Respiratory Syncytial VirusesPhase 3RSV-OA=ADJ-020NCT05966090

A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults

A Phase 3 study testing RSVPreF3 OA investigational vaccine and HZ/su vaccine in people with Respiratory Syncytial Viruses and Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 31 sites in 2 countries.

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

To assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with HZ/su vaccine and its safety in older adults, aged >=50 years of age. 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 Viruses, Respiratory Syncytial Virus Infections
What is being tested?: RSVPreF3 OA investigational vaccine and HZ/su vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 530 participants
Where: 31 sitesin 2 countries
Study dates: 28 Jul 2023to 29 Jul 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

A male or female participant ≥50 YOA at the time of the first study intervention administration.
Female participants of non-childbearing potential may be enrolled in the study.
Female participants of childbearing potential may be enrolled in the study, if the participant:
has practiced adequate contraception from 1 month prior to study intervention administration.
has a negative pregnancy test on the day of and prior to study intervention administration.
has agreed to continue effective contraception until the end of the study.

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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 any study specific procedure being performed.
Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.

Who cannot join

Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Any confirmed or suspected autoimmune disorders, immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, in particular any history of severe allergic reaction to any vaccine component.
History of Guillain-Barré syndrome.
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 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.
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.
Clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode of herpes zoster.
History of previous vaccination with any licensed or investigational recombinant adjuvanted zoster vaccine (HZ/su vaccine; Shingrix) before the study start or planned receipt through study participation.
History of previous vaccination with any licensed or investigational live herpes zoster vaccine (Zostavax) in the last 2 years from enrollment, or planned receipt through study participation.
Previous vaccination with licensed or investigational RSV vaccine.
Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions, 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 the first study intervention administration and ending 30 days after the last study intervention administration.
o In the case of COVID-19 and inactivated/subunit/split influenza vaccines, this time window can be decreased to 14 days before and after each study intervention administration provided COVID-19 vaccine use is in line with local governmental recommendations.
Planned or actual administration of adjuvanted quadrivalent influenza vaccine influenza vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration.
Administration of long-acting immune-modifying drugs during the period starting 180 days before the administration of first dose of study interventions 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 administration of first dose of study interventions 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 first study intervention dose or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled, topical or intra-articular steroids are allowed.
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 (IMP) (drug or invasive medical device).
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

31 sites in 2 countries.

Country

City, postcode or hospital

31 sites in 2 countries

Canada20 sites

GSK Investigational Site
Brampton, Ontario, L6T 0G1
GSK Investigational Site
Brampton, L6T 0G1
GSK Investigational Site
Guelph, Ontario, N1H 1B1
GSK Investigational Site
Guelph, N1H 1B1
GSK Investigational Site
Québec, Quebec, G1N 4V3
GSK Investigational Site
Québec, Quebec, G6W 0M5
GSK Investigational Site
Québec, Quebec, H9R 4S3
GSK Investigational Site
Québec, Quebec, J7J 2K8
GSK Investigational Site
Québec, G1N 4V3
GSK Investigational Site
Québec, G6W 0M5
GSK Investigational Site
Québec, H9R 4S3
GSK Investigational Site
Québec, J7J 2K8
GSK Investigational Site
Sarnia, N7T 4X3
GSK Investigational Site
Sherbrooke, Quebec, J1L 0H8
GSK Investigational Site
Sherbrooke, J1L 0H8
GSK Investigational Site
Toronto, Ontario, M4G 3E8
GSK Investigational Site
Toronto, Ontario, M9V 4B4
GSK Investigational Site
Toronto, M3H 5S4
GSK Investigational Site
Toronto, M4G 3E8
GSK Investigational Site
Toronto, M9V 4B4

Other trials in Canada

United States11 sites

GSK Investigational Site
Aurora, Colorado, 80012
GSK Investigational Site
Columbus, Georgia, 31904-8946
GSK Investigational Site
Corte Madera, California, 94925
GSK Investigational Site
Daphne, Alabama, 36526
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
New Orleans, Louisiana, 70115
GSK Investigational Site
North Miami Beach, Florida, 33162
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Tempe, Arizona, 85281
GSK Investigational Site
Versailles, Kentucky, 40383
GSK Investigational Site
West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With Herpes Zoster Recombinant Subunit (HZ/su) Vaccine in Adults Aged 50 Years and Older

To assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with HZ/su vaccine and its safety in older adults, aged >=50 years of age.

Conditions: Respiratory Syncytial Viruses, Respiratory Syncytial Virus Infections
Being tested: RSVPreF3 OA investigational vaccine, HZ/su vaccine
Keywords: Respiratory syncytial virus, Infection, Vaccine, Older adult, Immunogenicity, Safety
Medical subject headings: Respiratory Syncytial Virus Infections, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RSVPreF3 OA investigational vaccineBiological
Also called Respiratory Syncytial Virus PreFusion protein 3 Older Adults vaccine
One dose of RSVPreF3 OA investigational vaccine given intramuscularly on Day 1 (Coadministration group) or Day 31 (Control group).
HZ/su vaccineBiological
Also called Herpes Zoster recombinant subunit vaccine, Shingrix
Two doses of HZ/su vaccine given intramuscularly on Day 1 and Day 61.

Study groups in NCT05966090
Study group	Role	What they receive
Co-administration Group	Experimental	Participants received both herpes zoster recombinant subunit (HZ/su) vaccine and respiratory syncytial virus prefusion protein 3 older adult (RSVPreF3 OA) vaccine on Day 1 followed by second dose of HZ/su vaccine on Day 61. Receives: Biological: RSVPreF3 OA investigational vaccine; Biological: HZ/su vaccine
Control Group	Active comparator	Participants received HZ/su vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31 followed by second dose of HZ/su vaccine on Day 61. Receives: Biological: RSVPreF3 OA investigational vaccine; Biological: HZ/su vaccine

What is being measured

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

Adjusted Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies at 1 Month Post-second Dose of HZ/su Vaccination
Anti-gE antibodies were measured with enzyme linked immunosorbent assay (ELISA) and the results were expressed as GMC, in milli international units per milliliter (mIU/mL).
Measured: At 1 month post-second dose of HZ/su vaccination (Day 91)
Adjusted Geometric Mean Titers (GMT) of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination
Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.
Measured: At Day 31 for Co-administration Group and at Day 61 for Control Group
Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination
Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.
Measured: At Day 31 for Co-administration Group and at Day 61 for Control Group

Secondary outcomes (13)

Percentage of Participants With Seropositivity at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination
Seropositivity was defined as the percentage of participants whose antibody concentration was greater than or equal to the assay cut-off value (97 mIU/mL).
Measured: Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91)
GMC of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination
Anti-gE antibodies were measured with ELISA and the results were expressed as GMC.
Measured: Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91)
Mean Geometric Increase (MGI) of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination
The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Anti-gE antibodies were measured with ELISA.
Measured: At 1 month post-second dose of HZ/su vaccination (Day 91) compared to Pre-vaccination (Day 1)
Vaccine Response Rate (VRR) at 1 Month Post-second Dose of HZ/su Vaccination
The VRR was defined as the percentage of participants who had at least: a 4-fold increase post-vaccination anti-gE antibody concentration as compared to (over) the pre-vaccination anti-gE antibody concentration (for participants who were seropositive at pre-vaccination); or, a 4-fold increase post-vaccination anti-gE antibody concentration as compared to (over) the anti-gE antibody cut-off value for seropositivity (97 mIU/mL) (for participants who were seronegative at pre-vaccination).
Measured: At 1 month post-second dose of HZ/su vaccination (Day 91)
GMT of RSV-A Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination
Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.
Measured: At pre-vaccination (Day 1) and Day 31 for Co-administration Group and at pre-vaccination (Day 1) and Day 61 for Control Group
MGI of Respiratory Syncytial Virus-A Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Neutralizing titers were measured with neutralization assay.
Measured: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Control Group)
GMT of RSV-B Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination
Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.
Measured: At pre-vaccination (Day 1) and Day 31 for Co-administration Group and at pre-vaccination (Day 1) and Day 61 for Control Group
MGI of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Neutralizing titers were measured with neutralization assay.
Measured: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Control Group)
Percentage of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration
The solicited administration site events after vaccination included pain, erythema/redness, and swelling.
Measured: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Days 1 and 61 for Co-Administration Group and at Days 1, 31 and 61 for Control group)
Percentage of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration
The solicited systemic events after vaccination included arthralgia, fatigue, fever (pyrexia), headache, myalgia, shivering/chills, and gastrointestinal symptoms (nausea, vomiting, diarrhea, and abdominal pain).
Measured: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Days 1 and 61 for Co-Administration Group and at Days 1, 31 and 61 for Control group)
Percentage of Participants With Unsolicited Adverse Events
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study vaccine, which does not necessarily have a causal relationship with study vaccine. An unsolicited AE was an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs must had been communicated by participant/participant's caregiver(s) who had signed the informed consent. Unsolicited AEs included both serious and non-serious AEs.
Measured: Within 30 days (the day of vaccination and 29 subsequent days) after vaccine administration
Percentage of Participants With Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Measured: From first dose of study vaccine administration (Day 1) up to 6 months after last dose of study vaccine administration, approximately 241 days
Percentage of Participants With Potential Immune-mediated Diseases (pIMDs)
The pIMD was a subset of adverse events of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Measured: From first dose of study vaccine administration (Day 1) up to 6 months after last dose of study vaccine administration, approximately 241 days

Timeline

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

28 Jul 202329 Jul 2024

First posted28 Jul 2023
Study start28 Jul 2023
Primary completion19 Feb 2024
Study completion29 Jul 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 (1)Papers the sponsor has linked to this study.
Other trials for Respiratory Syncytial VirusesStudies 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: None (open label)
Enrolment: 530 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05966090
Sponsor's protocol ID: 219331
Acronym: RSV-OA=ADJ-020
Status last verified: Mar 2025
First submitted: 21 Jul 2023
Last updated: 1 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.

Publications

Roussy JF, Dennis P, Gupta AK, Wallace G, Abitbol A, Aggarwal N, Surber JG, Lee T, Smith BA, Gerard C, Hailemariam HA, David MP, Jastorff AM, Van der Wielen M. Immunogenicity and Safety of the Adjuvanted Respiratory Syncytial Virus Prefusion F Protein-Based Vaccine When Co-administered With the Adjuvanted Recombinant Herpes Zoster Subunit Vaccine in Adults >/= 50 Years of Age. Clin Infect Dis. 2026 Apr 29:ciag208. doi: 10.1093/cid/ciag208. Online ahead of print.
PubMed 42054374

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?

See locations

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A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
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RecruitingPhase 2
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All Respiratory Syncytial Viruses trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With Herpes Zoster Recombinant Subunit (HZ/su) Vaccine in Adults Aged 50 Years and Older
ClinicalTrials.gov ID: NCT05966090
Acronym / sponsor ID: RSV-OA=ADJ-020 / 219331
Conditions: Respiratory Syncytial Viruses, Respiratory Syncytial Virus Infections
Keywords: Respiratory syncytial virus, Infection, Vaccine, Older adult, Immunogenicity, Safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 530 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 28 Jul 2023 (actual)
Primary completion: 19 Feb 2024 (actual)
Study completion: 29 Jul 2024 (actual)
First posted: 28 Jul 2023 (actual)
Results: Posted 1 Apr 2025

Clinical summary

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

To assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with HZ/su vaccine and its safety in older adults, aged >=50 years of age.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Co-administration Group	Experimental	Biological: RSVPreF3 OA investigational vaccine, Biological: HZ/su vaccineParticipants received both herpes zoster recombinant subunit (HZ/su) vaccine and respiratory syncytial virus prefusion protein 3 older adult (RSVPreF3 OA) vaccine on Day 1 followed by second dose of HZ/su vaccine on Day 61.
Control Group	Active comparator	Biological: RSVPreF3 OA investigational vaccine, Biological: HZ/su vaccineParticipants received HZ/su vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31 followed by second dose of HZ/su vaccine on Day 61.

Who may qualify

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

Key inclusion criteria (9 listed)

A male or female participant ≥50 YOA at the time of the first study intervention administration.
Female participants of non-childbearing potential may be enrolled in the study.
Female participants of childbearing potential may be enrolled in the study, if the participant:
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 any study specific procedure being performed.
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.

Key exclusion criteria (24 listed)

Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Any confirmed or suspected autoimmune disorders, immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, in particular any history of severe allergic reaction to any vaccine component.
History of Guillain-Barré syndrome.

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 vaccineAlso: Respiratory Syncytial Virus PreFusion protein 3 Older Adults vaccineOne dose of RSVPreF3 OA investigational vaccine given intramuscularly on Day 1 (Coadministration group) or Day 31 (Control group).	Biological	Co-administration Group, Control Group
HZ/su vaccineAlso: Herpes Zoster recombinant subunit vaccine, ShingrixTwo doses of HZ/su vaccine given intramuscularly on Day 1 and Day 61.	Biological	Co-administration Group, Control Group

Primary outcome

Adjusted Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies at 1 Month Post-second Dose of HZ/su Vaccination
Time frame: At 1 month post-second dose of HZ/su vaccination (Day 91)
Anti-gE antibodies were measured with enzyme linked immunosorbent assay (ELISA) and the results were expressed as GMC, in milli international units per milliliter (mIU/mL).
Adjusted Geometric Mean Titers (GMT) of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination
Time frame: At Day 31 for Co-administration Group and at Day 61 for Control Group
Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.
Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination
Time frame: At Day 31 for Co-administration Group and at Day 61 for Control Group
Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.

13 secondary outcomes

Percentage of Participants With Seropositivity at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination
Time frame: Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91)
GMC of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination
Time frame: Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91)
Mean Geometric Increase (MGI) of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination
Time frame: At 1 month post-second dose of HZ/su vaccination (Day 91) compared to Pre-vaccination (Day 1)
Vaccine Response Rate (VRR) at 1 Month Post-second Dose of HZ/su Vaccination
Time frame: At 1 month post-second dose of HZ/su vaccination (Day 91)
GMT of RSV-A Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination
Time frame: At pre-vaccination (Day 1) and Day 31 for Co-administration Group and at pre-vaccination (Day 1) and Day 61 for Control Group
MGI of Respiratory Syncytial Virus-A Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
Time frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Control Group)
GMT of RSV-B Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination
Time frame: At pre-vaccination (Day 1) and Day 31 for Co-administration Group and at pre-vaccination (Day 1) and Day 61 for Control Group
MGI of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
Time frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Control Group)
Percentage of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration
Time frame: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Days 1 and 61 for Co-Administration Group and at Days 1, 31 and 61 for Control group)
Percentage of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration
Time frame: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Days 1 and 61 for Co-Administration Group and at Days 1, 31 and 61 for Control group)
Percentage of Participants With Unsolicited Adverse Events
Time frame: Within 30 days (the day of vaccination and 29 subsequent days) after vaccine administration
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: From first dose of study vaccine administration (Day 1) up to 6 months after last dose of study vaccine administration, approximately 241 days
Percentage of Participants With Potential Immune-mediated Diseases (pIMDs)
Time frame: From first dose of study vaccine administration (Day 1) up to 6 months after last dose of study vaccine administration, approximately 241 days

Results and safety

Results posted to the registry on 1 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Co-administration Group	265	256
Control Group	265	255

Primary outcome: Adjusted Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies at 1 Month Post-second Dose of HZ/su Vaccination

Time frame: At 1 month post-second dose of HZ/su vaccination (Day 91). Geometric mean (95% Confidence Interval). Unit: mIU/mL

Measure	Co-administration Group n = 199	Control Group n = 168
Value	49326.9 (44948.5 to 54131.7)	61192.7 (55306.4 to 67705.5)

Co-administration Group vs Control Group: Ratio: 1.24 (95% CI 1.08 to 1.42)

Population analysed: Per protocol set for HZ/su included all eligible participants in the exposed set who: received 2 doses of HZ/su vaccine, had immunogenicity results for anti-gE antibody concentrations, complied with the blood draw interval, without intercurrent medical conditions and without prohibited concomitant medication/vaccination, did not met any of the criteria for elimination up to blood sample collection. Participants with data available at the time of analysis were reported in this outcome measure.

Primary outcome: Adjusted Geometric Mean Titers (GMT) of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination

Time frame: At Day 31 for Co-administration Group and at Day 61 for Control Group. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Co-administration Group n = 237	Control Group n = 218
Value	8426.8 (7504.2 to 9462.7)	9628.7 (8532.7 to 10865.4)

Co-administration Group vs Control Group: ratio: 1.14 (95% CI 0.97 to 1.35)

Population analysed: Per protocol set for RSVPreF3 OA included all eligible participants in the exposed set who: received the RSVPreF3 OA vaccine, had immunogenicity results for RSV neutralizing titers, complied with the blood draw interval, without intercurrent medical conditions and without prohibited concomitant medication/vaccination and who did not met any of the criteria for elimination up to blood sample collection.Participants with data available at the time of analysis were reported in this outcome measure

Primary outcome: Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination

Time frame: At Day 31 for Co-administration Group and at Day 61 for Control Group. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Co-administration Group n = 237	Control Group n = 218
Value	10354.2 (9288.4 to 11542.3)	10143.4 (9057.5 to 11359.4)

Co-administration Group vs Control Group: ratio: 0.98 (95% CI 0.84 to 1.15)

Population analysed: Per protocol set for RSVPreF3 OA. Participants with data available at the time of analysis were reported in this outcome measure.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination (approximately up to 241 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Co-administration Group	13 of 265 (4.9%)	240 of 265 (90.6%)	0 of 265
Control Group	6 of 265 (2.3%)	235 of 265 (88.7%)	0 of 265

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42054374Roussy JF, Dennis P, Gupta AK, Wallace G, Abitbol A, Aggarwal N, Surber JG, Lee T, Smith BA, Gerard C, Hailemariam HA, David MP, Jastorff AM, Van der Wielen M. Immunogenicity and Safety of the Adjuvanted Respiratory Syncytial Virus Prefusion F Protein-Based Vaccine When Co-administered With the Adjuvanted Recombinant Herpes Zoster Subunit Vaccine in Adults >/= 50 Years of Age. Clin Infect Dis. 2026 Apr 29:ciag208. doi: 10.1093/cid/ciag208. Online ahead of print.
Individual participant dataSharing planned: Yes. GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf.

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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.

31 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 24 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 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Canada, United States. 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 1 Apr 2025). 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?

Adjusted Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies at 1 Month Post-second Dose of HZ/su Vaccination (time frame: At 1 month post-second dose of HZ/su vaccination (Day 91)). The study lists 3 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 NCT05966090, which also lists 1 linked publication.

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 1 Apr 2025.