Respiratory Syncytial Virus InfectionsPhase 3NCT05590403

A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above

A Phase 3 study testing RSVPreF3 OA investigational vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to demonstrate the non-inferiority (NI) of the immune response and evaluate safety of RSVPreF3 older adults (OA) investigational vaccine in adults 50-59 years of age (YOA), including those who are at increased risk (AIR) of respiratory syncytial virus (RSV)-lower respiratory tract disease… Read more about this study

Who is it for?: Ages 50 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: 1,544 participants
Where: No sites listed yet
Study dates: 28 Oct 2022to 12 Feb 2024
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 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol
Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
1. Specific inclusion criteria for all participants in Cohort 1 (Adults HA-RSV Group, Adults HA-Placebo Group, Adults AIR-RSV Group \& Adults AIR-Placebo Group)
A male or female participant 50-59 YOA at the time of the study intervention administration.
Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause.
Female participants of childbearing potential may be enrolled in the study, if the participant:

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has practiced adequate contraception from 1 month prior to study intervention administration until study end for this study, and
has a negative pregnancy test on the day of study intervention administration.
Specific inclusion criteria for participants in the Adults-HA Sub-cohort
Healthy participants as established by medical history and clinical examination before entering into the study.
Participants with chronic stable medical conditions with or without specific treatment, such as hypertension, hypercholesterolemia, or hypothyroidism, and who are not at increased risk for RSV-LRTD , are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months).
Specific inclusion criteria for participants in the Adults-AIR Sub cohort
Participants should be diagnosed with at least 1 of the following medical conditions and have a stable condition (no changes in the treatment or disease severity in the past 3 months):
Chronic pulmonary disease resulting in activity restricting symptoms or use of long-term medication
Chronic cardiovascular disease
Diabetes mellitus: types 1 and 2
Other diseases at increased risk for RSV-LRTD disease
Chronic kidney disease
Chronic liver disease 2. Specific inclusion criteria for Cohort 2 (OA-RSV Group)
A male or female participant ≥60 YOA at the time of the study intervention administration.
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 (no changes in the treatment or disease severity in the past 3 months).
Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.

Who cannot join

Medical conditions
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
Hypersensitivity to latex.
Unstable chronic illness.
Any history of dementia or any medical condition that moderately or severely impairs cognition.

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Recurrent 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. Study participants may decide to assign a caregiver to help them complete the study procedures.
Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
Prior/Concomitant therapy
Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Visit 4, Month 12).
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 the dose of study intervention administration, with the exception of inactivated and subunit influenza vaccines or COVID-19 vaccines (fully licensed or with EUA) which can be administered up to 14 days before or from 14 days after the study intervention administration.
Note: In case an emergency mass vaccination for an unforeseen public health threat is recommended and/or organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
Previous vaccination with an RSV vaccine, including investigational RSV vaccines.
Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or administration of long-acting immune modifying treatments or planned administration at any time up to the end of the study.
Up to 3 months prior to the study intervention administration:
For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
Administration of immunoglobulins and/or any blood products or plasma derivatives.
Up to 6 months prior to study intervention administration: long-acting immune modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
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 vaccine/product (drug or invasive medical device).
Other exclusions Other exclusions for all participants
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 period that will prohibit participating in the study until study end.
Participation of any study personnel or their immediate dependents, family, or household members.
Other exclusions for Cohort 1
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.

About this study

Official title: A Phase 3, Observer-blind, Randomized, Placebo-controlled Study to Evaluate the Non-inferiority of the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults ≥60 Years of Age

Conditions: Respiratory Syncytial Virus Infections
Being tested: RSVPreF3 OA investigational vaccine, Placebo
Keywords: Respiratory syncytial virus, Immunogenicity, Safety, Increased risk of respiratory syncytial virus lower respiratory tract disease, Adults aged 50-59 years of age, Older adults 60 years of age and above
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 administered intramuscularly at Day 1.
PlaceboDrug
One dose administered intramuscularly at Day 1.

Study groups in NCT05590403
Study group	Role	What they receive
Adults HA-RSV Group	Experimental	Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-Lower respiratory tract disease (RSV-LRTD), aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end. Receives: Biological: RSVPreF3 OA investigational vaccine
Adults HA-Placebo Group	Placebo comparator	Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end. Receives: Drug: Placebo
Adults AIR-RSV Group	Experimental	Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end. Receives: Biological: RSVPreF3 OA investigational vaccine
Adults AIR-Placebo Group	Placebo comparator	Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end. Receives: Drug: Placebo
OA-RSV Group	Experimental	Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end. Receives: Biological: RSVPreF3 OA investigational vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated subjects. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Measured: At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to 4 (>=4).
Measured: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Measured: At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.
Measured: At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)
RSV-A Neutralization Titers Expressed as Group GMT Titer in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Measured: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
RSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.
Measured: At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)
RSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Measured: At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
RSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.
Measured: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)

Secondary outcomes (16)

Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling)
Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.
Measured: During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness)
Assessed solicited systemic events were arthralgia, fatigue, headache, myalgia and fever [temperature equal to or above (>=) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.
Measured: During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs)
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Measured: During the 30-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting Any Serious Adverse Events (SAEs) Within 6 Months of Vaccination
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
Measured: From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting Any Onset Potential Immune Mediated Diseases (pIMDs) Within 6 Months of Vaccination
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Measured: From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting SAEs Related to Study Intervention Administration Within 12 Months of Vaccination
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
Measured: From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting pIMDs Related to Study Intervention Administration Within 12 Months of Vaccination
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Measured: From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting Any Fatal SAEs
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
Measured: From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.
Measured: At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.
Measured: At 6 months and at 12 months after study intervention administration
RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.
Measured: At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.
Measured: At 6 months and at 12 months after study intervention administration
Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention
Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Measured: At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention
Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Measured: At 6 months and at 12 months after study intervention administration
Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention
Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
Measured: At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12
Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
Measured: At 6 months and at 12 months after study intervention administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 202212 Feb 2024

First posted21 Oct 2022
Study start28 Oct 2022
Primary completion13 Mar 2023
Study completion12 Feb 2024

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.
Publications (2)Papers the sponsor has linked to this study.
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: 1,544 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05590403
Sponsor's protocol ID: 219238
Other IDs: 2022-001981-36
Status last verified: Feb 2025
First submitted: 18 Oct 2022
Last updated: 6 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Ferguson M, Schwarz TF, Nunez SA, Rodriguez-Garcia J, Mital M, Zala C, Pek B, Schmitt B, Toursarkissian N, Ochoa Mazarro D, Grosskopf J, Voors-Pette C, Mehta H, Amare Hailemariam H, Gerard C, Damaso S, David MP, Descamps D, Hill J, Vandermeulen C, Hulstrom V. Immune persistence and safety of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in adults 50-59 years of age, including at-increased-risk adults: A randomized controlled trial. Hum Vaccin Immunother. 2025 Dec;21(1):2579335. doi: 10.1080/21645515.2025.2579335. Epub 2025 Nov 5.
PubMed 41194599
Ferguson M, Schwarz TF, Nunez SA, Rodriguez-Garcia J, Mital M, Zala C, Schmitt B, Toursarkissian N, Mazarro DO, Grosskopf J, Voors-Pette C, Mehta H, Hailemariam HA, de Heusch M, Salaun B, Damaso S, David MP, Descamps D, Hill J, Vandermeulen C, Hulstrom V; RSV OA=ADJ-018 Study Group. Noninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to >/=60 Years of Age. Clin Infect Dis. 2024 Oct 15;79(4):1074-1084. doi: 10.1093/cid/ciae364.
PubMed 39099093

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization

All Respiratory Syncytial Virus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Observer-blind, Randomized, Placebo-controlled Study to Evaluate the Non-inferiority of the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults ≥60 Years of Age
ClinicalTrials.gov ID: NCT05590403
Acronym / sponsor ID: 219238
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory syncytial virus, Immunogenicity, Safety, Increased risk of respiratory syncytial virus lower respiratory tract disease, Adults aged 50-59 years of age, Older adults 60 years of age and above
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,544 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 28 Oct 2022 (actual)
Primary completion: 13 Mar 2023 (actual)
Study completion: 12 Feb 2024 (actual)
First posted: 21 Oct 2022 (actual)
Results: Posted 21 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Adults HA-RSV Group	Experimental	Biological: RSVPreF3 OA investigational vaccineHealthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-Lower respiratory tract disease (RSV-LRTD), aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Adults HA-Placebo Group	Placebo comparator	Drug: PlaceboHealthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
Adults AIR-RSV Group	Experimental	Biological: RSVPreF3 OA investigational vaccineAdults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Adults AIR-Placebo Group	Placebo comparator	Drug: PlaceboAdults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OA-RSV Group	Experimental	Biological: RSVPreF3 OA investigational vaccineOlder adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol
Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
1. Specific inclusion criteria for all participants in Cohort 1 (Adults HA-RSV Group, Adults HA-Placebo Group, Adults AIR-RSV Group \& Adults AIR-Placebo Group)
A male or female participant 50-59 YOA at the time of the study intervention administration.
Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause.

Key exclusion criteria (29 listed)

Medical conditions
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
Hypersensitivity to latex.
Unstable chronic illness.

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 administered intramuscularly at Day 1.	Biological	Adults AIR-RSV Group, Adults HA-RSV Group, OA-RSV Group
PlaceboOne dose administered intramuscularly at Day 1.	Drug	Adults AIR-Placebo Group, Adults HA-Placebo Group

Primary outcome

RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group
Time frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated subjects. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group
Time frame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to 4 (>=4).
RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group
Time frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group
Time frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.
RSV-A Neutralization Titers Expressed as Group GMT Titer in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
Time frame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
RSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
Time frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.
RSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
Time frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
RSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
Time frame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.

16 secondary outcomes

Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling)
Time frame: During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness)
Time frame: During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs)
Time frame: During the 30-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting Any Serious Adverse Events (SAEs) Within 6 Months of Vaccination
Time frame: From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting Any Onset Potential Immune Mediated Diseases (pIMDs) Within 6 Months of Vaccination
Time frame: From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting SAEs Related to Study Intervention Administration Within 12 Months of Vaccination
Time frame: From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting pIMDs Related to Study Intervention Administration Within 12 Months of Vaccination
Time frame: From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting Any Fatal SAEs
Time frame: From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention
Time frame: At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention
Time frame: At 6 months and at 12 months after study intervention administration
RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention
Time frame: At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention
Time frame: At 6 months and at 12 months after study intervention administration
Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention
Time frame: At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention
Time frame: At 6 months and at 12 months after study intervention administration
Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention
Time frame: At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12
Time frame: At 6 months and at 12 months after study intervention administration

Results and safety

Results posted to the registry on 21 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adults HA-RSV Group	383	363
Adults HA-Placebo Group	192	184
Adults AIR-RSV Group	386	369
Adults AIR-Placebo Group	191	180
OA-RSV Group	381	369

Primary outcome: RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group

Time frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31). Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Adults HA-RSV Group n = 326	OA-RSV Group n = 343
Value	7906.0 (7178.1 to 8707.7)	7518.9 (6843.2 to 8261.3)

Adults HA-RSV Group vs OA-RSV Group: GMT Ratio: 0.95 (95% CI 0.83 to 1.09)

Population analysed: Analysis was performed on the per protocol set (PPS) for humoral analysis which included all eligible participants who received the study intervention as per protocol, had RSV-A immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.

Primary outcome: RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group

Time frame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Adults HA-RSV Group n = 270	OA-RSV Group n = 275
Value	82.8 (78.3 to 86.8)	80.2 (75.6 to 84.3)

Adults HA-RSV Group vs OA-RSV Group: Difference in percentage: -2.65 (95% CI -8.54 to 3.28)

Population analysed: Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-A at pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.

Primary outcome: RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group

Time frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31). Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Adults HA-RSV Group n = 326	OA-RSV Group n = 342
Value	9024.8 (8240.8 to 9883.3)	8070.3 (7385.2 to 8819.1)

Adults HA-RSV Group vs OA-RSV Group: GMT Ratio: 0.89 (95% CI 0.79 to 1.02)

Population analysed: Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had RSV-B immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.

Primary outcome: RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group

Time frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Adults HA-RSV Group n = 255	OA-RSV Group n = 254
Value	78.2 (73.3 to 82.6)	74.3 (69.3 to 78.8)

Adults HA-RSV Group vs OA-RSV Group: Difference in percentage: -3.95 (95% CI -10.39 to 2.53)

Population analysed: Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-B at pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. SAEs and pIMDs were collected from Day 1 up to Month 6 post dose-administration. Related SAEs, related pIMDs and fatal SAEs were collected from Day 1 up to study end (Month 12).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adults HA-RSV Group	3 of 383 (0.8%)	325 of 383 (84.9%)	0 of 383
Adults HA-Placebo Group	4 of 192 (2.1%)	76 of 192 (39.6%)	0 of 192
Adults AIR-RSV Group	15 of 386 (3.9%)	318 of 386 (82.4%)	1 of 386
Adults AIR-Placebo Group	4 of 191 (2.1%)	74 of 191 (38.7%)	1 of 191
OA-RSV Group	9 of 381 (2.4%)	279 of 381 (73.2%)	0 of 381

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41194599Ferguson M, Schwarz TF, Nunez SA, Rodriguez-Garcia J, Mital M, Zala C, Pek B, Schmitt B, Toursarkissian N, Ochoa Mazarro D, Grosskopf J, Voors-Pette C, Mehta H, Amare Hailemariam H, Gerard C, Damaso S, David MP, Descamps D, Hill J, Vandermeulen C, Hulstrom V. Immune persistence and safety of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in adults 50-59 years of age, including at-increased-risk adults: A randomized controlled trial. Hum Vaccin Immunother. 2025 Dec;21(1):2579335. doi: 10.1080/21645515.2025.2579335. Epub 2025 Nov 5.
Derived from this study: PubMed 39099093Ferguson M, Schwarz TF, Nunez SA, Rodriguez-Garcia J, Mital M, Zala C, Schmitt B, Toursarkissian N, Mazarro DO, Grosskopf J, Voors-Pette C, Mehta H, Hailemariam HA, de Heusch M, Salaun B, Damaso S, David MP, Descamps D, Hill J, Vandermeulen C, Hulstrom V; RSV OA=ADJ-018 Study Group. Noninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to >/=60 Years of Age. Clin Infect Dis. 2024 Oct 15;79(4):1074-1084. doi: 10.1093/cid/ciae364.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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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.

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.

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 22 inclusion and 29 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 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 21 May 2024). 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 Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group (time frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05590403, which also lists 2 linked publications.

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 6 Mar 2025.