VAXCHORA Pediatric Study to Assess Safety and Immunogenicity

PHASE4CompletedINTERVENTIONAL
Enrollment

550

Participants

Timeline

Start Date

July 21, 2017

Primary Completion Date

September 10, 2019

Study Completion Date

March 6, 2020

Conditions
Cholera (Disorder)
Interventions
BIOLOGICAL

VAXCHORA (Cholera Vaccine, Live, Oral)

VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.

OTHER

Placebo

Placebo control for this study is normal (0.9%) saline.

Trial Locations (10)

14609

Rochester Clinical Research, Inc., Rochester

29464

Coastal Carolina Research Center, Mt. Pleasant

30322

Emory University, Atlanta

37203

Clinical Research Associates, Inc., Nashville

40536

University of Kentucky, Lexington

43123

Aventiv Research Inc., Columbus

64114

The Center for Pharmaceutical Research, Kansas City

66219

Johnson County Clin-Trials, Inc., Lenexa

67207

Heartland Research Associates, LLC, Wichita

02118

Boston Medical Center, Boston

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Emergent BioSolutions

INDUSTRY

lead

Bavarian Nordic

INDUSTRY