Evaluating the Infectivity, Safety, and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (D46/NS2/N/ΔM2-2-HindIII) in RSV-Seronegative Infants 6 to 24 Months of Age

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

April 6, 2017

Primary Completion Date

May 25, 2018

Study Completion Date

May 25, 2018

Conditions
Respiratory Syncytial Virus Infections
Interventions
BIOLOGICAL

D46/NS2/N/ΔM2-2-HindIII

10\^5 plaque-forming units (PFU) per 0.5ml vaccine; administered as nose drops

BIOLOGICAL

Placebo

Isotonic diluent; administered as nose drops

Trial Locations (10)

10461

Jacobi Med. Ctr. Bronx NICHD CRS, The Bronx

11794

SUNY Stony Brook NICHD CRS, Stony Brook

21205

Johns Hopkins University Center for Immunization Research, Baltimore

30322

Emory University School of Medicine NICHD CRS, Atlanta

60612

Rush Univ. Cook County Hosp. Chicago NICHD CRS, Chicago

80045

Univ. of Colorado Denver NICHD CRS, Aurora

90089

Usc La Nichd Crs, Los Angeles

90095-1752

David Geffen School of Medicine at UCLA NICHD CRS, Los Angeles

60614-3393

Lurie Children's Hospital of Chicago (LCH) CRS, Chicago

38105-3678

St. Jude Children's Research Hospital CRS, Memphis

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03102034 - Evaluating the Infectivity, Safety, and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (D46/NS2/N/ΔM2-2-HindIII) in RSV-Seronegative Infants 6 to 24 Months of Age | Biotech Hunter | Biotech Hunter