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

Wyeth is now a wholly owned subsidiary of Pfizer915 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

915

Conditions

Vaccines, Pneumococcal Conjugate Vaccine

Interventions

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female adults 65 years of age and older. * Determined by medical history, physical examination, and clinical judgment to be eligible for the study. * Expected to be available for the duration of the trial (up to approximately 13 months). Exclusion Criteria: * Received previous immunization with 23vPS. * Serious chronic disorders including metastatic malignancy * Known or suspected hypersensitivity to any vaccine or vaccine components

Outcomes

Primary Outcomes

Demonstrate 13vPnC without AlPO4 is as immunogenic as 13vPnC with AlPO4 to select a 13vPnC formulation.

Secondary Outcomes

Demonstrate that the selected 13vPnC formulation is as immunogenic as 23vPS (by IgG).

Safety and tolerability of the selected 13vPnC formulation given 12 months after a previous dose of the selected 13vPnC.