New RSV prevention strategy for infants under study in bogotá
NCT ID NCT07279298
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study will check how well two RSV prevention methods work in real life: a vaccine given to pregnant women and an antibody shot given to newborns. Researchers will follow about 1,100 infants under 6 months old who are hospitalized with severe respiratory infections in Bogotá, Colombia. The goal is to see if these immunizations reduce severe RSV cases and hospital stays.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RSVpreF vaccine (Abrysvo) and nirsevimab (Beyfortus)
- What this could lead to
- If effective, these immunizations could prevent severe RSV infections in young infants, reducing hospitalizations and deaths.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be less certain. Effectiveness may vary in real-world settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 1,097 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2026
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Infants younger than six months residing in Bogotá, Colombia, hospitalized for severe acute respiratory infection in sentinel hospitals and tested for RSV within 48 hours of admission. The population includes infants exposed to maternal RSVpreF vaccination, neonatal nirsevimab, or neither intervention. Extremely preterm infants (≤32 weeks gestation) and those hospitalized for non-respiratory conditions are excluded.
- Ages
-
1 day to 180 days
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: * Age: Infants younger than 6 months at the time of hospital admission. * Residence: Maternal residence in Bogotá, Colombia, verified through clinical record, identification document, or health system registry. * Clinical Condition: Hospitalization due to severe acute respiratory infection (SARI) meeting the district operational definition (presence of fever, cough, and/or signs of respiratory distress, requiring inpatient management). * Laboratory Testing: Respiratory specimen collected and tested for RSV by RT-PCR or validated antigen test within ≤48 hours of hospital admission, or repeated within 24-48 hours if initial test is negative. * Exposure Eligibility Window: Infant born ≥5 weeks after the start of the RSVpreF maternal vaccination campaign in Bogotá, ensuring opportunity for maternal immunization. Exclusion Criteria: * Prematurity: Infants born at ≤32 weeks of gestation. * Healthcare-associated respiratory infection: Symptom onset \>48 hours after hospital admission for another condition. * Non-respiratory hospital admission: Primary reason for hospitalization unrelated to respiratory disease (e.g., trauma, elective surgery). * Vaccination status unverifiable: Inability to confirm maternal RSVpreF vaccination status after reasonable attempts to verify through registry, vaccination card, or prenatal documentation. * Duplicate episodes: Readmission for the same respiratory episode ≤14 days after discharge (only the first episode will be included). * Delayed sampling: First respiratory sample obtained \>48-72 hours after initial admission to the health system. * Lethal congenital conditions: Congenital or genetic disorders incompatible with life or that substantially alter the expected clinical course. * Concurrent interventional study participation: Enrollment in another clinical trial that may affect respiratory outcomes. * Inability to establish mother-infant linkage due to adoption, loss of parental custody, or absence of biological maternal records.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bronchiolitis, viral are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Secretaria distrital de Salud
Bogotá, Colombia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- When the immune system Can't fight back: tracking three respiratory viruses
- A 5-Minute ultrasound could reveal how sick a Baby's lungs really are
- Nasal spray vaccine aims to shield children from RSV
- Inhaled interferon could be new weapon against severe RSV in young children
- New oral pill aims to fight RSV in adults
- New antiviral pill aims to shorten RSV symptoms in vulnerable adults