Trial reportThe Journal of infectious diseases2023
Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus Vaccine (RSVPreF3) in Mothers and Their Infants: A Phase 2 Randomized Trial.
Trial report in The Journal of infectious diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04126213 (A Phase II, Randomised, Observer-blind, Placebo Controlled Multi-country Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Intramuscular Dose of GSK Biologicals' Investigational RSV Maternal Unadjuvanted Vaccine), which is not on this map. Cited by 44 papers, 8 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II, Randomised, Observer-blind, Placebo Controlled Multi-country Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Intramuscular Dose of GSK Biologicals' Investigational RSV Maternal Unadjuvanted Vaccine (GSK3888550A), in Healthy Pregnant Women Aged 18 to 40 Years and Infants Born to Vaccinated Mothers
Who cites it
44 citing papers in PubMed, 8 syntheses or guidelines pooled it, 60 citations in OpenAlex.
- Respiratory Syncytial Virus Vaccination Is Associated With Increased Odds of Preterm Birth.Acta paediatrica (Oslo, Norway : 1992) · 2026Pooled it
- RSV-Pre-F Vaccination During Pregnancy and Neonatal Outcomes-A Systematic Review and Meta-Analysis.Immunity, inflammation and disease · 2026Pooled it
- The impact of maternal respiratory syncytial virus vaccination on infant and perinatal outcomes: a systematic review and meta-analysis of randomized controlled trials.Journal of perinatology : official journal of the California Perinatal Association · 2026Pooled it
- Efficacy and safety of maternal RSV vaccination against infant lower respiratory tract infections: a systematic review and meta-analysis.Frontiers in public health · 2026Pooled it
- Maternal RSV vaccine: a systematic review and meta-analysis of immunogenicity and perinatal safety.Immunologic research · 2025Pooled it
- Efficacy, immunogenicity and safety of respiratory syncytial virus prefusion F vaccine: systematic review and meta-analysis.BMC public health · 2024Pooled it
- Respiratory syncytial virus vaccination during pregnancy for improving infant outcomes.The Cochrane database of systematic reviews · 2024Pooled it
- Respiratory Syncytial Virus Maternal Vaccination in Infants below 6 Months of Age: Meta-Analysis of Safety, Immunogenicity, and Efficacy.Neonatology · 2024Pooled it
- Randomized, placebo-controlled phase 3 trial evaluating safety, immunogenicity, and reactogenicity of RSVPreF3-Mat in high-risk pregnant women and their infants.Human vaccines & immunotherapeutics · 2026Trial
- Replacing serum with dried blood microsampling for pharmacokinetics, viral neutralisation and immunogenicity bioanalysis supporting future paediatric development of RSM01, a candidate respiratory syncytial virus neutralising monoclonal antibody.BMC infectious diseases · 2024Trial
- CAUSAL-RSV: A study protocol for a causal mediation analysis of RSV vaccine effects in infants using real-world data.medRxiv : the preprint server for health sciences · 2026Article
- Delineating RSV-A and RSV-B: Epidemiological Patterns, Diagnostics, Clinical Severity, and Preventive Approaches.Journal of medical virology · 2026Review
- Introducing the Concept of Small Vulnerable Newborns (SVN) as an Additional Endpoint to Evaluate Birth Outcomes in the Context of RSV Immunization Studies-A Commentary.Influenza and other respiratory viruses · 2026Article
- Maternal RSV immunization: clinical efficacy, immunological mechanisms and public health implications for preventing infant lower respiratory tract infection.Journal of health, population, and nutrition · 2026Review
- Real-World Evidence Evaluation of Respiratory Syncytial Virus (RSV) Vaccines: Deep Dive into Vaccine Adverse Events Reporting System.Diseases (Basel, Switzerland) · 2026Article
- Maternal RSV vaccination: clinical efficacy, safety, and global policy considerations: a systematic review.Journal of pharmaceutical policy and practice · 2026Review
- Position statement of the Mexican Association of Pediatrics on the immunoprevention of respiratory syncytial virus infection during pregnancy and infancy.World journal of pediatrics : WJP · 2026Review
- Article
- Safety and efficacy of maternal RSV vaccination: a systematic review and meta-analysis.Clinical and experimental vaccine research · 2025Review
- Epidemiological Changes in Pediatric RSV Infections in Poland (2016-2024): Impact of the COVID-19 Pandemic.Journal of clinical medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors at 18 institutions in 10 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn a phase 1/2 study, a maternal respiratory syncytial virus vaccine candidate (RSVPreF3) demonstrated an acceptable safety profile and efficiently increased RSV-specific humoral immune responses in non-pregnant women.
methodsIn this phase 2 observer-blind, placebo-controlled, randomized clinical trial (NCT04126213), the safety of RSVPreF3 (60 or 120 µg), administered during late second or third trimester, was evaluated in 213 18- to 40-year-old healthy pregnant women through 6 months postdelivery and their offspring through infancy; immunogenicity was evaluated through day 43 postdelivery and day 181 postbirth, respectively.
resultsRSVPreF3 was well tolerated. No pregnancy-related or neonatal adverse events of special interest were considered vaccine/placebo related. In the 60 and 120 µg RSVPreF3 groups: (1) neutralizing antibody (nAb) titers in mothers increased 12.7- and 14.9-fold against RSV-A and 10.6- and 13.2-fold against RSV-B, respectively, 1 month postvaccination and remained 8.9-10.0-fold over prevaccination at day 43 postdelivery; (2) nAb titers were consistently higher compared to placebo recipients; (3) placental transfer ratios for anti-RSVPreF3 antibodies at birth were 1.62 and 1.90, respectively, and (4) nAb levels in infants were highest at birth and declined through day 181 postbirth.
conclusionsRSVPreF3 maternal vaccination had an acceptable safety risk profile and induced robust RSV-specific immune responses with successful antibody transfer to their newborns. CLINICAL TRIALS REGISTRATION: NCT04126213.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.