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

PHASE3CompletedINTERVENTIONAL
Enrollment

8,057

Participants

Timeline

Start Date

August 8, 2022

Primary Completion Date

March 27, 2024

Study Completion Date

April 9, 2025

Conditions
RSV ImmunizationHealthy Volunteer
Interventions
BIOLOGICAL

Nirsevimab

Pharmaceutical Form: Solution for Injection Route of Administration: Intramuscular

Trial Locations (240)

4103

Investigational Site Number: 2760013, Leipzig

10551

Investigational Site Number: 2760099, Berlin

13015

Investigational Site Number: 2500003, Marseille

13100

Investigational Site 2500041, Aix-en-Provence

13353

Investigational Site Number: 2760076, Berlin

13385

Investigational Site Number: 2500073, Marseille

13589

Investigational Site Number: 2760056, Berlin

14033

Investigational Site Number: 2500001, Caen

15236

Investigational Site Number: 2760030, Frankfurt (Oder)

18230

Investigational Site Number: 2500078, Saint-Doulchard

20251

Investigational Site Number: 2760033, Hamburg

20357

Investigational Site Number: 2760057, Hamburg

21000

Investigational Site Number: 2500023, Dijon

22415

Investigational Site Number: 2760096, Hamburg

25524

Investigational Site Number: 2760035, Itzehoe

29200

Investigational Site 2500007, Brest

Investigational Site Number: 2500038, Brest

Investigational Site Number: 2500045, Brest

29600

Investigational Site Number: 2500077, Morlaix

30400

Investigational Site Number: 2500011, Villeneuve-lès-Avignon

30625

Investigational Site Number: 2760007, Hanover

31059

Investigational Site Number: 2500015, Toulouse

32049

Investigational Site Number: 2760008, Herford

32756

Investigational Site Number: 2760051, Detmold

33076

Investigational Site Number: 2500014, Bordeaux

33260

Investigational Site Number: 2500071, La Teste-de-Buch

33500

Investigational Site Number: 2500072, Libourne

33617

Investigational Site Number: 2760050, Bielefeld

34119

Investigational Site Number: 2760095, Kassel

34295

Investigational Site Number: 2500067, Montpellier

34537

Investigational Site Number: 2760017, Bad Wildungen

37000

Investigational Site Number: 2500035, Tours

37075

Investigational Site Number: 2760016, Göttingen

Investigational Site Number: 2760060, Göttingen

38043

Investigational Site Number: 2500004, Grenoble

38118

Investigational Site Number: 2760018, Braunschweig

38440

Investigational Site Number: 2760093, Wolfsburg

38448

Investigational Site Number: 2760028, Wolfsburg

40000

Investigational Site Number: 2500068, Mont-de-Marsan

40217

Investigational Site Number: 2760059, Düsseldorf

40589

Investigational Site Number: 2760101, Düsseldorf

41236

Investigational Site Number: 2760023, Mönchengladbach

Investigational Site Number: 2760054, Mönchengladbach

41469

Investigational Site Number: 2760027, Neuss

44093

Investigational Site Number: 2500047, Nantes

44137

Investigational Site Number: 2760085, Dortmund

44230

Investigational Site 2500020, Saint-Sébastien-sur-Loire

44791

Investigational Site Number: 2760098, Bochum

45000

Investigational Site Number: 2500022, Orléans

45067

Investigational Site Number: 2500050, Orléans

46397

Investigational Site Number: 2760064, Bocholt

46483

Investigational Site Number: 2760002, Wesel

47799

Investigational Site Number: 2760065, Krefeld

48149

Investigational Site Number: 2760083, Münster

49565

Investigational Site Number: 2760025, Bramsche

50354

Investigational Site 2760010, Hürth

Investigational Site Number: 2760091, Hürth

53127

Investigational Site Number: 2760040, Bonn

54270

Investigational Site 2500008, Essey-lès-Nancy

54390

Investigational Site Number: 2500058, Frouard

55116

Investigational Site 2760006, Mainz

55131

Investigational Site Number: 2760086, Mainz

57548

Investigational Site Number: 2760084, Kirchen

59000

Investigational Site 2500046, Lille

59037

Investigational Site 2500005, Lille

59063

Investigational Site Number: 2760032, Hamm

60100

Investigational Site Number: 2500054, Creil

64000

Investigational Site Number:, Pau

65428

Investigational Site Number: 2760062, Rüsselsheim A. Main

65527

Investigational Site Number: 2760004, Niedernhausen

66119

Investigational Site Number: 2760092, Saarbrücken

67170

Investigational Site Number: 2500043, Brumath

67550

Investigational Site Number: 2500049, Vendenheim

67700

Investigational Site Number: 2500052, Saverne

68161

Investigational Site Number: 2760014, Mannheim

68330

Investigational Site Number: 2500060, Huningue

69120

Investigational Site Number: 2760049, Heidelberg

69677

Investigational Site Number: 2500019, Bron

73000

Investigational Site Number: 2500032, Chambéry

74160

Investigational Site Number: 2500074, Saint-Julien-en-Genevois

74540

Investigational Site Number: 2500027, Héry-sur-Alby

75011

Investigational Site Number: 2500024, Paris

75012

Investigational Site Number: 2500010, Paris

Investigational Site Number: 2500075, Paris

75016

Investigational Site Number: 2500051, Paris

76000

Investigational Site Number: 2500042, Rouen

76130

Investigational Site Number: 2500066, Mont-Saint-Aignan

76150

Investigational Site 2500021, Maromme

76889

Investigational Site Number: 2760044, Schweigen

77380

Investigational Site Number: 2500029, Combs-la-Ville

78300

Investigational Site Number: 2500018, Poissy

78532

Investigational Site Number: 2760067, Tuttlingen

79106

Investigational Site Number: 2760015, Freiburg I. Breisgau

80054

Investigational Site 2500002, Amiens

80638

Investigational Site Number: 2760094, München

81369

Investigational Site Number: 2760034, München

Investigational Site Number: 2760038, München

81375

Investigational Site Number: 2760019, München

81377

Investigational Site Number: 2760046, München

81925

Investigational Site Number: 2760061, München

82205

Investigational Site Number: 2760005, Gilching

83026

Investigational Site Number: 2760003, Rosenheim

83300

Investigational Site Number: 2500069, Draguignan

83471

Investigational Site 2760029, Schönau

86154

Investigational Site Number: 2760036, Augsburg

87042

Investigational Site Number: 2500012, Limoges

90542

Investigational Site Number: 2760081, Eckental

91100

Investigational Site Number: 2500013, Corbeil-Essonnes

91150

Investigational Site 2500030, Étampes

91160

Investigational Site Number: 2500037, Longjumeau

91301

Investigational Site Number: 2760047, Forchheim

92140

Investigational Site Number: 2500057, Clamart

Investigational Site Number: 2500065, Clamart

92250

Investigational Site 2500059, La Garenne-Colombes

92637

Investigational Site Number: 2760043, Weiden

92800

Investigational Site Number: 2500026, Puteaux

93053

Investigational Site Number: 2760001, Regensburg

94010

Investigational Site Number: 2500006, Créteil

Investigational Site Number: 2500039, Créteil

94032

Investigational Site Number: 2760071, Passau

94100

Investigational Site Number: 2500044, Saint-Maur-des-Fossés

94130

Investigational Site Number: 2500040, Nogent-sur-Marne

94195

Investigational Site Number: 2500063, Villeneuve-Saint-Georges

94270

Investigational Site Number: 2500034, Le Kremlin-Bicêtre

94300

Investigational Site 2500028, Vincennes

98527

Investigational Site Number: 2760069, Suhl

99086

Investigational Site Number: 2760045, Erfurt

06135

Investigational Site Number: 2500064, Grasse

06200

Investigational Site Number: 2500055, Nice

06300

Investigational Site Number: 2500009, Nice

07548

Investigational Site Number: 2760079, Gera

04179

Investigational Site Number: 2760020, Leipzig

HP7 0JD

Investigational Site Number: 8260007, Amersham

N24 0LZ

Investigational Site Number: 8260096, Ashford

OX16 9AD

Investigational Site Number: 8260053, Banbury

EN5 3DJ

Investigational Site Number: 8260057, Barnet

S75 2EP

Investigational Site Number: 8260004, Barnsley

SS16 5NL

Investigational Site Number: 8260107, Basildon

RG24 9NA

Investigational Site Number: 8260110, Basingstoke

BA1 3NG

Investigational Site Number: 8260067, Bath

BA2 3HT

Investigational Site 8260009, Bath

CH63 9JP

Investigational Site Number: 8260100, Bebington

BT7 2EB

Investigational Site Number: 8260073, Belfast

OX26 6HR

Investigational Site Number: 8260095, Bicester

BB2 3HH

Investigational Site Number: 8260029, Blackburn

SK10 5JH

Investigational Site Number: 8260108, Bollington

BL2 6NT

Investigational Site Number: 8260085, Bolton

BD9 6RJ

Investigational Site Number: 8260013, Bradford

DY5 1RU

Investigational Site Number: 8260112, Brierley Hill

BN2 5BE

Investigational Site Number: 8260058, Brighton

BS2 8EX

Investigational Site Number: 8260008, Bristol

BS34 6BQ

Investigational Site Number: 8260019, Bristol

BS37 4AX

Investigational Site 8260046, Bristol

IP33 2QZ

Investigational Site Number: 8260063, Bury St Edmunds

CF14 4XN

Investigational Site Number: 8260040, Cardiff

GL53 7AN

Investigational Site Number: 8260062, Cheltenham

KT16 0PZ

Investigational Site Number: 8260066, Chertsey

SN16 1GG

Investigational Site Number: 8260061, Chippenham

NN17 2UR

Investigational Site Number: 8260036, Corby

HU16 5JQ

Investigational Site Number: 8260054, Cottingham

DL3 6HX

Investigational Site Number: 8260035, Darlington

Investigational Site Number: 8260037, Darlington

DL3 8SQ

Investigational Site Number: 8260041, Darlington

DT1 2JY

Investigational Site 8260064, Dorchester

DD1 9SY

Investigational Site Number: 8260087, Dundee

EX2 5DW

Investigational Site 8260018, Exeter

ME7 5NY

Investigational Site Number: 8260020, Gillingham

NR31 6LA

Investigational Site Number: 8260056, Great Yarmouth

HA1 3UJ

Investigational Site Number: 8260069, Harrow

BH23 5ET

Investigational Site Number: 8260109, Highcliffe

IP4 5PD

Investigational Site Number: 8260101, Ipswich

E1 5WW

Investigational Site Number: 8260027, Leicester

LE1 6NB

Investigational Site Number: 8260091, Leicester

LE9 7RT

Investigational Site Number: 8260074, Leicester

PL14 3XA

Investigational Site Number: 8260088, Liskeard

L12 2AP

Investigational Site Number: 8260030, Liverpool

L5 8XR

Investigational Site Number: 8260092, Liverpool

E1 1BB

Investigational Site Number: 8260010, London

E9 6SR

Investigational Site Number: 8260039, London

NW1 2PG

Investigational Site Number: 8260075, London

NW3 2QG

Investigational Site Number: 8260011, London

NW3 2QU

Investigational Site Number: 8260076, London

NW5 1TR

Investigational Site Number: 8260077, London

SE1 7EH

Investigational Site Number: 8260084, London

SE5 9RS

Investigational Site Number: 8260079, London

SW10 9NH

Investigational Site Number: 8260078, London

SW17 0RE

Investigational Site Number: 8260001, London

W2 1NY

Investigational Site Number: 8260002, London

SK10 3BL

Investigational Site Number: 8260071, Macclesfield

M13 9WL

Investigational Site Number: 8260015, Manchester

CT9 4AN

Investigational Site Number: 8260097, Margate

TS4 3BW

Investigational Site Number: 8260012, Middlesbrough

MK6 5LD

Investigational Site Number: 8260042, Milton Keynes

CW5 5NX

Investigational Site Number: 8260072, Nantwich

NE1 4LP

Investigational Site Number: 8260044, Newcastle upon Tyne

PO30 5TG

Investigational Site Number: 8260119, Newport

TR7 1RU

Investigational Site Number: 8260045, Newquay

NR4 7UY

Investigational Site Number: 8260024, Norwich

NG7 2QW

Investigational Site 8260028, Nottingham

NG9 6DX

Investigational Site 8260043, Nottingham

OX3 9DU

Investigational Site Number: 8260022, Oxford

OX4 1XB

Investigational Site Number: 8260003, Oxford

TR18 3DX

Investigational Site Number: 8260080, Penzance

PE3 9GZ

Investigational Site Number: 8260093, Peterborough

PL6 8DH

Investigational Site Number: 8260081, Plymouth

BH15 2JB

Investigational Site Number: 8260094, Poole

BH16 5PW

Investigational Site 8260005, Poole

PO6 3LY

Investigational Site Number: 8260065, Portsmouth

L35 5DR

Investigational Site Number: 8260106, Prescot

PR2 9HT

Investigational Site Number: 8260117, Preston

RG1 5AN

Investigational Site Number: 8260016, Reading

RG8 7DP

Investigational Site Number: 8260086, Reading

RH1 5RH

Investigational Site Number: 8260103, Redhill

TR15 3DU

Investigational Site Number: 8260105, Redruth

SO51 8EN

Investigational Site 8260026, Romsey

WA7 2DA

Investigational Site Number: 8260068, Runcorn

M6 8HD

Investigational Site Number: 8260059, Salford

SP2 8BJ

Investigational Site Number: 8260111, Salisbury

S10 2TH

Investigational Site Number: 8260014, Sheffield

SO16 6YD

Investigational Site 8260051, Southampton

SG1 4AB

Investigational Site Number: 8260038, Stevenage

SK2 7JE

Investigational Site Number: 8260034, Stockport

TS19 8PE

Investigational Site Number: 8260025, Stockton-on-Tees

SR4 7TP

Investigational Site Number: 8260052, Sunderland

NG17 4JL

Investigational Site Number: 8260098, Sutton in Ashfield

BH19 1HB

Investigational Site Number: 8260083, Swanage

SN3 6BB

Investigational Site Number: 8260047, Swindon

M27 0FX

Investigational Site Number: 8260115, Swinton

OL6 9RW

Investigational Site Number: 8260102, Tameside

TA1 5DA

Investigational Site Number: 8260032, Taunton

PL11 2TB

Investigational Site Number: 8260031, Torpoint

OX12 9BN

Investigational Site 8260082, Wantage

PO8 8DL

Investigational Site Number: 8260017, Waterlooville

SO22 5DG

Investigational Site Number: 8260104, Winchester

BS25 1AF

Investigational Site Number: 8260021, Winscombe

OX28 6JS

Investigational Site Number: 8260006, Witney

OX29 4QB

Investigational Site Number: 8260060, Witney

BA21 4AT

Investigational Site Number: 8260050, Yeovil

YO24 1LW

Investigational Site Number: 8260116, York

YO31 8HE

Investigational Site 8260023, York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY