A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)

PHASE3CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

January 23, 2019

Primary Completion Date

June 8, 2020

Study Completion Date

June 8, 2020

Conditions
Pneumococcal Infections
Interventions
BIOLOGICAL

V114

V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose

BIOLOGICAL

Prevnar 13™

Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose

Trial Locations (19)

10122

Clinical Research Republica Dominicana ( Site 0401), Santo Domingo

10204

Fundacion Dominicana de Perinatologia PRO BEBE INC ( Site 0402), Distrito Nacional

10205

Caimed Dominicana S.A.S ( Site 0400), Santo Domingo

14642

University of Rochester Medical Center ( Site 0105), Rochester

16132

Ospedale San Martino ( Site 0800), Genova

19803

Nemours/Alfred I. duPont Hospital for Children ( Site 0113), Wilmington

30303

Children's Healthcare of Atlanta ( Site 0100), Atlanta

45229

Cincinnati Children's Hospital Medical Center ( Site 0101), Cincinnati

48201

Children's Hospital of Michigan ( Site 0111), Detroit

760045

Centro de Estudios en Infectologia Pediatrica SAS ( Site 0301), Santiago de Cali

07112

Newark Beth Israel Medical Center ( Site 0115), Newark

30150-221

Santa Casa de Misericordia de Belo Horizonte ( Site 0200), Belo Horizonte

40420-000

Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0205), Salvador

01221-900

Santa Casa de Misericordia de Sao Paulo ( Site 0202), São Paulo

080020

Clinica de la Costa Ltda. ( Site 0300), Barranquilla

115 27

Agia Sophia Children s Hospital ( Site 0700), Athens

546 42

Hippokration General Hospital of Thessaloniki ( Site 0701), Thessaloniki

0816-00383

Cevaxin ( Site 0500), Panama City

Cevaxin ( Site 0502), Panama City

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03731182 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE) | Biotech Hunter | Biotech Hunter