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Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects

Vaccines, Pneumococcal Conjugate Vaccine Clinical Trial

Official title:
A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of a Subsequent Dose of 13-valent Pneumococcal Conjugate Vaccine Administered to One Group of Individuals Who Participated in Study 6115A1-500

Clinical Trial Summary

This is a follow-up study to the core study NCT00269672 (6115A1-500). This study will further evaluate the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vPnC) when administered to subjects who have already received one dose of 13vPnC, and one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) one year later. This study will determine if a subsequent dose of 13vPnC one year later results in similar or greater immune response (body's ability to protect against disease) than that measured after the initial dose of 13vPnC.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

  • Vaccines, Pneumococcal Conjugate Vaccine
Clinical Trial Details
NCT number NCT00500357
Study type Interventional
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status Completed
Phase Phase 3
Start date November 2007
Completion date January 2010
View Details
See also
  Status Clinical Trial Phase
Completed NCT00574795 - Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants Phase 3
Completed NCT00269672 - Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects Phase 2
Completed NCT00580684 - Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children Phase 4
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