Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life

NCT ID: NCT05437510

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 8057 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-08
• Study Completion Date: 2025-04-09

Brief Summary

The purpose of this study was to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection (LRTI) caused by confirmed RSV infection (henceforth referred to as RSV LRTI hospitalizations) in all infants under 12 months of age who were not eligible to receive palivizumab.

The visit frequency was 1 in-person dosing/randomization visit, with monthly safety follow-up electronic contacts through the first 6 months post dosing/randomization for all participants. The study also included a 12-month (Day 366) follow-up telephone call. The D366 follow-up telephone call was the final follow-up telephone call for France, Germany and UK non-reconsented participants. The study included an 18-month (D546) and a 24-month (D731, final telephone call) follow-up telephone call for UK reconsented participants.

Detailed Description

12 months post-dosing/randomization for France, Germany and UK non-reconsented participants, 24 months post-dosing/randomization for UK reconsented participants. D01 was the day of randomization (both study groups) and immunization (nirsevimab group).

Conditions

RSV Immunization; Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Nirsevimab

1 intramuscular injection at Day 01

Group Type: EXPERIMENTAL

Nirsevimab

Intervention Type: BIOLOGICAL

Pharmaceutical Form: Solution for Injection Route of Administration: Intramuscular

No preventive intervention for RSV

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nirsevimab

Pharmaceutical Form: Solution for Injection Route of Administration: Intramuscular

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Born at ≥ 29 weeks gestational age and aged 0 to 12 months (calendar age), who entered their first RSV season on the day of inclusion in the study (D01)
• Informed consent form was signed and dated by the parent(s) or other LAR(s) (and by an independent witness if required by local regulations)
• Participant and parent/LAR were able to attend the scheduled visit and to comply with all study procedures

Exclusion Criteria

• Participants were not eligible for the study if any of the following criteria are met:
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• Active confirmed RSV infection at the time of dosing/randomization
• Active LRTI at the time of dosing/randomization
• Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances
• Laboratory confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent/LAR, contraindicating intramuscular injection
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
• Any condition that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
• Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration.
• A prospective participant was not included in the study until the condition has resolved or the febrile event has subsided
• Mother of the infant participant was administered an RSV vaccine during her pregnancy with the infant participant
• Receipt of any monoclonal antibody by the infant participant
• Receipt of immune globulins, blood or blood-derived products in the past 3 months by the infant participant
• Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
• Eligible to receive palivizumab at time of inclusion (as per local guidelines)
• In an emergency setting or hospitalized involuntarily
• Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

The above information were not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site 2500041

Aix-en-Provence, , France

Investigational Site 2500002

Amiens, , France

Investigational Site Number: 2500014

Bordeaux, , France

Investigational Site 2500007

Brest, , France

Investigational Site Number: 2500038

Brest, , France

Investigational Site Number: 2500045

Brest, , France

Investigational Site Number: 2500019

Bron, , France

Investigational Site Number: 2500043

Brumath, , France

Investigational Site Number: 2500001

Caen, , France

Investigational Site Number: 2500032

Chambéry, , France

Investigational Site Number: 2500057

Clamart, , France

Investigational Site Number: 2500065

Clamart, , France

Investigational Site Number: 2500029

Combs-la-Ville, , France

Investigational Site Number: 2500013

Corbeil-Essonnes, , France

Investigational Site Number: 2500054

Creil, , France

Investigational Site Number: 2500006

Créteil, , France

Investigational Site Number: 2500039

Créteil, , France

Investigational Site Number: 2500023

Dijon, , France

Investigational Site Number: 2500069

Draguignan, , France

Investigational Site 2500008

Essey-lès-Nancy, , France

Investigational Site 2500030

Étampes, , France

Investigational Site Number: 2500058

Frouard, , France

Investigational Site Number: 2500064

Grasse, , France

Investigational Site Number: 2500004

Grenoble, , France

Investigational Site Number: 2500027

Héry-sur-Alby, , France

Investigational Site Number: 2500060

Huningue, , France

Investigational Site 2500059

La Garenne-Colombes, , France

Investigational Site Number: 2500071

La Teste-de-Buch, , France

Investigational Site Number: 2500034

Le Kremlin-Bicêtre, , France

Investigational Site Number: 2500072

Libourne, , France

Investigational Site 2500046

Lille, , France

Investigational Site 2500005

Lille, , France

Investigational Site Number: 2500012

Limoges, , France

Investigational Site Number: 2500037

Longjumeau, , France

Investigational Site 2500021

Maromme, , France

Investigational Site Number: 2500003

Marseille, , France

Investigational Site Number: 2500073

Marseille, , France

Investigational Site Number: 2500068

Mont-de-Marsan, , France

Investigational Site Number: 2500066

Mont-Saint-Aignan, , France

Investigational Site Number: 2500067

Montpellier, , France

Investigational Site Number: 2500077

Morlaix, , France

Investigational Site Number: 2500047

Nantes, , France

Investigational Site Number: 2500055

Nice, , France

Investigational Site Number: 2500009

Nice, , France

Investigational Site Number: 2500040

Nogent-sur-Marne, , France

Investigational Site Number: 2500022

Orléans, , France

Investigational Site Number: 2500050

Orléans, , France

Investigational Site Number: 2500024

Paris, , France

Investigational Site Number: 2500010

Paris, , France

Investigational Site Number: 2500075

Paris, , France

Investigational Site Number: 2500051

Paris, , France

Investigational Site Number:

Pau, , France

Investigational Site Number: 2500018

Poissy, , France

Investigational Site Number: 2500026

Puteaux, , France

Investigational Site Number: 2500042

Rouen, , France

Investigational Site Number: 2500078

Saint-Doulchard, , France

Investigational Site Number: 2500074

Saint-Julien-en-Genevois, , France

Investigational Site Number: 2500044

Saint-Maur-des-Fossés, , France

Investigational Site 2500020

Saint-Sébastien-sur-Loire, , France

Investigational Site Number: 2500052

Saverne, , France

Investigational Site Number: 2500015

Toulouse, , France

Investigational Site Number: 2500035

Tours, , France

Investigational Site Number: 2500049

Vendenheim, , France

Investigational Site Number: 2500011

Villeneuve-lès-Avignon, , France

Investigational Site Number: 2500063

Villeneuve-Saint-Georges, , France

Investigational Site 2500028

Vincennes, , France

Investigational Site Number: 2760036

Augsburg, , Germany

Investigational Site Number: 2760017

Bad Wildungen, , Germany

Investigational Site Number: 2760099

Berlin, , Germany

Investigational Site Number: 2760076

Berlin, , Germany

Investigational Site Number: 2760056

Berlin, , Germany

Investigational Site Number: 2760050

Bielefeld, , Germany

Investigational Site Number: 2760064

Bocholt, , Germany

Investigational Site Number: 2760098

Bochum, , Germany

Investigational Site Number: 2760040

Bonn, , Germany

Investigational Site Number: 2760025

Bramsche, , Germany

Investigational Site Number: 2760018

Braunschweig, , Germany

Investigational Site Number: 2760051

Detmold, , Germany

Investigational Site Number: 2760085

Dortmund, , Germany

Investigational Site Number: 2760059

Düsseldorf, , Germany

Investigational Site Number: 2760101

Düsseldorf, , Germany

Investigational Site Number: 2760081

Eckental, , Germany

Investigational Site Number: 2760045

Erfurt, , Germany

Investigational Site Number: 2760047

Forchheim, , Germany

Investigational Site Number: 2760030

Frankfurt (Oder), , Germany

Investigational Site Number: 2760015

Freiburg I. Breisgau, , Germany

Investigational Site Number: 2760079

Gera, , Germany

Investigational Site Number: 2760005

Gilching, , Germany

Investigational Site Number: 2760016

Göttingen, , Germany

Investigational Site Number: 2760060

Göttingen, , Germany

Investigational Site Number: 2760033

Hamburg, , Germany

Investigational Site Number: 2760057

Hamburg, , Germany

Investigational Site Number: 2760096

Hamburg, , Germany

Investigational Site Number: 2760032

Hamm, , Germany

Investigational Site Number: 2760007

Hanover, , Germany

Investigational Site Number: 2760049

Heidelberg, , Germany

Investigational Site Number: 2760008

Herford, , Germany

Investigational Site 2760010

Hürth, , Germany

Investigational Site Number: 2760091

Hürth, , Germany

Investigational Site Number: 2760035

Itzehoe, , Germany

Investigational Site Number: 2760095

Kassel, , Germany

Investigational Site Number: 2760084

Kirchen, , Germany

Investigational Site Number: 2760065

Krefeld, , Germany

Investigational Site Number: 2760020

Leipzig, , Germany

Investigational Site Number: 2760013

Leipzig, , Germany

Investigational Site 2760006

Mainz, , Germany

Investigational Site Number: 2760086

Mainz, , Germany

Investigational Site Number: 2760014

Mannheim, , Germany

Investigational Site Number: 2760023

Mönchengladbach, , Germany

Investigational Site Number: 2760054

Mönchengladbach, , Germany

Investigational Site Number: 2760094

München, , Germany

Investigational Site Number: 2760034

München, , Germany

Investigational Site Number: 2760038

München, , Germany

Investigational Site Number: 2760019

München, , Germany

Investigational Site Number: 2760046

München, , Germany

Investigational Site Number: 2760061

München, , Germany

Investigational Site Number: 2760083

Münster, , Germany

Investigational Site Number: 2760027

Neuss, , Germany

Investigational Site Number: 2760004

Niedernhausen, , Germany

Investigational Site Number: 2760071

Passau, , Germany

Investigational Site Number: 2760001

Regensburg, , Germany

Investigational Site Number: 2760003

Rosenheim, , Germany

Investigational Site Number: 2760062

Rüsselsheim A. Main, , Germany

Investigational Site Number: 2760092

Saarbrücken, , Germany

Investigational Site 2760029

Schönau, , Germany

Investigational Site Number: 2760044

Schweigen, , Germany

Investigational Site Number: 2760069

Suhl, , Germany

Investigational Site Number: 2760067

Tuttlingen, , Germany

Investigational Site Number: 2760043

Weiden, , Germany

Investigational Site Number: 2760002

Wesel, , Germany

Investigational Site Number: 2760093

Wolfsburg, , Germany

Investigational Site Number: 2760028

Wolfsburg, , Germany

Investigational Site Number: 8260007

Amersham, , United Kingdom

Investigational Site Number: 8260096

Ashford, , United Kingdom

Investigational Site Number: 8260053

Banbury, , United Kingdom

Investigational Site Number: 8260057

Barnet, , United Kingdom

Investigational Site Number: 8260004

Barnsley, , United Kingdom

Investigational Site Number: 8260107

Basildon, , United Kingdom

Investigational Site Number: 8260110

Basingstoke, , United Kingdom

Investigational Site Number: 8260067

Bath, , United Kingdom

Investigational Site 8260009

Bath, , United Kingdom

Investigational Site Number: 8260100

Bebington, , United Kingdom

Investigational Site Number: 8260073

Belfast, , United Kingdom

Investigational Site Number: 8260095

Bicester, , United Kingdom

Investigational Site Number: 8260029

Blackburn, , United Kingdom

Investigational Site Number: 8260108

Bollington, , United Kingdom

Investigational Site Number: 8260085

Bolton, , United Kingdom

Investigational Site Number: 8260013

Bradford, , United Kingdom

Investigational Site Number: 8260112

Brierley Hill, , United Kingdom

Investigational Site Number: 8260058

Brighton, , United Kingdom

Investigational Site Number: 8260008

Bristol, , United Kingdom

Investigational Site Number: 8260019

Bristol, , United Kingdom

Investigational Site 8260046

Bristol, , United Kingdom

Investigational Site Number: 8260063

Bury St Edmunds, , United Kingdom

Investigational Site Number: 8260040

Cardiff, , United Kingdom

Investigational Site Number: 8260062

Cheltenham, , United Kingdom

Investigational Site Number: 8260066

Chertsey, , United Kingdom

Investigational Site Number: 8260061

Chippenham, , United Kingdom

Investigational Site Number: 8260036

Corby, , United Kingdom

Investigational Site Number: 8260054

Cottingham, , United Kingdom

Investigational Site Number: 8260035

Darlington, , United Kingdom

Investigational Site Number: 8260037

Darlington, , United Kingdom

Investigational Site Number: 8260041

Darlington, , United Kingdom

Investigational Site 8260064

Dorchester, , United Kingdom

Investigational Site Number: 8260087

Dundee, , United Kingdom

Investigational Site 8260018

Exeter, , United Kingdom

Investigational Site Number: 8260020

Gillingham, , United Kingdom

Investigational Site Number: 8260056

Great Yarmouth, , United Kingdom

Investigational Site Number: 8260069

Harrow, , United Kingdom

Investigational Site Number: 8260109

Highcliffe, , United Kingdom

Investigational Site Number: 8260101

Ipswich, , United Kingdom

Investigational Site Number: 8260027

Leicester, , United Kingdom

Investigational Site Number: 8260091

Leicester, , United Kingdom

Investigational Site Number: 8260074

Leicester, , United Kingdom

Investigational Site Number: 8260088

Liskeard, , United Kingdom

Investigational Site Number: 8260030

Liverpool, , United Kingdom

Investigational Site Number: 8260092

Liverpool, , United Kingdom

Investigational Site Number: 8260010

London, , United Kingdom

Investigational Site Number: 8260039

London, , United Kingdom

Investigational Site Number: 8260075

London, , United Kingdom

Investigational Site Number: 8260011

London, , United Kingdom

Investigational Site Number: 8260076

London, , United Kingdom

Investigational Site Number: 8260077

London, , United Kingdom

Investigational Site Number: 8260084

London, , United Kingdom

Investigational Site Number: 8260079

London, , United Kingdom

Investigational Site Number: 8260078

London, , United Kingdom

Investigational Site Number: 8260001

London, , United Kingdom

Investigational Site Number: 8260002

London, , United Kingdom

Investigational Site Number: 8260071

Macclesfield, , United Kingdom

Investigational Site Number: 8260015

Manchester, , United Kingdom

Investigational Site Number: 8260097

Margate, , United Kingdom

Investigational Site Number: 8260012

Middlesbrough, , United Kingdom

Investigational Site Number: 8260042

Milton Keynes, , United Kingdom

Investigational Site Number: 8260072

Nantwich, , United Kingdom

Investigational Site Number: 8260044

Newcastle upon Tyne, , United Kingdom

Investigational Site Number: 8260119

Newport, , United Kingdom

Investigational Site Number: 8260045

Newquay, , United Kingdom

Investigational Site Number: 8260024

Norwich, , United Kingdom

Investigational Site 8260028

Nottingham, , United Kingdom

Investigational Site 8260043

Nottingham, , United Kingdom

Investigational Site Number: 8260022

Oxford, , United Kingdom

Investigational Site Number: 8260003

Oxford, , United Kingdom

Investigational Site Number: 8260080

Penzance, , United Kingdom

Investigational Site Number: 8260093

Peterborough, , United Kingdom

Investigational Site Number: 8260081

Plymouth, , United Kingdom

Investigational Site Number: 8260094

Poole, , United Kingdom

Investigational Site 8260005

Poole, , United Kingdom

Investigational Site Number: 8260065

Portsmouth, , United Kingdom

Investigational Site Number: 8260106

Prescot, , United Kingdom

Investigational Site Number: 8260117

Preston, , United Kingdom

Investigational Site Number: 8260016

Reading, , United Kingdom

Investigational Site Number: 8260086

Reading, , United Kingdom

Investigational Site Number: 8260103

Redhill, , United Kingdom

Investigational Site Number: 8260105

Redruth, , United Kingdom

Investigational Site 8260026

Romsey, , United Kingdom

Investigational Site Number: 8260068

Runcorn, , United Kingdom

Investigational Site Number: 8260059

Salford, , United Kingdom

Investigational Site Number: 8260111

Salisbury, , United Kingdom

Investigational Site Number: 8260014

Sheffield, , United Kingdom

Investigational Site 8260051

Southampton, , United Kingdom

Investigational Site Number: 8260038

Stevenage, , United Kingdom

Investigational Site Number: 8260034

Stockport, , United Kingdom

Investigational Site Number: 8260025

Stockton-on-Tees, , United Kingdom

Investigational Site Number: 8260052

Sunderland, , United Kingdom

Investigational Site Number: 8260098

Sutton in Ashfield, , United Kingdom

Investigational Site Number: 8260083

Swanage, , United Kingdom

Investigational Site Number: 8260047

Swindon, , United Kingdom

Investigational Site Number: 8260115

Swinton, , United Kingdom

Investigational Site Number: 8260102

Tameside, , United Kingdom

Investigational Site Number: 8260032

Taunton, , United Kingdom

Investigational Site Number: 8260031

Torpoint, , United Kingdom

Investigational Site 8260082

Wantage, , United Kingdom

Investigational Site Number: 8260017

Waterlooville, , United Kingdom

Investigational Site Number: 8260104

Winchester, , United Kingdom

Investigational Site Number: 8260021

Winscombe, , United Kingdom

Investigational Site Number: 8260006

Witney, , United Kingdom

Investigational Site Number: 8260060

Witney, , United Kingdom

Investigational Site Number: 8260050

Yeovil, , United Kingdom

Investigational Site Number: 8260116

York, , United Kingdom

Investigational Site 8260023

York, , United Kingdom

Countries

France; Germany; United Kingdom

References

Munro APS, Drysdale SB, Cathie K, Flamein F, Knuf M, Collins AM, Hill HC, Kaiser F, Cohen R, Pinquier D, Vassilouthis NC, Carreno M, Moreau C, Bourron P, Marcelon L, Mari K, Roberts M, Tissieres P, Royal S, Faust SN; HARMONIE Study Group. 180-day efficacy of nirsevimab against hospitalisation for respiratory syncytial virus lower respiratory tract infections in infants (HARMONIE): a randomised, controlled, phase 3b trial. Lancet Child Adolesc Health. 2025 Jun;9(6):404-412. doi: 10.1016/S2352-4642(25)00102-6.

Reference Type: DERIVED

PMID: 40379431 (View on PubMed)

Drysdale SB, Cathie K, Flamein F, Knuf M, Collins AM, Hill HC, Kaiser F, Cohen R, Pinquier D, Felter CT, Vassilouthis NC, Jin J, Bangert M, Mari K, Nteene R, Wague S, Roberts M, Tissieres P, Royal S, Faust SN; HARMONIE Study Group. Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants. N Engl J Med. 2023 Dec 28;389(26):2425-2435. doi: 10.1056/NEJMoa2309189.

Reference Type: DERIVED

PMID: 38157500 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=25372&tenant=MT_SNY_9011

VAS00006 Plain Language Results Summary

Other Identifiers

U1111-1272-2514

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022-000099-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VAS00006

Identifier Type: -

Identifier Source: org_study_id