Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease
| Status: | Completed |
|---|---|
| Conditions: | Vaccines, Anemia |
| Therapuetic Areas: | Hematology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 6 - 17 |
| Updated: | 3/30/2013 |
| Start Date: | November 2009 |
| End Date: | March 2013 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Children With Sickle Cell Disease Previously Immunized With 23vPS Vaccine
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.
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.
We found this trial at
4
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials