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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

NCT00980655 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2018-12-20

Study results available
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Summary

People who have received an allogeneic hematopoetic stem cell transplant (HSCT) are more likely than other people to get ill from a germ called Streptococcus pneumoniae. Most people who have had a stem cell transplant are offered a vaccine called 23-valent pneumococcal polysaccharide vaccine (23vPS) to help protect against this germ. The purpose of this study is to evaluate the immune response in HSCT recipients who receive a 13 valent pneumococcal vaccine (13vPnC) followed by 23vPS.

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-18
Primary Completion
2013-05-16
Completion
2013-05-16

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Netherlands
  • Poland
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00980655 on ClinicalTrials.gov