of the diary cards, attend regular phone calls/study site visits, perform self-swabbing (study participants in China only).
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- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 1 year).
- Serious or unstable chronic illness.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- Prior/Concomitant Therapy:
- Previous vaccination with RSV vaccine.
- Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention(s) during the period beginning 30 days before the dose of study intervention(s), or their planned use during the study period.
- Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after study intervention administration, with the exception of COVID-19 and inactivated/subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study intervention.
- Administration of long-acting immune-modifying drugs or planned administration at any time during the study period (e.g., infliximab).
- Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention administration or planned administration during the study period.
- Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the study intervention administration or planned administration during the study period. For corticosteroids, this will mean prednisone >=20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
- 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:
- History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
- Bedridden participants.
- Planned move during the study conduct that prohibits participation until study end.
- Participation of any study personnel or their immediate dependents, family, or household members.
Trial locations and contacts
40 sites in 7 countries.
40 sites in 7 countries
Poland9 sites
GSK Investigational Site
Elblag, 82-300
GSK Investigational Site
Katowice, 40-282
GSK Investigational Site
Katowice, 40-600
GSK Investigational Site
Krakow, 31-501
GSK Investigational Site
Lodz, 91-363
GSK Investigational Site
Lublin, 20-362
GSK Investigational Site
Sochaczew, 96-500
GSK Investigational Site
Warsaw, 00-215
GSK Investigational Site
Wroclaw, 50-088
China7 sites
GSK Investigational Site
Shanghai, Putuo, 200065
GSK Investigational Site
Shanghai, Putuo
GSK Investigational Site
Shanghai, Shanghai Municipality
GSK Investigational Site
Shanghai, 200136
GSK Investigational Site
Shanghai, 201620
GSK Investigational Site
Shanghai, 201901
GSK Investigational Site
Shanghai
Finland7 sites
GSK Investigational Site
Espoo, 02230
GSK Investigational Site
Helsinki, 00290
GSK Investigational Site
Kokkola, 67100
GSK Investigational Site
Oulu, 90220
GSK Investigational Site
Seinäjoki, 60100
GSK Investigational Site
Tampere, 33100
GSK Investigational Site
Turku, 20520
United Kingdom7 sites
GSK Investigational Site
Belfast, BT7 2EB
GSK Investigational Site
Blackpool, FY3 7EN
GSK Investigational Site
Bristol, BS37 4AX
GSK Investigational Site
Cambridgeshire, CB7 5JD
GSK Investigational Site
Eynsham, OX29 4QB
GSK Investigational Site
Hounslow, TW3 3EL
GSK Investigational Site
Witney, OX28 6JS
Spain6 sites
GSK Investigational Site
Ávila, 05071
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Burgos, 09006
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Salamanca, 37007
GSK Investigational Site
Valladolid, 47003
South Korea3 sites
GSK Investigational Site
Guri-si, 471-701
GSK Investigational Site
Incheon, 400-711
GSK Investigational Site
Seoul, 152-703
About this study
Official title: A Phase 3, Randomized, Controlled, Partially Blind, Immuno-bridging Study to Evaluate Immunogenicity, Reactogenicity, Safety and the Occurrence of RSV Associated Respiratory Tract Illness After Administration of a Single Dose of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Older
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.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- RSVPreF3 OA investigational vaccine, Placebo (Saline solution)
- Keywords
- Respiratory syncytial virus (RSV), Older adults, Acute respiratory illness (ARI), Lower respiratory tract disease (LRTD), Immune response, Efficacy study, Safety study
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSVPreF3 OA investigational vaccineBiological
One dose of the RSVPreF3 OA investigational vaccine is administered intramuscularly at Day 1.
Placebo (Saline solution)Drug
One dose of placebo is administered intramuscularly at Day 1.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: RSVPreF3 OA investigational vaccine |
| 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). Receives: Biological: RSVPreF3 OA investigational vaccine |
| 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). Receives: Drug: Placebo (Saline solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: At Day 31
Percentage of Participants With Seroresponse for RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination
Measured: At Day 31 compared to baseline (Day 1)
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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].
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Throughout the study period (up to 6 months post dose [administered at Day 1 (baseline)])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start5 Aug 2024
- Primary completion24 Apr 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,620 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551181
- Sponsor's protocol ID
- 219815
- Other IDs
- 2023-509455-13-00, 2023
- Status last verified
- Apr 2026
- First submitted
- 9 Aug 2024
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Controlled, Partially Blind, Immuno-bridging Study to Evaluate Immunogenicity, Reactogenicity, Safety and the Occurrence of RSV Associated Respiratory Tract Illness After Administration of a Single Dose of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Older
- ClinicalTrials.gov ID
- NCT06551181
- Acronym / sponsor ID
- 219815
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Respiratory syncytial virus (RSV), Older adults, Acute respiratory illness (ARI), Lower respiratory tract disease (LRTD), Immune response, Efficacy study, Safety study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,620 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 13 Aug 2024 (actual)
- Results
- Posted 19 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RSV OA vaccine Group (Overseas) | Experimental | Biological: RSVPreF3 OA investigational vaccineOverseas 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). |
| RSV OA vaccine Group (China) | Experimental | Biological: RSVPreF3 OA investigational vaccineChinese 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). |
| Placebo Group (China) | Experimental | Drug: Placebo (Saline solution)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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult male or female of ≥60 YOA at the time of study intervention administration, who live in the community dwelling (CD participants).
- 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, attend regular phone calls/study site visits, perform self-swabbing (study participants in China only), ability to access and utilize a phone or other electronic communications).
- Participants who are medically stable in the opinion of the investigator at the time of vaccination. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.
- Written or witnessed informed consent obtained from the participant (participant must be able to understand the informed consent) prior to performance of any study specific procedure.
Key exclusion criteria (23 listed)
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
- Any clinical conditions for which serum samples would be prohibited for transfer to local central lab for testing. These clinical conditions include hepatitis B, hepatitis C, HIV and Syphilis based on medical history and physical examination (all participants) and laboratory screening tests (overseas participants).
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).
- Any history of dementia or any medical condition that moderately or severely impairs cognition.
- Recurrent history or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g. completion of the diary cards, attend regular phone calls/study site visits, perform self-swabbing (study participants in China only).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSVPreF3 OA investigational vaccineOne dose of the RSVPreF3 OA investigational vaccine is administered intramuscularly at Day 1. | Biological | RSV OA vaccine Group (China), RSV OA vaccine Group (Overseas) |
| Placebo (Saline solution)One dose of placebo is administered intramuscularly at Day 1. | Drug | Placebo Group (China) |
Primary outcome
RSV-A Neutralizing Titers Expressed as Adjusted Geometric Mean Titers (GMTs) at 1 Month Post RSVPreF3 OA Vaccination
Time frame: At Day 31
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.
Percentage of Participants With Seroresponse for RSV-A Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination
Time frame: At Day 31 compared to baseline (Day 1)
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).
RSV-B Neutralizing Titers Expressed as Adjusted GMTs at 1 Month Post RSVPreF3 OA Vaccination
Time frame: At Day 31
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.
Percentage of Participants With Seroresponse for RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination
Time frame: At Day 31 compared to baseline (Day 1)
20 secondary outcomes
RSV-A Neutralizing Titers Expressed as Unadjusted GMTs at Baseline and 1 Month Post RSVPreF3 OA Vaccination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1 (baseline) to Day 7
Number of Participants Reporting Any Solicited Systemic Adverse Events
Time frame: Day 1 (baseline) to Day 7
Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Throughout the study period (up to 6 months post dose [administered at Day 1 (baseline)])
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RSVPreF3 OA investigational vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 40 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Poland, China, Finland, United Kingdom, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RSV-A Neutralizing Titers Expressed as Adjusted Geometric Mean Titers (GMTs) at 1 Month Post RSVPreF3 OA Vaccination (time frame: At Day 31). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.