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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Vaccines, Pneumococcal Conjugate Vaccine

Treatments: Biological: 13-valent Pneumococcal Conjugate Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00500357

6115A1-3009

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• Previous participant of study 6115A1-500 and received 13vPnC +AlPO4 / 23vPS

• Generally healthy male or female adults 65 years of age or older

• Available for the duration of the trial - approximately 1 month

• No history of severe adverse reaction associated with a vaccine

  • MMSE score less than or equal to 21 was an exclusion criteria.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)