Study to Evaluate 13 Valent Pneumococcal Conjugate Vaccine (13vPnC) Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients

PHASE3CompletedINTERVENTIONAL
Enrollment

251

Participants

Timeline

Start Date

January 18, 2010

Primary Completion Date

May 16, 2013

Study Completion Date

May 16, 2013

Conditions
Vaccines, Pneumococcal Conjugate Vaccine
Interventions
BIOLOGICAL

13vPnC

"0.5mL 13vPnC dose will be administered intramuscularly into the left limb at visits 1,2,3 and 5.~Starting 3-6 months after HSCT 3 doses given at monthly intervals. 4th dose given 6 months after 3rd dose."

BIOLOGICAL

23vPS

0.5mL dose of 23vPS will be administered intramuscularly at visit 6. 23vPS given 1 month after 4th dose of 13vPnC.

Trial Locations (47)

1200

Clinical University St Luc, Brussels

3000

Universitaire Ziekenhuizen Leuven (UZ) Gasthuisberg, Leuven

4000

CHU Liege, Liège

8000

Algemeen Ziekenhuis St.-Jan A.V., Bruges

9000

Universitair Ziekenhuis Gent, Belgium

10032

Columbia University Medical Center Research Pharmacy, New York

Columbia University Medical Center-Presbyterian Hospital Building, New York

Columbia University/Taub Institute Irving Center for Clinical Research, New York

New York-Presbyterian Morgan Stanley Children's Hospital, New York

10065

Memorial Sloan Kettering Cancer Center, New York

11040

Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park

13353

Charite Universitaetsmedizin, Berlin

15006

Fakultni nemocnice v Motole, Prague

19104

The Children's Hospital of Philadelphia, Philadelphia

20246

Clinical Trial Center North MediGate GmbH, Hamburg

Klinik und Poliklinik fuer Paediatrische Haematologie und Onkologie, Hamburg

Universitaetsklinikum Hamburg Eppendorf Clinical Trial Center North MediGate GmbH, Hamburg

Universitaetsklinikum Hamburg-Eppendorf, Onkologisches Zentrum, Hamburg

25000

Hôpital Jean Minjoz, Besançon

28006

Hospital Universitario La Princesa, Madrid

28009

Hospital Universitario Infantil Niño Jesús, Madrid

37007

Hospital Universitario de Salamanca, Salamanca

40536

University of Kentucky, Lexington

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

48149

"Universitaetsklinikum Muenster,", Münster

Universitaetsklinikum Muenster, Münster

75010

Hôpital Saint Louis, Paris

75019

CHRU Robert Debré, Paris

Hopital Robert Debre, Paris

75475

Hopital Saint-Louis, Paris

75935

Hopital Robert Debre - Service Pharmacie, Paris

77030

Texas Children's Hospital, Houston

94000

Hopital Henri Mondor, Créteil

94010

Hôpital Henri Mondor, Pharmacie, Créteil

R3E 0V9

CancerCare Manitoba, Winnipeg

H1T 2M4

Hopital Maisonneuve-Rosemont, Montreal

625 00

Fakultni nemocnice Brno/Interni hematoonkologicka klinika, Bmo

07740

Universitatsklinikum Jena, Jena

3584 EA

UMC Utrecht, Wilhelmina Kinder Ziekenhuis, Utrecht

80-952

Klinika Hematologii i Transplantologii, Gdansk

31-223

"NZOZ HIPOKRATES-II Sp. z o.o.", Krakow

50-345

Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej, Wroclaw

413 45

Sahlgrenska Universitetssjukhuset, Gothenburg

141 86

Karolinska Universitetssjukhuset Huddinge, Huddinge

Karolinska University Hospital Huddinge, Stockholm

221 85

Universitetssjukhuset i Lund, Barnonkologen Avd 64, Lund

751 85

Akademiska Sjukhuset, Infektionskliniken, Uppsala

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY