RSV vaccine study tests multidose vial safety
NCT ID NCT06473519
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested an RSV vaccine in 453 healthy women aged 18-49. It compared a multidose vial with a preservative to a single-dose vial without one. The goal was to see if both versions are safe and produce a similar immune response. Participants received one shot and were followed for about 6 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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453 people
The number who actually took part.
- Started
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Jun 2024
- Finished
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Sep 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 49 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Healthy nonpregnant, nonbreastfeeding females 18 through 49 years of age at Visit 1 (Day 1). 2. Willing and able to comply with all scheduled visits, investigational plan, lifestyle considerations, and other study procedures. 3. Available for the duration of the study and can be contacted by telephone during study participation. 4. Capable of giving signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the ICD and in the protocol. Exclusion Criteria: 1. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 2. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the vaccines being administered in the study. 3. Immunocompromised participants with known or suspected immunodeficiency, as determined by history, laboratory tests, and/or physical examination. 4. History or active autoimmune disease, including but not limited to systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1). 5. Bleeding diathesis or any condition that would, in the opinion of the investigator, contraindicate intramuscular injection. 6. Previous vaccination with any licensed or investigational RSV vaccine, or planned receipt of a nonstudy RSV vaccine throughout the study. 7. Receipt of chronic systemic treatment with immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before enrollment through conclusion of the study. 8. Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration or planned receipt throughout the study. 9. Current alcohol abuse or illicit drug use. 10. Individuals who are pregnant or breastfeeding. 11. Participation in other studies involving an investigational product within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable. 12. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
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Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
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Clinical Research Prime Rexburg
Rexburg, Idaho, 83440, United States
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Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, 78229, United States
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Headlands Research - Detroit
Southfield, Michigan, 48034, United States
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Qps-Mra, Llc
South Miami, Florida, 33143, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an inhaled drug tame RSV symptoms in adults?
- Can a new vaccine shield adults from RSV?
- Can a booster RSV shot shield the immunocompromised?
- One shot, two viruses? new mRNA vaccine targets RSV and hMPV
- New mRNA vaccine aims to shield against RSV