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Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Suptavumab 30 mg/kg
Placebo Matched to Suptavumab
Suptavumab 30 mg/kg- 1 Dose
Suptavumab 30 mg/kg - 2 Doses
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Infections

Eligibility Criteria

undefined - 6 Months (Child)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

  1. Preterm, otherwise healthy male or female infant who is ≤6 months of age at the time of the first dose (i.e., infant must be treated on or before their 6 month birthday)
  2. Gestational age is ≤35 weeks, 6 days at birth
  3. Parent(s) or legal guardian(s) of the infant is able to understand the study requirements and willing to provide informed consent

Key Exclusion Criteria:

  1. Eligible, recommended and have access to receive palivizumab per AAP or other local guidelines, standard practice, or by their healthcare provider
  2. History of CLD defined as requirement of supplemental oxygen for 28 days after birth
  3. Known hemodynamically significant congenital heart disease
  4. Known immunodeficiency, neuromuscular disease, or congenital abnormalities of the airway
  5. Known renal or hepatic dysfunction
  6. Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
  7. Known or suspected impairment of immunological functions or autoimmune diseases
  8. History of anaphylaxis
  9. Previously received palivizumab or any other investigational RSV prophylaxis or vaccine product
  10. Previous reaction to IV immunoglobulin, blood products or other foreign proteins, including vaccines and monoclonal antibodies

Note: Other inclusion and exclusion criteria apply

Sites / Locations

  • Regeneron Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Part A: Suptavumab 30 mg/kg

Part B: Placebo Matched to Suptavumab

Part B: Suptavumab 30 mg/kg- 1 Dose

Part B: Suptavumab 30 mg/kg - 2 Doses

Arm Description

Outcomes

Primary Outcome Measures

Part A: Serum Concentration of Suptavumab Over Time
Part A was primarily designed to determine the pharmacokinetics (PK) of suptavumab in infants to inform the dose regimen used in Part B of the study. The study protocol specified the process and criteria for assessment of the dose. The dose used in Part B was to remain the same as Part A if the PK data up to Day 57 demonstrated that the individual PK observations were consistent with model-predicted concentrations, following age and body weight corrections.
Part B: Percentage of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Infection (Hospitalization or Outpatient Visit With Lower Respiratory Tract Infection [LRTI]) Up to Day 150
A medically attended RSV infection defined as an infant with positive RSV test by Reverse-transcriptase polymerase chain reaction (RT-PCR) with any of following events: Hospitalized (on basis of assessment of admitting physician) for RSV infection or outpatient visit (emergency room [ER], urgent care [UC], or pediatric clinic visits [for either a sick or well visit]) with RSV lower respiratory tract infection (LRTI). An RSV LRTI in an infant: RSV proven respiratory infection (i.e positive RSV RT-PCR test) with parent(s)/guardian(s) report of cough/difficulty breathing, & with 1 of following signs of LRTI, as assessed by healthcare provider: - lower chest wall in drawing -hypoxemia (peripheral capillary oxygen saturation <95% breathing room air) - Wheezing/crackles. The 150-day efficacy assessment period: first study drug intake through the Day 150 visit.

Secondary Outcome Measures

Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any untoward medical occurrence in participants, who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed/worsened/became serious during on-treatment period (defined as time between the date of first study drug administration & date of end of study/last visit).Serious AE: Any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious & non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03(Grade 3 [severe] & Grade 4[life-threatening]) was used in this study to grade clinical AEs.
Part B: Serum Concentration of Suptavumab
Serum samples for drug concentration will be collected at pre-specified time points
Part B: Number of Participants With At Least One Positive Anti-Drug Antibody (ADA) Assay
ADA category of each participant was classified as pre-existing immunoreactivity (a positive ADA response at baseline with a <4-fold increase in titer for all post baseline samples), treatment-boosted (a positive response at baseline with at least one post baseline titer at >=4-fold the baseline titer), or treatment-emergent (TE [any positive post baseline assay response when baseline results were negative or missing]). TE ADA responses were further classified as persistent (treatment-emergent positive ADA response detected in at least 2 consecutive post baseline samples separated by at least a 12-week post baseline period [based on nominal sampling time], with no ADA-negative samples in-between, regardless of any missing samples or a positive response at the last ADA sampling time point), indeterminate (a positive assay response at the last collection time point only, regardless of any missing samples), or transient (not persistent/indeterminate, regardless of any missing samples).
Part B: Percentage of Participants Hospitalized With Medically Attended RSV Infection or Outpatient Visit Lower Respiratory Tract Infection (LRTI) or Upper Respiratory Tract Infection (URTI) Up to Day 150
A medically attended RSV infection was defined as an infant with a positive RSV test by RT-PCR with any of the following events: -Hospitalized (on the basis of the assessment of the admitting physician) for RSV infection - or Outpatient visit (ER, UC), or pediatric clinic visits [for either a sick or well visit]) with RSV LRTI. An RSV LRTI in an infant: RSV-proven respiratory infection (i.e, positive RSV RT-PCR test) with parent(s)/guardian(s) report of cough or difficulty breathing, and with 1 of the following signs of LRTI, as assessed by a healthcare provider: -Lower chest wall indrawing -Hypoxemia (peripheral capillary oxygen saturation <95% breathing room air) -Wheezing or crackles. The 150-day efficacy assessment period:first study drug intake through the Day 150 visit.

Full Information

First Posted
December 21, 2014
Last Updated
October 8, 2018
Sponsor
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02325791
Brief Title
Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of a Human Monoclonal Antibody, REGN2222, for the Prevention of Medically Attended RSV Infection in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 21, 2015 (undefined)
Primary Completion Date
July 5, 2017 (Actual)
Study Completion Date
September 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age at the time of enrollment in their respective geographic location. In order to optimize the potential benefit in this vulnerable population, we conducted this study during the RSV season using dosing regimens that are expected to be effective.
Detailed Description
This study occurred in two parts: Part A and Part B. Part A of the study was an open-label, PK evaluation of intramuscular (IM) administered suptavumab in preterm infants for whom palivizumab was not recommended to enable the selection of dosing regimens for Part B. Part B of the study was randomized, double-blind, and placebo-controlled, designed to evaluate efficacy, safety, serum concentration and immunogenicity of IM administration of suptavumab in preterm infants for whom palivizumab was not recommended. The total duration of Part B was up to 265 days (includes a 28-day screening period, 57-day treatment period and 180-day follow-up period). Up to 1515 subjects were planned to be included in Part B of the study. Participants were randomly assigned to 1 of 3 different groups, each with 505 infants; one group received one dose of suptavumab and one dose of placebo, the second group received two doses of suptavumab, and the third group received two doses of placebo. There was a separate genetic testing sub study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: Suptavumab 30 mg/kg
Arm Type
Experimental
Arm Title
Part B: Placebo Matched to Suptavumab
Arm Type
Experimental
Arm Title
Part B: Suptavumab 30 mg/kg- 1 Dose
Arm Type
Experimental
Arm Title
Part B: Suptavumab 30 mg/kg - 2 Doses
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Suptavumab 30 mg/kg
Other Intervention Name(s)
REGN2222
Intervention Description
Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.
Intervention Type
Drug
Intervention Name(s)
Placebo Matched to Suptavumab
Intervention Description
Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.
Intervention Type
Drug
Intervention Name(s)
Suptavumab 30 mg/kg- 1 Dose
Intervention Description
Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
Intervention Type
Drug
Intervention Name(s)
Suptavumab 30 mg/kg - 2 Doses
Intervention Description
Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
Primary Outcome Measure Information:
Title
Part A: Serum Concentration of Suptavumab Over Time
Description
Part A was primarily designed to determine the pharmacokinetics (PK) of suptavumab in infants to inform the dose regimen used in Part B of the study. The study protocol specified the process and criteria for assessment of the dose. The dose used in Part B was to remain the same as Part A if the PK data up to Day 57 demonstrated that the individual PK observations were consistent with model-predicted concentrations, following age and body weight corrections.
Time Frame
Day 1 through Day 150
Title
Part B: Percentage of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Infection (Hospitalization or Outpatient Visit With Lower Respiratory Tract Infection [LRTI]) Up to Day 150
Description
A medically attended RSV infection defined as an infant with positive RSV test by Reverse-transcriptase polymerase chain reaction (RT-PCR) with any of following events: Hospitalized (on basis of assessment of admitting physician) for RSV infection or outpatient visit (emergency room [ER], urgent care [UC], or pediatric clinic visits [for either a sick or well visit]) with RSV lower respiratory tract infection (LRTI). An RSV LRTI in an infant: RSV proven respiratory infection (i.e positive RSV RT-PCR test) with parent(s)/guardian(s) report of cough/difficulty breathing, & with 1 of following signs of LRTI, as assessed by healthcare provider: - lower chest wall in drawing -hypoxemia (peripheral capillary oxygen saturation <95% breathing room air) - Wheezing/crackles. The 150-day efficacy assessment period: first study drug intake through the Day 150 visit.
Time Frame
From first study drug administration up to Day 150
Secondary Outcome Measure Information:
Title
Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
Any untoward medical occurrence in participants, who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed/worsened/became serious during on-treatment period (defined as time between the date of first study drug administration & date of end of study/last visit).Serious AE: Any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious & non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03(Grade 3 [severe] & Grade 4[life-threatening]) was used in this study to grade clinical AEs.
Time Frame
Baseline through Day 150
Title
Part B: Serum Concentration of Suptavumab
Description
Serum samples for drug concentration will be collected at pre-specified time points
Time Frame
Day 29, 57, 85, 113 and Day 150 Post-dose
Title
Part B: Number of Participants With At Least One Positive Anti-Drug Antibody (ADA) Assay
Description
ADA category of each participant was classified as pre-existing immunoreactivity (a positive ADA response at baseline with a <4-fold increase in titer for all post baseline samples), treatment-boosted (a positive response at baseline with at least one post baseline titer at >=4-fold the baseline titer), or treatment-emergent (TE [any positive post baseline assay response when baseline results were negative or missing]). TE ADA responses were further classified as persistent (treatment-emergent positive ADA response detected in at least 2 consecutive post baseline samples separated by at least a 12-week post baseline period [based on nominal sampling time], with no ADA-negative samples in-between, regardless of any missing samples or a positive response at the last ADA sampling time point), indeterminate (a positive assay response at the last collection time point only, regardless of any missing samples), or transient (not persistent/indeterminate, regardless of any missing samples).
Time Frame
Day 1 through Day 150
Title
Part B: Percentage of Participants Hospitalized With Medically Attended RSV Infection or Outpatient Visit Lower Respiratory Tract Infection (LRTI) or Upper Respiratory Tract Infection (URTI) Up to Day 150
Description
A medically attended RSV infection was defined as an infant with a positive RSV test by RT-PCR with any of the following events: -Hospitalized (on the basis of the assessment of the admitting physician) for RSV infection - or Outpatient visit (ER, UC), or pediatric clinic visits [for either a sick or well visit]) with RSV LRTI. An RSV LRTI in an infant: RSV-proven respiratory infection (i.e, positive RSV RT-PCR test) with parent(s)/guardian(s) report of cough or difficulty breathing, and with 1 of the following signs of LRTI, as assessed by a healthcare provider: -Lower chest wall indrawing -Hypoxemia (peripheral capillary oxygen saturation <95% breathing room air) -Wheezing or crackles. The 150-day efficacy assessment period:first study drug intake through the Day 150 visit.
Time Frame
From the first study drug administration up to Day 150

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: Preterm, otherwise healthy male or female infant who is ≤6 months of age at the time of the first dose (i.e., infant must be treated on or before their 6 month birthday) Gestational age is ≤35 weeks, 6 days at birth Parent(s) or legal guardian(s) of the infant is able to understand the study requirements and willing to provide informed consent Key Exclusion Criteria: Eligible, recommended and have access to receive palivizumab per AAP or other local guidelines, standard practice, or by their healthcare provider History of CLD defined as requirement of supplemental oxygen for 28 days after birth Known hemodynamically significant congenital heart disease Known immunodeficiency, neuromuscular disease, or congenital abnormalities of the airway Known renal or hepatic dysfunction Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders Known or suspected impairment of immunological functions or autoimmune diseases History of anaphylaxis Previously received palivizumab or any other investigational RSV prophylaxis or vaccine product Previous reaction to IV immunoglobulin, blood products or other foreign proteins, including vaccines and monoclonal antibodies Note: Other inclusion and exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Regeneron Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Regeneron Study Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Regeneron Study Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Regeneron Study Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Regeneron Study Site
City
Bell Gardens
State/Province
California
Country
United States
Facility Name
Regeneron Study Site
City
Dinuba
State/Province
California
Country
United States
Facility Name
Regeneron Study Site
City
Downey
State/Province
California
Country
United States
Facility Name
Regeneron Study Site
City
Huntington Beach
State/Province
California
Country
United States
Facility Name
Regeneron Study Site
City
La Puente
State/Province
California
Country
United States
Facility Name
Regeneron Study Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Regeneron Study Site
City
Madera
State/Province
California
Country
United States
Facility Name
Regeneron Study Site
City
Palmdale
State/Province
California
Country
United States
Facility Name
Regeneron Study Site
City
Ventura
State/Province
California
Country
United States
Facility Name
Regeneron Study Site
City
West Covina
State/Province
California
Country
United States
Facility Name
Regeneron Study Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Regeneron Study Site
City
Thornton
State/Province
Colorado
Country
United States
Facility Name
Regeneron Study Site
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Regeneron Study Site
City
Boynton Beach
State/Province
Florida
Country
United States
Facility Name
Regeneron Study Site
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Regeneron Study Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Regeneron Study Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Regeneron Study Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Regeneron Study Site
City
Pensacola
State/Province
Florida
Country
United States
Facility Name
Regeneron Study Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Regeneron Study Site
City
Winter Park
State/Province
Florida
Country
United States
Facility Name
Regeneron Study Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Regeneron Study Site
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
Regeneron Study Site
City
Dalton
State/Province
Georgia
Country
United States
Facility Name
Regeneron Study Site
City
Meridian
State/Province
Idaho
Country
United States
Facility Name
Regeneron Study Site
City
Nampa
State/Province
Idaho
Country
United States
Facility Name
Regeneron Study Site
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
Regeneron Study Site
City
South Bend
State/Province
Indiana
Country
United States
Facility Name
Regeneron Study Site
City
Hutchinson
State/Province
Kansas
Country
United States
Facility Name
Regeneron Study Site
City
Topeka
State/Province
Kansas
Country
United States
Facility Name
Regeneron Study Site
City
Bardstown
State/Province
Kentucky
Country
United States
Facility Name
Regeneron Study Site
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Regeneron Study Site
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Regeneron Study Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Regeneron Study Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Regeneron Study Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Regeneron Study Site
City
Silver Spring
State/Province
Maryland
Country
United States
Facility Name
Regeneron Study Site
City
Fall River
State/Province
Massachusetts
Country
United States
Facility Name
Regeneron Study Site
City
Woburn
State/Province
Massachusetts
Country
United States
Facility Name
Regeneron Study Site
City
Stevensville
State/Province
Michigan
Country
United States
Facility Name
Regeneron Study Site
City
Duluth
State/Province
Minnesota
Country
United States
Facility Name
Regeneron Study Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Regeneron Study Site
City
Saint Paul
State/Province
Minnesota
Country
United States
Facility Name
Regeneron Study Site
City
Jackson
State/Province
Mississippi
Country
United States
Facility Name
Regeneron Study Site
City
Bridgeton
State/Province
Missouri
Country
United States
Facility Name
Regeneron Study Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Regeneron Study Site
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
Regeneron Study Site
City
Norfolk
State/Province
Nebraska
Country
United States
Facility Name
Regeneron Study Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Regeneron Study Site
City
Reno
State/Province
Nevada
Country
United States
Facility Name
Regeneron Study Site
City
Lebanon
State/Province
New Hampshire
Country
United States
Facility Name
Regeneron Study Site
City
Neptune
State/Province
New Jersey
Country
United States
Facility Name
Regeneron Study Site
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
Regeneron Study Site
City
Bronx
State/Province
New York
Country
United States
Facility Name
Regeneron Study Site
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Regeneron Study Site
City
Mineola
State/Province
New York
Country
United States
Facility Name
Regeneron Study Site
City
New Hyde Park
State/Province
New York
Country
United States
Facility Name
Regeneron Study Site
City
New York
State/Province
New York
Country
United States
Facility Name
Regeneron Study Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Regeneron Study Site
City
Syracuse
State/Province
New York
Country
United States
Facility Name
Regeneron Study Site
City
Boone
State/Province
North Carolina
Country
United States
Facility Name
Regeneron Study Site
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Regeneron Study Site
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Regeneron Study Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Regeneron Study Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Regeneron Study Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Regeneron Study Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Regeneron Study Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Regeneron Study Site
City
Fairfield
State/Province
Ohio
Country
United States
Facility Name
Regeneron Study Site
City
Mayfield Heights
State/Province
Ohio
Country
United States
Facility Name
Regeneron Study Site
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Regeneron Study Site
City
Youngstown
State/Province
Ohio
Country
United States
Facility Name
Regeneron Study Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Regeneron Study Site
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Regeneron Study Site
City
Gresham
State/Province
Oregon
Country
United States
Facility Name
Regeneron Study Site
City
Allentown
State/Province
Pennsylvania
Country
United States
Facility Name
Regeneron Study Site
City
Erie
State/Province
Pennsylvania
Country
United States
Facility Name
Regeneron Study Site
City
Hermitage
State/Province
Pennsylvania
Country
United States
Facility Name
Regeneron Study Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Regeneron Study Site
City
Cheraw
State/Province
South Carolina
Country
United States
Facility Name
Regeneron Study Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Regeneron Study Site
City
North Charleston
State/Province
South Carolina
Country
United States
Facility Name
Regeneron Study Site
City
Alcoa
State/Province
Tennessee
Country
United States
Facility Name
Regeneron Study Site
City
Kingsport
State/Province
Tennessee
Country
United States
Facility Name
Regeneron Study Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Regeneron Study Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Regeneron Study Site
City
Fort Sam Houston
State/Province
Texas
Country
United States
Facility Name
Regeneron Study Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Regeneron Study Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Regeneron Study Site
City
Layton
State/Province
Utah
Country
United States
Facility Name
Regeneron Study Site
City
Roy
State/Province
Utah
Country
United States
Facility Name
Regeneron Study Site
City
Saint George
State/Province
Utah
Country
United States
Facility Name
Regeneron Study Site
City
Syracuse
State/Province
Utah
Country
United States
Facility Name
Regeneron Study Site
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Regeneron Study Site
City
Midlothian
State/Province
Virginia
Country
United States
Facility Name
Regeneron Study Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Regeneron Study Site
City
Vienna
State/Province
Virginia
Country
United States
Facility Name
Regeneron Study Site
City
Huntington
State/Province
West Virginia
Country
United States
Facility Name
Regeneron Study Site
City
Kingwood
State/Province
West Virginia
Country
United States
Facility Name
Regeneron Study Site
City
Morgantown
State/Province
West Virginia
Country
United States
Facility Name
Regeneron Study Site
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
Regeneron Study Site
City
Marshfield
State/Province
Wisconsin
Country
United States
Facility Name
Regeneron Study Site
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Regeneron Study Site
City
Hobart
State/Province
Tasmania
Country
Australia
Facility Name
Regeneron Study Site
City
Sofia
State/Province
Sofia-Grad
Country
Bulgaria
Facility Name
Regeneron Study Site
City
Kazanlak
State/Province
Stara Zagora
Country
Bulgaria
Facility Name
Regeneron Study Site
City
Blagoevgrad
Country
Bulgaria
Facility Name
Regeneron Study Site
City
Dobrich
Country
Bulgaria
Facility Name
Regeneron Study Site
City
Gabrovo
Country
Bulgaria
Facility Name
Regeneron Study Site
City
Lom
Country
Bulgaria
Facility Name
Regeneron Study Site
City
Montana
Country
Bulgaria
Facility Name
Regeneron Study Site
City
Pleven
Country
Bulgaria
Facility Name
Regeneron Study Site
City
Plovdiv
Country
Bulgaria
Facility Name
Regeneron Study Site
City
Ruse
Country
Bulgaria
Facility Name
Regeneron Study Site
City
Silistra
Country
Bulgaria
Facility Name
Regeneron Study Site
City
Sliven
Country
Bulgaria
Facility Name
Regeneron Study Site
City
Vidin
Country
Bulgaria
Facility Name
Regeneron Study Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Regeneron Study Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Regeneron Study Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Regeneron Study Site
City
La Florida
State/Province
Santiago
Country
Chile
Facility Name
Regeneron Study Site
City
Providencia
State/Province
Santiago
Country
Chile
Facility Name
Regeneron Study Site
City
Puente Alto
State/Province
Santiago
Country
Chile
Facility Name
Regeneron Study Site
City
Recoleta
State/Province
Santiago
Country
Chile
Facility Name
Regeneron Study Site
City
San Jose
State/Province
Santiago
Country
Chile
Facility Name
Regeneron Study Site
City
San Ramon
State/Province
Santiago
Country
Chile
Facility Name
Regeneron Study Site
City
Aalborg
Country
Denmark
Facility Name
Regeneron Study Site
City
Hjorring
Country
Denmark
Facility Name
Regeneron Study Site
City
Naestved
Country
Denmark
Facility Name
Regeneron Study Site
City
Viborg
Country
Denmark
Facility Name
Regeneron Study Site
City
Oulu
State/Province
Oulun Iaani
Country
Finland
Facility Name
Regeneron Study Site
City
Tampere
State/Province
Oulun Iaani
Country
Finland
Facility Name
Regeneron Study Site
City
Pori
Country
Finland
Facility Name
Regeneron Study Site
City
Turku
Country
Finland
Facility Name
Regeneron Study Site
City
Bochum
Country
Germany
Facility Name
Regeneron Study Site
City
Bramsche
Country
Germany
Facility Name
Regeneron Study Site
City
Bretten
Country
Germany
Facility Name
Regeneron Study Site
City
Frankenthal
Country
Germany
Facility Name
Regeneron Study Site
City
Freiburg
Country
Germany
Facility Name
Regeneron Study Site
City
Hamburg
Country
Germany
Facility Name
Regeneron Study Site
City
Herxheim
Country
Germany
Facility Name
Regeneron Study Site
City
Leipzig
Country
Germany
Facility Name
Regeneron Study Site
City
Mainz
Country
Germany
Facility Name
Regeneron Study Site
City
Mannheim
Country
Germany
Facility Name
Regeneron Study Site
City
Moenchengladbach
Country
Germany
Facility Name
Regeneron Study Site
City
Munich
Country
Germany
Facility Name
Regeneron Study Site
City
Sankt Augustin
Country
Germany
Facility Name
Regeneron Study Site
City
Wanzleben
Country
Germany
Facility Name
Regeneron Study Site
City
Szeged
State/Province
Csongrad
Country
Hungary
Facility Name
Regeneron Study Site
City
Budapest
Country
Hungary
Facility Name
Regeneron Study Site
City
Gyula
Country
Hungary
Facility Name
Regeneron Study Site
City
Nyiregyhaza
Country
Hungary
Facility Name
Regeneron Study Site
City
Pecs
Country
Hungary
Facility Name
Regeneron Study Site
City
Veszprem
Country
Hungary
Facility Name
Regeneron Study Site
City
Utrecht
Country
Netherlands
Facility Name
Regeneron Study Site
City
Palmerston North
State/Province
Manawatu-Wanganui
Country
New Zealand
Facility Name
Regeneron Study Site
City
Auckland
State/Province
North Island
Country
New Zealand
Facility Name
Regeneron Study Site
City
Wellington
Country
New Zealand
Facility Name
Regeneron Study Site
City
Ciudad de Panama
Country
Panama
Facility Name
Regeneron Study Site
City
San Juan
Country
Puerto Rico
Facility Name
Regeneron Study Site
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Regeneron Study Site
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Regeneron Study Site
City
Ga-Rankuwa
State/Province
North - West
Country
South Africa
Facility Name
Regeneron Study Site
City
Esplugues de Llobregat
State/Province
Barcelona
Country
Spain
Facility Name
Regeneron Study Site
City
Granada
Country
Spain
Facility Name
Regeneron Study Site
City
La Coruna
Country
Spain
Facility Name
Regeneron Study Site
City
Madrid
Country
Spain
Facility Name
Regeneron Study Site
City
Malaga
Country
Spain
Facility Name
Regeneron Study Site
City
Manises
Country
Spain
Facility Name
Regeneron Study Site
City
Santiago de Compostela
Country
Spain
Facility Name
Regeneron Study Site
City
Sevilla
Country
Spain
Facility Name
Regeneron Study Site
City
Goteborg
Country
Sweden
Facility Name
Regeneron Study Site
City
Uppsala
Country
Sweden
Facility Name
Regeneron Study Site
City
Ankara
Country
Turkey
Facility Name
Regeneron Study Site
City
Istanbul
Country
Turkey
Facility Name
Regeneron Study Site
City
Izmir
Country
Turkey
Facility Name
Regeneron Study Site
City
Kocaeli
Country
Turkey
Facility Name
Regeneron Study Site
City
Chernivtsi
State/Province
Chernivets'ka Oblast'
Country
Ukraine
Facility Name
Regeneron Study Site
City
Dnipropetrovsk
State/Province
Dnipropetrovs'ka Oblast'
Country
Ukraine
Facility Name
Regeneron Study Site
City
Odessa
State/Province
Odes'ka Oblast'
Country
Ukraine
Facility Name
Regeneron Study Site
City
Vinnytsia
State/Province
Vinnyts'ka Oblast'
Country
Ukraine
Facility Name
Regeneron Study Site
City
Kharkiv
Country
Ukraine
Facility Name
Regeneron Study Site
City
Kyiv
Country
Ukraine
Facility Name
Regeneron Study Site
City
Poltava
Country
Ukraine
Facility Name
Regeneron Study Site
City
Sumy
Country
Ukraine
Facility Name
Regeneron Study Site
City
Ternopil
Country
Ukraine
Facility Name
Regeneron Study Site
City
Zaporizhzhia
Country
Ukraine
Facility Name
Regeneron Study Site
City
Coventry
State/Province
Birmingham
Country
United Kingdom
Facility Name
Regeneron Study Site
City
Southampton
State/Province
Hampshire
Country
United Kingdom
Facility Name
Regeneron Study Site
City
Gillingham
State/Province
Kent
Country
United Kingdom
Facility Name
Regeneron Study Site
City
London
State/Province
London, City Of
Country
United Kingdom
Facility Name
Regeneron Study Site
City
Oldham
State/Province
Manchester
Country
United Kingdom
Facility Name
Regeneron Study Site
City
Stockport
State/Province
Manchester
Country
United Kingdom
Facility Name
Regeneron Study Site
City
Belfast
Country
United Kingdom
Facility Name
Regeneron Study Site
City
Birmingham
Country
United Kingdom
Facility Name
Regeneron Study Site
City
Glasgow
Country
United Kingdom
Facility Name
Regeneron Study Site
City
Manchester
Country
United Kingdom
Facility Name
Regeneron Study Site
City
Poole
Country
United Kingdom
Facility Name
Regeneron Study Site
City
Reading
Country
United Kingdom
Facility Name
Regeneron Study Site
City
Sheffield
Country
United Kingdom
Facility Name
Regeneron Study Site
City
Stockton on Tees
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32897368
Citation
Simoes EAF, Forleo-Neto E, Geba GP, Kamal M, Yang F, Cicirello H, Houghton MR, Rideman R, Zhao Q, Benvin SL, Hawes A, Fuller ED, Wloga E, Pizarro JMN, Munoz FM, Rush SA, McLellan JS, Lipsich L, Stahl N, Yancopoulos GD, Weinreich DM, Kyratsous CA, Sivapalasingam S. Suptavumab for the Prevention of Medically Attended Respiratory Syncytial Virus Infection in Preterm Infants. Clin Infect Dis. 2021 Dec 6;73(11):e4400-e4408. doi: 10.1093/cid/ciaa951.
Results Reference
derived

Learn more about this trial

Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants

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