A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)

PHASE3CompletedINTERVENTIONAL
Enrollment

277

Participants

Timeline

Start Date

September 12, 2018

Primary Completion Date

November 4, 2021

Study Completion Date

November 4, 2021

Conditions
Pneumococcal Infections
Interventions
BIOLOGICAL

V114

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose.

BIOLOGICAL

Prevnar 13™

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg), and aluminum phosphate adjuvant (125 mcg aluminum) in each 0.5 ml dose

BIOLOGICAL

PNEUMOVAX™23

23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose

Trial Locations (52)

1200

Cliniques Universitaires Saint-Luc ( Site 0122), Brussels

2010

St. Vincent's Hospital ( Site 0041), Sydney

2145

The Children s Hospital at Westmead ( Site 0191), Westmead

3000

UZ Leuven ( Site 0119), Leuven

3004

The Alfred Hospital ( Site 0037), Melbourne

3050

Royal Melbourne Hospital ( Site 0039), Parkville

3084

Austin Health-Austin Hospital ( Site 0038), Heidelberg

4000

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0121), Liège

5000

Royal Adelaide Hospital ( Site 0040), Adelaide

8000

AZ Sint Jan Brugge-Oostende ( Site 0118), Bruges

8800

AZ Delta ( Site 0120), Roeselare

10467

Montefiore Einstein Center ( Site 0164), The Bronx

11520

Hospital Espanol ( Site 0059), México

14080

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0058), Mexico City

Instituto Nacional de Cancerologia. ( Site 0060), México

21287

Johns Hopkins - University ( Site 0023), Baltimore

25030

Hopital Jean Minjoz Besancon ( Site 0085), Besançon

32610

University of Florida ( Site 0011), Gainesville

38700

CHU de Grenoble Hopital Nord ( Site 0083), La Tronche

40225

Universitaetsklinikum Duesseldorf ( Site 0107), Düsseldorf

44106

Cleveland Clinic Foundation ( Site 0168), Cleveland

45229

Cincinnati Children's Hospital Medical Center ( Site 0010), Cincinnati

46237

Indiana Blood and Marrow Transplantation ( Site 0001), Indianapolis

50931

Universitaetsklinikum Koeln ( Site 0105), Cologne

55131

Universitaetsmedizin Mainz ( Site 0106), Mainz

59037

CHRU de Lille - Hopital Claude Huriez ( Site 0090), Lille

60637

University of Chicago ( Site 0016), Chicago

64108

Children's Mercy Hospital ( Site 0167), Kansas City

64460

Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0187), Monterrey

Servicio de hematologia Universidad Autonoma de Nuevo Leon ( Site 0057), Monterrey

66160

University of Kansas Medical Center ( Site 0007), Kansas City

75012

Hopital Saint-Antoine ( Site 0089), Paris

77030

Baylor College of Medicine - Texas Children's Hospital ( Site 0165), Houston

80045

Children's Hospital Colorado ( Site 0166), Aurora

94000

CHU Henri Mondor ( Site 0081), Créteil

94305

Stanford Health Care ( Site 0005), Palo Alto

97239

Oregon Health & Science University ( Site 0018), Portland

760032

Fundacion Valle del Lili ( Site 0073), Santiago de Cali

760042

Centro Medico Imbanaco de Cali S.A ( Site 0075), Santiago de Cali

41253-190

Hospital Sao Rafael ( Site 0049), Salvador

30150-221

Santa Casa de Misericordia de Belo Horizonte ( Site 0050), Belo Horizonte

80510-130

Instituto de Cancer e Transplante de Curitiba ICTR ( Site 0051), Curitiba

B3H 1V7

Nova Scotia Health Authority QEII-HSC ( Site 0033), Halifax

L8V 1C3

Juravinski Cancer Centre ( Site 0032), Hamilton

H1T 2M4

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0031), Montreal

050034

Hospital Pablo Tobon Uribe ( Site 0077), Medellín

06002

CHU de Nice ( Site 0084), Nice

04530

Instituto Nacional de Pediatria ( Site 0062), Mexico City

06720

Hospital Infantil de Mexico Federico Gomez ( Site 0061), Mexico City

141 86

Karolinska Universitetssjukhuset ( Site 0143), Stockholm

751 85

Akademiska Sjukhuset ( Site 0144), Uppsala

413 45

Sahlgrenska Universitetssjukhuset ( Site 0145), Gothenburg

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03565900 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM) | Biotech Hunter | Biotech Hunter