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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects

Vaccines, Pneumococcal Conjugate Vaccine Clinical Trial

Official title:
A Randomized, Open Label, Controlled Phase II Study to Evaluate Safety, Tolerability and Immunogenicity After Two Different 13-Valent Pneumococcal Conjugate Vaccine Formulations in Elderly Subjects Aged 65 Years and Older Who Are Naive to Previous 23vPS Immunization

Clinical Trial Summary

There is evidence that aluminum phosphate (AlPO4) contained as an adjuvant in conjugate vaccines enhances the immune response in infants. There is no data so far evaluating whether this also applies to adults. The objective of this study is to compare the immune response of 2 different 13-valent pneumococcal conjugate (13vPnC) formulations with and without AlPO4 to select a formulation and to compare the immune response to the chosen 13vPnC formulation relative to the immune response to 23-valent pneumococcal polysaccharide vaccine (23vPS).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

  • Vaccines, Pneumococcal Conjugate Vaccine
Clinical Trial Details
NCT number NCT00269672
Study type Interventional
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status Completed
Phase Phase 2
Start date September 2005
Completion date February 2007
View Details
See also
  Status Clinical Trial Phase
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Completed NCT00580684 - Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children Phase 4
Completed NCT00500357 - Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects Phase 3
Completed NCT00581620 - Study Evaluating Prevenar Immunogenicity in High Risk Children Phase 4
Completed NCT00475033 - Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Phase 3
Completed 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 Phase 3
Completed NCT00676091 - Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil Phase 3
Completed NCT00683410 - Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent) N/A