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RSV InfectionNIRSE-GALNCT06180993

Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization

An observational study of RSV Infection, run by Federico Martinón Torres at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A longitudinal observational study based on routinely collected data on hospital and health care use for RSV infections will be undertaken. The Galician public health registries will be used for data collection including baseline information and follow-up data. Read more about this study

Who is it for?
Ages 1 day to 24 months
Conditions the study is for
RSV Infection
What is being tested?
Nirsevimab
How many people
42,000 participants
Where
1 siteSpain
Study dates
25 Sep 2023to 31 Oct 2026
Phase
Observational
Are there results?
None posted in the registry

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 24 months
  • All sexes
  • Child

Study population: All children born between April 1st, 2023 and March 1st, 2026, both dates included, in Galicia (North- west Spain)

Who may be able to join

  • Subjects born in Galicia from April 1st, 2023 and March 1st, 2026

Who cannot join

  • No specific criteria has been reported

Trial locations and contacts

1 site in 1 country.

Spain1 site, 1 recruiting

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruña, 15707

    Federico Martinón Torres, PhD, MD, +34981955373, federico.martinon.torres@sergas.es

    Recruiting

Other trials in Spain

About this study

A longitudinal observational study based on routinely collected data on hospital and health care use for RSV infections will be undertaken. The Galician public health registries will be used for data collection including baseline information and follow-up data. Historical data will be retrieved for comparison purposes. The study aims to observe and analyze data from all the eligible children in Galicia for nirsevimab treatment. The number of eligible children is expected to be approximately 14,000 per each RSV season.

Read the detailed description

The purpose of this study is to evaluate the impact of nirsevimab in preventing RSV in healthy infants and high-risk children less than 24 months of age at the start of RSV season in Galicia.

The target population to receive nirsevimab is around 14,000 subjects including all healthy newborns during the RSV season, those < 6 months at the start of the season, as well as those < 24 months with comorbidities at the start of the season. Nirsevimab will be administered as part of the immunization program of Galicia and following the implementation plan designed by the Public Health authorities, using the vaccination facilities of the Galician system, i.e., hospitals and primary care centres. Appointments for administration and registration of administered doses will be performed as per usual immunization protocols. The expected coverage with nirsevimab in the target population is expected to be high (>80%).

RSV testing is routinely performed in the hospital and emergency department settings. The Galician Regional Surveillance Information System will retrieve all the existing information of the different electronic databases for new RSV cases detected in Galicia, including hospitalization, primary care, drug administration and immunization. RSV case ascertainment and classification will be per- formed by a specialized clinical team according to pre-established definitions.

Conditions
RSV Infection
Being tested
Nirsevimab
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.

  • NirsevimabBiological

    Also called Beyfortus

    Nirsevimab will be administered administered in a single dose at birth for birth cohort and at the beginning of the campaign for the other cohorts under study

Study groups in NCT06180993
Study groupRoleWhat they receive
At birth cohortSubjects born from September 25, 2023 to March 31 in each of the 3 RSV seasons under study 2023/2024, 2024/2025, 2025/2026
Receives: Biological: Nirsevimab
Risk CohortSubjects with risk factors born between 1 October 2021 and 31 March 2023
Receives: Biological: Nirsevimab
Catch-up cohortSubjects born between 1 April and 24 September 2023
Receives: Biological: Nirsevimab

What is being measured

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

  1. Incidence of RSV LRTI hospitalization through the RSV season

    Measured: 8 months (from October to May)

Timeline

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

  1. First posted26 Dec 2023
  2. Study start25 Sep 2023
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion31 Oct 2026 (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
Other
Time perspective
Prospective
Enrolment
42,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06180993
Sponsor's protocol ID
NIRSE-GAL
Acronym
NIRSE-GAL
Status last verified
Dec 2023
First submitted
8 Dec 2023
Last updated
26 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Razzini JL, Gine-Vazquez I, Jin J, Santiago-Perez MI, Perez-Martinez O, Otero-Barros MT, Suarez-Gaiche N, Kramer R, Platero-Alonso L, Alvarez-Gil RM, Ces-Ozores OM, Nartallo-Penas V, Miras-Carballal S, Pineiro-Sotelo M, Gonzalez-Perez JM, Rodriguez-Tenreiro-Sanchez C, Manzanares-Casteleiro A, Dacosta-Urbieta A, Alvarez-Smith C, Rivero-Calle I, Salas A, Duran-Parrondo C, Mallah N, Martinon-Torres F. Impact of universal nirsevimab prophylaxis in infants on hospital and primary care outcomes across two respiratory syncytial virus seasons in Galicia, Spain (NIRSE-GAL): a population-based prospective observational study. Lancet Infect Dis. 2026 May;26(5):522-534. doi: 10.1016/S1473-3099(25)00742-X. Epub 2026 Jan 12.

    PubMed 41539320

  • Manzanares A, Pardo-Seco J, Rivero-Calle I, Dacosta-Urbieta A, Mallah N, Santiago-Perez MI, Perez-Martinez O, Otero-Barros MT, Suarez-Gaiche N, Kramer R, Jin J, Platero-Alonso L, Alvarez-Gil RM, Ces-Ozores OM, Nartallo-Penas V, Miras-Carballal S, Pineiro-Sotelo M, Gonzalez-Perez JM, Rodriguez-Tenreiro-Sanchez C, Salas A, Duran-Parrondo C, Martinon-Torres F. Respiratory syncytial virus-related lower respiratory tract infection hospitalizations in infants receiving nirsevimab in Galicia (Spain): the NIRSE-GAL study. Eur J Pediatr. 2025 May 2;184(5):321. doi: 10.1007/s00431-025-06151-3.

    PubMed 40314706

  • Mallah N, Ares-Gomez S, Pardo-Seco J, Malvar-Pintos A, Santiago-Perez MI, Perez-Martinez O, Otero-Barros MT, Suarez-Gaiche N, Kramer R, Jin J, Platero-Alonso L, Alvarez-Gil RM, Ces-Ozores OM, Nartallo-Penas V, Miras-Carballal S, Pineiro-Sotelo M, Gonzalez-Perez JM, Rodriguez-Tenreiro C, Rivero-Calle I, Salas A, Duran-Parrondo C, Martinon-Torres F. Assessment of effectiveness and impact of universal prophylaxis with nirsevimab for prevention of hospitalizations due to respiratory syncytial virus in infants. The NIRSE-GAL study protocol. Hum Vaccin Immunother. 2024 Dec 31;20(1):2348135. doi: 10.1080/21645515.2024.2348135. Epub 2024 May 13.

    PubMed 38738683

  • Ares-Gomez S, Mallah N, Santiago-Perez MI, Pardo-Seco J, Perez-Martinez O, Otero-Barros MT, Suarez-Gaiche N, Kramer R, Jin J, Platero-Alonso L, Alvarez-Gil RM, Ces-Ozores OM, Nartallo-Penas V, Miras-Carballal S, Pineiro-Sotelo M, Malvar-Pintos A, Gonzalez-Perez JM, Rodriguez-Tenreiro-Sanchez C, Rivero-Calle I, Salas A, Duran-Parrondo C, Martinon-Torres F; NIRSE-GAL study group. Effectiveness and impact of universal prophylaxis with nirsevimab in infants against hospitalisation for respiratory syncytial virus in Galicia, Spain: initial results of a population-based longitudinal study. Lancet Infect Dis. 2024 Aug;24(8):817-828. doi: 10.1016/S1473-3099(24)00215-9. Epub 2024 Apr 30.

    PubMed 38701823

Questions about this trial

What is this clinical trial studying?

An observational study of RSV Infection, run by Federico Martinón Torres at 1 site in Spain.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Dec 2023. 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 Spain. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of RSV LRTI hospitalization through the RSV season (time frame: 8 months (from October to May)). 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 NCT06180993, which also lists 4 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 26 Dec 2023.

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