Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-05-31

Brief Summary

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The purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well tolerated and produces an immune response in older adults.

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Detailed Description

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This study is an extension study (V110-007-10) which met requirements for posting on clinicaltrials.gov. The original study (V110-007-00) was completed in 2004 and did not meet the criteria for registration.

Conditions

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Pneumococcal Infection

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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1st Revaccination Group

Group Type EXPERIMENTAL

pneumococcal 23v polysaccharide vaccine

Intervention Type BIOLOGICAL

Duration of Treatment: Single vaccination on Day 1

2nd Revaccination Group

Group Type EXPERIMENTAL

pneumococcal 23v polysaccharide vaccine

Intervention Type BIOLOGICAL

Duration of Treatment: Single vaccination on Day 1

Interventions

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pneumococcal 23v polysaccharide vaccine

Duration of Treatment: Single vaccination on Day 1

Intervention Type BIOLOGICAL

Other Intervention Names

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V110 PNEUMOVAX

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal or negative urine pregnancy test if female
* No fever on the day of vaccination

Exclusion Criteria

* History of allergy to vaccine components
* History of pneumococcal disease
* Received any live virus vaccination within 4 weeks prior to study start
* Received any inactivated vaccination within 7 days prior to study start
* Received any blood products within 5 months prior to study start
* Participated in an investigational drug or vaccine study in the past 30 days
* Received immunosuppressive therapy
* Patient has an immune deficiency

Minimum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes