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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Drug: Suptavumab 30 mg/kg; Drug: Placebo Matched to Suptavumab; Drug: Suptavumab 30 mg/kg- 1 Dose; Drug: Suptavumab 30 mg/kg - 2 Doses

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.

• Study Type: Interventional
• Enrollment (Actual): 1177
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Tasmania
    • Hobart, Tasmania, Australia
      • Regeneron Study Site
• Bulgaria
  • Blagoevgrad, Bulgaria
    • Regeneron Study Site
  • Dobrich, Bulgaria
    • Regeneron Study Site
  • Gabrovo, Bulgaria
    • Regeneron Study Site
  • Lom, Bulgaria
    • Regeneron Study Site
  • Montana, Bulgaria
    • Regeneron Study Site
  • Pleven, Bulgaria
    • Regeneron Study Site
  • Plovdiv, Bulgaria
    • Regeneron Study Site
  • Ruse, Bulgaria
    • Regeneron Study Site
  • Silistra, Bulgaria
    • Regeneron Study Site
  • Sliven, Bulgaria
    • Regeneron Study Site
  • Vidin, Bulgaria
    • Regeneron Study Site
  • Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria
      • Regeneron Study Site
  • Stara Zagora
    • Kazanlak, Stara Zagora, Bulgaria
      • Regeneron Study Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Regeneron Study Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Regeneron Study Site
  • Ontario
    • Ottawa, Ontario, Canada
      • Regeneron Study Site
• Chile
  • Santiago
    • La Florida, Santiago, Chile
      • Regeneron Study Site
    • Providencia, Santiago, Chile
      • Regeneron Study Site
    • Puente Alto, Santiago, Chile
      • Regeneron Study Site
    • Recoleta, Santiago, Chile
      • Regeneron Study Site
    • San Jose, Santiago, Chile
      • Regeneron Study Site
    • San Ramon, Santiago, Chile
      • Regeneron Study Site
• Denmark
  • Aalborg, Denmark
    • Regeneron Study Site
  • Hjorring, Denmark
    • Regeneron Study Site
  • Naestved, Denmark
    • Regeneron Study Site
  • Viborg, Denmark
    • Regeneron Study Site
• Finland
  • Pori, Finland
    • Regeneron Study Site
  • Turku, Finland
    • Regeneron Study Site
  • Oulun Iaani
    • Oulu, Oulun Iaani, Finland
      • Regeneron Study Site
    • Tampere, Oulun Iaani, Finland
      • Regeneron Study Site
• Germany
  • Bochum, Germany
    • Regeneron Study Site
  • Bramsche, Germany
    • Regeneron Study Site
  • Bretten, Germany
    • Regeneron Study Site
  • Frankenthal, Germany
    • Regeneron Study Site
  • Freiburg, Germany
    • Regeneron Study Site
  • Hamburg, Germany
    • Regeneron Study Site
  • Herxheim, Germany
    • Regeneron Study Site
  • Leipzig, Germany
    • Regeneron Study Site
  • Mainz, Germany
    • Regeneron Study Site
  • Mannheim, Germany
    • Regeneron Study Site
  • Moenchengladbach, Germany
    • Regeneron Study Site
  • Munich, Germany
    • Regeneron Study Site
  • Sankt Augustin, Germany
    • Regeneron Study Site
  • Wanzleben, Germany
    • Regeneron Study Site
• Hungary
  • Budapest, Hungary
    • Regeneron Study Site
  • Gyula, Hungary
    • Regeneron Study Site
  • Nyiregyhaza, Hungary
    • Regeneron Study Site
  • Pecs, Hungary
    • Regeneron Study Site
  • Veszprem, Hungary
    • Regeneron Study Site
  • Csongrad
    • Szeged, Csongrad, Hungary
      • Regeneron Study Site
• Netherlands
  • Utrecht, Netherlands
    • Regeneron Study Site
• New Zealand
  • Wellington, New Zealand
    • Regeneron Study Site
  • Manawatu-Wanganui
    • Palmerston North, Manawatu-Wanganui, New Zealand
      • Regeneron Study Site
  • North Island
    • Auckland, North Island, New Zealand
      • Regeneron Study Site
• Panama
  • Ciudad de Panama, Panama
    • Regeneron Study Site
• Puerto Rico
  • San Juan, Puerto Rico
    • Regeneron Study Site
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa
      • Regeneron Study Site
    • Pretoria, Gauteng, South Africa
      • Regeneron Study Site
  • North - West
    • Ga-Rankuwa, North - West, South Africa
      • Regeneron Study Site
• Spain
  • Granada, Spain
    • Regeneron Study Site
  • La Coruna, Spain
    • Regeneron Study Site
  • Madrid, Spain
    • Regeneron Study Site
  • Malaga, Spain
    • Regeneron Study Site
  • Manises, Spain
    • Regeneron Study Site
  • Santiago de Compostela, Spain
    • Regeneron Study Site
  • Sevilla, Spain
    • Regeneron Study Site
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain
      • Regeneron Study Site
• Sweden
  • Goteborg, Sweden
    • Regeneron Study Site
  • Uppsala, Sweden
    • Regeneron Study Site
• Turkey
  • Ankara, Turkey
    • Regeneron Study Site
  • Istanbul, Turkey
    • Regeneron Study Site
  • Izmir, Turkey
    • Regeneron Study Site
  • Kocaeli, Turkey
    • Regeneron Study Site
• Ukraine
  • Kharkiv, Ukraine
    • Regeneron Study Site
  • Kyiv, Ukraine
    • Regeneron Study Site
  • Poltava, Ukraine
    • Regeneron Study Site
  • Sumy, Ukraine
    • Regeneron Study Site
  • Ternopil, Ukraine
    • Regeneron Study Site
  • Zaporizhzhia, Ukraine
    • Regeneron Study Site
  • Chernivets'ka Oblast'
    • Chernivtsi, Chernivets'ka Oblast', Ukraine
      • Regeneron Study Site
  • Dnipropetrovs'ka Oblast'
    • Dnipropetrovsk, Dnipropetrovs'ka Oblast', Ukraine
      • Regeneron Study Site
  • Odes'ka Oblast'
    • Odessa, Odes'ka Oblast', Ukraine
      • Regeneron Study Site
  • Vinnyts'ka Oblast'
    • Vinnytsia, Vinnyts'ka Oblast', Ukraine
      • Regeneron Study Site
• United Kingdom
  • Belfast, United Kingdom
    • Regeneron Study Site
  • Birmingham, United Kingdom
    • Regeneron Study Site
  • Glasgow, United Kingdom
    • Regeneron Study Site
  • Manchester, United Kingdom
    • Regeneron Study Site
  • Poole, United Kingdom
    • Regeneron Study Site
  • Reading, United Kingdom
    • Regeneron Study Site
  • Sheffield, United Kingdom
    • Regeneron Study Site
  • Stockton on Tees, United Kingdom
    • Regeneron Study Site
  • Birmingham
    • Coventry, Birmingham, United Kingdom
      • Regeneron Study Site
  • Hampshire
    • Southampton, Hampshire, United Kingdom
      • Regeneron Study Site
  • Kent
    • Gillingham, Kent, United Kingdom
      • Regeneron Study Site
  • London, City Of
    • London, London, City Of, United Kingdom
      • Regeneron Study Site
  • Manchester
    • Oldham, Manchester, United Kingdom
      • Regeneron Study Site
    • Stockport, Manchester, United Kingdom
      • Regeneron Study Site
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Regeneron Investigational Site
    • Mobile, Alabama, United States
      • Regeneron Study Site
  • Arkansas
    • Little Rock, Arkansas, United States
      • Regeneron Study Site
  • California
    • Anaheim, California, United States
      • Regeneron Study Site
    • Bell Gardens, California, United States
      • Regeneron Study Site
    • Dinuba, California, United States
      • Regeneron Study Site
    • Downey, California, United States
      • Regeneron Study Site
    • Huntington Beach, California, United States
      • Regeneron Study Site
    • La Puente, California, United States
      • Regeneron Study Site
    • Los Angeles, California, United States
      • Regeneron Study Site
    • Madera, California, United States
      • Regeneron Study Site
    • Palmdale, California, United States
      • Regeneron Study Site
    • Ventura, California, United States
      • Regeneron Study Site
    • West Covina, California, United States
      • Regeneron Study Site
  • Colorado
    • Aurora, Colorado, United States
      • Regeneron Study Site
    • Thornton, Colorado, United States
      • Regeneron Study Site
  • Connecticut
    • Hartford, Connecticut, United States
      • Regeneron Study Site
  • Florida
    • Boynton Beach, Florida, United States
      • Regeneron Study Site
    • Gainesville, Florida, United States
      • Regeneron Study Site
    • Jacksonville, Florida, United States
      • Regeneron Study Site
    • Miami, Florida, United States
      • Regeneron Study Site
    • Orlando, Florida, United States
      • Regeneron Study Site
    • Pensacola, Florida, United States
      • Regeneron Study Site
    • Tampa, Florida, United States
      • Regeneron Study Site
    • Winter Park, Florida, United States
      • Regeneron Study Site
  • Georgia
    • Atlanta, Georgia, United States
      • Regeneron Study Site
    • Columbus, Georgia, United States
      • Regeneron Study Site
    • Dalton, Georgia, United States
      • Regeneron Study Site
  • Idaho
    • Meridian, Idaho, United States
      • Regeneron Study Site
    • Nampa, Idaho, United States
      • Regeneron Study Site
  • Illinois
    • Peoria, Illinois, United States
      • Regeneron Study Site
  • Indiana
    • South Bend, Indiana, United States
      • Regeneron Study Site
  • Kansas
    • Hutchinson, Kansas, United States
      • Regeneron Study Site
    • Topeka, Kansas, United States
      • Regeneron Study Site
  • Kentucky
    • Bardstown, Kentucky, United States
      • Regeneron Study Site
    • Louisville, Kentucky, United States
      • Regeneron Study Site
  • Louisiana
    • Metairie, Louisiana, United States
      • Regeneron Study Site
    • New Orleans, Louisiana, United States
      • Regeneron Study Site
    • Shreveport, Louisiana, United States
      • Regeneron Study Site
  • Maryland
    • Baltimore, Maryland, United States
      • Regeneron Study Site
    • Silver Spring, Maryland, United States
      • Regeneron Study Site
  • Massachusetts
    • Fall River, Massachusetts, United States
      • Regeneron Study Site
    • Woburn, Massachusetts, United States
      • Regeneron Study Site
  • Michigan
    • Stevensville, Michigan, United States
      • Regeneron Study Site
  • Minnesota
    • Duluth, Minnesota, United States
      • Regeneron Study Site
    • Minneapolis, Minnesota, United States
      • Regeneron Study Site
    • Saint Paul, Minnesota, United States
      • Regeneron Study Site
  • Mississippi
    • Jackson, Mississippi, United States
      • Regeneron Study Site
  • Missouri
    • Bridgeton, Missouri, United States
      • Regeneron Study Site
    • Kansas City, Missouri, United States
      • Regeneron Study Site
  • Nebraska
    • Lincoln, Nebraska, United States
      • Regeneron Study Site
    • Norfolk, Nebraska, United States
      • Regeneron Study Site
    • Omaha, Nebraska, United States
      • Regeneron Study Site
  • Nevada
    • Reno, Nevada, United States
      • Regeneron Study Site
  • New Hampshire
    • Lebanon, New Hampshire, United States
      • Regeneron Study Site
  • New Jersey
    • Neptune, New Jersey, United States
      • Regeneron Study Site
    • New Brunswick, New Jersey, United States
      • Regeneron Study Site
  • New York
    • Bronx, New York, United States
      • Regeneron Study Site
    • Brooklyn, New York, United States
      • Regeneron Study Site
    • Mineola, New York, United States
      • Regeneron Study Site
    • New Hyde Park, New York, United States
      • Regeneron Study Site
    • New York, New York, United States
      • Regeneron Study Site
    • Rochester, New York, United States
      • Regeneron Study Site
    • Syracuse, New York, United States
      • Regeneron Study Site
  • North Carolina
    • Boone, North Carolina, United States
      • Regeneron Study Site
    • Chapel Hill, North Carolina, United States
      • Regeneron Study Site
    • Durham, North Carolina, United States
      • Regeneron Study Site
    • Raleigh, North Carolina, United States
      • Regeneron Study Site
  • Ohio
    • Cincinnati, Ohio, United States
      • Regeneron Study Site
    • Cleveland, Ohio, United States
      • Regeneron Study Site
    • Columbus, Ohio, United States
      • Regeneron Study Site
    • Dayton, Ohio, United States
      • Regeneron Study Site
    • Fairfield, Ohio, United States
      • Regeneron Study Site
    • Mayfield Heights, Ohio, United States
      • Regeneron Study Site
    • Toledo, Ohio, United States
      • Regeneron Study Site
    • Youngstown, Ohio, United States
      • Regeneron Study Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Regeneron Study Site
    • Tulsa, Oklahoma, United States
      • Regeneron Study Site
  • Oregon
    • Gresham, Oregon, United States
      • Regeneron Study Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States
      • Regeneron Study Site
    • Erie, Pennsylvania, United States
      • Regeneron Study Site
    • Hermitage, Pennsylvania, United States
      • Regeneron Study Site
  • South Carolina
    • Charleston, South Carolina, United States
      • Regeneron Study Site
    • Cheraw, South Carolina, United States
      • Regeneron Study Site
    • Greenville, South Carolina, United States
      • Regeneron Study Site
    • North Charleston, South Carolina, United States
      • Regeneron Study Site
  • Tennessee
    • Alcoa, Tennessee, United States
      • Regeneron Study Site
    • Kingsport, Tennessee, United States
      • Regeneron Study Site
    • Nashville, Tennessee, United States
      • Regeneron Study Site
  • Texas
    • Austin, Texas, United States
      • Regeneron Study Site
    • Fort Sam Houston, Texas, United States
      • Regeneron Study Site
    • Houston, Texas, United States
      • Regeneron Study Site
    • San Antonio, Texas, United States
      • Regeneron Study Site
  • Utah
    • Layton, Utah, United States
      • Regeneron Study Site
    • Roy, Utah, United States
      • Regeneron Study Site
    • Saint George, Utah, United States
      • Regeneron Study Site
    • Syracuse, Utah, United States
      • Regeneron Study Site
  • Virginia
    • Charlottesville, Virginia, United States
      • Regeneron Study Site
    • Midlothian, Virginia, United States
      • Regeneron Study Site
    • Richmond, Virginia, United States
      • Regeneron Study Site
    • Vienna, Virginia, United States
      • Regeneron Study Site
  • West Virginia
    • Huntington, West Virginia, United States
      • Regeneron Study Site
    • Kingwood, West Virginia, United States
      • Regeneron Study Site
    • Morgantown, West Virginia, United States
      • Regeneron Study Site
  • Wisconsin
    • Madison, Wisconsin, United States
      • Regeneron Study Site
    • Marshfield, Wisconsin, United States
      • Regeneron Study Site
    • Milwaukee, Wisconsin, United States
      • Regeneron Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Suptavumab 30 mg/kg	Drug: Suptavumab 30 mg/kg; Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.; Other Names: REGN2222
Experimental: Part B: Placebo Matched to Suptavumab	Drug: Placebo Matched to Suptavumab; Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.
Experimental: Part B: Suptavumab 30 mg/kg- 1 Dose	Drug: Suptavumab 30 mg/kg- 1 Dose; Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
Experimental: Part B: Suptavumab 30 mg/kg - 2 Doses	Drug: Suptavumab 30 mg/kg - 2 Doses; Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 through Day 150
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.	From first study drug administration up to Day 150

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline through Day 150
Part B: Serum Concentration of Suptavumab	Serum samples for drug concentration will be collected at pre-specified time points	Day 29, 57, 85, 113 and Day 150 Post-dose
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).	Day 1 through Day 150
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.	From the first study drug administration up to Day 150

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 21, 2015
• Primary Completion (Actual): July 5, 2017
• Study Completion (Actual): September 26, 2017

Study Registration Dates

• First Submitted: December 21, 2014
• First Submitted That Met QC Criteria: December 21, 2014
• First Posted (Estimate): December 25, 2014

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Disease Attributes; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Infections; Communicable Diseases; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: R2222-RSV-1332

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No