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

NCT05437510 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: VAS00006U1111-1272-25142022-000099-20
• Study Type: interventional
• Target: 8,057
• Locations: 3 countries
• Sites: 240

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.

Conditions

RSV Immunization; Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) Hospitalization Through the Respiratory Syncytial Virus Season

  LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: \<2 months, ≥60 breaths per minute (/min); 2 to 6 months, ≥50 breaths/min; \>6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation \<95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. RSV season was the period of increased RSV infection.

  From dosing/randomization (Day 1) up to approximately 7 months

Secondary Outcomes (17)

• Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season

  From dosing/randomization (Day 1) up to approximately 7 months

• Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through the Respiratory Syncytial Virus Season in Each Country

  From dosing/randomization (Day 1) up to approximately 7 months

• Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season

  From dosing/randomization (Day 1) up to approximately 7 months

• Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through 151 Days Post-dosing/Randomization

  From dosing/randomization (Day 1) to Day 151

• Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through 151 Days Post-dosing/Randomization

  From dosing/randomization (Day 1) to Day 151

Study Arms (2)

Nirsevimab

EXPERIMENTAL

1 intramuscular injection at Day 01

Biological: Nirsevimab

No preventive intervention for RSV

NO INTERVENTION

No intervention

Interventions

Nirsevimab BIOLOGICAL

Pharmaceutical Form: Solution for Injection Route of Administration: Intramuscular

Nirsevimab

Eligibility Criteria

• Age: 0 Days - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead
• AstraZeneca: collaborator

Study Sites (240)

Investigational Site 2500041

Aix-en-Provence, 13100, France

Location

Investigational Site 2500002

Amiens, 80054, France

Location

Investigational Site Number: 2500014

Bordeaux, 33076, France

Location

Investigational Site 2500007

Brest, 29200, France

Location

Investigational Site Number: 2500038

Brest, 29200, France

Location

Investigational Site Number: 2500045

Brest, 29200, France

Location

Investigational Site Number: 2500019

Bron, 69677, France

Location

Investigational Site Number: 2500043

Brumath, 67170, France

Location

Investigational Site Number: 2500001

Caen, 14033, France

Location

Investigational Site Number: 2500032

Chambéry, 73000, France

Location

Investigational Site Number: 2500057

Clamart, 92140, France

Location

Investigational Site Number: 2500065

Clamart, 92140, France

Location

Investigational Site Number: 2500029

Combs-la-Ville, 77380, France

Location

Investigational Site Number: 2500013

Corbeil-Essonnes, 91100, France

Location

Investigational Site Number: 2500054

Creil, 60100, France

Location

Investigational Site Number: 2500006

Créteil, 94010, France

Location

Investigational Site Number: 2500039

Créteil, 94010, France

Location

Investigational Site Number: 2500023

Dijon, 21000, France

Location

Investigational Site Number: 2500069

Draguignan, 83300, France

Location

Investigational Site 2500008

Essey-lès-Nancy, 54270, France

Location

Investigational Site 2500030

Étampes, 91150, France

Location

Investigational Site Number: 2500058

Frouard, 54390, France

Location

Investigational Site Number: 2500064

Grasse, 06135, France

Location

Investigational Site Number: 2500004

Grenoble, 38043, France

Location

Investigational Site Number: 2500027

Héry-sur-Alby, 74540, France

Location

Investigational Site Number: 2500060

Huningue, 68330, France

Location

Investigational Site 2500059

La Garenne-Colombes, 92250, France

Location

Investigational Site Number: 2500071

La Teste-de-Buch, 33260, France

Location

Investigational Site Number: 2500034

Le Kremlin-Bicêtre, 94270, France

Location

Investigational Site Number: 2500072

Libourne, 33500, France

Location

Investigational Site 2500046

Lille, 59000, France

Location

Investigational Site 2500005

Lille, 59037, France

Location

Investigational Site Number: 2500012

Limoges, 87042, France

Location

Investigational Site Number: 2500037

Longjumeau, 91160, France

Location

Investigational Site 2500021

Maromme, 76150, France

Location

Investigational Site Number: 2500003

Marseille, 13015, France

Location

Investigational Site Number: 2500073

Marseille, 13385, France

Location

Investigational Site Number: 2500068

Mont-de-Marsan, 40000, France

Location

Investigational Site Number: 2500066

Mont-Saint-Aignan, 76130, France

Location

Investigational Site Number: 2500067

Montpellier, 34295, France

Location

Investigational Site Number: 2500077

Morlaix, 29600, France

Location

Investigational Site Number: 2500047

Nantes, 44093, France

Location

Investigational Site Number: 2500055

Nice, 06200, France

Location

Investigational Site Number: 2500009

Nice, 06300, France

Location

Investigational Site Number: 2500040

Nogent-sur-Marne, 94130, France

Location

Investigational Site Number: 2500022

Orléans, 45000, France

Location

Investigational Site Number: 2500050

Orléans, 45067, France

Location

Investigational Site Number: 2500024

Paris, 75011, France

Location

Investigational Site Number: 2500010

Paris, 75012, France

Location

Investigational Site Number: 2500075

Paris, 75012, France

Location

Investigational Site Number: 2500051

Paris, 75016, France

Location

Investigational Site Number:

Pau, 64000, France

Location

Investigational Site Number: 2500018

Poissy, 78300, France

Location

Investigational Site Number: 2500026

Puteaux, 92800, France

Location

Investigational Site Number: 2500042

Rouen, 76000, France

Location

Investigational Site Number: 2500078

Saint-Doulchard, 18230, France

Location

Investigational Site Number: 2500074

Saint-Julien-en-Genevois, 74160, France

Location

Investigational Site Number: 2500044

Saint-Maur-des-Fossés, 94100, France

Location

Investigational Site 2500020

Saint-Sébastien-sur-Loire, 44230, France

Location

Investigational Site Number: 2500052

Saverne, 67700, France

Location

Investigational Site Number: 2500015

Toulouse, 31059, France

Location

Investigational Site Number: 2500035

Tours, 37000, France

Location

Investigational Site Number: 2500049

Vendenheim, 67550, France

Location

Investigational Site Number: 2500011

Villeneuve-lès-Avignon, 30400, France

Location

Investigational Site Number: 2500063

Villeneuve-Saint-Georges, 94195, France

Location

Investigational Site 2500028

Vincennes, 94300, France

Location

Investigational Site Number: 2760036

Augsburg, 86154, Germany

Location

Investigational Site Number: 2760017

Bad Wildungen, 34537, Germany

Location

Investigational Site Number: 2760099

Berlin, 10551, Germany

Location

Investigational Site Number: 2760076

Berlin, 13353, Germany

Location

Investigational Site Number: 2760056

Berlin, 13589, Germany

Location

Investigational Site Number: 2760050

Bielefeld, 33617, Germany

Location

Investigational Site Number: 2760064

Bocholt, 46397, Germany

Location

Investigational Site Number: 2760098

Bochum, 44791, Germany

Location

Investigational Site Number: 2760040

Bonn, 53127, Germany

Location

Investigational Site Number: 2760025

Bramsche, 49565, Germany

Location

Investigational Site Number: 2760018

Braunschweig, 38118, Germany

Location

Investigational Site Number: 2760051

Detmold, 32756, Germany

Location

Investigational Site Number: 2760085

Dortmund, 44137, Germany

Location

Investigational Site Number: 2760059

Düsseldorf, 40217, Germany

Location

Investigational Site Number: 2760101

Düsseldorf, 40589, Germany

Location

Investigational Site Number: 2760081

Eckental, 90542, Germany

Location

Investigational Site Number: 2760045

Erfurt, 99086, Germany

Location

Investigational Site Number: 2760047

Forchheim, 91301, Germany

Location

Investigational Site Number: 2760030

Frankfurt (Oder), 15236, Germany

Location

Investigational Site Number: 2760015

Freiburg I. Breisgau, 79106, Germany

Location

Investigational Site Number: 2760079

Gera, 07548, Germany

Location

Investigational Site Number: 2760005

Gilching, 82205, Germany

Location

Investigational Site Number: 2760016

Göttingen, 37075, Germany

Location

Investigational Site Number: 2760060

Göttingen, 37075, Germany

Location

Investigational Site Number: 2760033

Hamburg, 20251, Germany

Location

Investigational Site Number: 2760057

Hamburg, 20357, Germany

Location

Investigational Site Number: 2760096

Hamburg, 22415, Germany

Location

Investigational Site Number: 2760032

Hamm, 59063, Germany

Location

Investigational Site Number: 2760007

Hanover, 30625, Germany

Location

Investigational Site Number: 2760049

Heidelberg, 69120, Germany

Location

Investigational Site Number: 2760008

Herford, 32049, Germany

Location

Investigational Site 2760010

Hürth, 50354, Germany

Location

Investigational Site Number: 2760091

Hürth, 50354, Germany

Location

Investigational Site Number: 2760035

Itzehoe, 25524, Germany

Location

Investigational Site Number: 2760095

Kassel, 34119, Germany

Location

Investigational Site Number: 2760084

Kirchen, 57548, Germany

Location

Investigational Site Number: 2760065

Krefeld, 47799, Germany

Location

Investigational Site Number: 2760020

Leipzig, 04179, Germany

Location

Investigational Site Number: 2760013

Leipzig, 4103, Germany

Location

Investigational Site 2760006

Mainz, 55116, Germany

Location

Investigational Site Number: 2760086

Mainz, 55131, Germany

Location

Investigational Site Number: 2760014

Mannheim, 68161, Germany

Location

Investigational Site Number: 2760023

Mönchengladbach, 41236, Germany

Location

Investigational Site Number: 2760054

Mönchengladbach, 41236, Germany

Location

Investigational Site Number: 2760094

München, 80638, Germany

Location

Investigational Site Number: 2760034

München, 81369, Germany

Location

Investigational Site Number: 2760038

München, 81369, Germany

Location

Investigational Site Number: 2760019

München, 81375, Germany

Location

Investigational Site Number: 2760046

München, 81377, Germany

Location

Investigational Site Number: 2760061

München, 81925, Germany

Location

Investigational Site Number: 2760083

Münster, 48149, Germany

Location

Investigational Site Number: 2760027

Neuss, 41469, Germany

Location

Investigational Site Number: 2760004

Niedernhausen, 65527, Germany

Location

Investigational Site Number: 2760071

Passau, 94032, Germany

Location

Investigational Site Number: 2760001

Regensburg, 93053, Germany

Location

Investigational Site Number: 2760003

Rosenheim, 83026, Germany

Location

Investigational Site Number: 2760062

Rüsselsheim A. Main, 65428, Germany

Location

Investigational Site Number: 2760092

Saarbrücken, 66119, Germany

Location

Investigational Site 2760029

Schönau, 83471, Germany

Location

Investigational Site Number: 2760044

Schweigen, 76889, Germany

Location

Investigational Site Number: 2760069

Suhl, 98527, Germany

Location

Investigational Site Number: 2760067

Tuttlingen, 78532, Germany

Location

Investigational Site Number: 2760043

Weiden, 92637, Germany

Location

Investigational Site Number: 2760002

Wesel, 46483, Germany

Location

Investigational Site Number: 2760093

Wolfsburg, 38440, Germany

Location

Investigational Site Number: 2760028

Wolfsburg, 38448, Germany

Location

Investigational Site Number: 8260007

Amersham, HP7 0JD, United Kingdom

Location

Investigational Site Number: 8260096

Ashford, N24 0LZ, United Kingdom

Location

Investigational Site Number: 8260053

Banbury, OX16 9AD, United Kingdom

Location

Investigational Site Number: 8260057

Barnet, EN5 3DJ, United Kingdom

Location

Investigational Site Number: 8260004

Barnsley, S75 2EP, United Kingdom

Location

Investigational Site Number: 8260107

Basildon, SS16 5NL, United Kingdom

Location

Investigational Site Number: 8260110

Basingstoke, RG24 9NA, United Kingdom

Location

Investigational Site Number: 8260067

Bath, BA1 3NG, United Kingdom

Location

Investigational Site 8260009

Bath, BA2 3HT, United Kingdom

Location

Investigational Site Number: 8260100

Bebington, CH63 9JP, United Kingdom

Location

Investigational Site Number: 8260073

Belfast, BT7 2EB, United Kingdom

Location

Investigational Site Number: 8260095

Bicester, OX26 6HR, United Kingdom

Location

Investigational Site Number: 8260029

Blackburn, BB2 3HH, United Kingdom

Location

Investigational Site Number: 8260108

Bollington, SK10 5JH, United Kingdom

Location

Investigational Site Number: 8260085

Bolton, BL2 6NT, United Kingdom

Location

Investigational Site Number: 8260013

Bradford, BD9 6RJ, United Kingdom

Location

Investigational Site Number: 8260112

Brierley Hill, DY5 1RU, United Kingdom

Location

Investigational Site Number: 8260058

Brighton, BN2 5BE, United Kingdom

Location

Investigational Site Number: 8260008

Bristol, BS2 8EX, United Kingdom

Location

Investigational Site Number: 8260019

Bristol, BS34 6BQ, United Kingdom

Location

Investigational Site 8260046

Bristol, BS37 4AX, United Kingdom

Location

Investigational Site Number: 8260063

Bury St Edmunds, IP33 2QZ, United Kingdom

Location

Investigational Site Number: 8260040

Cardiff, CF14 4XN, United Kingdom

Location

Investigational Site Number: 8260062

Cheltenham, GL53 7AN, United Kingdom

Location

Investigational Site Number: 8260066

Chertsey, KT16 0PZ, United Kingdom

Location

Investigational Site Number: 8260061

Chippenham, SN16 1GG, United Kingdom

Location

Investigational Site Number: 8260036

Corby, NN17 2UR, United Kingdom

Location

Investigational Site Number: 8260054

Cottingham, HU16 5JQ, United Kingdom

Location

Investigational Site Number: 8260035

Darlington, DL3 6HX, United Kingdom

Location

Investigational Site Number: 8260037

Darlington, DL3 6HX, United Kingdom

Location

Investigational Site Number: 8260041

Darlington, DL3 8SQ, United Kingdom

Location

Investigational Site 8260064

Dorchester, DT1 2JY, United Kingdom

Location

Investigational Site Number: 8260087

Dundee, DD1 9SY, United Kingdom

Location

Investigational Site 8260018

Exeter, EX2 5DW, United Kingdom

Location

Investigational Site Number: 8260020

Gillingham, ME7 5NY, United Kingdom

Location

Investigational Site Number: 8260056

Great Yarmouth, NR31 6LA, United Kingdom

Location

Investigational Site Number: 8260069

Harrow, HA1 3UJ, United Kingdom

Location

Investigational Site Number: 8260109

Highcliffe, BH23 5ET, United Kingdom

Location

Investigational Site Number: 8260101

Ipswich, IP4 5PD, United Kingdom

Location

Investigational Site Number: 8260027

Leicester, E1 5WW, United Kingdom

Location

Investigational Site Number: 8260091

Leicester, LE1 6NB, United Kingdom

Location

Investigational Site Number: 8260074

Leicester, LE9 7RT, United Kingdom

Location

Investigational Site Number: 8260088

Liskeard, PL14 3XA, United Kingdom

Location

Investigational Site Number: 8260030

Liverpool, L12 2AP, United Kingdom

Location

Investigational Site Number: 8260092

Liverpool, L5 8XR, United Kingdom

Location

Investigational Site Number: 8260010

London, E1 1BB, United Kingdom

Location

Investigational Site Number: 8260039

London, E9 6SR, United Kingdom

Location

Investigational Site Number: 8260075

London, NW1 2PG, United Kingdom

Location

Investigational Site Number: 8260011

London, NW3 2QG, United Kingdom

Location

Investigational Site Number: 8260076

London, NW3 2QU, United Kingdom

Location

Investigational Site Number: 8260077

London, NW5 1TR, United Kingdom

Location

Investigational Site Number: 8260084

London, SE1 7EH, United Kingdom

Location

Investigational Site Number: 8260079

London, SE5 9RS, United Kingdom

Location

Investigational Site Number: 8260078

London, SW10 9NH, United Kingdom

Location

Investigational Site Number: 8260001

London, SW17 0RE, United Kingdom

Location

Investigational Site Number: 8260002

London, W2 1NY, United Kingdom

Location

Investigational Site Number: 8260071

Macclesfield, SK10 3BL, United Kingdom

Location

Investigational Site Number: 8260015

Manchester, M13 9WL, United Kingdom

Location

Investigational Site Number: 8260097

Margate, CT9 4AN, United Kingdom

Location

Investigational Site Number: 8260012

Middlesbrough, TS4 3BW, United Kingdom

Location

Investigational Site Number: 8260042

Milton Keynes, MK6 5LD, United Kingdom

Location

Investigational Site Number: 8260072

Nantwich, CW5 5NX, United Kingdom

Location

Investigational Site Number: 8260044

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Investigational Site Number: 8260119

Newport, PO30 5TG, United Kingdom

Location

Investigational Site Number: 8260045

Newquay, TR7 1RU, United Kingdom

Location

Investigational Site Number: 8260024

Norwich, NR4 7UY, United Kingdom

Location

Investigational Site 8260028

Nottingham, NG7 2QW, United Kingdom

Location

Investigational Site 8260043

Nottingham, NG9 6DX, United Kingdom

Location

Investigational Site Number: 8260022

Oxford, OX3 9DU, United Kingdom

Location

Investigational Site Number: 8260003

Oxford, OX4 1XB, United Kingdom

Location

Investigational Site Number: 8260080

Penzance, TR18 3DX, United Kingdom

Location

Investigational Site Number: 8260093

Peterborough, PE3 9GZ, United Kingdom

Location

Investigational Site Number: 8260081

Plymouth, PL6 8DH, United Kingdom

Location

Investigational Site Number: 8260094

Poole, BH15 2JB, United Kingdom

Location

Investigational Site 8260005

Poole, BH16 5PW, United Kingdom

Location

Investigational Site Number: 8260065

Portsmouth, PO6 3LY, United Kingdom

Location

Investigational Site Number: 8260106

Prescot, L35 5DR, United Kingdom

Location

Investigational Site Number: 8260117

Preston, PR2 9HT, United Kingdom

Location

Investigational Site Number: 8260016

Reading, RG1 5AN, United Kingdom

Location

Investigational Site Number: 8260086

Reading, RG8 7DP, United Kingdom

Location

Investigational Site Number: 8260103

Redhill, RH1 5RH, United Kingdom

Location

Investigational Site Number: 8260105

Redruth, TR15 3DU, United Kingdom

Location

Investigational Site 8260026

Romsey, SO51 8EN, United Kingdom

Location

Investigational Site Number: 8260068

Runcorn, WA7 2DA, United Kingdom

Location

Investigational Site Number: 8260059

Salford, M6 8HD, United Kingdom

Location

Investigational Site Number: 8260111

Salisbury, SP2 8BJ, United Kingdom

Location

Investigational Site Number: 8260014

Sheffield, S10 2TH, United Kingdom

Location

Investigational Site 8260051

Southampton, SO16 6YD, United Kingdom

Location

Investigational Site Number: 8260038

Stevenage, SG1 4AB, United Kingdom

Location

Investigational Site Number: 8260034

Stockport, SK2 7JE, United Kingdom

Location

Investigational Site Number: 8260025

Stockton-on-Tees, TS19 8PE, United Kingdom

Location

Investigational Site Number: 8260052

Sunderland, SR4 7TP, United Kingdom

Location

Investigational Site Number: 8260098

Sutton in Ashfield, NG17 4JL, United Kingdom

Location

Investigational Site Number: 8260083

Swanage, BH19 1HB, United Kingdom

Location

Investigational Site Number: 8260047

Swindon, SN3 6BB, United Kingdom

Location

Investigational Site Number: 8260115

Swinton, M27 0FX, United Kingdom

Location

Investigational Site Number: 8260102

Tameside, OL6 9RW, United Kingdom

Location

Investigational Site Number: 8260032

Taunton, TA1 5DA, United Kingdom

Location

Investigational Site Number: 8260031

Torpoint, PL11 2TB, United Kingdom

Location

Investigational Site 8260082

Wantage, OX12 9BN, United Kingdom

Location

Investigational Site Number: 8260017

Waterlooville, PO8 8DL, United Kingdom

Location

Investigational Site Number: 8260104

Winchester, SO22 5DG, United Kingdom

Location

Investigational Site Number: 8260021

Winscombe, BS25 1AF, United Kingdom

Location

Investigational Site Number: 8260006

Witney, OX28 6JS, United Kingdom

Location

Investigational Site Number: 8260060

Witney, OX29 4QB, United Kingdom

Location

Investigational Site Number: 8260050

Yeovil, BA21 4AT, United Kingdom

Location

Investigational Site Number: 8260116

York, YO24 1LW, United Kingdom

Location

Investigational Site 8260023

York, YO31 8HE, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 40379431 DERIVED

• 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.

  PMID: 38157500 DERIVED

Related Links

• VAS00006 Plain Language Results Summary

MeSH Terms

Interventions

nirsevimab

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1 in-person randomization visit, with monthly safety and efficacy follow-up conducted through electronic contact through the first 6 months post-dosing/randomization. The study also included a 12-month (D366) 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.

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: August 8, 2022
• Primary Completion: March 27, 2024
• Study Completion: April 9, 2025
• Last Updated: October 9, 2025
• Results First Posted: April 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

FR (66); GB (108); DE (66)