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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

915 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-02-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Vaccines, Pneumococcal Conjugate Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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13-valent Pneumococcal Conjugate Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes