Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-03-31

Brief Summary

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This study is to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18 years of age. They will be given the vaccination twice, each vaccination separated by approximately 6 months.

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Detailed Description

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Conditions

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Pneumococcal Conjugate Vaccine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

13-valent Pneumoccocal Conjugate Vaccine

Intervention Type BIOLOGICAL

2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.

Interventions

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13-valent Pneumoccocal Conjugate Vaccine

2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.

Intervention Type BIOLOGICAL

Other Intervention Names

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13vPnC

Eligibility Criteria

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Inclusion Criteria

* Male or female subject between the ages of \>=6 to \<18 years.
* Diagnosis of SCD
* 23vPS vaccination at least 6 months prior to enrollment.

Exclusion Criteria

* Previous vaccination with pneumococcal conjugate vaccine.
* Previous reaction to any vaccine or vaccine-related component or contraindication to vaccination with pneumococcal conjugate vaccine.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No