Respiratory Syncytial Virus InfectionsPhase 3NCT06614725

A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When Given to Older Adults 60 Years of Age and Above and Adults 50-59 Years of Age at Increased Risk (AIR) of Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV-LRTD)

A Phase 3 study testing RSVPreF3 OA investigational vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 14 sites in India.

Completed

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

Official record

Search all trials

Trial summary

The purpose of the study is to evaluate the immunogenicity and safety of a single dose of investigational RSVPreF3 OA vaccine in Indian older adults 60 years of age (YOA) and above and Indian adults 50-59 YOA at increased risk of RSV-LRTD. 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: 751 participants
Where: 14 sitesIndia
Study dates: 1 Oct 2024to 14 Nov 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 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 (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.
Specific inclusion criteria for all participants in Cohort 1 (Older adults)
Male or female, >= 60 YOA at the time of the study intervention administration.
Participants who are medically stable in the opinion of the investigator at the time of 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.
Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living.

Show all 27Show fewer

Specific inclusion criteria for all participants in Cohort 2 (Adults-AIR)
Male or female, 50-59 YOA at the time of the study intervention administration.
Participants should be diagnosed with at least 1 of the following medical conditions and considered medically stable by the investigator:
Chronic pulmonary disease resulting in activity restricting symptoms or use of long term medication:
Chronic obstructive pulmonary disease (COPD)
Asthma
Cystic fibrosis
Other chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema, or bronchiectasis
Chronic cardiovascular disease:
Chronic heart failure (CHF)
Pre-existing coronary artery disease (CAD not otherwise specified)
Cardiac arrhythmia
Diabetes mellitus: type 1 or type 2
Other diseases at increased risk for RSV-LRTD disease:
Chronic kidney disease
Chronic liver disease
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
has practiced adequate contraception from 1 month prior to study intervention administration, and
has a negative pregnancy test on the day of and prior to study intervention administration, and
has agreed to continue adequate contraception for at least 1 month after the study intervention administration.

Who cannot join

Medical Conditions
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
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).
Unstable chronic illness.
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 eDiary, attend phone call/study site visits).
Any history of dementia or any medical condition that moderately or severely impairs cognition.

Show all 27Show fewer

Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease).
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
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
Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days (Day -29 to Day 1) before the dose of study interventions or their planned use during the study period (Day 1 up to Month 6).
Previous vaccination with licensed or investigational RSV vaccine. 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, subunit and split influenza vaccines or COVID-19 vaccines (fully licensed or with emergency use authorization [EUA]) which can be administered up to 14 days before or from 14 days after the study intervention administration.
Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.
Up to 3 months prior to the study intervention administration:
For corticosteroids, this will mean prednisone equivalent >= 20 mg/day for adult participants. 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 intervention (drug/invasive medical device).
Other Exclusion Criteria 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.
Participation of any study personnel or their immediate dependents, family, or household members.
Planned move during the study conduct that prohibits participation until study end.
Bedridden participants.
Other Exclusion Criteria for cohort 2 (Adults-AIR)
Pregnant or lactating female participant.
Female participant planning to become pregnant or planning to discontinue contraceptive precautions.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

India14 sites

GSK Investigational Site
Ahmedabad, 380015
GSK Investigational Site
Ahmedabad, 380061
GSK Investigational Site
Aligarh, 202002
GSK Investigational Site
Bangalore, 560002
GSK Investigational Site
Belagavi, 590019
GSK Investigational Site
Darjeeling, 734012
GSK Investigational Site
Delhi, 110060
GSK Investigational Site
Kanpur, Uttar Pradesh, 208002
GSK Investigational Site
Kelambākkam, 603103
GSK Investigational Site
Kochi, 682026
GSK Investigational Site
Kolkata, 700073
GSK Investigational Site
Pune-411 043, 411043
GSK Investigational Site
Raipur
GSK Investigational Site
Vadu Budruk Pune, 412216

Other trials in India

About this study

Official title: A Phase 3, Randomized, Placebo-controlled, Observer-blind Study in India to Evaluate Immune Response, Reactogenicity and Safety of a Single Intramuscular Dose of RSVPreF3 OA Investigational Vaccine When Administered to Older Adults >=60 Years of Age and Adults 50-59 Years of Age at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease

Conditions: Respiratory Syncytial Virus Infections
Being tested: RSVPreF3 OA investigational vaccine, Placebo
Keywords: RSV, Respiratory Syncytial Virus, RSVPreF3 OA vaccine, Immunogenicity, Safety, Reactogenicity, At increased risk (AIR), Older Adults, Respiratory syncytial virus lower respiratory tract disease (RSV-LRTD)
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
1 dose of RSVPreF3 OA investigational vaccine administered intramuscularly on Day 1 to participants in OA-RSV and Adults-AIR-RSV groups.
PlaceboCombination product
1 dose of placebo (saline solution) administered intramuscularly on Day 1 to participants in OA-Placebo and Adults-AIR-Placebo groups.

Study groups in NCT06614725
Study group	Role	What they receive
OA-RSV group	Experimental	Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Receives: Biological: RSVPreF3 OA investigational vaccine
OA-Placebo group	Placebo comparator	OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1. Receives: Combination Product: Placebo
Adults-AIR-RSV group	Experimental	Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Receives: Biological: RSVPreF3 OA investigational vaccine
Adults-AIR-Placebo group	Placebo comparator	Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1. Receives: Combination Product: Placebo

What is being measured

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

RSV-A Neutralizing Titers Expressed as Geometric Mean Titers (GMTs)
RSV-A neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60).
Measured: At Day 1 (pre-study intervention administration)
RSV-A Neutralizing Titers Expressed as GMTs
RSV-A neutralizing titers are given as GMTs and are expressed as ED60.
Measured: At Day 31 (1 month post-study intervention administration)
RSV-B Neutralizing Titers Expressed as GMTs
RSV-B neutralizing titers are given as GMTs and are expressed as ED60.
Measured: At Day 1 (pre-study intervention administration)
RSV-B Neutralizing Titers Expressed as GMTs
RSV-B neutralizing titers are given as GMTs and are expressed as ED60.
Measured: At Day 31 (1 month post-study intervention administration)

Secondary outcomes (5)

Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site adverse events (AEs) were redness (erythema), pain and swelling at administration site. Any = occurrence of the AE regardless of intensity grade or relationship to the study interventions.
Measured: From Day 1 (day of administration) to Day 4
Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events were arthralgia (joint pain), fatigue (tiredness), fever (pyrexia), headache, and myalgia (muscle pain). Fever was defined as temperature ≥38.0 degrees Celsius (°C), regardless of the location of measurement. The route for measuring temperature could be oral or axillary. Any = occurrence of the symptom regardless of intensity grade or relationship to the study interventions.
Measured: From Day 1 (day of administration) to Day 4
Number of Participants Reporting Any Unsolicited 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, and potential immune-mediated diseases (pIMDs). Any = occurrence of the event regardless of intensity grade or relation to the study intervention.
Measured: From Day 1 (day of administration) to Day 30
Number of Participants Reporting Any Serious Adverse Events (SAEs)
An SAE was any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, was considered or defined as an important medical event, or abnormal pregnancy outcomes. Any = occurrence of the event regardless of the intensity grade or relation to the study intervention.
Measured: From Day 1 (day of administration) to Month 6 (throughout the study period)
Number of Participants Reporting Any pIMDs
pIMDs were a subset of adverse events of special interest (AESIs) that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology. Any = occurrence of the event regardless of the intensity grade or relation to the study intervention.
Measured: From Day 1 (day of administration) to Month 6 (throughout the study period)

Timeline

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

1 Oct 202414 Nov 2025

First posted26 Sep 2024
Study start1 Oct 2024
Primary completion3 Jun 2025
Study completion14 Nov 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: 751 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06614725
Sponsor's protocol ID: 221265
Status last verified: May 2026
First submitted: 24 Sep 2024
Last updated: 23 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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

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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Placebo-controlled, Observer-blind Study in India to Evaluate Immune Response, Reactogenicity and Safety of a Single Intramuscular Dose of RSVPreF3 OA Investigational Vaccine When Administered to Older Adults >=60 Years of Age and Adults 50-59 Years of Age at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease
ClinicalTrials.gov ID: NCT06614725
Acronym / sponsor ID: 221265
Conditions: Respiratory Syncytial Virus Infections
Keywords: RSV, Respiratory Syncytial Virus, RSVPreF3 OA vaccine, Immunogenicity, Safety, Reactogenicity, At increased risk (AIR), Older Adults
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 751 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Oct 2024 (actual)
Primary completion: 3 Jun 2025 (actual)
Study completion: 14 Nov 2025 (actual)
First posted: 26 Sep 2024 (actual)
Results: Posted 23 Jun 2026

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: 4

Arm	Type	Receives
OA-RSV group	Experimental	Biological: RSVPreF3 OA investigational vaccineOlder adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
OA-Placebo group	Placebo comparator	Combination Product: PlaceboOA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
Adults-AIR-RSV group	Experimental	Biological: RSVPreF3 OA investigational vaccineAdult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
Adults-AIR-Placebo group	Placebo comparator	Combination Product: PlaceboAdult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.

Who may qualify

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

Key inclusion criteria (27 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 (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.
Specific inclusion criteria for all participants in Cohort 1 (Older adults)
Male or female, >= 60 YOA at the time of the study intervention administration.
Participants who are medically stable in the opinion of the investigator at the time of 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.

Key exclusion criteria (27 listed)

Medical Conditions
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
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).
Unstable chronic illness.
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 eDiary, attend phone call/study site visits).

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 vaccine1 dose of RSVPreF3 OA investigational vaccine administered intramuscularly on Day 1 to participants in OA-RSV and Adults-AIR-RSV groups.	Biological	Adults-AIR-RSV group, OA-RSV group
Placebo1 dose of placebo (saline solution) administered intramuscularly on Day 1 to participants in OA-Placebo and Adults-AIR-Placebo groups.	Combination product	Adults-AIR-Placebo group, OA-Placebo group

Primary outcome

RSV-A Neutralizing Titers Expressed as Geometric Mean Titers (GMTs)
Time frame: At Day 1 (pre-study intervention administration)
RSV-A neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60).
RSV-A Neutralizing Titers Expressed as GMTs
Time frame: At Day 31 (1 month post-study intervention administration)
RSV-A neutralizing titers are given as GMTs and are expressed as ED60.
RSV-B Neutralizing Titers Expressed as GMTs
Time frame: At Day 1 (pre-study intervention administration)
RSV-B neutralizing titers are given as GMTs and are expressed as ED60.
RSV-B Neutralizing Titers Expressed as GMTs
Time frame: At Day 31 (1 month post-study intervention administration)
RSV-B neutralizing titers are given as GMTs and are expressed as ED60.

5 secondary outcomes

Number of Participants Reporting Any Solicited Administration Site Events
Time frame: From Day 1 (day of administration) to Day 4
Number of Participants Reporting Any Solicited Systemic Events
Time frame: From Day 1 (day of administration) to Day 4
Number of Participants Reporting Any Unsolicited AEs
Time frame: From Day 1 (day of administration) to Day 30
Number of Participants Reporting Any Serious Adverse Events (SAEs)
Time frame: From Day 1 (day of administration) to Month 6 (throughout the study period)
Number of Participants Reporting Any pIMDs
Time frame: From Day 1 (day of administration) to Month 6 (throughout the study period)

Results and safety

Results posted to the registry on 23 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OA-RSV Group	260	259
OA-Placebo Group	130	129
Adults-AIR-RSV Group	240	240
Adults-AIR-Placebo Group	120	119

Primary outcome: RSV-A Neutralizing Titers Expressed as Geometric Mean Titers (GMTs)

Time frame: At Day 1 (pre-study intervention administration). Geometric mean (95% Confidence Interval). Unit: Titers

Measure	OA-RSV Group n = 256	OA-Placebo Group n = 129	Adults-AIR-RSV Group n = 239	Adults-AIR-Placebo Group n = 120
Value	1210.0 (1096.6 to 1335.2)	1316.7 (1123.3 to 1543.4)	1255.0 (1128.3 to 1395.9)	1105.3 (964.8 to 1266.3)

Population analysed: Analysis was performed on the per protocol set(PPS) for RSV-A 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 prohibited concomitant medication/vaccination and intercurrent conditions that may interfere with immunogenicity.Only participants included in pre-vaccination timepoint and with data available for RSV-A titers at Day1 were included in the analysis.

Primary outcome: RSV-A Neutralizing Titers Expressed as GMTs

Time frame: At Day 31 (1 month post-study intervention administration). Geometric mean (95% Confidence Interval). Unit: Titers

Measure	OA-RSV Group n = 248	OA-Placebo Group n = 122	Adults-AIR-RSV Group n = 234	Adults-AIR-Placebo Group n = 117
Value	10777.9 (9475.5 to 12259.3)	1304.5 (1109.6 to 1533.6)	14982.7 (13096.7 to 17140.4)	1129.5 (980.8 to 1300.7)

Population analysed: Analysis was performed on the PPS for RSV-A. Only participants included in both pre-vaccination and 1-month post vaccination timepoints and with data available for RSV-A titers at 1-month post dose were included in the analysis.

Primary outcome: RSV-B Neutralizing Titers Expressed as GMTs

Time frame: At Day 1 (pre-study intervention administration). Geometric mean (95% Confidence Interval). Unit: Titers

Measure	OA-RSV Group n = 256	OA-Placebo Group n = 129	Adults-AIR-RSV Group n = 239	Adults-AIR-Placebo Group n = 120
Value	1561.3 (1411.0 to 1727.6)	1571.0 (1348.9 to 1829.8)	1579.1 (1406.2 to 1773.3)	1548.4 (1323.6 to 1811.3)

Population analysed: Analysis was performed on the per protocol set(PPS) for RSV-B 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 prohibited concomitant medication/vaccination and intercurrent conditions that may interfere with immunogenicity.Only participants included in pre-vaccination timepoint and with data available for RSV-B titers at Day1 were included in the analysis.

Primary outcome: RSV-B Neutralizing Titers Expressed as GMTs

Time frame: At Day 31 (1 month post-study intervention administration). Geometric mean (95% Confidence Interval). Unit: Titers

Measure	OA-RSV Group n = 248	OA-Placebo Group n = 122	Adults-AIR-RSV Group n = 234	Adults-AIR-Placebo Group n = 117
Value	11834.9 (10560.7 to 13263.0)	1721.1 (1477.0 to 2005.6)	15846.5 (13910.4 to 18052.0)	1398.4 (1211.1 to 1614.6)

Population analysed: Analysis was performed on the PPS for RSV-B. Only participants included in both pre-vaccination and 1-month post vaccination timepoints and with data available for RSV-B titers at 1-month post dose were included in the analysis.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OA-RSV Group	0 of 260 (0%)	154 of 260 (59.2%)	0 of 260
OA-Placebo Group	0 of 130 (0%)	64 of 130 (49.2%)	0 of 130
Adults-AIR-RSV Group	1 of 240 (0.4%)	141 of 240 (58.8%)	0 of 240
Adults-AIR-Placebo Group	0 of 120 (0%)	57 of 120 (47.5%)	0 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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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.

14 sites in 1 country: 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 14 sites in India.

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 27 inclusion and 27 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in India. 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. 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 23 Jun 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 Geometric Mean Titers (GMTs) (time frame: At Day 1 (pre-study intervention administration)). 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?

On the ClinicalTrials.gov record for NCT06614725.

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 23 Jun 2026.