Open-label, Multicenter Trial of RSV Vaccination to Reduce Moderate-to-severe Exacerbations in COPD Frequent Exacerbators: Clinical Effectiveness and RSV-specific Immune Responses

Objectives: To determine whether respiratory syncytial virus (RSV) vaccination reduces the rate of all-cause moderate-to-severe acute exacerbations of COPD (AECOPD) in high-risk patients, and to characterise RSV-specific infection and immune responses in this population.
Hypothesis: RSV vaccination in COPD frequent exacerbators receiving dual long-acting bronchodilators will reduce all-cause moderate-to-severe AECOPD by at least 20-25% over 12 months.
Design and subjects: This multicentre, two-arm, open-label, prospective study will recruit 320 COPD patients with 2 moderate or severe AECOPD in the prior year despite dual long-acting bronchodilator therapy. Eligible subjects will be allocated 1:1 to receive RSV vaccination plus standard care or standard care alone and followed for 12 months.
Interventions: Participants in the vaccine arm will receive a single dose of a licensed RSV vaccine in addition to usual COPD management. Controls will receive usual care without RSV vaccination during the study period.
Main outcome measures: The primary outcome is the rate of all-cause moderate-to-severe AECOPD per patient-year. Secondary outcomes include RSV-positive AECOPD, RSV infection incidence confirmed by virological testing, severe AECOPD requiring hospitalisation, time to first moderate-to-severe AECOPD, and changes in plasma RSV-specific antibody titres over 12 months.
Data analysis and expected results: Exacerbation rates will be compared between groups using negative binomial regression with adjustment for key covariates on an intention-to-treat basis. The investigators expect RSV vaccination to achieve a clinically meaningful (20%) reduction in all-cause moderate-to-severe AECOPD and to provide mechanistic insights linking RSV immunity, RSV infection, and exacerbation risk in COPD frequent exacerbators.

Start Date01 Jul 2027

Sponsor / Collaborator

The Chinese University of Hong Kong

[+1]

NCT07712380

/ Not yet recruitingPhase 2

A Randomized, Observer-blind, Placebo-controlled Exploratory Study to Evaluate Whether Administration of Adjuvanted RZV or RSVPreF3 Vaccine Can Attenuate Coronary Plaque Progression in Individuals 50 Years of Age and Above Who Are at Risk for Cardiovascular Events

This study is designed to evaluate whether the adjuvanted recombinant zoster vaccine (RZV) or the adjuvanted respiratory syncytial virus PreFusion protein 3 (RSVPreF3) vaccine can attenuate the progression of coronary plaque in adult individuals at risk for cardiovascular events.

Start Date31 Aug 2026

Sponsor / Collaborator

GSK Plc

NCT07050732

/ RecruitingPhase 2IIT

Immunogenicity and Safety of Multiple-Dose Adjuvanted RSVPreF3 (Arexvy®) Vaccination Among Immunocompromised Persons

This clinical trial is being done to learn more about how well a vaccine (Arexvy®) for respiratory syncytial virus, also known as RSV, works in people with weakened immune systems. The main questions it aims to answer are:
* Does 1 or 2 doses of Arexvy work better in people with weakened immune systems?
* What medical problems do participants have after receiving Arexvy?
Participants with weakened immune systems will:
* Receive 3 study vaccines over the course of 1 year
* Keep a diary of symptoms for 7 days after each vaccine
* Have 3 in-person follow up study visits for checkups and tests over the course of 1.5 years
* Have 6 phone follow up study visits over the course of 1.5 years

Start Date04 Dec 2025

Sponsor / Collaborator

The Johns Hopkins University

[+1]

100 Clinical Results associated with Respiratory Syncytial Virus Vaccine (GSK)

100 Translational Medicine associated with Respiratory Syncytial Virus Vaccine (GSK)

100 Patents (Medical) associated with Respiratory Syncytial Virus Vaccine (GSK)

Literatures (Medical) associated with Respiratory Syncytial Virus Vaccine (GSK)

31 Dec 2026·Human Vaccines & Immunotherapeutics

Randomized, placebo-controlled phase 3 trial evaluating safety, immunogenicity, and reactogenicity of RSVPreF3-Mat in high-risk pregnant women and their infants

Article

Author: Sánchez, Marta García ; Välimaa, Hanna ; Kantele, Anu ; Hua, Nancy ; Jose, Lisa ; Kim, Joon Hyung ; Kirabo, Martha ; Lese, Patricia ; Pirela, Hemir David Escobar ; Middleton, Guy ; Bebia, Zourab ; Dieussaert, Ilse ; Reyes, Osvaldo ; Vigil-De Gracia, Paulino

Respiratory syncytial virus (RSV) causes respiratory illness among infants; maternal vaccination confers passive protection through placental antibody transfer. This phase 3, randomized, placebo-controlled trial evaluated safety, reactogenicity, and immunogenicity of RSV prefusion protein F3 maternal vaccine (RSVPreF3-Mat), administered at 24^0/7 to 36^0/7 weeks of gestation to high-risk pregnant women (women with obstetric complications and/or human immunodeficiency virus infection or in pregnant adolescents), and their infants up to 1 year post-birth. Enrollment was stopped and the study unblinded after an increased risk of preterm birth, associated with RSVPreF3 vaccine, was observed in another trial in healthy pregnant women. One hundred and sixty-nine maternal participants received either vaccine or placebo. No serious adverse events in maternal or infant participants were considered vaccine-related. Preterm birth occurred in 18.2% and 19.7% of participants in the vaccine and placebo groups, respectively, with one neonatal death in each group. In the vaccine group, increase in maternal neutralizing antibody titers against RSV subtype A and B was observed at Day 31 post-vaccination and remained high at delivery. Geometric mean ratio of titers at delivery over pre-vaccination for RSV A and B were 8.87- and 8.21-fold, respectively. Similarly, anti-RSVPreF3-Mat immunoglobulin G (IgG) levels showed increase at Day 31 post-vaccination and remained high at delivery (14.12-fold increase over pre-vaccination) with placental transfer ratio of RSVPreF3 IgG-specific antibodies at delivery of 1.33. In this study of high-risk pregnant women, RSVPreF3-Mat demonstrated an acceptable safety profile, induced robust immune responses with successful placental antibody transfer, and showed balanced rates of preterm birth between the groups. Trial registration: EudraCT: 2021-000994-96; NCT: NCT04980391.

31 Dec 2026·Human Vaccines & Immunotherapeutics

Quantifying vaccine dissemination for uptake comparisons between vaccines

Article

Author: Dirks, Abigail ; Getz, Ken ; Ford, Madison ; Do, Hana

Vaccine hesitancy is a complex public health concern, but it has been difficult to characterize and monitor the speed of uptake of individual vaccines. The study was aimed to determine whether vaccine uptake can be quantified and mapped to individual vaccines and to consider methods for comparing vaccine uptake between vaccines. Vaccines assessed were selected based on their similarity to COVID-19 and the 2020 pandemic by the following criteria: the vaccine impacts the broader public and has global health effects, was approved between 2006 and 2024, protects against a virus, and does not follow a seasonal pattern, unless it had a significant outbreak between 2006 and 2024 before it became a seasonal vaccine. Main outcomes included diffusion curves of each vaccine, both in terms of estimated global units dispensed and estimated proportion of the US population that is vaccinated. Metrics included average units dispensed globally per month, mean coverage of the target population, maximum coverage of the target population, and rate of change in number of vaccinations over time. Metrics are estimates which rely on sales data and imputation. Diffusion curves were mapped for individual vaccines, and five vaccines were determined to have the fastest relative uptake, although not all differences were statistically significant. The five vaccines were Arexvy, Comirnaty, Gardasil/Gardasil 9, Heplisav-B, and the ID Biomedical H1N1 Monovalent Vaccine. Collection, mapping, and analysis of estimated vaccine diffusion curves inform understanding of vaccine hesitancy and the impact of strategies and tactics to improve and accelerate vaccine uptake.

01 Jul 2026·VACCINE

Safety, immunogenicity, and dose ranging of a bivalent respiratory syncytial virus and human metapneumovirus glycoprotein F-molecular clamp vaccine candidate in older adults: 1-month interim analysis of an ongoing randomised, observer-blind, placebo- and active-controlled, phase 1 trial

Article

Author: Dutton, Julie L ; O'Donnell, Jake S ; Gillard, Marianne ; Wolf, Rebecca ; Young, Andrew ; Kulenovic, Smail ; Magdalena, Juana ; Moller, Christopher ; Harrison, Michael ; Della Cioppa, Giovanni ; Chappell, Keith J ; Dodeur, Vincent ; Sahai, Nischal ; Hanon, Emmanuel

BACKGROUND:

Respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) are important causes of acute respiratory tract disease in older adults. Multipathogen vaccines in ready-to-use liquid formulations are needed. VXB-241 is a recombinant RSV-hMPV unadjuvanted fully liquid vaccine candidate.

METHODS:

This ongoing first-in-human randomised, placebo- and RSV vaccine active-controlled, observer-blind, dose-ranging trial is being conducted in older adults aged 60-83 years preceded by a few sentinel younger adults aged 18-40 years. On day 1, older adults were randomised to receive one of six intramuscular treatments: VXB-241 at 60 μg (30 μg RSV preF +30 μg hMPV preF), 120 μg (60 + 60), 240 μg (120 + 120), or 480 μg (240 + 240), the licensed AS01_E-adjuvanted RSV vaccine (Arexvy™/RSVPreF3, GSK), or placebo. We report 1-month interim safety and immunogenicity results.

RESULTS:

A total of 270 older adults were screened; 128 were randomised and completed the month-1 visit. Solicited adverse events occurred in 23.8% of placebo, 76.2% of RSVPreF3, and 35.0%-59.1% of VXB-241 recipients, with no dose-response effect among VXB-241 recipients, except at the highest dose level. Most reactions were mild and transient. Most unsolicited adverse events were unrelated to treatment. No safety signal was detected. At month 1, RSV-A, RSV-B, hMPV-A and hMPV-B neutralising antibody titres were higher than placebo in all active treatment arms. At the 240 μg VXB-241 dose level, geometric mean fold increases were 15.06 for RSV-A and 8.07 for RSV-B versus 10.81 for RSV-A and 4.91 for RSV-B after RSVPreF3 injection, and 7.50 for hMPV-A and 6.56 for hMPV-B, with negligible increases after RSVPreF3 injection.

CONCLUSIONS:

VXB-241 showed a clinically acceptable safety and reactogenicity profile and elicited strong neutralising immune responses against RSV and hMPV in older adults. Neutralising immune responses against RSV-A and RSV-B by VXB-241 were at least as good as those obtained with the licensed adjuvanted RSVPreF3 active control.

311

News (Medical) associated with Respiratory Syncytial Virus Vaccine (GSK)

09 Jul 2026

·www.pharmaceutical-technology.com

Moderna secures up to 24 million RSV vaccine dose contract with Europe

According to the EC, the procurement is an important step in reducing the burden on healthcare services. Credit: Billion Photos/Shutterstock.com. Moderna has agreed a contract with the European Commission (EC) that will see tens of millions of respiratory syncytial virus (RSV) vaccine doses accessible to member countries in time for the 2026-2027 winter season. Upon the request of six unnamed countries, the EC signed a joint procurement framework contract with Moderna to access up to 24 million doses of the mRNA-based mRESVIA, with no minimum order required. The contract will run for a period of up to four years. Moderna’s mRESVIA was approved in Europe for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 and older in August 2024. The vaccine has also been available to younger age groups who are at increased risk of RSV-induced disease. Earlier this year, a European Medicines Agency (EMA) committee recommended that the license be expanded to include all adults aged 18 years and older, meaning the jab’s use could significantly expand. This vaccine protects against diseases of the lungs, such as bronchitis and pneumonia, caused by RSV in adults. mRESVIA delivers genetic instructions to cells so they can synthesise an inert form of the virus. Once the system recognises this protein, it produces protective antibodies. RSV is a common respiratory virus that causes mild, cold-like symptoms. While most people usually recover in around a week without the need for medical treatment, RSV can cause severe illness and death in more vulnerable groups such as older adults. Over 156,000 adults are hospitalised in Europe each year due to the virus. According to the EC, the procurement is an important step in reducing the burden on healthcare services, especially during the winter season when RSV cases – and other infectious diseases – are at their highest. The European Centre for Disease Prevention and Control has maintained the importance of immunisation in vulnerable population groups. Wider access to a preventative vaccine also reduces antibiotic consumption, lowering the number of patients who are prescribed antibiotics unnecessarily or as a precaution. Combatting antimicrobial resistance is a key target of the EMA. Hadja Lahbib, European commissioner for equality, preparedness and crisis management, said: “With today’s joint procurement for an RSV vaccine, we are helping member states to enhance their preparedness against this serious virus before the upcoming winter season. This will protect the most vulnerable and reduce the pressure that respiratory infections place on our hospitals during the winter months. Being prepared today means saving lives when the next peak season arrives.” The EC’s procurement of mRESVIA contrasts with a more hesitant approach in the US, where there have been significant policy shifts to reduce reliance on mRNA-based products. The US Food and Drug Administration (FDA) widened mRESVIA’s use to all adults at increased risk of lower tract respiratory disease (LRTD) caused by RSV in June 2025. However, it has still not been recommended for all adults regardless of disease risk. Moderna’s main competitors in the RSV space are GSK’s Arexvy and Pfizer’s Abrysvo, which remain the top-selling RSV vaccines globally.

VaccineDrug ApprovalmRNAClinical Study

25 Mar 2026

·www.prnewswire.com

Clover Announces Additional Positive U.S. Phase I Clinical Data for RSV Re-Vaccination in Older Adults

-- Additional data from RSV re-vaccination trial demonstrates trend of approximately 60-80% higher RSV neutralizing antibodies (nAbs) for Clover's RSV vaccine compared head-to-head versus AREXVY (GSK) in older adults who previously received an initial dose of AREXVY -- -- Re-vaccination with Clover's RSV vaccine boosted RSV nAbs to approximately 120-135% of the peak levels observed after an initial dose of AREXVY (cross-trial comparison) -- -- Results further strengthen profile of potential best-in-class RSV+hMPV±PIV3 combination vaccines, with the potential ability to re-vaccinate individuals previously receiving approved RSV vaccines to restore and broaden protection -- March 24, 2026 -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world, today announced additional positive data from a Phase I clinical trial in the U.S. evaluating re-vaccination with the company's RSV PreF vaccine candidate (SCB-1019) compared head-to-head versus GSK's RSV vaccine (AREXVY) in older adults that previously received AREXVY at least 2 seasons prior to enrolling. The results announced today are from 62 participants, whereas the results announced in October 2025 were from 34 participants. "These additional clinical data in nearly double the number of subjects compared to the prior analysis re-affirm our differentiated ability to re-vaccinate older adults previously receiving an approved RSV vaccine, further strengthening the potential best-in-class profile for our RSV+hMPV±PIV3 combination vaccine candidates," said Joshua Liang, Chief Executive Officer & Board Director of Clover. "While currently approved protein-based RSV vaccines are safe & effective, critical gaps persist globally, including (1) the inability to prevent significant respiratory disease burden caused by other viruses related to RSV such as human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) and (2) the inability to re-vaccinate effectively when protection against RSV disease wanes. Enrollment in the Phase II clinical trial for our RSV+hMPV±PIV3 combination vaccines remains ongoing." The Phase I trial in the U.S. enrolled older adults (60-85 years) who previously received an initial dose of GSK's RSV vaccine (AREXVY) at least 2 seasons prior. Participants were randomized to receive either a heterologous SCB-1019 (Clover RSV PreF) revaccination dose, a homologous AREXVY (GSK RSV PreF) revaccination dose or saline placebo. The study is assessing safety, reactogenicity and immunogenicity. An analysis for immunogenicity in all enrolled participants has been performed. Preliminary and exploratory results from 62 participants (30 participants receiving SCB-1019, 26 participants receiving AREXVY, 6 participants receiving saline placebo) are summarized below: SCB-1019 heterologous re-vaccination induced an approximately 60-80% higher trend in RSV-A and RSV-B nAb geometric mean titers (GMTs) compared to AREXVY homologous re-vaccination; no significant changes in RSV nAbs were observed for the placebo group An exploratory cross-trial comparison to sera from Clover's prior clinical study in RSV vaccine-naïve older adults receiving an initial dose of AREXVY suggests that SCB-1019 heterologous re-vaccination restores RSV-A and RSV-B nAb GMTs to approximately 120-135% of peak levels observed following an initial dose of AREXVY, whereas AREXVY heterologous re-vaccination restored GMTs to only approximately 75% of peak levels AREXVY homologous re-vaccination induced an approximately 40-fold increase in "off-target" antibodies against the T4-foldon trimerization tag utilized in AREXVY Given that more than 40% of eligible adults 60 years and older in the U.S. have previously received a protein-based RSV vaccine (comprising approximately 15 million doses)[1], and clinical data to-date for currently approved RSV vaccines have not supported RSV re-vaccination policy recommendations despite waning efficacy observed after the initial dose, Clover's clinical data to-date suggest the potential for Clover's RSV+hMPV±PIV3 combination vaccine candidates to both restore protection against RSV and broaden protection to hMPV±PIV3 in this population.Clover's RSV+hMPV±PIV3 combination vaccine candidates are currently being evaluated in an ongoing Phase II clinical trial that initiated enrollment in January 2026. Clover Biopharmaceuticals is a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world. With integrated research and development, manufacturing and commercial capabilities as well as strong partnerships with organizations globally, Clover has a diverse pipeline of candidates that have the potential to meaningfully reduce the burden of vaccine-preventable diseases—and to make more diseases preventable. The content above comes from the network. if any infringement, please contact us to modify.

VaccineClinical Result

16 Mar 2026

·www.businesswire.com

GSK’s RSV Vaccine, AREXVY, Approved in US for Expanded Age Indication in Adults Aged 18–49 Years at Increased Risk

In the US, an estimated 21 million adults under 50 have at least one risk factor for severe RSV infection 1 * GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has expanded the approved age indication of AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV. AREXVY was previously approved in the US for the prevention of RSV-related LRTD in adults aged 60 and older, and adults aged 50–59 at increased risk for LRTD caused by RSV. This vaccine is not for use in pregnant individuals. Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development, said: “This age expansion can help address a significant medical need for adults in the United States at higher risk of severe RSV disease due to certain underlying conditions, and help ease pressure on the healthcare system. We are proud of this latest step in our strategy to bring RSV prevention to broader adult populations.” The annual RSV burden among US adults aged 18–49 years is about 17,000 hospitalizations, 277,000 emergency department admissions, and 1.97 million outpatient visits.2† Most hospitalizations in younger adults occur in those with chronic medical conditions which place them at increased risk for severe RSV disease (e.g. chronic cardiopulmonary, kidney or renal disease, obesity and diabetes).2† The FDA’s decision was supported by data from a Phase IIIb trial (NCT06389487) demonstrating a non-inferior immune response compared to adults aged 60 years and above.3 Vaccine efficacy was demonstrated in the earlier Phase III trial (NCT04886596).4 The safety profile was consistent with findings from the broader Phase III program that supported the initial US approval, with the most common adverse events being injection site pain, fatigue, myalgia, headache, and arthralgia within four days of vaccination.3 GSK continues to advance regulatory submissions for its RSV vaccine across multiple geographies to expand availability and support long-term growth objectives. AREXVY contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant before administration. The use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees. The vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in 70 countries. In addition, it is approved for use in individuals aged 50–59 who are at increased risk due to certain underlying medical conditions in more than 60 countries. In the European Economic Area it is approved for adults aged 18 years and older. The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus. NCT06389487 is a Phase IIIb, open-label multi-country immunogenicity trial to evaluate the non-inferiority of the immune response and evaluate safety in participants aged 18–49 at increased risk for lower respiratory tract disease (LRTD) caused by RSV (n=426), compared to participants aged 60 years and above (n=429) after a single dose of GSK’s RSV vaccine. An additional cohort of 603 participants aged 18–49 was followed up for adverse events separate to safety follow up of the initial cohort. A total of 1,458 participants were enrolled across 52 locations in six countries, including 16 US sites. The study assessed the immune response in participants aged 18–49 with pre-defined stable chronic diseases leading to an increased risk for RSV disease, compared to those aged 60 years and above. The trial’s primary endpoints were RSV-A and RSV-B neutralization titres of adults aged 18–49 years at one month after the vaccine administration compared to adults aged 60 and older. There were also safety and immunogenicity secondary and tertiary endpoints. Safety and reactogenicity data were consistent with results from the initial data read out in NCT04886596. The most common local adverse event was pain. The most common systemic adverse events were myalgia, fatigue and headache, which were largely transient and mild to moderate in intensity. About RSV in adults RSV is a common contagious virus affecting the lungs and breathing passages and impacts an estimated 64 million people of all ages globally every year.5 Adults can be at increased risk for RSV disease due to certain comorbidities, immune compromised status, or advanced age.6 RSV can exacerbate certain conditions, including chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death.6 Compared to children, adults hospitalized for RSV are at a higher risk of severe complications, require more costly treatments, have a higher fatality rate, and the true number of RSV-related cases is likely underestimated due to lack of routine testing.7,8,9,10 References: 1 Horn et al, “Characteristics Associated with the Presence of One or More Risk Factors for Severe Respiratory Syncytial Virus Disease among Adults in the United States”, poster presented at ID Week 2024 [available on demand: P691 - DV-009542.pdf] 2 McLaughlin JM, et al. Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis. Page 17 Supplementary Data. Open Forum Infect Dis. 2022 Jun 17;9(7):ofac300. doi: 10.1093/ofid/ofac300. PMID: 35873302; PMCID: PMC9301578. 3 Clinicaltrials.gov. A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above. Available at: https://clinicaltrials.gov/study/NCT06389487. Last accessed: March 2026. 4 Clinicaltrials.gov. Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above. Available at: https://clinicaltrials.gov/study/NCT04886596. Last accessed: March 2026. 5 National Institute of Allergy and Infectious Diseases, Respiratory Syncytial Virus (RSV). Available at: https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv. Last accessed: March 2026. 6 Falsey, A, R et al. Respiratory syncytial virus infection in elderly and high-risk adults, in New Engl J Med 2005; 352:1749-59. doi: 10.1056/NEJMoa043951. 7 Alfano F, et al. Respiratory Syncytial Virus Infection in Older Adults: An Update. Drugs Aging. 2014;41:487–505. 8 Niekler P, et al. Hospitalizations due to respiratory syncytial virus (RSV) infections in Germany: a nationwide clinical and direct cost data analysis (2010–2019). Infection. 2024;52(5):1715–1724. 9 Günen H, et al. Key Challenges to Understanding the Burden of Respiratory Syncytial Virus in Older Adults in Southeast Asia, the Middle East, and North Africa: An Expert Perspective. Adv Ther. 2024;41(11):4312–4334. 10 Grace M, et al. Economic burden of respiratory syncytial virus infection in adults: a systematic literature review. J Med Econ. 2023;26(1):742–759. The content above comes from the network. if any infringement, please contact us to modify.

VaccineDrug ApprovalClinical Result

100 Deals associated with Respiratory Syncytial Virus Vaccine (GSK)

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Respiratory Diseases	United States	GlaxoSmithKline Biologicals SA	10 Jun 2024
Lower Respiratory Tract Infections	United States	GlaxoSmithKline Biologicals SA	03 May 2023
Respiratory Syncytial Virus Infections	United States	GlaxoSmithKline Biologicals SA	03 May 2023

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06614725 (CTgov)	Phase 3	Respiratory Syncytial Virus Infections	751	RSVPreF3 OA investigational vaccine (OA-RSV Group)	wdsozadsye(ihgekaneyv) = vwurprmojo jmncpwksfv (tsazczocvp, uooqejjvhx - ojyworyfof) View more	-	23 Jun 2026
				Placebo (OA-Placebo Group)	wdsozadsye(ihgekaneyv) = nlkzcgumaa jmncpwksfv (tsazczocvp, tocmcspoff - yvgtdisokd) View more
NCT06551181 (CTgov)	Phase 3	Respiratory Syncytial Virus Infections	2,620	RSVPreF3 OA investigational vaccine (RSV OA Vaccine Group (China))	raoyprpoai(euhdznqfai) = btzkakutzt ylhnxkmnvj (dthhnnthaa, fuuokwccrz - iqlczivuts) View more	-	19 May 2026
				RSVPreF3 OA investigational vaccine (RSV OA Vaccine Group (Overseas))	raoyprpoai(euhdznqfai) = enhzxhnutc ylhnxkmnvj (dthhnnthaa, rsdulzdklu - qmcctbosnj) View more
NCT06374394 (CTgov)	Phase 3	Respiratory Syncytial Virus Infections	841	COVID-19 mRNA vaccine+RSVPreF3 OA investigational vaccine (Co-Ad Group)	uiszelctal(jqngqbhdux) = ncvvtdlpmh nngchcszrc (zknfllyqfr, hdadekngun - fjjfwxdbyj) View more	-	26 Dec 2025
				COVID-19 mRNA vaccine+RSVPreF3 OA investigational vaccine (Control Group)	uiszelctal(jqngqbhdux) = oeclyokazf nngchcszrc (zknfllyqfr, zqbldvlkul - oxccpacewq) View more
NCT06389487 (CTgov)	Phase 3	Respiratory Syncytial Virus Infections	1,459	RSVPreF3 OA investigational vaccine (Part A: RSV-A-AIR Group)	hgxdikrscp(qfmgyjkrkh) = yjwlfixeyu wqhcczjrtu (izethkagfg, kwjwoqxsre - kaxdbaexdv) View more	-	25 Sep 2025
				RSVPreF3 OA investigational vaccine (Part A: RSV-OA Group)	hgxdikrscp(qfmgyjkrkh) = dsgvbytkhq wqhcczjrtu (izethkagfg, uuxdimyihj - nrwgftucvy) View more
NCT05921903 (RSV OA=ADJ-023, CTgov)	Phase 2	Respiratory Syncytial Virus Infections	386	RSVPreF3 OA Investigational Vaccine (RSV_IC_2 Group)	wijljuhahn(xvfgaojfdi) = brgziklwcw ikeqeyujnx (mtshiooqji, fnzrricuuw - wdkjrdtimd) View more	-	16 Jul 2025
				RSVPreF3 OA Investigational Vaccine (RSV_IC_1 Group)	ihyqgefqik(iblfswhnos) = tqxsojcxjt bdnxohtops (pvttvvrbht, sqxxidpgyj - ezcnqczzwo) View more
NCT05879107 (CTgov)	Phase 3	Respiratory Syncytial Virus Infections	1,113	PCV20+RSVPreF3 OA investigational vaccine (Co-administration Group)	tdrknpgsyt(rxhdagvhkc) = xpluxcvero waoxtkxaet (xcmmjwozsb, ujkxbytgbe - ashzjclicr) View more	-	18 May 2025
				PCV20+RSVPreF3 OA investigational vaccine (Control Group)	tdrknpgsyt(rxhdagvhkc) = nwuwspzuah waoxtkxaet (xcmmjwozsb, doamwxnkse - anosutifoy) View more
NCT04886596 (AReSVi-006, Pubmed) Manual	Phase 3	Respiratory Syncytial Virus Infections	24,966	RSVPreF3 OA	cfdnehffmr(vzjezkdlcm) = btnhpflufq legkevmlak (nvlkyjcpkd, 46.7 - 74.8) View more	Positive	11 Apr 2025
				Placebo	pgjwchttjg(qtlqslhwvr) = ttllplvvst xjnrfpbtlj (rujxmiaifs )
NCT05966090 (RSV-OA=ADJ-020, CTgov)	Phase 3	Respiratory Syncytial Virus Infections	530	HZ/su vaccine+RSVPreF3 OA investigational vaccine (Co-administration Group)	xmpqvvffxv(louqzwzetj) = fsnyzzvmsa swcfhfdihq (gtwmaongmi, oliykmriio - dvefbnylfb) View more	-	01 Apr 2025
				HZ/su vaccine+RSVPreF3 OA investigational vaccine (Control Group)	xmpqvvffxv(louqzwzetj) = pjiczlquqs swcfhfdihq (gtwmaongmi, apgdubpqor - vvdraeumix) View more
NCT04886596 (AReSVi-006, Company_Website) Manual	Phase 3	Respiratory Syncytial Virus Infections	-	Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)	azodldgspy(jmmrrcyfvn) = fiblrldlbb rbvsshlgad (velvfyjjxq ) View more	Positive	08 Oct 2024
				Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) (Season one)	azodldgspy(jmmrrcyfvn) = znbdpmccuw rbvsshlgad (velvfyjjxq ) View more
NCT04732871 (Phase 3 Trial, Pubmed \| J Infect Dis)	Phase 3	-	1,653	AS01E-adjuvanted RSV prefusion F protein-based vaccine	jinihtrpjn(vvxtfuynzo) = Serious adverse events were reported by 3.9% of participants within 6 months post-dose 1; 1 case was considered vaccine related ihwammdpwr (ifxsldvcpd ) View more	Positive	25 Jul 2024

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Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis