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Respiratory Syncytial Virus InfectionsNCT07279298

Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV in Children Under 6 Months in Bogotá

An observational study of Respiratory Syncytial Virus Infections and Severe Acute Respiratory Infection, run by Bogotá District Health Secretariat at 1 site in Colombia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study aims to evaluate the real-world effectiveness of two preventive immunization strategies against Respiratory Syncytial Virus (RSV)-associated severe acute respiratory infection in infants less than six months of age in Bogotá, Colombia. Read more about this study

Who is it for?
Ages 1 day to 180 days
What is being tested?
RSVpreF vaccine (Abrysvo) and Nirsevimab (Beyfortus) or unexposed
Type of treatment
Vaccines
How many people
1,097 participants
Where
1 siteColombia
Study dates
1 Jan 2026to 31 Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 1 day to 180 days
  • All sexes
  • No healthy volunteers
  • Child

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Secretaria distrital de Salud

    Bogotá

Other trials in Colombia

About this study

Official title: Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection Associated With Respiratory Syncytial Virus-RSV- in Infants Under 6 Months of Age in Bogotá: a Case-control Study With a Negative Test Design

This study aims to evaluate the real-world effectiveness of two preventive immunization strategies against Respiratory Syncytial Virus (RSV)-associated severe acute respiratory infection in infants less than six months of age in Bogotá, Colombia. The strategies include maternal vaccination with RSVpreF administered between 28 and 36 weeks of gestation and neonatal immunization with nirsevimab for infants born to mothers who did not receive RSVpreF during pregnancy. Using a test-negative case-control design embedded in the city's sentinel surveillance system, infants hospitalized for severe respiratory infection will be systematically tested for RSV. Comparative vaccine effectiveness will be estimated to determine the impact of maternal RSV vaccination and neonatal monoclonal antibody immunization on RSV-associated hospitalizations, intensive care admissions, and mortality. The study will generate real-world evidence to inform local and regional public health decisions and guide the implementation of cost-effective hybrid immunization strategies against RSV in middle-income settings.

Read the detailed description

Respiratory Syncytial Virus (RSV) is a leading cause of hospitalization, morbidity, and mortality among infants, particularly during the first months of life. In 2026, Bogotá will introduce a hybrid immunization strategy combining maternal vaccination with RSVpreF during weeks 28-36 of pregnancy and neonatal immunization with nirsevimab for infants whose mothers were not vaccinated. Despite evidence from clinical trials, real-world comparative effectiveness data for hybrid RSV immunization strategies in Latin America remain limited.

This observational study will employ a prospective test-negative case-control design using the city's sentinel surveillance network for severe respiratory infection. All eligible infants under six months hospitalized for severe acute respiratory infection will undergo laboratory testing for RSV. Cases will be defined as RSV-positive infants, and controls as RSV-negative infants. Exposure to RSVpreF or nirsevimab will be validated through Bogotá's immunization registry.

Primary outcomes include laboratory-confirmed RSV-associated hospitalization, admission to intensive care, and death within the first six months of life. Multilevel logistic regression models adjusted for relevant confounders will be used to estimate vaccine effectiveness. Findings will provide rigorous real-world evidence to support policy decisions, optimize resource allocation, and guide the expansion of hybrid RSV prevention strategies in Colombia and other middle-income countries.

Being tested
RSVpreF vaccine (Abrysvo) and Nirsevimab (Beyfortus) or unexposed
Medical subject headings
Respiratory Syncytial Virus Infections, Bronchiolitis, Viral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RSVpreF vaccine (Abrysvo) and Nirsevimab (Beyfortus) or unexposedBiological

    Maternal vaccination administered between 28 and 36 weeks of gestation and Single-dose monoclonal antibody administered to newborns whose mothers did not receive effective RSVpreF vaccination or unexposed

Study groups in NCT07279298
Study groupRoleWhat they receive
Case (RSV-positive test result)An infant younger than six months of age, resident in Bogotá, hospitalized for severe acute respiratory infection (SARI) and meeting the district operational criteria for SARI, who has a respiratory specimen collected within ≤48 hours of hospital admission (or repeated within 24-48 hours if the first result was negative) that tests positive for Respiratory Syncytial Virus (RSV) by RT-PCR or a validated antigen assay. Only infants born ≥5 weeks after the start of the maternal RSVpreF vaccination campaign are eligible for inclusion.
Receives: Biological: RSVpreF vaccine (Abrysvo) and Nirsevimab (Beyfortus) or unexposed
Control (RSV-negative test result)An infant younger than six months of age, resident in Bogotá, hospitalized for severe acute respiratory infection (SARI) and meeting the same operational criteria as cases, who has a respiratory specimen collected within ≤48 hours of admission (or repeated within 24-48 hours if needed) that tests negative for RSV. Controls may test positive for other respiratory viruses or bacteria. Only infants born ≥5 weeks after the start of the maternal RSVpreF vaccination campaign are eligible.
Receives: Biological: RSVpreF vaccine (Abrysvo) and Nirsevimab (Beyfortus) or unexposed

What is being measured

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

  1. Hospitalization for RSV-associated Severe Acute Respiratory Infection

    Proportion of infants hospitalized with laboratory-confirmed Respiratory Syncytial Virus (RSV)-associated severe acute respiratory infection, defined as meeting the district operational criteria for SARI and testing positive for RSV by RT-PCR or validated antigen testing within ≤48 hours of hospital admission. The measure compares the likelihood of RSV-related hospitalization among infants exposed to maternal RSVpreF vaccination, neonatal nirsevimab administration, or no RSV-specific immunization.

    Measured: From birth up to 6 months of age (≤180 days of life)

Timeline

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

  1. First posted12 Dec 2025
  2. Study start1 Jan 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
1,097 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07279298
Sponsor's protocol ID
SDSCTI20250014
Status last verified
Aug 2026
First submitted
1 Dec 2025
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Coultas JA, Smyth R, Openshaw PJ. Respiratory syncytial virus (RSV): a scourge from infancy to old age. Thorax. 2019 Oct;74(10):986-993. doi: 10.1136/thoraxjnl-2018-212212. Epub 2019 Aug 5.

    PubMed 31383776

  • Mazur NI, Caballero MT, Nunes MC. Severe respiratory syncytial virus infection in children: burden, management, and emerging therapies. Lancet. 2024 Sep 21;404(10458):1143-1156. doi: 10.1016/S0140-6736(24)01716-1. Epub 2024 Sep 9.

    PubMed 39265587

  • Wang X, Li Y, Shi T, Bont LJ, Chu HY, Zar HJ, Wahi-Singh B, Ma Y, Cong B, Sharland E, Riley RD, Deng J, Figueras-Aloy J, Heikkinen T, Jones MH, Liese JG, Markic J, Mejias A, Nunes MC, Resch B, Satav A, Yeo KT, Simoes EAF, Nair H; Respiratory Virus Global Epidemiology Network; RESCEU investigators. Global disease burden of and risk factors for acute lower respiratory infections caused by respiratory syncytial virus in preterm infants and young children in 2019: a systematic review and meta-analysis of aggregated and individual participant data. Lancet. 2024 Mar 30;403(10433):1241-1253. doi: 10.1016/S0140-6736(24)00138-7. Epub 2024 Feb 14.

    PubMed 38367641

  • Everard ML. The relationship between respiratory syncytial virus infections and the development of wheezing and asthma in children. Curr Opin Allergy Clin Immunol. 2006 Feb;6(1):56-61. doi: 10.1097/01.all.0000200506.62048.06.

    PubMed 16505613

  • Mezarina Esquivel, Hugo Antonio, Rojas Medina, Aurea Rosa, Bada Mancilla, Carlos Alfonso, Castañeda Campozano, Ruth Elizabeth, & Carhuancho Aguilar, José Raphael. (2016). Características clínicas y epidemiológicas de la infección respiratoria aguda grave por virus sincitial respiratorio en menores de 5 años. Horizonte Médico (Lima), 16(3), 6-11.

  • Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, Abraham J, Adair T, Aggarwal R, Ahn SY, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Barker-Collo S, Bartels DH, Bell ML, Benjamin EJ, Bennett D, Bhalla K, Bikbov B, Bin Abdulhak A, Birbeck G, Blyth F, Bolliger I, Boufous S, Bucello C, Burch M, Burney P, Carapetis J, Chen H, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahodwala N, De Leo D, Degenhardt L, Delossantos A, Denenberg J, Des Jarlais DC, Dharmaratne SD, Dorsey ER, Driscoll T, Duber H, Ebel B, Erwin PJ, Espindola P, Ezzati M, Feigin V, Flaxman AD, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabriel SE, Gakidou E, Gaspari F, Gillum RF, Gonzalez-Medina D, Halasa YA, Haring D, Harrison JE, Havmoeller R, Hay RJ, Hoen B, Hotez PJ, Hoy D, Jacobsen KH, James SL, Jasrasaria R, Jayaraman S, Johns N, Karthikeyan G, Kassebaum N, Keren A, Khoo JP, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lipnick M, Lipshultz SE, Ohno SL, Mabweijano J, MacIntyre MF, Mallinger L, March L, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGrath J, Mensah GA, Merriman TR, Michaud C, Miller M, Miller TR, Mock C, Mocumbi AO, Mokdad AA, Moran A, Mulholland K, Nair MN, Naldi L, Narayan KM, Nasseri K, Norman P, O'Donnell M, Omer SB, Ortblad K, Osborne R, Ozgediz D, Pahari B, Pandian JD, Rivero AP, Padilla RP, Perez-Ruiz F, Perico N, Phillips D, Pierce K, Pope CA 3rd, Porrini E, Pourmalek F, Raju M, Ranganathan D, Rehm JT, Rein DB, Remuzzi G, Rivara FP, Roberts T, De Leon FR, Rosenfeld LC, Rushton L, Sacco RL, Salomon JA, Sampson U, Sanman E, Schwebel DC, Segui-Gomez M, Shepard DS, Singh D, Singleton J, Sliwa K, Smith E, Steer A, Taylor JA, Thomas B, Tleyjeh IM, Towbin JA, Truelsen T, Undurraga EA, Venketasubramanian N, Vijayakumar L, Vos T, Wagner GR, Wang M, Wang W, Watt K, Weinstock MA, Weintraub R, Wilkinson JD, Woolf AD, Wulf S, Yeh PH, Yip P, Zabetian A, Zheng ZJ, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2095-128. doi: 10.1016/S0140-6736(12)61728-0.

    PubMed 23245604

  • Instituto Nacional de Salud (Colombia). Protocolo de vigilancia en salud pública de infección respiratoria aguda. Versión 09 [Internet]. 2024 [citado 2025 Jul 31]. Disponible en: https://doi.org/10.33610/CBNQ7644

  • Hyrkas-Palmu H, Hugg TT, Jaakkola JJK, Ikaheimo TM. The influence of weather and urban environment characteristics on upper respiratory tract infections: a systematic review. Front Public Health. 2025 Feb 10;13:1487125. doi: 10.3389/fpubh.2025.1487125. eCollection 2025.

    PubMed 39995623

  • Deng S, Cong B, Edgoose M, De Wit F, Nair H, Li Y. Risk factors for respiratory syncytial virus-associated acute lower respiratory infection in children under 5 years: An updated systematic review and meta-analysis. Int J Infect Dis. 2024 Sep;146:107125. doi: 10.1016/j.ijid.2024.107125. Epub 2024 Jun 28.

    PubMed 38945430

  • Galvis, Clara Esperanza, Troncoso, Gloria, Agudelo-Pérez, Sergio, Romero, Héctor, Parra Buitrago, Andrea, & Gutiérrez, Iván Felipe. (2024). Consenso de expertos sobre las recomendaciones de profilaxis con palivizumab para el Virus Sincitial Respiratorio en niños en Colombia. Infectio, 28(3), 180-191. Epub September 12, 2024.https://doi.org/10.22354/24223794.1189

  • Novoa Pizarro JM, Lindemann Tappert BC, Luchsinger Farias VR, Vargas Munita SL. [Prevention of respiratory syncytial virus infection in infants. What has been done and where are we today?]. Andes Pediatr. 2023 Dec;94(6):672-680. doi: 10.32641/andespediatr.v94i6.4861. Spanish.

    PubMed 38329302

  • Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Brooks D, Grenham A, Wahlby Hamren U, Mankad VS, Ren P, Takas T, Abram ME, Leach A, Griffin MP, Villafana T; MELODY Study Group. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275.

    PubMed 35235726

  • Kampmann, B., et al. (2023).

  • Torres JP, Saure D, Goic M, Thraves C, Pacheco J, Burgos J, Trigo N, Del Solar F, Neira I, Diaz G, O'Ryan M, Basso LJ. Effectiveness and impact of nirsevimab in Chile during the first season of a national immunisation strategy against RSV (NIRSE-CL): a retrospective observational study. Lancet Infect Dis. 2025 Nov;25(11):1189-1198. doi: 10.1016/S1473-3099(25)00233-6. Epub 2025 Jun 10.

    PubMed 40513593

  • Perez Marc G, Vizzotti C, Fell DB, Di Nunzio L, Olszevicki S, Mankiewicz SW, Braem V, Rearte R, Atwell JE, Bianchi A, Fuentes N, Zadoff R, Vecchio G, Gabriela Abalos M, Fan R, Del Carmen Morales G, Gessner BD, Jodar L, Libster R, Rearte A; BERNI study working group. Real-world effectiveness of RSVpreF vaccination during pregnancy against RSV-associated lower respiratory tract disease leading to hospitalisation in infants during the 2024 RSV season in Argentina (BERNI study): a multicentre, retrospective, test-negative, case-control study. Lancet Infect Dis. 2025 Sep;25(9):1044-1054. doi: 10.1016/S1473-3099(25)00156-2. Epub 2025 May 5.

    PubMed 40339585

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Syncytial Virus Infections and Severe Acute Respiratory Infection, run by Bogotá District Health Secretariat at 1 site in Colombia.

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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Hospitalization for RSV-associated Severe Acute Respiratory Infection (time frame: From birth up to 6 months of age (≤180 days of life)). 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 NCT07279298, which also lists 15 linked publications.

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 6 Aug 2026.

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Clinical Trial NCT07279298 | AzTrials