Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
Public ClinicalTrials.gov record NCT02325791. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02325791
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,177 participants
Conditions and interventions
Conditions
Interventions
- Suptavumab 30 mg/kg Drug
- Placebo Matched to Suptavumab Drug
- Suptavumab 30 mg/kg- 1 Dose Drug
- Suptavumab 30 mg/kg - 2 Doses Drug
Drug
Eligibility (public fields only)
- Age range
- Up to 6 Months
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 21, 2015 (Type not available)
- Primary completion
- Jul 5, 2017 (Actual)
- Completion
- Sep 26, 2017 (Actual)
- Last update posted
- Nov 6, 2018
2015 – 2017
United States locations
- U.S. sites
- 107
- U.S. states
- 36
- U.S. cities
- 107
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regeneron Investigational Site | Birmingham | Alabama | — | — |
| Regeneron Study Site | Mobile | Alabama | — | — |
| Regeneron Study Site | Little Rock | Arkansas | — | — |
| Regeneron Study Site | Anaheim | California | — | — |
| Regeneron Study Site | Bell Gardens | California | — | — |
| Regeneron Study Site | Dinuba | California | — | — |
| Regeneron Study Site | Downey | California | — | — |
| Regeneron Study Site | Huntington Beach | California | — | — |
| Regeneron Study Site | La Puente | California | — | — |
| Regeneron Study Site | Los Angeles | California | — | — |
| Regeneron Study Site | Madera | California | — | — |
| Regeneron Study Site | Palmdale | California | — | — |
| Regeneron Study Site | Ventura | California | — | — |
| Regeneron Study Site | West Covina | California | — | — |
| Regeneron Study Site | Aurora | Colorado | — | — |
| Regeneron Study Site | Thornton | Colorado | — | — |
| Regeneron Study Site | Hartford | Connecticut | — | — |
| Regeneron Study Site | Boynton Beach | Florida | — | — |
| Regeneron Study Site | Gainesville | Florida | — | — |
| Regeneron Study Site | Jacksonville | Florida | — | — |
| Regeneron Study Site | Miami | Florida | — | — |
| Regeneron Study Site | Orlando | Florida | — | — |
| Regeneron Study Site | Pensacola | Florida | — | — |
| Regeneron Study Site | Tampa | Florida | — | — |
| Regeneron Study Site | Winter Park | Florida | — | — |
| Regeneron Study Site | Atlanta | Georgia | — | — |
| Regeneron Study Site | Columbus | Georgia | — | — |
| Regeneron Study Site | Dalton | Georgia | — | — |
| Regeneron Study Site | Meridian | Idaho | — | — |
| Regeneron Study Site | Nampa | Idaho | — | — |
| Regeneron Study Site | Peoria | Illinois | — | — |
| Regeneron Study Site | South Bend | Indiana | — | — |
| Regeneron Study Site | Hutchinson | Kansas | — | — |
| Regeneron Study Site | Topeka | Kansas | — | — |
| Regeneron Study Site | Bardstown | Kentucky | — | — |
| Regeneron Study Site | Louisville | Kentucky | — | — |
| Regeneron Study Site | Metairie | Louisiana | — | — |
| Regeneron Study Site | New Orleans | Louisiana | — | — |
| Regeneron Study Site | Shreveport | Louisiana | — | — |
| Regeneron Study Site | Baltimore | Maryland | — | — |
| Regeneron Study Site | Silver Spring | Maryland | — | — |
| Regeneron Study Site | Fall River | Massachusetts | — | — |
| Regeneron Study Site | Woburn | Massachusetts | — | — |
| Regeneron Study Site | Stevensville | Michigan | — | — |
| Regeneron Study Site | Duluth | Minnesota | — | — |
| Regeneron Study Site | Minneapolis | Minnesota | — | — |
| Regeneron Study Site | Saint Paul | Minnesota | — | — |
| Regeneron Study Site | Jackson | Mississippi | — | — |
| Regeneron Study Site | Bridgeton | Missouri | — | — |
| Regeneron Study Site | Kansas City | Missouri | — | — |
| Regeneron Study Site | Lincoln | Nebraska | — | — |
| Regeneron Study Site | Norfolk | Nebraska | — | — |
| Regeneron Study Site | Omaha | Nebraska | — | — |
| Regeneron Study Site | Reno | Nevada | — | — |
| Regeneron Study Site | Lebanon | New Hampshire | — | — |
| Regeneron Study Site | Neptune City | New Jersey | — | — |
| Regeneron Study Site | New Brunswick | New Jersey | — | — |
| Regeneron Study Site | Brooklyn | New York | — | — |
| Regeneron Study Site | Mineola | New York | — | — |
| Regeneron Study Site | New Hyde Park | New York | — | — |
| Regeneron Study Site | New York | New York | — | — |
| Regeneron Study Site | Rochester | New York | — | — |
| Regeneron Study Site | Syracuse | New York | — | — |
| Regeneron Study Site | The Bronx | New York | — | — |
| Regeneron Study Site | Boone | North Carolina | — | — |
| Regeneron Study Site | Chapel Hill | North Carolina | — | — |
| Regeneron Study Site | Durham | North Carolina | — | — |
| Regeneron Study Site | Raleigh | North Carolina | — | — |
| Regeneron Study Site | Cincinnati | Ohio | — | — |
| Regeneron Study Site | Cleveland | Ohio | — | — |
| Regeneron Study Site | Columbus | Ohio | — | — |
| Regeneron Study Site | Dayton | Ohio | — | — |
| Regeneron Study Site | Fairfield | Ohio | — | — |
| Regeneron Study Site | Mayfield Heights | Ohio | — | — |
| Regeneron Study Site | Toledo | Ohio | — | — |
| Regeneron Study Site | Youngstown | Ohio | — | — |
| Regeneron Study Site | Oklahoma City | Oklahoma | — | — |
| Regeneron Study Site | Tulsa | Oklahoma | — | — |
| Regeneron Study Site | Gresham | Oregon | — | — |
| Regeneron Study Site | Allentown | Pennsylvania | — | — |
| Regeneron Study Site | Erie | Pennsylvania | — | — |
| Regeneron Study Site | Hermitage | Pennsylvania | — | — |
| Regeneron Study Site | Charleston | South Carolina | — | — |
| Regeneron Study Site | Cheraw | South Carolina | — | — |
| Regeneron Study Site | Greenville | South Carolina | — | — |
| Regeneron Study Site | North Charleston | South Carolina | — | — |
| Regeneron Study Site | Alcoa | Tennessee | — | — |
| Regeneron Study Site | Kingsport | Tennessee | — | — |
| Regeneron Study Site | Nashville | Tennessee | — | — |
| Regeneron Study Site | Austin | Texas | — | — |
| Regeneron Study Site | Fort Sam Houston | Texas | — | — |
| Regeneron Study Site | Houston | Texas | — | — |
| Regeneron Study Site | San Antonio | Texas | — | — |
| Regeneron Study Site | Layton | Utah | — | — |
| Regeneron Study Site | Roy | Utah | — | — |
| Regeneron Study Site | St. George | Utah | — | — |
| Regeneron Study Site | Syracuse | Utah | — | — |
| Regeneron Study Site | Charlottesville | Virginia | — | — |
| Regeneron Study Site | Midlothian | Virginia | — | — |
| Regeneron Study Site | Richmond | Virginia | — | — |
| Regeneron Study Site | Vienna | Virginia | — | — |
| Regeneron Study Site | Huntington | West Virginia | — | — |
| Regeneron Study Site | Kingwood | West Virginia | — | — |
| Regeneron Study Site | Morgantown | West Virginia | — | — |
| Regeneron Study Site | Madison | Wisconsin | — | — |
| Regeneron Study Site | Marshfield | Wisconsin | — | — |
| Regeneron Study Site | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 98 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02325791, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 6, 2018 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02325791 live on ClinicalTrials.gov.