Clinical trial NCT05437510: 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
Official title: A Phase IIIb Randomized Open-label Study of Nirsevimab (Versus no Intervention) in Preventing Hospitalizations Due to Respiratory Syncytial Virus in Infants (HARMONIE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: RSV Immunization
Healthy Volunteer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2022-06-29
Enrollment: 8057
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Number of Participants With Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) Hospitalization Through the Respiratory Syncytial Virus Season
timeFrame: From dosing/randomization (Day 1) up to approximately 7 months
Secondary outcomes:
measure: Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season
timeFrame: From dosing/randomization (Day 1) up to approximately 7 months
measure: Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through the Respiratory Syncytial Virus Season in Each Country
timeFrame: From dosing/randomization (Day 1) up to approximately 7 months
measure: Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season
timeFrame: From dosing/randomization (Day 1) up to approximately 7 months
measure: Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through 151 Days Post-dosing/Randomization
timeFrame: From dosing/randomization (Day 1) to Day 151
measure: Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through 151 Days Post-dosing/Randomization
timeFrame: From dosing/randomization (Day 1) to Day 151
measure: Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through 151 Days Post-dosing/Randomization
timeFrame: From dosing/randomization (Day 1) to Day 151
measure: Number of Participants With Immediate Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 30 minutes post-dosing/randomization on Day 1
measure: Number of Participants With Non-Serious Treatment-Emergent Adverse Events
timeFrame: From dosing/randomization (Day 1) to Day 31
measure: 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)
timeFrame: From dosing/randomization (Day 1) to Day 366
measure: Number of Participants With Treatment-Related Serious Adverse Event (for United Kingdom Reconsented Participants)
timeFrame: From Day 366 to Day 731
measure: Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through 181 Days Post-dosing/Randomization
timeFrame: From dosing/randomization (Day 1) to Day 181
measure: Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through 181 Days Post-dosing/Randomization
timeFrame: From dosing/randomization (Day 1) to Day 181
measure: Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization From Days 181 to 366 Post-dosing/Randomization
timeFrame: From Day 181 to Day 366
measure: Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection From Days 181 to 366 Post-dosing/Randomization
timeFrame: From Day 181 to Day 366
measure: 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)
timeFrame: From Day 366 to Day 731
measure: 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)
timeFrame: From Day 366 to Day 731
measure: Number of Participants With Recurrent Wheeze (for United Kingdom Reconsented Participants)
timeFrame: From dosing/randomization (Day 1) to Day 731
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Investigational Site 2500041
city: Amiens
country: France
facility: Investigational Site 2500002
city: Bordeaux
country: France
facility: Investigational Site Number: 2500014
city: Brest
country: France
facility: Investigational Site 2500007
city: Brest
country: France
facility: Investigational Site Number: 2500038
city: Brest
country: France
facility: Investigational Site Number: 2500045
city: Bron
country: France
facility: Investigational Site Number: 2500019
city: Brumath
country: France
facility: Investigational Site Number: 2500043
city: Caen
country: France
facility: Investigational Site Number: 2500001
city: Chambery
country: France
facility: Investigational Site Number: 2500032
city: Clamart
country: France
facility: Investigational Site Number: 2500057
city: Clamart
country: France
facility: Investigational Site Number: 2500065
city: Combs-la-Ville
country: France
facility: Investigational Site Number: 2500029
city: Corbeil-Essonnes
country: France
facility: Investigational Site Number: 2500013
city: Creil
country: France
facility: Investigational Site Number: 2500054
city: Creteil
country: France
facility: Investigational Site Number: 2500006
city: Creteil
country: France
facility: Investigational Site Number: 2500039
city: Dijon
country: France
facility: Investigational Site Number: 2500023
city: Draguignan
country: France
facility: Investigational Site Number: 2500069
city: Essey-lès-Nancy
country: France
facility: Investigational Site 2500008
city: Frouard
country: France
facility: Investigational Site Number: 2500058
city: Grasse
country: France
facility: Investigational Site Number: 2500064
city: Grenoble
country: France
facility: Investigational Site Number: 2500004
city: Hery-Sur-Alby
country: France
facility: Investigational Site Number: 2500027
city: Huningue
country: France
facility: Investigational Site Number: 2500060
city: La Garenne-Colombes
country: France
facility: Investigational Site 2500059
city: La Teste-de-Buch
country: France
facility: Investigational Site Number: 2500071
city: Le Kremlin-Bicêtre
country: France
facility: Investigational Site Number: 2500034
city: Libourne
country: France
facility: Investigational Site Number: 2500072
city: Lille
country: France
facility: Investigational Site 2500046
city: Lille
country: France
facility: Investigational Site 2500005
city: Limoges
country: France
facility: Investigational Site Number: 2500012
city: Longjumeau
country: France
facility: Investigational Site Number: 2500037
city: Maromme
country: France
facility: Investigational Site 2500021
city: Marseille
country: France
facility: Investigational Site Number: 2500003
city: Marseille
country: France
facility: Investigational Site Number: 2500073
city: Mont-de-Marsan
country: France
facility: Investigational Site Number: 2500068
city: Mont-Saint-Aignan
country: France
facility: Investigational Site Number: 2500066
city: Montpellier
country: France
facility: Investigational Site Number: 2500067
city: Morlaix
country: France
facility: Investigational Site Number: 2500077
city: Nantes
country: France
facility: Investigational Site Number: 2500047
city: Nice
country: France
facility: Investigational Site Number: 2500055
city: Nice
country: France
facility: Investigational Site Number: 2500009
city: Nogent-sur-Marne
country: France
facility: Investigational Site Number: 2500040
city: Orleans
country: France
facility: Investigational Site Number: 2500022
city: Orleans
country: France
facility: Investigational Site Number: 2500050
city: Paris
country: France
facility: Investigational Site Number: 2500024
city: Paris
country: France
facility: Investigational Site Number: 2500010
city: Paris
country: France
facility: Investigational Site Number: 2500075
city: Paris
country: France
facility: Investigational Site Number: 2500051
city: Pau
country: France
facility: Investigational Site Number:
city: Poissy
country: France
facility: Investigational Site Number: 2500018
city: Puteaux
country: France
facility: Investigational Site Number: 2500026
city: Rouen
country: France
facility: Investigational Site Number: 2500042
city: Saint-Doulchard
country: France
facility: Investigational Site Number: 2500078
city: Saint-Julien-en-Genevois
country: France
facility: Investigational Site Number: 2500074
city: Saint-Maur-des-Fossés
country: France
facility: Investigational Site Number: 2500044
city: Saint-Sébastien-sur-Loire
country: France
facility: Investigational Site 2500020
city: Saverne
country: France
facility: Investigational Site Number: 2500052
city: Toulouse
country: France
facility: Investigational Site Number: 2500015
city: Tours
country: France
facility: Investigational Site Number: 2500035
city: Vendenheim
country: France
facility: Investigational Site Number: 2500049
city: Villeneuve-lès-Avignon
country: France
facility: Investigational Site Number: 2500011
city: Villeneuve-Saint-Georges
country: France
facility: Investigational Site Number: 2500063
city: Vincennes
country: France
facility: Investigational Site 2500028
city: Étampes
country: France
facility: Investigational Site 2500030
city: Augsburg
country: Germany
facility: Investigational Site Number: 2760036
city: Bad Wildungen
country: Germany
facility: Investigational Site Number: 2760017
city: Berlin
country: Germany
facility: Investigational Site Number: 2760099
city: Berlin
country: Germany
facility: Investigational Site Number: 2760076
city: Berlin
country: Germany
facility: Investigational Site Number: 2760056
city: Bielefeld
country: Germany
facility: Investigational Site Number: 2760050
city: Bocholt
country: Germany
facility: Investigational Site Number: 2760064
city: Bochum
country: Germany
facility: Investigational Site Number: 2760098
city: Bonn
country: Germany
facility: Investigational Site Number: 2760040
city: Bramsche
country: Germany
facility: Investigational Site Number: 2760025
city: Braunschweig
country: Germany
facility: Investigational Site Number: 2760018
city: Detmold
country: Germany
facility: Investigational Site Number: 2760051
city: Dortmund
country: Germany
facility: Investigational Site Number: 2760085
city: Dusseldorf
country: Germany
facility: Investigational Site Number: 2760101
city: Düsseldorf
country: Germany
facility: Investigational Site Number: 2760059
city: Eckental
country: Germany
facility: Investigational Site Number: 2760081
city: Erfurt
country: Germany
facility: Investigational Site Number: 2760045
city: Forchheim
country: Germany
facility: Investigational Site Number: 2760047
city: Frankfurt/Oder
country: Germany
facility: Investigational Site Number: 2760030
city: Freiburg I. Breisgau
country: Germany
facility: Investigational Site Number: 2760015
city: Gera
country: Germany
facility: Investigational Site Number: 2760079
city: Gilching
country: Germany
facility: Investigational Site Number: 2760005
city: Göttingen
country: Germany
facility: Investigational Site Number: 2760016
city: Göttingen
country: Germany
facility: Investigational Site Number: 2760060
city: Hamburg
country: Germany
facility: Investigational Site Number: 2760033
city: Hamburg
country: Germany
facility: Investigational Site Number: 2760057
city: Hamburg
country: Germany
facility: Investigational Site Number: 2760096
city: Hamm
country: Germany
facility: Investigational Site Number: 2760032
city: Hannover
country: Germany
facility: Investigational Site Number: 2760007
city: Heidelberg
country: Germany
facility: Investigational Site Number: 2760049
city: Herford
country: Germany
facility: Investigational Site Number: 2760008
city: Hürth
country: Germany
facility: Investigational Site 2760010
city: Hürth
country: Germany
facility: Investigational Site Number: 2760091
city: Itzehoe
country: Germany
facility: Investigational Site Number: 2760035
city: Kassel
country: Germany
facility: Investigational Site Number: 2760095
city: Kirchen
country: Germany
facility: Investigational Site Number: 2760084
city: Krefeld
country: Germany
facility: Investigational Site Number: 2760065
city: Leipzig
country: Germany
facility: Investigational Site Number: 2760020
city: Leipzig
country: Germany
facility: Investigational Site Number: 2760013
city: Mainz
country: Germany
facility: Investigational Site 2760006
city: Mainz
country: Germany
facility: Investigational Site Number: 2760086
city: Mannheim
country: Germany
facility: Investigational Site Number: 2760014
city: Munchen
country: Germany
facility: Investigational Site Number: 2760046
city: Mönchengladbach
country: Germany
facility: Investigational Site Number: 2760023
city: Mönchengladbach
country: Germany
facility: Investigational Site Number: 2760054
city: München
country: Germany
facility: Investigational Site Number: 2760094
city: München
country: Germany
facility: Investigational Site Number: 2760034
city: München
country: Germany
facility: Investigational Site Number: 2760038
city: München
country: Germany
facility: Investigational Site Number: 2760019
city: München
country: Germany
facility: Investigational Site Number: 2760061
city: Münster
country: Germany
facility: Investigational Site Number: 2760083
city: Neuss
country: Germany
facility: Investigational Site Number: 2760027
city: Niedernhausen
country: Germany
facility: Investigational Site Number: 2760004
city: Passau
country: Germany
facility: Investigational Site Number: 2760071
city: Regensburg
country: Germany
facility: Investigational Site Number: 2760001
city: Rosenheim
country: Germany
facility: Investigational Site Number: 2760003
city: Rüsselsheim A. Main
country: Germany
facility: Investigational Site Number: 2760062
city: Saarbrücken
country: Germany
facility: Investigational Site Number: 2760092
city: Schweigen
country: Germany
facility: Investigational Site Number: 2760044
city: Schönau
country: Germany
facility: Investigational Site 2760029
city: Suhl
country: Germany
facility: Investigational Site Number: 2760069
city: Tuttlingen
country: Germany
facility: Investigational Site Number: 2760067
city: Weiden
country: Germany
facility: Investigational Site Number: 2760043
city: Wesel
country: Germany
facility: Investigational Site Number: 2760002
city: Wolfsburg
country: Germany
facility: Investigational Site Number: 2760093
city: Wolfsburg
country: Germany
facility: Investigational Site Number: 2760028
city: Amersham
country: United Kingdom
facility: Investigational Site Number: 8260007
city: Ashford
country: United Kingdom
facility: Investigational Site Number: 8260096
city: Banbury
country: United Kingdom
facility: Investigational Site Number: 8260053
city: Barnet
country: United Kingdom
facility: Investigational Site Number: 8260057
city: Barnsley
country: United Kingdom
facility: Investigational Site Number: 8260004
city: Basildon
country: United Kingdom
facility: Investigational Site Number: 8260107
city: Basingstoke
country: United Kingdom
facility: Investigational Site Number: 8260110
city: Bath
country: United Kingdom
facility: Investigational Site Number: 8260067
city: Bath
country: United Kingdom
facility: Investigational Site 8260009
city: Bebington
country: United Kingdom
facility: Investigational Site Number: 8260100
city: Belfast
country: United Kingdom
facility: Investigational Site Number: 8260073
city: Bicester
country: United Kingdom
facility: Investigational Site Number: 8260095
city: Blackburn
country: United Kingdom
facility: Investigational Site Number: 8260029
city: Bollington
country: United Kingdom
facility: Investigational Site Number: 8260108
city: Bolton
country: United Kingdom
facility: Investigational Site Number: 8260085
city: Bradford
country: United Kingdom
facility: Investigational Site Number: 8260013
city: Brierley Hill
country: United Kingdom
facility: Investigational Site Number: 8260112
city: Brighton
country: United Kingdom
facility: Investigational Site Number: 8260058
city: Bristol
country: United Kingdom
facility: Investigational Site Number: 8260008
city: Bristol
country: United Kingdom
facility: Investigational Site Number: 8260019
city: Bristol
country: United Kingdom
facility: Investigational Site 8260046
city: Bury St. Edmunds
country: United Kingdom
facility: Investigational Site Number: 8260063
city: Cardiff
country: United Kingdom
facility: Investigational Site Number: 8260040
city: Cheltenham
country: United Kingdom
facility: Investigational Site Number: 8260062
city: Chertsey
country: United Kingdom
facility: Investigational Site Number: 8260066
city: Chippenham
country: United Kingdom
facility: Investigational Site Number: 8260061
city: Corby
country: United Kingdom
facility: Investigational Site Number: 8260036
city: Cottingham
country: United Kingdom
facility: Investigational Site Number: 8260054
city: Darlington
country: United Kingdom
facility: Investigational Site Number: 8260035
city: Darlington
country: United Kingdom
facility: Investigational Site Number: 8260037
city: Darlington
country: United Kingdom
facility: Investigational Site Number: 8260041
city: Dorchester
country: United Kingdom
facility: Investigational Site 8260064
city: Dundee
country: United Kingdom
facility: Investigational Site Number: 8260087
city: Exeter
country: United Kingdom
facility: Investigational Site 8260018
city: Gillingham
country: United Kingdom
facility: Investigational Site Number: 8260020
city: Great Yarmouth
country: United Kingdom
facility: Investigational Site Number: 8260056
city: Harrow
country: United Kingdom
facility: Investigational Site Number: 8260069
city: Highcliffe
country: United Kingdom
facility: Investigational Site Number: 8260109
city: Ipswich
country: United Kingdom
facility: Investigational Site Number: 8260101
city: Leicester
country: United Kingdom
facility: Investigational Site Number: 8260027
city: Leicester
country: United Kingdom
facility: Investigational Site Number: 8260091
city: Leicester
country: United Kingdom
facility: Investigational Site Number: 8260074
city: Liskeard
country: United Kingdom
facility: Investigational Site Number: 8260088
city: Liverpool
country: United Kingdom
facility: Investigational Site Number: 8260030
city: Liverpool
country: United Kingdom
facility: Investigational Site Number: 8260092
city: London
country: United Kingdom
facility: Investigational Site Number: 8260010
city: London
country: United Kingdom
facility: Investigational Site Number: 8260039
city: London
country: United Kingdom
facility: Investigational Site Number: 8260075
city: London
country: United Kingdom
facility: Investigational Site Number: 8260011
city: London
country: United Kingdom
facility: Investigational Site Number: 8260076
city: London
country: United Kingdom
facility: Investigational Site Number: 8260077
city: London
country: United Kingdom
facility: Investigational Site Number: 8260084
city: London
country: United Kingdom
facility: Investigational Site Number: 8260079
city: London
country: United Kingdom
facility: Investigational Site Number: 8260078
city: London
country: United Kingdom
facility: Investigational Site Number: 8260001
city: London
country: United Kingdom
facility: Investigational Site Number: 8260002
city: Macclesfield
country: United Kingdom
facility: Investigational Site Number: 8260071
city: Manchester
country: United Kingdom
facility: Investigational Site Number: 8260015
city: Margate
country: United Kingdom
facility: Investigational Site Number: 8260097
city: Middlesbrough
country: United Kingdom
facility: Investigational Site Number: 8260012
city: Milton Keynes
country: United Kingdom
facility: Investigational Site Number: 8260042
city: Nantwich
country: United Kingdom
facility: Investigational Site Number: 8260072
city: Newcastle Upon Tyne
country: United Kingdom
facility: Investigational Site Number: 8260044
city: Newport
country: United Kingdom
facility: Investigational Site Number: 8260119
city: Newquay
country: United Kingdom
facility: Investigational Site Number: 8260045
city: Norwich
country: United Kingdom
facility: Investigational Site Number: 8260024
city: Nottingham
country: United Kingdom
facility: Investigational Site 8260028
city: Nottingham
country: United Kingdom
facility: Investigational Site 8260043
city: Oxford
country: United Kingdom
facility: Investigational Site Number: 8260022
city: Oxford
country: United Kingdom
facility: Investigational Site Number: 8260003
city: Penzance
country: United Kingdom
facility: Investigational Site Number: 8260080
city: Peterborough
country: United Kingdom
facility: Investigational Site Number: 8260093
city: Plymouth
country: United Kingdom
facility: Investigational Site Number: 8260081
city: Poole
country: United Kingdom
facility: Investigational Site Number: 8260094
city: Poole
country: United Kingdom
facility: Investigational Site 8260005
city: Portsmouth
country: United Kingdom
facility: Investigational Site Number: 8260065
city: Prescot
country: United Kingdom
facility: Investigational Site Number: 8260106
city: Preston
country: United Kingdom
facility: Investigational Site Number: 8260117
city: Reading
country: United Kingdom
facility: Investigational Site Number: 8260016
city: Reading
country: United Kingdom
facility: Investigational Site Number: 8260086
city: Redhill
country: United Kingdom
facility: Investigational Site Number: 8260103
city: Redruth
country: United Kingdom
facility: Investigational Site Number: 8260105
city: Romsey
country: United Kingdom
facility: Investigational Site 8260026
city: Runcorn
country: United Kingdom
facility: Investigational Site Number: 8260068
city: Salford
country: United Kingdom
facility: Investigational Site Number: 8260059
city: Salisbury
country: United Kingdom
facility: Investigational Site Number: 8260111
city: Sheffield
country: United Kingdom
facility: Investigational Site Number: 8260014
city: Southampton
country: United Kingdom
facility: Investigational Site 8260051
city: Stevenage
country: United Kingdom
facility: Investigational Site Number: 8260038
city: Stockport
country: United Kingdom
facility: Investigational Site Number: 8260034
city: Stockton-on-Tees
country: United Kingdom
facility: Investigational Site Number: 8260025
city: Sunderland
country: United Kingdom
facility: Investigational Site Number: 8260052
city: Sutton In Ashfield
country: United Kingdom
facility: Investigational Site Number: 8260098
city: Swanage
country: United Kingdom
facility: Investigational Site Number: 8260083
city: Swindon
country: United Kingdom
facility: Investigational Site Number: 8260047
city: Swinton
country: United Kingdom
facility: Investigational Site Number: 8260115
city: Tameside
country: United Kingdom
facility: Investigational Site Number: 8260102
city: Taunton
country: United Kingdom
facility: Investigational Site Number: 8260032
city: Torpoint
country: United Kingdom
facility: Investigational Site Number: 8260031
city: Wantage
country: United Kingdom
facility: Investigational Site 8260082
city: Waterlooville
country: United Kingdom
facility: Investigational Site Number: 8260017
city: Winchester
country: United Kingdom
facility: Investigational Site Number: 8260104
city: Winscombe
country: United Kingdom
facility: Investigational Site Number: 8260021
city: Witney
country: United Kingdom
facility: Investigational Site Number: 8260006
city: Witney
country: United Kingdom
facility: Investigational Site Number: 8260060
city: Yeovil
country: United Kingdom
facility: Investigational Site Number: 8260050
city: York
country: United Kingdom
facility: Investigational Site Number: 8260116
city: York
country: United Kingdom
facility: Investigational Site 8260023
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: