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Respiratory Syncytial Virus InfectionsPhase 3NCT05238025

MVA-BN-RSV Vaccine Trial

A Phase 3 study testing MVA-BN-RSV vaccine and Tris Buffered Saline (TBS) in people with Respiratory Syncytial Virus Infections, run by Bavarian Nordic at 120 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Phase 3 randomized, double blind study comparing recombinant MVA-BN-RSV vaccine vs placebo for efficacy and safety in adults >=60 years of age Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
MVA-BN-RSV vaccine and Tris Buffered Saline (TBS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20,419 participants
Where
120 sitesin 2 countries
Study dates
19 Apr 2022to 1 Sep 2023
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male and female subjects ≥60 years of age.
  • Informed Consent signed by the subject.
  • Subjects may have one or more chronic medical conditions e.g., mild to moderate underlying illnesses such as chronic cardiac diseases and chronic lung disease (asthma and chronic obstructive pulmonary disease [COPD]), congestive heart failure (CHF), hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, that is clinically stable as assessed by the investigator.
  • Absence of known, current, and life-limiting diagnoses that render survival to completion of the protocol unlikely.
  • Ability to comply with trial requirements, which necessitates access to transportation to on-site visits, including symptom visits for a nasopharyngeal swab.
  • Willingness and ability to utilize an application on a personal device (i.e., smartphone, tablet, etc.) or a provisioned device to record solicited events and record all per protocol required data during the surveillance period.
  • For women of childbearing potential (WOCBP), agreement to use an acceptable method of contraception during the trial and a negative urine pregnancy test within 24 hours prior to vaccination.

Who cannot join

  • History of or current clinical manifestation of any serious medical condition that in the opinion of the investigator would compromise the safety of the subject, confound data interpretation, or would limit the subject's ability to complete the trial.
  • History of or active autoimmune disease, including diabetes mellitus type I. Vitiligo or hypothyroidism requiring thyroid replacement therapy are not exclusions. Rheumatoid arthritis not requiring immunomodulatory and/or immunosuppressant treatment is not an exclusion.
  • Known or suspected impairment of immunologic functions, including chronic inflammatory bowel disorders.
  • Clinically significant mental disorder that would prevent patients from giving informed consent and complying with study procedures (e.g., completion of the electronic diary).
  • Active or recent (within 6 months before enrollment) history of chronic alcohol abuse.
  • History of a serious reaction to any prior vaccination or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization.
Show all 18Show fewer
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g., tris(hydroxymethyl)-amino methane, chicken embryo fibroblast proteins, gentamycin, ciprofloxacin; this includes:
  • Known allergy to eggs or aminoglycosides
  • History of anaphylaxis or severe allergic reaction to any vaccine
  • Any administration or planned administration of:
  • A licensed live or vector-based vaccine within 30 days prior to or after trial vaccine administration.
  • A licensed inactivated or ribonucleic acid (RNA)-based vaccine within 14 days prior to or after trial vaccine administration.
  • Previous vaccination with an RSV vaccine, or any planned vaccination with an RSV vaccine other than the trial vaccine.
  • Planned chronic, systemic administration (defined as more than 14 days) of >10 mg prednisone (or equivalent)/day or any other systemic use of immunemodifying drugs during a period starting from 3 months prior to first administration of the trial vaccine and ending at the End of Study Visit (EOS). The use of topical, inhaled, ophthalmic and nasal glucocorticoids is permitted.
  • Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to first administration of the trial vaccine and during the trial.
  • Known uncontrolled coagulation disorder. Anticoagulant treatment under adequate control for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or stroke in the setting of atrial fibrillation are permitted.
  • Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days prior to the administration of the trial vaccine, or planned administration of such a drug or vaccine between enrollment in the trial and until the end of the clinical trial including follow-up. [For US Only]
  • Involvement with this trial as research personnel.

Trial locations and contacts

120 sites in 2 countries.

120 sites in 2 countries

United States105 sites

  • MedPharmics, LLC

    Albuquerque, New Mexico, 87102

  • Accellacare and McFarland Clinic

    Ames, Iowa, 50010

  • Synexus Clinical Research US, Inc.

    Anderson, South Carolina, 29621

  • Velocity Clinical Research Anderson

    Anderson, South Carolina, 29621

  • Clinical Alliance for Research and Education Infectious Disease

    Annandale, Virginia, 22003-7347

  • North Alabama Research Center, LLC

    Athens, Alabama, 35611

  • Lynn Institute of Denver

    Aurora, Colorado, 80012

  • Tekton Research, Inc.

    Austin, Texas, 78745

  • Central Alabama Research

    Birmingham, Alabama, 35209

  • Achieve Clinical Research, LLC d/b/a Accel Research Sites

    Birmingham, Alabama, 35216

  • Bingham Memorial Hospital

    Blackfoot, Idaho, 83221

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

  • Hope Clinical Research, LLC

    Canoga Park, California, 91303

  • Accellacare - Raleigh Medical Group

    Cary, North Carolina, 27518

  • Accellacare Research of Charlotte

    Charlotte, North Carolina, 28209

  • Great Lakes Clinical Trials at Ravenswood Rheumatology

    Chicago, Illinois, 60625

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • Velocity Clinical Research

    Cincinnati, Ohio, 45242

  • Innovative Research Of West Florida, Inc.

    Clearwater, Florida, 33756

  • Centricity Research Columbus Multispecialty

    Columbus, Georgia, 31904

  • Certified Research Associates

    Cortland, New York, 13045

  • Accel Research Site - Neurostudies

    Decatur, Georgia, 30030

  • Henry Ford Health Hospital

    Detroit, Michigan, 48202

  • Velocity Clinical Research- Providence

    East Greenwich, Rhode Island, 02818

  • Invesclinic US LLC

    Edinburg, Texas, 78539

  • Centennial Medical Group

    Elkridge, Maryland, 21075

  • Meridian Clinical Research LLC

    Endwell, New York, 13760

  • AES Evansville

    Evansville, Indiana, 47714

  • Lenzmeier Family Medicine / CCT Research

    Glendale, Arizona, 85308

  • Meridian Clinical Research, LLC

    Grand Island, Nebraska, 68803

  • PharmQuest

    Greensboro, North Carolina, 27408

  • Synexus Clinical Research US, Inc.

    Henderson, Nevada, 89052

  • Doral Medical Research

    Hialeah, Florida, 33016

  • Olympus Family Medicine/CCT Research

    Holladay, Utah, 84117

  • DM Clinical Research

    Houston, Texas, 77065

  • Marvel Clinical Research 002, LLC

    Huntington Beach, California, 92647

  • Join Clinical Trials

    Huntington Park, California, 90255

  • Medical Affiliation Research Center

    Huntsville, Alabama, 35801

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404

  • Snake River Research, PLLC

    Idaho Falls, Idaho, 83404

  • Accellacare of Knoxville

    Knoxville, Tennessee, 37938

  • Paradigm Clinical Research Center

    La Mesa, California, 91942

  • Atella Clinical Research LLC

    La Palma, California, 90623

  • Chemidox Clinical Trials Inc.

    Lancaster, California, 93534

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

  • Santa Rosa Medical Centers of Nevada/ CCT Research

    Las Vegas, Nevada, 89119

  • Tanner Clinic

    Layton, Utah, 84041

  • Lifeline Primary Care/CCT Research

    Lilburn, Georgia, 30047

  • Main Street Physician's Care-Waterway

    Little River, South Carolina, 29566

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72204

  • ARK Clinical Research

    Long Beach, California, 90806

  • Matrix Clinical Research

    Los Angeles, California, 90057

  • K2 Medical Research, LLC

    Maitland, Florida, 32751

  • Aventiv Research Inc.

    Mesa, Arizona, 85210

  • SMS Clinical Research

    Mesquite, Texas, 75149

  • Med Pharmics, LLC

    Metairie, Louisiana, 70006

  • ActivMed Practices and Research, LLC

    Methuen, Massachusetts, 01844

  • Optimus U Corporation

    Miami, Florida, 33125

  • De La Cruz Research Center, LLC

    Miami, Florida, 33184

  • Global Health Research Center, Inc

    Miami Lakes, Florida, 33016

  • Tekton Research

    Moore, Oklahoma, 73160

  • CHEAR Center LLC

    New York, New York, 10455

  • Meridian Clinical Research, LLC

    Norfolk, Nebraska, 68701

  • Accelacare- DuPage Medical Group

    Oak Lawn, Illinois, 60453

  • South Ogden Family Medicine/ CCT Research

    Ogden, Utah, 84405

  • Lynn Health Science Institute East

    Oklahoma City, Oklahoma, 73111

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • University Of Nebraska Medical Center

    Omaha, Nebraska, 68105

  • Quality Clinical Research Inc

    Omaha, Nebraska, 68114

  • Meridian Clinical Research Associates, LLC

    Omaha, Nebraska, 68134

  • Midwest Regional Health Services, LLC/CCT Research

    Omaha, Nebraska, 68144

  • Pines Care Research Center, LLC

    Pembroke Pines, Florida, 33024

  • IDEAL Clinical Research

    Pembroke Pines, Florida, 33026

  • DM Clinical Research

    Philadelphia, Pennsylvania, 19107

  • Phoenix Clinical LLC

    Phoenix, Arizona, 85014

  • Pain Center of Arizona

    Phoenix, Arizona, 85018

  • Cognitive Clinical Trials, LLC

    Phoenix, Arizona, 85044

  • Research Your Health

    Plano, Texas, 75093

  • Sound Medical Research

    Port Orchard, Washington, 98366

  • Meridian Clinical Research, LLC

    Portsmouth, Virginia, 23703

  • Accellacare - Raleigh Medical Group

    Raleigh, North Carolina, 27609

  • Amici Clinical Research

    Raritan, New Jersey, 08869

  • Rochester Clinical Research Inc.

    Rochester, New York, 14609

  • Meridian Clinical Research

    Rockville, Maryland, 20854

  • Accellacare, Inc. - Rocky Mount

    Rocky Mount, North Carolina, 27804

  • Be Well Clinical Studies

    Round Rock, Texas, 78681

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • California Research Foundation

    San Diego, California, 92123

  • Meridian Clinical Research, LLC

    Savannah, Georgia, 31406

  • Meridian Clinical Research

    Sioux City, Iowa, 51106

  • MultiCare Health System-DMOB (Deaconess Medical Office Building)

    Spokane, Washington, 99204

  • Edward A. Doisy Research Center-Saint Louis University Center for Vaccine Development

    St Louis, Missouri, 63104

  • The Clinical Research Center, LLC

    St Louis, Missouri, 63141

  • Accellacare - Piedmont

    Statesville, North Carolina, 28625

  • Centricity Research Suffolk Primary Care

    Suffolk, Virginia, 23435

  • Mt Olympus Medical Research LLC

    Sugar Land, Texas, 77479

  • Fiel Family and Sports Medicine/CCT Research

    Tempe, Arizona, 85283

  • HOPE Research Institute

    Tempe, Arizona, 85284

  • DM Clinical Research

    Tomball, Texas, 77375

  • Tucson Neuroscience Research, LLC

    Tucson, Arizona, 85710

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088

  • Accellacare of Wilmington

    Wilmington, North Carolina, 28401

  • Progressive Medicine of the Triad, LLC

    Winston-Salem, North Carolina, 27103

  • Tekton Research Inc.

    Yukon, Oklahoma, 73099

Other trials in United States

Germany15 sites

  • Klinische Forschung Berlin GbR

    Berlin, 10787

  • Studienzentrum Diabetespraxis Dr. Braun

    Berlin, 13187

  • MECS Cottbus GmbH

    Cottbus, 03050

  • Klinsche Forschung Dresden GmbH

    Dresden, 01069

  • IKF Institut fuer klinische Forschung Frankfurt

    Frankfurt, 60596

  • Klinische Forschung Hannover-Mitte GmbH

    Hanover, 30159

  • Siteworks GmbH

    Hanover, 30449

  • Medizinische Hochschule Hannover (MHH)

    Hanover, 30625

  • Siteworks Zentrum für Klinische Studien Heidelberg

    Heidelberg, 69115

  • SIBAmed Studienzentrum GmbH & Co. KG

    Leipzig, 04103

  • Dermatologische Gemeinschaftspraxis Dres. Quist

    Mainz, 55128

  • RED Institut GmbH

    Oldenburg, 23758

  • Siteworks Prufzentrum Rendsburg - HNO Research GmbH

    Rendsburg, 24768

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055

  • Intermed GmbH, Institut fuer medizinische Forschung und Arzneimittelsicherheit

    Wiesbaden, 65189

Other trials in Germany

About this study

Official title: A Randomized, Double-blind, Phase 3 Trial to Assess Clinical Efficacy, Safety and Reactogenicity of the Recombinant MVA-BN® -RSV Vaccine in Adults ≥60 Years of Age

Phase 3 randomized, double blind study comparing recombinant MVA-BN-RSV vaccine vs placebo for efficacy and safety in adults >=60 years of age

Being tested
MVA-BN-RSV vaccine, Tris Buffered Saline (TBS)
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.

  • MVA-BN-RSV vaccineBiological

    One injection, suspension for injection, intramuscular use, 0.5mL MVA-BN-RSV virus with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL in a Tris buffer at pH 7.7.

  • Tris Buffered Saline (TBS)Biological

    One injection, solution for injection, intramuscular use, 0.5mL TBS, pH 7.7.

Study groups in NCT05238025
Study groupRoleWhat they receive
Group 1: Single dose MVA-BN-RSVExperimentalSingle dose (Week 0): MVA-BN-RSV virus with a titer of at least 3x10E8 Inf.U/0.5mL (intramuscular vaccination)
Receives: Biological: MVA-BN-RSV vaccine
Group 2: Single dose PlaceboExperimentalSingle dose of TBS (intramuscular injection; 0.5mL)
Receives: Biological: Tris Buffered Saline (TBS)

What is being measured

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

  1. Occurrence of PCR Confirmed RSV-associated LRTD With at Least 3 Symptoms

    RSV-associated lower respiratory tract disease (LRTD) is defined by the presence of clinical evidence of at least 1 sign or symptom of acute respiratory disease (ARD) and at least 3 LRTD signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)

    Measured: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

  2. Occurrence of PCR Confirmed RSV-associated LRTD With at Least 2 Symptoms

    RSV-associated lower respiratory tract disease (LRTD) is defined by the presence of clinical evidence of at least 1 sign or symptom of acute respiratory disease (ARD) and at least 2 LRTD signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)

    Measured: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

Secondary outcomes (13)

  1. Occurrence of PCR Confirmed RSV-associated ARD

    RSV-associated acute respiratory disease (ARD) is defined by the presence of either one ARD symptom lasting for at least 24 hours or two simultaneously occurring ARD symptoms (irrespective of duration), with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)

    Measured: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

  2. Occurrence of Complications Related to PCR-confirmed RSV Disease

    RSV-specific complications include the presence of acute clinical consequences of RSV infection, such as pneumonia (incl. bacterial superinfection), sepsis, positive blood culture, and pneumothorax as well as longer term consequences of RSV-specific symptoms, such as persistent worsening of chronic conditions (e.g. COPD), new onset of persistent medical conditions (e.g. chronically impaired lung function, asthma) or a worsening of the functional status of the patient, e.g. new onset of nursing or assisted living need. RSV disease had to be confirmed by PCR testing.

    Measured: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

  3. Occurrence of Hospitalization Due to Confirmed RSV Disease or Due to Any Complication Related to RSV-confirmed Respiratory Disease

    Hospitalization due to PCR confirmed RSV disease and/or any complication related to PCR-confirmed RSV disease. RSV-specific complications include the presence of acute clinical consequences of RSV infection, such as pneumonia (incl. bacterial superinfection), sepsis, positive blood culture, and pneumothorax as well as longer term consequences of RSV-specific symptoms, such as persistent worsening of chronic conditions (e.g. COPD), new onset of persistent medical conditions (e.g. chronically impaired lung function, asthma) or a worsening of the functional status of the patient, e.g. new onset of nursing or assisted living need. RSV disease had to be confirmed by PCR testing.

    Measured: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

  4. Occurrence of Severe PCR Confirmed RSV-associated LRTD

    Severe RSV-associated LRTD is defined by the presence of clinical evidence of at least 1 sign or symptom of ARD and at least 1 of the following signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR): 1) hypoxemia (oxygen saturation <92% at rest in conjunction with an at least 3% decrease from baseline); 2) respiratory rate >25 breaths/Min; 3) imaging evidence of new onset of bronchitis, bronchiolitis, or pneumonia

    Measured: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

  5. Number of Participants With Serious Adverse Events

    Number and percentage of study participants reporting any serious adverse events at any time during the trial period.

    Measured: From vaccination through study termination, up to 16 months

  6. Number of Participants With Grade 3 or Higher Adverse Events

    Number and percentage of study participants reporting any grade 3 or higher unsolicited adverse events assessed as related to study vaccine

    Measured: Within 29 days after vaccination

  7. Number of Participants With Solicited Local Adverse Events

    Number and percentage of study participants reporting injection site reactions (solicited via electronic diaries) within 8 days after vaccination. The number of participants analyzed and the percentages are based on the subset of participants in the Safety Set that completed the electronic diary.

    Measured: Within 8 days after vaccination

  8. Number of Participants With Solicited Systemic Adverse Events

    Number and percentage of study participants reporting systemic reactions (solicited via electronic diaries) within 8 days after vaccination. The number of participants analyzed and the percentages are based on the subset of participants in the Safety Set that completed the electronic diary.

    Measured: Within 8 days after vaccination

  9. Number of Participants With Unsolicited Adverse Events

    Number and percentage of study participants reporting any unsolicited adverse events within 29 days after vaccination.

    Measured: Within 29 days after vaccination

  10. RSV-specific T-cell Responses

    RSV-specific T-cell responses measured 1 week post vaccination in a subset of the study population

    Measured: 1 week after vaccination

  11. RSV-specific Serum IgG Antibody Titers

    Geometric Mean Titers (GMTs) based on RSV-specific Immunoglobulin G (IgG) Enzyme-linked Immunosorbent Assay (ELISA)

    Measured: 2 weeks after vaccination

  12. RSV-specific Serum Neutralizing Antibody Titers (Subtype A)

    Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Results below the lower limit of quantitation (LLOQ) are included with a value of 1/2 LLOQ

    Measured: 2 weeks after vaccination

  13. RSV-specific Serum Neutralizing Antibody Titers (Subtype B)

    Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype B). Results below the lower limit of quantitation (LLOQ) are included with a value of 1/2 LLOQ

    Measured: 2 weeks after vaccination

Timeline

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

  1. First posted14 Feb 2022
  2. Study start19 Apr 2022
  3. Primary completion29 Jun 2023
  4. Study completion1 Sep 2023

Why it stopped: The trial was terminated after the first RSV season because of the failure to meet the primary outcome measures of vaccine efficacy

Resources

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
20,419 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05238025
Sponsor's protocol ID
RSV-MVA-004
Status last verified
Oct 2024
First submitted
3 Feb 2022
Last updated
31 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jordan E, Jenkins V, Silbernagl G, Chavez MPV, Schmidt D, Schnorfeil F, Schultz S, Chen L, Salgado F, Jacquet JM, Welte T, De Moerlooze L. A multivalent RSV vaccine based on the modified vaccinia Ankara vector shows moderate protection against disease caused by RSV in older adults in a phase 3 clinical study. Vaccine. 2024 Dec 2;42(26):126427. doi: 10.1016/j.vaccine.2024.126427. Epub 2024 Oct 25.

    PubMed 39461302

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MVA-BN-RSV vaccine and Tris Buffered Saline (TBS) in people with Respiratory Syncytial Virus Infections, run by Bavarian Nordic at 120 sites in 2 countries.

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 7 inclusion and 18 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: stopped early, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2024). 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?

Occurrence of PCR Confirmed RSV-associated LRTD With at Least 3 Symptoms (time frame: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months). The study lists 2 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 NCT05238025, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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