NCT00980655

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

A Phase 3, Open-label Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Followed By 23-valent Pneumococcal Polysaccharide Vaccine In Recipients Of Allogeneic Hematopoietic Stem Cell Transplant Aged 2 Years And Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2010-01-18
• Primary completion: 2013-05-16
• Completion: 2013-05-16
• First posted: 2009-09-21
• Last updated: 2018-12-20
• Results posted: 2014-04-21

Locations

47 sites across 10 countries: United States, Belgium, Canada, Czechia, France, Germany, Netherlands, Poland, Spain, Sweden