13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study will be to assess the safety, tolerability, and immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) when given to healthy adults older than 50 years of age who haven't received 23-valent pneumococcal polysaccharide vaccine in Mexico.

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Detailed Description

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Conditions

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Pneumococcal Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

=\> 65 years of age

Group Type EXPERIMENTAL

vaccine-13vPnC

Intervention Type BIOLOGICAL

Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)

Group 2

50 to 64 years of age

Group Type EXPERIMENTAL

vaccine-13vPnC

Intervention Type BIOLOGICAL

Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)

Interventions

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vaccine-13vPnC

Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)

Intervention Type BIOLOGICAL

vaccine-13vPnC

Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)

Intervention Type BIOLOGICAL

Other Intervention Names

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13-valent pneumococcal conjugate vaccine 13-valent pneumococcal conjugate vaccine

Eligibility Criteria

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Inclusion Criteria

* Male or female older than 50 years of age
* Eligibility must be determined by medical history, physical exam and clinical judgment
* Able to complete an electronic diary
* Available for duration of study
* Negative pregnancy test for subjects in group 2 age 50 to 64 years
* Practice abstinence or use reliable birth control if age is 50 to 64 years

Exclusion Criteria

* History of allergic reaction to any vaccine
* Previous vaccination with licensed or experimental pneumococcal vaccine
* S. pneumonia infection within past 5 years before investigational product administration
* Known or suspected immunodeficiency or received treatment including cytotoxic agents or systemic corticosteroids, serious chronic disorder such as malignancy cancer
* Receipt of plasma products or immunoglobulins within 60 days
* Bleeding conditions or diathesis
* Receipt of investigational product within 28 days before study entry
* Other severe acute or chronic medical or psychiatric condition

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes