Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-02-28

Brief Summary

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The objective of this study is to compare the safety, tolerability and immunologic response to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that have never received a previous dose of 23vPS.

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Detailed Description

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Conditions

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Pneumococcal Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1.1

Group 1.1 = 13vPnC then 13vPnC

Group Type EXPERIMENTAL

13 valent Pneumococcal Conjugate Vaccine

Intervention Type BIOLOGICAL

0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1

Group 1.2

Group 1.2 = 13vPnC then 23vPS

Group Type EXPERIMENTAL

13 valent Pneumococcal Conjugate Vaccine

Intervention Type BIOLOGICAL

0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1

23-valent Pneumococcal Polysaccharide Vaccine

Intervention Type BIOLOGICAL

0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1

Group 2

Group 2 = 23vPS then 13vPnC

Group Type EXPERIMENTAL

13 valent Pneumococcal Conjugate Vaccine

Intervention Type BIOLOGICAL

0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1

23-valent Pneumococcal Polysaccharide Vaccine

Intervention Type BIOLOGICAL

0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1

Interventions

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13 valent Pneumococcal Conjugate Vaccine

0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1

Intervention Type BIOLOGICAL

13 valent Pneumococcal Conjugate Vaccine

0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1

Intervention Type BIOLOGICAL

13 valent Pneumococcal Conjugate Vaccine

0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1

Intervention Type BIOLOGICAL

23-valent Pneumococcal Polysaccharide Vaccine

0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1

Intervention Type BIOLOGICAL

23-valent Pneumococcal Polysaccharide Vaccine

0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male or Female, aged 60 to 64 years.
* Healthy.

Exclusion Criteria

* Previous vaccination with any licensed or experimental pneumococcal vaccine.
* History of severe adverse reaction associated with a vaccine.
* Immunodeficiency.

Minimum Eligible Age

60 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes