Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-06-30

Brief Summary

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The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.

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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

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

Group Type EXPERIMENTAL

13vPnC

Intervention Type BIOLOGICAL

13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.

Group 2

Group Type EXPERIMENTAL

13vPnC

Intervention Type BIOLOGICAL

13vPnC will be administered by intramuscular injection at approximately 12 months of age.

Interventions

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13vPnC

13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.

Intervention Type BIOLOGICAL

13vPnC

13vPnC will be administered by intramuscular injection at approximately 12 months of age.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy children previously immunized with 1 or 2 doses of Prevenar.
* Group 1: Male or female subjects between the age of \>=140 and \<=196 days of age at time of enrollment.
* Group 2: Male or female subjects between the age of \>=336 and \<=392 days of age at time of enrollment
* Available for entire study period.

Exclusion Criteria

* Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component.
* Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.

Minimum Eligible Age

140 Days

Maximum Eligible Age

392 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes