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 (VAS00006)

September 19, 2025 updated by: Sanofi Pasteur, a Sanofi Company

A Phase IIIb Randomized Open-label Study of Nirsevimab (Versus no Intervention) in Preventing Hospitalizations Due to Respiratory Syncytial Virus in Infants (HARMONIE)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Biological: Nirsevimab

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).

Study Type

Interventional

Enrollment (Actual)

8057

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Aix-en-Provence, France, 13100
    - Investigational Site 2500041
  - Amiens, France, 80054
    - Investigational Site 2500002
  - Bordeaux, France, 33076
    - Investigational Site Number: 2500014
  - Brest, France, 29200
    - Investigational Site 2500007
  - Brest, France, 29200
    - Investigational Site Number: 2500038
  - Brest, France, 29200
    - Investigational Site Number: 2500045
  - Bron, France, 69677
    - Investigational Site Number: 2500019
  - Brumath, France, 67170
    - Investigational Site Number: 2500043
  - Caen, France, 14033
    - Investigational Site Number: 2500001
  - Chambéry, France, 73000
    - Investigational Site Number: 2500032
  - Clamart, France, 92140
    - Investigational Site Number: 2500057
  - Clamart, France, 92140
    - Investigational Site Number: 2500065
  - Combs-la-Ville, France, 77380
    - Investigational Site Number: 2500029
  - Corbeil-Essonnes, France, 91100
    - Investigational Site Number: 2500013
  - Creil, France, 60100
    - Investigational Site Number: 2500054
  - Créteil, France, 94010
    - Investigational Site Number: 2500006
  - Créteil, France, 94010
    - Investigational Site Number: 2500039
  - Dijon, France, 21000
    - Investigational Site Number: 2500023
  - Draguignan, France, 83300
    - Investigational Site Number: 2500069
  - Essey-lès-Nancy, France, 54270
    - Investigational Site 2500008
  - Frouard, France, 54390
    - Investigational Site Number: 2500058
  - Grasse, France, 06135
    - Investigational Site Number: 2500064
  - Grenoble, France, 38043
    - Investigational Site Number: 2500004
  - Huningue, France, 68330
    - Investigational Site Number: 2500060
  - Héry-sur-Alby, France, 74540
    - Investigational Site Number: 2500027
  - La Garenne-Colombes, France, 92250
    - Investigational Site 2500059
  - La Teste-de-Buch, France, 33260
    - Investigational Site Number: 2500071
  - Le Kremlin-Bicêtre, France, 94270
    - Investigational Site Number: 2500034
  - Libourne, France, 33500
    - Investigational Site Number: 2500072
  - Lille, France, 59000
    - Investigational Site 2500046
  - Lille, France, 59037
    - Investigational Site 2500005
  - Limoges, France, 87042
    - Investigational Site Number: 2500012
  - Longjumeau, France, 91160
    - Investigational Site Number: 2500037
  - Maromme, France, 76150
    - Investigational Site 2500021
  - Marseille, France, 13015
    - Investigational Site Number: 2500003
  - Marseille, France, 13385
    - Investigational Site Number: 2500073
  - Mont-Saint-Aignan, France, 76130
    - Investigational Site Number: 2500066
  - Mont-de-Marsan, France, 40000
    - Investigational Site Number: 2500068
  - Montpellier, France, 34295
    - Investigational Site Number: 2500067
  - Morlaix, France, 29600
    - Investigational Site Number: 2500077
  - Nantes, France, 44093
    - Investigational Site Number: 2500047
  - Nice, France, 06200
    - Investigational Site Number: 2500055
  - Nice, France, 06300
    - Investigational Site Number: 2500009
  - Nogent-sur-Marne, France, 94130
    - Investigational Site Number: 2500040
  - Orléans, France, 45000
    - Investigational Site Number: 2500022
  - Orléans, France, 45067
    - Investigational Site Number: 2500050
  - Paris, France, 75011
    - Investigational Site Number: 2500024
  - Paris, France, 75012
    - Investigational Site Number: 2500010
  - Paris, France, 75012
    - Investigational Site Number: 2500075
  - Paris, France, 75016
    - Investigational Site Number: 2500051
  - Pau, France, 64000
    - Investigational Site Number:
  - Poissy, France, 78300
    - Investigational Site Number: 2500018
  - Puteaux, France, 92800
    - Investigational Site Number: 2500026
  - Rouen, France, 76000
    - Investigational Site Number: 2500042
  - Saint-Doulchard, France, 18230
    - Investigational Site Number: 2500078
  - Saint-Julien-en-Genevois, France, 74160
    - Investigational Site Number: 2500074
  - Saint-Maur-des-Fossés, France, 94100
    - Investigational Site Number: 2500044
  - Saint-Sébastien-sur-Loire, France, 44230
    - Investigational Site 2500020
  - Saverne, France, 67700
    - Investigational Site Number: 2500052
  - Toulouse, France, 31059
    - Investigational Site Number: 2500015
  - Tours, France, 37000
    - Investigational Site Number: 2500035
  - Vendenheim, France, 67550
    - Investigational Site Number: 2500049
  - Villeneuve-Saint-Georges, France, 94195
    - Investigational Site Number: 2500063
  - Villeneuve-lès-Avignon, France, 30400
    - Investigational Site Number: 2500011
  - Vincennes, France, 94300
    - Investigational Site 2500028
  - Étampes, France, 91150
    - Investigational Site 2500030
Germany
- - Augsburg, Germany, 86154
    - Investigational Site Number: 2760036
  - Bad Wildungen, Germany, 34537
    - Investigational Site Number: 2760017
  - Berlin, Germany, 10551
    - Investigational Site Number: 2760099
  - Berlin, Germany, 13353
    - Investigational Site Number: 2760076
  - Berlin, Germany, 13589
    - Investigational Site Number: 2760056
  - Bielefeld, Germany, 33617
    - Investigational Site Number: 2760050
  - Bocholt, Germany, 46397
    - Investigational Site Number: 2760064
  - Bochum, Germany, 44791
    - Investigational Site Number: 2760098
  - Bonn, Germany, 53127
    - Investigational Site Number: 2760040
  - Bramsche, Germany, 49565
    - Investigational Site Number: 2760025
  - Braunschweig, Germany, 38118
    - Investigational Site Number: 2760018
  - Detmold, Germany, 32756
    - Investigational Site Number: 2760051
  - Dortmund, Germany, 44137
    - Investigational Site Number: 2760085
  - Düsseldorf, Germany, 40217
    - Investigational Site Number: 2760059
  - Düsseldorf, Germany, 40589
    - Investigational Site Number: 2760101
  - Eckental, Germany, 90542
    - Investigational Site Number: 2760081
  - Erfurt, Germany, 99086
    - Investigational Site Number: 2760045
  - Forchheim, Germany, 91301
    - Investigational Site Number: 2760047
  - Frankfurt (Oder), Germany, 15236
    - Investigational Site Number: 2760030
  - Freiburg I. Breisgau, Germany, 79106
    - Investigational Site Number: 2760015
  - Gera, Germany, 07548
    - Investigational Site Number: 2760079
  - Gilching, Germany, 82205
    - Investigational Site Number: 2760005
  - Göttingen, Germany, 37075
    - Investigational Site Number: 2760016
  - Göttingen, Germany, 37075
    - Investigational Site Number: 2760060
  - Hamburg, Germany, 20251
    - Investigational Site Number: 2760033
  - Hamburg, Germany, 20357
    - Investigational Site Number: 2760057
  - Hamburg, Germany, 22415
    - Investigational Site Number: 2760096
  - Hamm, Germany, 59063
    - Investigational Site Number: 2760032
  - Hanover, Germany, 30625
    - Investigational Site Number: 2760007
  - Heidelberg, Germany, 69120
    - Investigational Site Number: 2760049
  - Herford, Germany, 32049
    - Investigational Site Number: 2760008
  - Hürth, Germany, 50354
    - Investigational Site 2760010
  - Hürth, Germany, 50354
    - Investigational Site Number: 2760091
  - Itzehoe, Germany, 25524
    - Investigational Site Number: 2760035
  - Kassel, Germany, 34119
    - Investigational Site Number: 2760095
  - Kirchen, Germany, 57548
    - Investigational Site Number: 2760084
  - Krefeld, Germany, 47799
    - Investigational Site Number: 2760065
  - Leipzig, Germany, 04179
    - Investigational Site Number: 2760020
  - Leipzig, Germany, 4103
    - Investigational Site Number: 2760013
  - Mainz, Germany, 55116
    - Investigational Site 2760006
  - Mainz, Germany, 55131
    - Investigational Site Number: 2760086
  - Mannheim, Germany, 68161
    - Investigational Site Number: 2760014
  - Mönchengladbach, Germany, 41236
    - Investigational Site Number: 2760023
  - Mönchengladbach, Germany, 41236
    - Investigational Site Number: 2760054
  - München, Germany, 80638
    - Investigational Site Number: 2760094
  - München, Germany, 81369
    - Investigational Site Number: 2760034
  - München, Germany, 81369
    - Investigational Site Number: 2760038
  - München, Germany, 81375
    - Investigational Site Number: 2760019
  - München, Germany, 81925
    - Investigational Site Number: 2760061
  - München, Germany, 81377
    - Investigational Site Number: 2760046
  - Münster, Germany, 48149
    - Investigational Site Number: 2760083
  - Neuss, Germany, 41469
    - Investigational Site Number: 2760027
  - Niedernhausen, Germany, 65527
    - Investigational Site Number: 2760004
  - Passau, Germany, 94032
    - Investigational Site Number: 2760071
  - Regensburg, Germany, 93053
    - Investigational Site Number: 2760001
  - Rosenheim, Germany, 83026
    - Investigational Site Number: 2760003
  - Rüsselsheim A. Main, Germany, 65428
    - Investigational Site Number: 2760062
  - Saarbrücken, Germany, 66119
    - Investigational Site Number: 2760092
  - Schweigen, Germany, 76889
    - Investigational Site Number: 2760044
  - Schönau, Germany, 83471
    - Investigational Site 2760029
  - Suhl, Germany, 98527
    - Investigational Site Number: 2760069
  - Tuttlingen, Germany, 78532
    - Investigational Site Number: 2760067
  - Weiden, Germany, 92637
    - Investigational Site Number: 2760043
  - Wesel, Germany, 46483
    - Investigational Site Number: 2760002
  - Wolfsburg, Germany, 38440
    - Investigational Site Number: 2760093
  - Wolfsburg, Germany, 38448
    - Investigational Site Number: 2760028
United Kingdom
- - Amersham, United Kingdom, HP7 0JD
    - Investigational Site Number: 8260007
  - Ashford, United Kingdom, N24 0LZ
    - Investigational Site Number: 8260096
  - Banbury, United Kingdom, OX16 9AD
    - Investigational Site Number: 8260053
  - Barnet, United Kingdom, EN5 3DJ
    - Investigational Site Number: 8260057
  - Barnsley, United Kingdom, S75 2EP
    - Investigational Site Number: 8260004
  - Basildon, United Kingdom, SS16 5NL
    - Investigational Site Number: 8260107
  - Basingstoke, United Kingdom, RG24 9NA
    - Investigational Site Number: 8260110
  - Bath, United Kingdom, BA1 3NG
    - Investigational Site Number: 8260067
  - Bath, United Kingdom, BA2 3HT
    - Investigational Site 8260009
  - Bebington, United Kingdom, CH63 9JP
    - Investigational Site Number: 8260100
  - Belfast, United Kingdom, BT7 2EB
    - Investigational Site Number: 8260073
  - Bicester, United Kingdom, OX26 6HR
    - Investigational Site Number: 8260095
  - Blackburn, United Kingdom, BB2 3HH
    - Investigational Site Number: 8260029
  - Bollington, United Kingdom, SK10 5JH
    - Investigational Site Number: 8260108
  - Bolton, United Kingdom, BL2 6NT
    - Investigational Site Number: 8260085
  - Bradford, United Kingdom, BD9 6RJ
    - Investigational Site Number: 8260013
  - Brierley Hill, United Kingdom, DY5 1RU
    - Investigational Site Number: 8260112
  - Brighton, United Kingdom, BN2 5BE
    - Investigational Site Number: 8260058
  - Bristol, United Kingdom, BS2 8EX
    - Investigational Site Number: 8260008
  - Bristol, United Kingdom, BS34 6BQ
    - Investigational Site Number: 8260019
  - Bristol, United Kingdom, BS37 4AX
    - Investigational Site 8260046
  - Bury St Edmunds, United Kingdom, IP33 2QZ
    - Investigational Site Number: 8260063
  - Cardiff, United Kingdom, CF14 4XN
    - Investigational Site Number: 8260040
  - Cheltenham, United Kingdom, GL53 7AN
    - Investigational Site Number: 8260062
  - Chertsey, United Kingdom, KT16 0PZ
    - Investigational Site Number: 8260066
  - Chippenham, United Kingdom, SN16 1GG
    - Investigational Site Number: 8260061
  - Corby, United Kingdom, NN17 2UR
    - Investigational Site Number: 8260036
  - Cottingham, United Kingdom, HU16 5JQ
    - Investigational Site Number: 8260054
  - Darlington, United Kingdom, DL3 6HX
    - Investigational Site Number: 8260035
  - Darlington, United Kingdom, DL3 6HX
    - Investigational Site Number: 8260037
  - Darlington, United Kingdom, DL3 8SQ
    - Investigational Site Number: 8260041
  - Dorchester, United Kingdom, DT1 2JY
    - Investigational Site 8260064
  - Dundee, United Kingdom, DD1 9SY
    - Investigational Site Number: 8260087
  - Exeter, United Kingdom, EX2 5DW
    - Investigational Site 8260018
  - Gillingham, United Kingdom, ME7 5NY
    - Investigational Site Number: 8260020
  - Great Yarmouth, United Kingdom, NR31 6LA
    - Investigational Site Number: 8260056
  - Harrow, United Kingdom, HA1 3UJ
    - Investigational Site Number: 8260069
  - Highcliffe, United Kingdom, BH23 5ET
    - Investigational Site Number: 8260109
  - Ipswich, United Kingdom, IP4 5PD
    - Investigational Site Number: 8260101
  - Leicester, United Kingdom, E1 5WW
    - Investigational Site Number: 8260027
  - Leicester, United Kingdom, LE1 6NB
    - Investigational Site Number: 8260091
  - Leicester, United Kingdom, LE9 7RT
    - Investigational Site Number: 8260074
  - Liskeard, United Kingdom, PL14 3XA
    - Investigational Site Number: 8260088
  - Liverpool, United Kingdom, L12 2AP
    - Investigational Site Number: 8260030
  - Liverpool, United Kingdom, L5 8XR
    - Investigational Site Number: 8260092
  - London, United Kingdom, E1 1BB
    - Investigational Site Number: 8260010
  - London, United Kingdom, E9 6SR
    - Investigational Site Number: 8260039
  - London, United Kingdom, NW1 2PG
    - Investigational Site Number: 8260075
  - London, United Kingdom, NW3 2QG
    - Investigational Site Number: 8260011
  - London, United Kingdom, NW3 2QU
    - Investigational Site Number: 8260076
  - London, United Kingdom, NW5 1TR
    - Investigational Site Number: 8260077
  - London, United Kingdom, SE1 7EH
    - Investigational Site Number: 8260084
  - London, United Kingdom, SE5 9RS
    - Investigational Site Number: 8260079
  - London, United Kingdom, SW10 9NH
    - Investigational Site Number: 8260078
  - London, United Kingdom, SW17 0RE
    - Investigational Site Number: 8260001
  - London, United Kingdom, W2 1NY
    - Investigational Site Number: 8260002
  - Macclesfield, United Kingdom, SK10 3BL
    - Investigational Site Number: 8260071
  - Manchester, United Kingdom, M13 9WL
    - Investigational Site Number: 8260015
  - Margate, United Kingdom, CT9 4AN
    - Investigational Site Number: 8260097
  - Middlesbrough, United Kingdom, TS4 3BW
    - Investigational Site Number: 8260012
  - Milton Keynes, United Kingdom, MK6 5LD
    - Investigational Site Number: 8260042
  - Nantwich, United Kingdom, CW5 5NX
    - Investigational Site Number: 8260072
  - Newcastle upon Tyne, United Kingdom, NE1 4LP
    - Investigational Site Number: 8260044
  - Newport, United Kingdom, PO30 5TG
    - Investigational Site Number: 8260119
  - Newquay, United Kingdom, TR7 1RU
    - Investigational Site Number: 8260045
  - Norwich, United Kingdom, NR4 7UY
    - Investigational Site Number: 8260024
  - Nottingham, United Kingdom, NG7 2QW
    - Investigational Site 8260028
  - Nottingham, United Kingdom, NG9 6DX
    - Investigational Site 8260043
  - Oxford, United Kingdom, OX3 9DU
    - Investigational Site Number: 8260022
  - Oxford, United Kingdom, OX4 1XB
    - Investigational Site Number: 8260003
  - Penzance, United Kingdom, TR18 3DX
    - Investigational Site Number: 8260080
  - Peterborough, United Kingdom, PE3 9GZ
    - Investigational Site Number: 8260093
  - Plymouth, United Kingdom, PL6 8DH
    - Investigational Site Number: 8260081
  - Poole, United Kingdom, BH15 2JB
    - Investigational Site Number: 8260094
  - Poole, United Kingdom, BH16 5PW
    - Investigational Site 8260005
  - Portsmouth, United Kingdom, PO6 3LY
    - Investigational Site Number: 8260065
  - Prescot, United Kingdom, L35 5DR
    - Investigational Site Number: 8260106
  - Preston, United Kingdom, PR2 9HT
    - Investigational Site Number: 8260117
  - Reading, United Kingdom, RG1 5AN
    - Investigational Site Number: 8260016
  - Reading, United Kingdom, RG8 7DP
    - Investigational Site Number: 8260086
  - Redhill, United Kingdom, RH1 5RH
    - Investigational Site Number: 8260103
  - Redruth, United Kingdom, TR15 3DU
    - Investigational Site Number: 8260105
  - Romsey, United Kingdom, SO51 8EN
    - Investigational Site 8260026
  - Runcorn, United Kingdom, WA7 2DA
    - Investigational Site Number: 8260068
  - Salford, United Kingdom, M6 8HD
    - Investigational Site Number: 8260059
  - Salisbury, United Kingdom, SP2 8BJ
    - Investigational Site Number: 8260111
  - Sheffield, United Kingdom, S10 2TH
    - Investigational Site Number: 8260014
  - Southampton, United Kingdom, SO16 6YD
    - Investigational Site 8260051
  - Stevenage, United Kingdom, SG1 4AB
    - Investigational Site Number: 8260038
  - Stockport, United Kingdom, SK2 7JE
    - Investigational Site Number: 8260034
  - Stockton-on-Tees, United Kingdom, TS19 8PE
    - Investigational Site Number: 8260025
  - Sunderland, United Kingdom, SR4 7TP
    - Investigational Site Number: 8260052
  - Sutton in Ashfield, United Kingdom, NG17 4JL
    - Investigational Site Number: 8260098
  - Swanage, United Kingdom, BH19 1HB
    - Investigational Site Number: 8260083
  - Swindon, United Kingdom, SN3 6BB
    - Investigational Site Number: 8260047
  - Swinton, United Kingdom, M27 0FX
    - Investigational Site Number: 8260115
  - Tameside, United Kingdom, OL6 9RW
    - Investigational Site Number: 8260102
  - Taunton, United Kingdom, TA1 5DA
    - Investigational Site Number: 8260032
  - Torpoint, United Kingdom, PL11 2TB
    - Investigational Site Number: 8260031
  - Wantage, United Kingdom, OX12 9BN
    - Investigational Site 8260082
  - Waterlooville, United Kingdom, PO8 8DL
    - Investigational Site Number: 8260017
  - Winchester, United Kingdom, SO22 5DG
    - Investigational Site Number: 8260104
  - Winscombe, United Kingdom, BS25 1AF
    - Investigational Site Number: 8260021
  - Witney, United Kingdom, OX28 6JS
    - Investigational Site Number: 8260006
  - Witney, United Kingdom, OX29 4QB
    - Investigational Site Number: 8260060
  - Yeovil, United Kingdom, BA21 4AT
    - Investigational Site Number: 8260050
  - York, United Kingdom, YO24 1LW
    - Investigational Site Number: 8260116
  - York, United Kingdom, YO31 8HE
    - Investigational Site 8260023

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 year (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nirsevimab 1 intramuscular injection at Day 01	Biological: Nirsevimab Pharmaceutical Form: Solution for Injection Route of Administration: Intramuscular
No Intervention: No preventive intervention for RSV No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) Hospitalization Through the Respiratory Syncytial Virus Season Time Frame: From dosing/randomization (Day 1) up to approximately 7 months	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 Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Collaborators

AstraZeneca

Investigators

Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

VAS00006 Plain Language Results Summary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2022

Primary Completion (Actual)

March 27, 2024

Study Completion (Actual)

April 9, 2025

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

June 24, 2022

First Posted (Actual)

June 29, 2022

Study Record Updates

Last Update Posted (Estimated)

October 9, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

VAS00006
U1111-1272-2514 (Registry Identifier: ICTRP)
2022-000099-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

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Clinical Trials on Healthy Volunteer

University Magna Graecia

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Healthy Volunteer | Healthy Volunteer Study

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TrueLab Biopharmaceutical Co., Ltd
SAPRO Consulting Pty Ltd

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Healthy Volunteer

Australia
Aspargo Labs, Inc

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Healthy Volunteer
Aspargo Labs, Inc

Not yet recruiting

Bioequivalence Study of Liquid Metformin (100 and 250 mg/mL) vs IR Tablets

Healthy Volunteer
Aspargo Labs, Inc

Not yet recruiting

PK and Relative Bioavailability of Liquid Metformin vs Tablets in Healthy Adults

Healthy Volunteer
AbbVie

Recruiting

A Study to Evaluate How the Study Drug Moves Through the Body, Adverse Events, and How the Body Tolerates ABBV-547 Injections

Healthy Volunteer

United States
Johns Hopkins University

Recruiting

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Healthy Volunteer

United States
Pfizer

Recruiting

Study About Whether Atirmociclib/PF-07220060 Proportionally Increases Exposure as Dose Increases in Healthy Participants

Healthy Volunteer

United States
Vedic Lifesciences Pvt. Ltd.

Not yet recruiting

Single Oral Dose Comparative Bioavailability Study of Investigational Product in Healthy Human Subjects Under Fasting Conditions.

Healthy Volunteer

India

Clinical Trials on Nirsevimab

Sanofi

Recruiting

A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea

Respiratory Syncytial Virus

South Korea
Han Tongyan

Completed

Real-World Effectiveness of Nirsevimab Against RSV-Related and All-Cause Respiratory Tract Infections in Chinese Infants

Lower Respiratory Tract Infections | RSV Infections

China
Centre Hospitalier Annecy Genevois

Recruiting

Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination (PIPELINE-RSV-F)

RSV Immunization

France
Menzies School of Health Research
University of Sydney; Murdoch Childrens Research Institute

Not yet recruiting

THRIVE - Trial of Passive Humoral RSV Immunity for Value and Effectiveness (THRIVE)

Respiratory Syncytial Virus (RSV) | Respiratory Infection Virus

Australia
AstraZeneca
IQVIA RDS Inc.

Completed

Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China (CHIMES)

Lower Respiratory Tract Infection

China
Hospices Civils de Lyon

Not yet recruiting

The Effectiveness of Early Immunisation With Nirsevimab on Preschool Wheezing in France, Based on an Analysis of Data From the French Health System Database. (INSPIRATION)

Asthma Childhood | Infant Wheeze | Preschool Age Children

France
AstraZeneca
IQVIA Pty Ltd

Completed

A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab (JUBILUS)

Respiratory Syncytial Virus Infections

Japan
Meyer Children's Hospital IRCCS

Recruiting

Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.

Respiratory Synctial Virus Infections

Italy
AstraZeneca
IQVIA Pty Ltd

Completed

Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children (MUSIC)

RSV Infection

United States, Belgium, Spain, Japan, Poland, South Africa, United Kingdom, Ukraine
Duke University
Columbia University; Emory University; Centers for Disease Control and Prevention and other collaborators

Recruiting

Safety of RSV Preventive Monoclonal Antibody

Fever | Adverse Event Following Immunisation

United States

Outcome Measure	Measure Description	Time Frame
Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season Time Frame: From dosing/randomization (Day 1) up to approximately 7 months	LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; >6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation <95%). Very severe RSV LRTI was defined as RSV LRTI hospitalization with oxygen saturation <90% (at any time during hospitalization) and oxygen supplementation. 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
Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through the Respiratory Syncytial Virus Season in Each Country Time Frame: From dosing/randomization (Day 1) up to approximately 7 months	LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/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. Number of participants with RSV LRTI hospitalization through the RSV season in France, UK, and Germany is presented.	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 Time Frame: From dosing/randomization (Day 1) to Day 151	LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/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. Number of participants with RSV LRTI hospitalization through 151 days post-dosing/randomization in France, UK, Germany, and overall is presented.	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 Time Frame: From dosing/randomization (Day 1) to Day 151	LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; >6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation <95%). Very severe RSV LRTI was defined as RSV LRTI hospitalization with oxygen saturation <90% (at any time during hospitalization) and oxygen supplementation. Hospitalization was defined as the decision to admit to in-patient care by the treating physician. Number of participants with very severe RSV LRTI through 151 days post-dosing/randomization in France, UK, Germany, and overall is presented.	From dosing/randomization (Day 1) to Day 151
Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through 151 Days Post-dosing/Randomization Time Frame: From dosing/randomization (Day 1) to Day 151	LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/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. Number of participants with hospitalization for all-cause LRTI through 151 days post-dosing/randomization in France, UK, Germany, and overall is presented.	From dosing/randomization (Day 1) to Day 151
Number of Participants With Immediate Treatment-Emergent Adverse Events (TEAEs) Time Frame: Up to 30 minutes post-dosing/randomization on Day 1	An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were either events with the start date and time posterior to the start of the treatment period and up to the end of the treatment period or events with the start date and time prior to the start of the treatment period, whose severity was greater than 1 or missing and stop date is missing or not before the treatment period. Immediate events were recorded to capture medically relevant AEs which occurred within the first 30 minutes after immunization.	Up to 30 minutes post-dosing/randomization on Day 1
Number of Participants With Non-Serious Treatment-Emergent Adverse Events Time Frame: From dosing/randomization (Day 1) to Day 31	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were either events with the start date and time posterior to the start of the treatment period and up to the end of the treatment period or events with the start date and time prior to the start of the treatment period, whose severity was greater than 1 or missing and stop date was missing or not before the treatment period.	From dosing/randomization (Day 1) to Day 31
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events of Special Interest (AESIs) and Treatment-Emergent Medically Attended Adverse Events (MAAEs) Time Frame: From dosing/randomization (Day 1) to Day 366	AE: untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not related to it. TEAEs: events with start date/time posterior to start of treatment period(TP) and up to end of TP, or events with start date/time prior to start of TP, whose severity was>1/missing; stop date was missing/not before TP. SAE: AE at any dose resulting in death, persistent or significant disability/incapacity, required inpatient hospitalization/prolongation of existing hospitalization, was life-threatening or congenital anomaly/birth defect or medically important event. MAAE: new onset/worsening of condition that prompted participant or participant's parent/legally acceptable representative to seek unplanned medical advice at physician's office/Emergency Department. AESI: scientific, medical concern specific to Sponsor's study intervention/program for which ongoing monitoring and rapid communication by investigator to Sponsor was appropriate.	From dosing/randomization (Day 1) to Day 366
Number of Participants With Treatment-Related Serious Adverse Event (for United Kingdom Reconsented Participants) Time Frame: From Day 366 to Day 731	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were either events with the start date and time posterior to the start of the treatment period and up to the end of the treatment period or events with the start date and time prior to the start of the treatment period, whose severity was greater than 1 or missing and stop date is missing or not before the treatment period. SAE: AE at any dose resulting in death, persistent or significant disability/incapacity, required inpatient hospitalization/prolongation of existing hospitalization, was life-threatening or congenital anomaly/birth defect or medically important event. A treatment-related TEAE was a TEAE considered by the investigator as related or with unknown/missing relationship to treatment for participants who received nirsevimab on Day 1.	From Day 366 to Day 731
Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through 181 Days Post-dosing/Randomization Time Frame: From dosing/randomization (Day 1) to Day 181	LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/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. Number of participants with RSV LRTI hospitalization through 181 days post-dosing/randomization in France, UK, Germany, and overall is presented.	From dosing/randomization (Day 1) to Day 181
Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization From Days 181 to 366 Post-dosing/Randomization Time Frame: From Day 181 to Day 366	LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/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. Number of participants with RSV LRTI hospitalization from Days 181 to 366 post-dosing/randomization (with no RSV LRTI hospitalizations before Day 181) in France, UK, Germany, and overall is presented.	From Day 181 to Day 366
Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection From Days 181 to 366 Post-dosing/Randomization Time Frame: From Day 181 to Day 366	LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/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. Number of participants with hospitalization for all-cause LRTI from Days 181 to 366 post-dosing/randomization (with no hospitalizations for all-cause LRTI before Day 181) is presented.	From Day 181 to Day 366
Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season Time Frame: From dosing/randomization (Day 1) up to approximately 7 months	LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/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. Number of participants with hospitalization for all-cause LRTI through the RSV season in France, UK, Germany, and overall is presented.	From dosing/randomization (Day 1) up to approximately 7 months
Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through 181 Days Post-dosing/Randomization Time Frame: From dosing/randomization (Day 1) to Day 181	LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/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. Number of participants with hospitalization for all-cause LRTI through 181 days post-dosing/randomization in France, UK, Germany, and overall is presented.	From dosing/randomization (Day 1) to Day 181
Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization From Days 366 to 731 Post-dosing/Randomization (for United Kingdom Reconsented Participants) Time Frame: From Day 366 to Day 731	LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/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. Number of participants with RSV LRTI hospitalization from Days 366 to 731 post-dosing/randomization (with no RSV LRTI hospitalizations before Day 366) in UK reconsented participants is presented.	From Day 366 to Day 731
Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection From Days 366 to 731 Post-dosing/Randomization (for United Kingdom Reconsented Participants) Time Frame: From Day 366 to Day 731	LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/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. Number of participants with hospitalization for all-cause LRTI from Days 366 to 731 post-dosing/randomization (with no hospitalizations for all-cause LRTI before Day 366) in UK reconsented participants is presented.	From Day 366 to Day 731
Number of Participants With Recurrent Wheeze (for United Kingdom Reconsented Participants) Time Frame: From dosing/randomization (Day 1) to Day 731	Wheeze was defined as a physician-diagnosed wheeze or asthma or related ear, nose and throat (ENT)/respiratory symptoms at an office visit or an illness for which the child was prescribed medication to treat an ENT/respiratory condition. Recurrent wheeze event was defined as 2 or more protocol-defined wheeze episodes throughout follow-up period.	From dosing/randomization (Day 1) to Day 731

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 (VAS00006)

A Phase IIIb Randomized Open-label Study of Nirsevimab (Versus no Intervention) in Preventing Hospitalizations Due to Respiratory Syncytial Virus in Infants (HARMONIE)

Study Overview

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Detailed Description

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product manufactured in and exported from the U.S.

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