PIPELINE-RSV International Trial. Pregnancy and Infant PrEparedness pLatform IN Europe (PIPELINE)- RSV International Immunisation Adaptive Platform Trial.

RSV (which stands for Respiratory Syncytial Virus) is an infection that causes cold-like symptoms and is most common during winter months. Most people with RSV infection get better by themselves but babies and younger children can become very poorly. About 1 in 15 infants with confirmed RSV within the first 12 months of life will be hospitalised, and a very small proportion will be seriously ill and may die.
Currently there are two different prevention options that can be used to prevent RSV infection in babies. One is a vaccine given to the mother during pregnancy, and the other is a monoclonal antibody given by injection to the baby. Although both prevention options work well on their own and are safe, neither provides 100% protection to the infant. It is not known whether giving both medicines, one to the mother in pregnancy and one to the infant, would provide better protection than giving only one medicine - this is what the PIPELINE-RSV study will look at.
PIPELINE-RSV-International will recruit about 1500 pregnant women from across Europe in UK, Switzerland, the Netherlands and Belgium. A parallel trial, PIPELINE-RSV-France, running in France will recruit about 1000 pregnant women in France; the protocols will align on key aspects and the data will be analysed together. The study will include three study groups with different prevention options used in each: (1) a vaccine given to the mother in pregnancy, (2) an injection given to the baby at the beginning of RSV season, or (3) both a vaccine given to the mother in pregnancy and an injection given to the baby at around 4 months of age. Each mother-baby pair will be randomly allocated to group by a computer. The numbers of babies in each of these groups who acquire RSV will be compared. In some countries only two of the three study groups may be available.
Pregnant women and their babies will be followed until the baby reaches 12 months of age. Information will be collected about medically-important side effects either the mother or the baby had from their medicine(s) and any symptoms of RSV the baby had. Visits with the mother and baby will occur at birth, and 4 and 12 months later; these will ideally be in-person at birth and at 12 months. The mother will complete questionnaires via a Web-based platform to report any non-routine in-person visits, once in pregnancy and after the baby is born twice a month or monthly (more often in the winter), to also report baby's symptoms, to report their trial experience when the baby is 4 and 12 months' old, and to provide their views on vaccination at birth, and when the baby is 4 and 12 months' old. If the baby develops symptoms that might be RSV, their mother or another caregiver will be asked to take a sample using a swab from the baby's nose or mouth, and to send it by post for testing to find out if the baby has RSV.
As well as the main research study, there are also some substudies. A questionnaire will be given to women who consent to take part, to find out their motivations for joining the study and how they prefer to receive information about taking part in studies. A small number of women will be asked to take part in a study to look at how mothers' and babies' immune systems respond to the two different study prevention options , and to investigate different ways of collecting samples from their babies. In addition, researchers will use data from the study to see whether giving both medicines is cost-effective compared with giving just one medicine.
The study might be adapted in the future to look at other medicines for preventing RSV infection, when they become available.

Start Date01 Sep 2025

Sponsor / Collaborator

Penta Global Blockchain Foundation, Inc.

NCT07097012

/ Not yet recruitingPhase 4IIT

Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy - A Pilot Feasibility Trial

The goal of this clinical trial is to learn if the RSV vaccine (protects against respiratory syncytial virus) and Tdap vaccine (protects against pertussis) are most effective in pregnant individuals when taken together at the same visit, or separately at different visits. This clinical trial will also learn about the safety and immune responses of these vaccines in pregnancy.
The Main question:
-Is it possible to run a successful trial that tests how safe and effective it is to give Tdap and RSV vaccines in pregnancy either at the same time or one after the other, at different visits?
The Secondary question:
-To determine how safe and how well the Tdap and RSV vaccines work when given in pregnancy either at the same time or one after the other, at different visits.
The Exploratory (optional participation) questions:
* To measure the levels of antibodies against whooping cough (pertussis) and RSV in mothers at 7 and 19 months after giving birth, depending on whether they got the vaccines at the same time or one after the other during pregnancy.
* To measure whooping cough antibody levels in the babies at 2, 7, and 19 months of age, whose mothers who received the vaccines in pregnancy.
* To measure the levels of RSV antibodies in the mothers' breast milk at 1 week, 2 weeks, 4 weeks, and 2 months after giving birth.
Participants will be randomly assigned to Group 1 (vaccines given at the same time, same visit) or Group 2 (vaccines given one after the other, at different visits).
There are 4 visits as part of the main study, and 6 additional visits as part of the optional study (exploratory questions).
Visit 1-2: Blood collection and vaccines administered Visit 3-4: Blood work (cord blood sample collection from infant, after delivery, if possible) Visit 5-8: Breast milk collection Visit 8-10: Blood collection (infant blood collection only at Visit 8).
Participants will be asked to keep a diary of symptoms throughout the study.

Start Date01 Sep 2025

Sponsor / Collaborator

Canadian Immunization Research Network

[+6]

NCT07122661

/ Active, not recruitingNot Applicable

STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia

This Pfizer-sponsored real-world retrospective non-interventional study will be conducted within a research network comprised of independent hospitals across Australia using data collected during routine standard of care clinical encounters available in health records, supplemented with information from the official national immunisation registry, the Australian Immunisation Register. Additional data from accredited pathology laboratories will be included. There will be no active enrollment of study participants, no direct contact with study participants, and no collection of any primary data outside of the standard of care.
This study will use a test negative design to evaluate real-world vaccine effectiveness of RSVpreF vaccination during pregnancy against RSV-associated outcomes in infants.

Start Date11 Aug 2025

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with RSVpreF

100 Translational Medicine associated with RSVpreF

100 Patents (Medical) associated with RSVpreF

402

Literatures (Medical) associated with RSVpreF

01 Jan 2026·AMERICAN HEART JOURNAL

A pragmatic individually randomized trial to evaluate bivalent RSV prefusion F protein–based vaccine effectiveness for preventing RSV hospitalizations in adults aged 60 years or above (DAN-RSV): Rationale and trial design

Article

Author: Zhang, Pingping ; Skovdal, Mette ; Moulton, Lawrence H ; Schwarz, Claudia ; Modin, Daniel ; Solomon, Scott D ; Begier, Elizabeth ; Larsen, Lykke ; Gonzalez, Elisa ; Gessner, Bradford D ; Skaarup, Kristoffer G ; Biering-Sørensen, Tor ; Lindholm, Matias G ; Dalager-Pedersen, Michael ; Claggett, Brian L ; Christensen, Sine H ; Martel, Cyril Jean-Marie ; Larsen, Carsten S ; Stæhr Jensen, Jens Ulrik ; Wiese, Lothar ; Aliabadi, Negar ; Køber, Lars ; Lassen, Mats C Højbjerg ; Johansen, Niklas D

BACKGROUND:

Respiratory syncytial virus (RSV) can cause serious illness in older adults and those with chronic conditions. While the bivalent RSVpreF vaccine has been shown to protect against RSV-related respiratory tract disease, its impact on severe RSV-related and broader cardiorespiratory hospitalizations remains untested in a fully powered randomized trial. This pragmatic, individually randomized, open-label, parallel-group trial aims to evaluate RSVpreF vaccine effectiveness (VE) in reducing the risk of RSV-related and all-cause cardiorespiratory hospitalizations in adults aged 60 and older.

METHODS:

DAN-RSV is randomizing Danish adults 1:1 to receive either RSVpreF or no RSV vaccine. The trial uses nationwide registries for recruitment, where eligible citizens are identified and invited via the national electronic messaging system and can provide electronic informed consent remotely. Baseline, safety, and outcome data are collected through the national health registries using the civil registration number provided at consent. Up to 130,000 participants will be enrolled during the 2024/2025 winter season. The primary objective is to assess vaccine effectiveness (VE) against RSV-related respiratory tract disease hospitalization. Secondary endpoints include RSV-related and all-cause lower respiratory tract disease hospitalizations, RSV-related and all-cause cardiorespiratory hospitalizations, and all-cause death.

CONCLUSION:

DAN-RSV is an innovative trial combining the gold standard of individual randomization with pragmatic data collection via centralized health records and national health registries. This design offers a feasible approach to assess the impact of RSVpreF on clinically meaningful cardio-respiratory outcomes in adults ≥60 years in a real-world setting - while minimizing bias through use of randomization. The results will support cost-effectiveness analyses and inform future vaccination policies.

TRIAL REGISTRATION:

NCT06684743, registered November 9, 2024 (https://clinicaltrials.gov/study/NCT06684743).

31 Dec 2025·Expert Review of Vaccines

Potential public health and economic impact of maternal vaccination with bivalent respiratory syncytial virus prefusion F (RSVpreF) vaccine for the prevention of acute respiratory infection among infants in the United States

Article

Author: Shea, Kimberly M. ; Gessner, Bradford D. ; Averin, Ahuva ; Pugh, Sarah ; Weycker, Derek ; Atwood, Mark ; Quinn, Erin ; Cane, Alejandro ; Law, Amy W. ; Atwell, Jessica E.

BACKGROUND:

The U.S. Advisory Committee on Immunization Practices recommends use of bivalent stabilized prefusion F subunit vaccine (RSVpreF) among pregnant persons to protect their infants against lower respiratory tract illness due to RSV (RSV-LRTI).

RESEARCH DESIGN AND METHODS:

Using a cohort model depicting clinical outcomes and economic costs of RSV acute respiratory infection (RSV-ARI) among US infants from birth to age 1 year, we evaluated the impact of seasonally administered maternal RSVpreF versus no intervention. Outcomes included cases of medically attended RSV-ARI, RSV-related deaths, medical costs, and indirect costs. Costs were reported in 2023 US$.

RESULTS:

Among the 3.7 million US infants aged <12 months each year, a total of 1,148,967 RSV-ARI cases (hospital: 48,384; emergency department [ED]: 246,118; outpatient clinic [OC]: 854,465) were projected to occur, yielding total annual costs of $2.4 billion (direct: $1.7B; indirect: $0.7B). With 54.9% uptake, RSVpreF would prevent 89,908 cases (hospital: 10,308; ED: 20,538; OC: 59,062), corresponding with a $368 million decrease (direct: $286 M; indirect: $81 M) in total 1-year costs.

CONCLUSION:

Even with limited uptake and without considering benefits to pregnant persons or reductions in RSV-related sequelae, maternal vaccination with RSVpreF would substantially reduce the public health and economic burden of RSV-ARI in US infants.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Cost-effectiveness of immunization strategies to protect infants against respiratory syncytial virus in the Netherlands

Article

Author: Atwood, Mark ; van den Boer, Jennie ; Langedijk, Annefleur C. ; van den Dungen, Floris ; Averin, Ahuva ; Smit, Lucy ; Law, Amy ; Quinn, Erin ; Harteveld, Lisette ; Mendes, Diana ; van Houten, Marlies

The European Medicines Agency has authorized two interventions to prevent lower respiratory tract disease due to respiratory syncytial virus (RSV-LRTD) in infants: nirsevimab, a monoclonal antibody, and bivalent stabilized prefusion F subunit maternal vaccine (RSVpreF). In the Netherlands, RSV-LRTD protection is recommended for all infants with nirsevimab given preferential recommendation over RSVpreF. We evaluated cost-effectiveness of various intervention strategies to prevent RSV in the Netherlands. We employed a cohort model to evaluate clinical and economic outcomes associated with RSV-LRTD during the first year of life among infants receiving RSVpreF with complementary nirsevimab and, alternatively, nirsevimab alone versus no intervention. Model inputs, based principally on Dutch data, include rates of disease, case-fatality, general mortality; disutility; and costs of interventions, medical care, treatment-related travel, and disease-associated work loss. Uptake of interventions assumed 70%; effectiveness was based on a published study using Phase III trial data. Analyses were conducted from the societal perspective using 2023 EUR; annual discount rates were 3% for costs and 1.5% for quality-adjusted life-years (QALYs). With no intervention, there were 10,482 RSV-LRTD cases with total associated costs of € 17.4M. Nirsevimab alone prevented 4,905 cases, yielding 100 QALYs; total costs increased by € 59.3M due to high intervention costs and cost-effectiveness was € 592,404/QALY (vs. no intervention). RSVpreF with complementary nirsevimab for infants prevented 4,723 cases, yielding 108 QALYs; total costs increased by € 35.5M and cost-effectiveness was € 329,187/QALY (vs. no intervention). Maternal RSVpreF with complementary nirsevimab was more cost-effective than nirsevimab alone.

388

News (Medical) associated with RSVpreF

07 Aug 2025

·endpoints.news

CDC adopts advisors' recommendation for Merck’s infant RSV antibody

The CDC now recommends the use of Merck’s recently-approved RSV antibody in infants, after advisors to the agency voted in favor of the product in June. CDC Director Susan Monarez adopted the recommendation of the Advisory Committee on Immunization Practices on Monday after taking the helm of the agency last week. Merck’s Enflonsia was approved by the FDA earlier in June to prevent RSV lower respiratory tract disease in infants entering their first respiratory virus season. Inclusion of the antibody in CDC’s guidelines was the final step for Merck as it challenges Sanofi and AstraZeneca’s Beyfortus in the market. Beyfortus raked in almost $2 billion in sales in 2024 after being approved in 2023. The June ACIP meeting was the first since HHS Secretary Robert F. Kennedy Jr. fired and replaced the committee’s roster of members. Two of the seven new members had voted against the drug, raising safety concerns with the RSV antibodies. Retsef Levi, a supply chain professor at MIT, had issues with what he believed was an imbalance in deaths, specifically highlighting Beyfortus’ clinical trial data despite that product not being up for recommendation. Cody Meissner, the only former ACIP member to be included in the rebuilt panel, voted for the drug and underscored the real-world benefit that Beyfortus and Pfizer’s maternal RSV vaccine had demonstrated so far. “This is a truly spectacular accomplishment,” Meissner said at the meeting. Kennedy last month adopted guidance made by the previous ACIP panelists in April, recommending adult RSV vaccines for people 50 to 59 at higher risk of severe disease. Kennedy also recently adopted a June recommendation from the rebuilt ACIP panel to continue annual flu shots but remove thimerosal from them . That ingredient has been a source of consternation from people hesitant or skeptical about vaccination, and its alleged risks have been pushed by Children’s Health Defense, an organization Kennedy used to run. But the FDA notes that vaccines without thimerosal are available and that a “robust body of peer-reviewed scientific studies” have concluded that vaccines with the ingredient are safe.

VaccineDrug Approval

23 Jul 2025

·www.businesswire.com

As RSV Season Approaches, the Federation of Medical Women of Canada Urges National Response to Protect Infants Across the Country

TORONTO--(BUSINESS WIRE)--Today, the Federation of Medical Women of Canada (FMWC) released its latest white paper through the Maternal RSV Task Force—a national group of experts in maternal, infant, and public health—highlighting the urgent need for equitable access to maternal RSV prevention across Canada. With the 2025–2026 RSV season approaching, the task force is calling for immediate action to protect infants, especially healthy, full-term newborns who account for the majority of severe RSV cases. Respiratory Syncytial Virus (RSV) is the leading cause of infant hospitalizations in Canada, with 1 in 50 infants hospitalized during their first year of life1. The RSV virus causes upper and lower respiratory tract infections (LRTI)2, and babies who develop LRTI in early childhood have almost double the risk of premature death from respiratory disease relative to unaffected individuals.3 Although two newly approved RSV immunization options have been authorized by Health Canada — a maternal vaccine RSVpreF (Abrysvo™, Pfizer) and a monoclonal antibody for infants nirsevimab (Beyfortus™, Sanofi) — access remains inconsistent across provinces and territories. Ontario is leading by covering both RSVpreF for pregnant women and pregnant people and nirsevimab for infants, yet provinces like B.C. only cover the older monoclonal antibody, palivizumab, for high-risk infants — leaving 98% of infants unprotected and at risk for RSV.4 “With two safe and effective immunization options now available, we have the tools to protect infants from RSV—but awareness, access, and equity remain critical challenges,” says Dr. Vivien Brown, Family Physician and Co-Chair of the FMWC Maternal RSV Task Force. “This white paper highlights the urgent need for national coordination, public funding, and ongoing education to ensure that every pregnant woman and pregnant person, regardless of where they live, can protect their infant from this serious and preventable disease.” The white paper outlines 13 short- and long-term recommendations to improve RSV prevention in Canada, including: Public funding for RSV immunization (maternal vaccine year-round; nirsevimab seasonally) Authorizing pharmacists to administer publicly funded vaccines Tailoring education for a range of healthcare providers, including midwives and pharmacists Engaging with manufacturers to clarify the predicted availability of immunization options Implementing a universal, national immunization registry Strengthening national guidance on vaccination and provincial implementation “This is fundamentally about health equity,” says Dr. Shelley Ross, Family Physician and Co-Chair of the FMWC Maternal RSV Task Force. “Our hope is that by providing a clear, evidence-based roadmap that outlines the steps we can take as a united healthcare system, we can close the gaps and ensure every infant in Canada has the opportunity to be protected from RSV, regardless of geography or circumstance.” The task force also launched RSVProtect.ca, a national hub for healthcare providers and the public, offering up-to-date information and comprehensive educational resources on RSV and RSV protection strategies. The FMWC urges pregnant women and pregnant people to speak with their healthcare providers about RSV prevention options and calls on policymakers to help close the access gap as the upcoming 2025–2026 RSV season begins. For more details on the FMWC Maternal RSV White Paper and its recommendations, please visit www.rsvprotect.ca. About FMWC The Federation of Medical Women of Canada (FMWC) is a national organization recognized for its leadership and advocacy for women's evolving health. We are committed to promoting the well-being and health of women and women-identifying individuals both within the medical profession and society at large. The FMWC has a 100-year history in Canada, is a member of the non-governmental organization (NGO) section of the Department of Global Affairs at the United Nations (UN) and is a member of the Medical Women's International Association (MWIA), making us a part of the Economic and Social Council of the UN (ECOSO). For more information, please visit: www.fmwc.ca. 1 Government of Canada. Respiratory syncytial virus (RSV) vaccines: Canadian Immunization Guide. https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian- immunization-guide-part-4-active-vaccines/respiratory-syncytial-virus.html. Updated May 14, 2025. Accessed May 21, 2025. 2 Sanchez-Martinez A, Moore T, Freitas TS, et al. Recent advances in the prevention and treatment of respiratory syncytial virus disease. J Gen Virol. 2025;106(4). doi: 10.1099/jgv.0.002095 3 Zar HJ, Cacho F, Kootbodien T, et al. Early-life respiratory syncytial virus disease and long-term respiratory health. Lancet Respir Med. 2024;12(10):810-821. 4 Paes B, Brown V, Courtney E, et al. Optimal implementation of an Ontario nirsevimab program for respiratory syncytial virus (RSV) prophylaxis: Recommendations from a provincial RSV expert panel. Hum Vaccin Immunother. 2024;20(1):2429236.

VaccineClinical Study

14 Jul 2025

·www.pharmaceutical-technology.com

GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients

Broader label coverages for Pfizer and Moderna’s vaccines mean they have made in-roads into GSK’s RSV dominant market share. MAXSHOT.PL via Shutterstock. GSK has applied to the US Food and Drug Administration (FDA) to extend use of its respiratory syncytial virus (RSV) vaccine Arexvy to adults under the age of 50 who are at increased risk of the disease. GSK’s Arexvy is already approved in the US for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, and for those aged 50-59 years who are at increased risk. If the latest regulatory submission is approved by the FDA, the vaccine will have indications in those aged 18 years and above. A decision by the FDA is expected in H1 2026. GSK’s application is based on a Phase IIIb trial (NCT06389487) that produced comparable results to data from the Phase III programme that supported the initial approval of the vaccine in the US. A single dose of the vaccine in adults aged 18-49 at increased risk of RSV-LRTD elicited robust immune responses that were non-inferior to those observed in adults aged 60 and above. Safety data was also in line with previous results, with the most common adverse events being local pain, fatigue, muscle ache, and headache, all of which were short-lasting. The label expansion sought by GSK is a bid to compete with Pfizer and Moderna in the younger age groups of the RSV vaccine market. Pfizer’s Abrysvo and Moderna’s mRESVIA are both approved to prevent LRTD in individuals aged 18 to 59 at increased disease risk. The broader label coverages for Abrysvo and mRESVIA mean Pfizer and Moderna have made in-roads into GSK’s RSV dominant market share, courtesy of Arexvy’s higher sales in older age groups. Arexvy initially captured a larger market share due to its stronger contracts with retail pharmacies and slightly earlier approval in the US market. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence The RSV market is one of the most lucrative in the pharmaceutical industry. Around 64 million people of all ages globally every year are impacted by RSV, a common respiratory virus that causes seasonal infections such as the flu. It is also a leading cause of pneumonia and death in infants and older adults. The global RSV market is set to reach $6.3bn in value by 2030, according to analysis by GlobalData. US vaccine pressures Despite vying for RSV market share, all three companies are operating within a highly pressurised vaccine landscape in the US. Revenue for Arexvy, Abrysvo, and mRESVIA in 2024 was significantly impacted by the tightening of US RSV vaccine recommendations, which led to reduced vaccination rates. FDA approvals do not automatically mean shots enter national immunisation schedules. That is instead recommended by the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP). A brief boost came in April, after the ACIP expanded the eligible at-risk group to people aged 50 and older. However, changes to the panel made by US health secretary Robert F Kennedy (RFK) Jr have ushered in new uncertainty surrounding the future of vaccines in the US. RFK Jr controversially axed the entire ACIP panel in June, replacing it with well-known vaccine sceptics and individuals lacking vaccine knowledge. The move has cast doubts on how immunisation recommendations will be voted on going forward, with infectious disease experts concerned about the consequences to public health. Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now

VaccinePhase 3Clinical ResultDrug Approval

100 Deals associated with RSVpreF

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Approved

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Indication	Country/Location	Organization	Date
Pneumonia due to respiratory syncytial virus	European Union	Pfizer Europe MA EEIG	23 Aug 2023
Pneumonia due to respiratory syncytial virus	Iceland	Pfizer Europe MA EEIG	23 Aug 2023
Pneumonia due to respiratory syncytial virus	Liechtenstein	Pfizer Europe MA EEIG	23 Aug 2023
Pneumonia due to respiratory syncytial virus	Norway	Pfizer Europe MA EEIG	23 Aug 2023
Respiratory Syncytial Virus Infections	United States	Pfizer Inc.	31 May 2023
Lower Respiratory Tract Infections	Canada	Pfizer Canada ULC	04 Jan 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Herpes Zoster	Phase 3	United States	Pfizer Inc.	04 Apr 2025
Influenza, Human	Phase 3	Australia	Pfizer Inc.	13 Apr 2022
Respiratory Tract Infections	Phase 3	United States	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	Japan	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	Argentina	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	Australia	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	Brazil	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	Canada	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	Chile	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	Denmark	Pfizer Inc.	17 Jun 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05842967 (MONET, CTgov)	Phase 3	Respiratory Syncytial Virus Infections	885	SSA+RSVpreF (SSA: RSVpreF)	btzvxkmguq = dlbhyhaauv dnkajmqdoi (qvcgofjtsr, clufcrxywr - osqezjuhlr) View more	-	08 Aug 2025
				SSA (SSA: Placebo)	btzvxkmguq = qfzeqcqeoq dnkajmqdoi (qvcgofjtsr, ksxnawyvts - gwwsamkomp) View more
NCT04424316 (MATISSE, CTgov)	Phase 3	Respiratory Tract Infections	14,727	RSVpreF (Infant Participants: RSVpreF)	yoedbeosvd = cwpgfkxrls jpbzyhqair (ipcmfpsejv, tbnteyssua - gkkddsqsgc) View more	-	11 Feb 2025
				placebo+RSVpreF (Infant Participants: Placebo)	yoedbeosvd = fgddrsdaac jpbzyhqair (ipcmfpsejv, kkqryqnpnl - zwqoqwabyx) View more
NCT05035212 (2021-003693-31, Pubmed \| Clin Infect Dis)	Phase 3	-	-	Bivalent RSV Prefusion F (RSVpreF) Vaccine (RSVpreF 120-µg)	ohnxxmxanr(kzbsszuhey) = ajaajdvedh dgbzwrlmyl (vpdjlppbij )	Positive	10 Feb 2025
				Bivalent RSV Prefusion F (RSVpreF) Vaccine (Placebo)	ohnxxmxanr(kzbsszuhey) = xifnnzvqdg dgbzwrlmyl (vpdjlppbij )
NCT04424316 (MATISSE, Pubmed \| Obstet Gynecol)	Phase 3	Obstetric Labor, Premature	-	Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine (RSVpreF)	qptsaxtpab(mkjvfbawzq) = no clinically significant increase in adverse events of special interest, including preterm birth, low birth weight, or neonatal hospitalization, was observed among pregnant people in the overall analysis hwevqfyetw (yeeckyxpqy ) View more	Positive	02 Jan 2025
				Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine (Placebo)
NCT05886777 (CTgov)	Phase 2	COVID-19 \| Infectious Lung Disorder	1,142	QIV+RSVpreF (Group 1: [RSVpreF + BNT162b2] + QIV)	wtevsyhrtk = htubmrzjrt qqlrgqgjaz (jykdopzcfn, ewjlibieao - mlvzgsknfn) View more	-	18 Dec 2024
				Placebo+BNT162b2+RSVpreF (Group 2: [RSVpreF+BNT162b2] + Placebo)	wtevsyhrtk = xxitbtxbxz qqlrgqgjaz (jykdopzcfn, izogsasrmt - qzuonmaspp) View more
NCT05788237 (CTgov)	Phase 1	Influenza, Human	508	RSVpreF+qIRV (SSA: Group 1: RSVpreF + qIRV)	hwnwfqqrsk = ebvgvmhkfj zxpxypnxlo (eyopjxynjl, ohrwnqfzrd - jnuibibjuf) View more	-	22 Nov 2024
				qIRV (SSA: Group 2: qIRV)	hwnwfqqrsk = jtdutpiwzv zxpxypnxlo (eyopjxynjl, cbvrqccyzt - gulliqifge) View more
NCT05842967 (MONeT, PipelineReview) Manual	Phase 3	Respiratory Syncytial Virus Infections	203	ABRYSVO	exhqllgslk(gefcejqueb) = ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other studies of the vaccine. mbffwovwnh (xkptmzncpl ) View more	Positive	12 Aug 2024
NCT04785612 (Phase 2a study, CTgov)	Phase 2	Respiratory Syncytial Virus Infections	70	RSVPreF (RSVPreF)	cpytqyepbm(tjehtlschn) = zevlrqljdg tqdorqmvmn (jigibhpbws, sqnrinhooe - jkiqsxxkhf) View more	-	07 Aug 2024
				Placebo (Placebo)	cpytqyepbm(tjehtlschn) = cknpgnijvd tqdorqmvmn (jigibhpbws, ttmndsdqai - eixlkispje) View more
NCT04424316 (MATISSE, Pubmed)	Phase 3	Respiratory Syncytial Virus Infections	-	RSVpreF vaccine	rdgvtirdwo(jlepsxrgej) = urwuhmzhtg rluownjsbj (hqzoetoerw ) View more	Positive	08 Jun 2024
				bivalent RSVpreF maternal vaccination (Placebo)	rdgvtirdwo(jlepsxrgej) = ikmztmebjs rluownjsbj (hqzoetoerw ) View more
NCT05842967 (MONeT, Corporate Publications) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive \| Asthma \| Diabetes Mellitus ... View more	-	ABRYSVO	yqivdfggbv(mlbrlhruaa) = Participants demonstrated RSV-A and RSV-B subgroup neutralizing responses non-inferior to the response seen in the Phase 3 (NCT05035212) RENOIR study of ABRYSVO in more than 34,000 adults aged 60 or older where vaccine efficacy was previously demonstrated. mmiyioqkjb (qhiixtjtke ) Met View more	Positive	09 Apr 2024

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Clinical Trial

Approval

Regulation