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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Conjugate Vaccine

Treatments: Biological: 13-valent Pneumoccocal Conjugate Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00918580

B1851013

6096A1-3014

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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158 participants in 1 patient group

1

Experimental group

Treatment:

Biological: 13-valent Pneumoccocal Conjugate Vaccine