Pneumococcal infection MedDRA version: 9.1 Level: LLT Classification code 10061353 Term: Pneumococcal infection
Conditions
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subject between the ages of =6 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of culture-proven invasive disease caused by S. pneumoniae within the last year. 2. Subject has/had a major illness or condition that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in, and completion of the study. 3. Subject has/had a major illness or condition that, in the investigator’s judgment, could preclude the evaluation of the subject’s response to vaccination. 4. History of hematopoietic stem cell transplantation. 5. Previous vaccination with PnC vaccine. 6. Has a dose of 23vPS recommended between enrollment and the blood draw at visit 4. 7. Previous anaphylactic reaction to any vaccine or vaccine-related component. 8. Contraindication to vaccination with pneumococcal conjugate vaccine. 9. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 10. Receipt of immunoglobulin infusion or injection during the 42 days preceding enrollment. 11. Known or suspected immune deficiency or suppression. 12. Pregnant or breast feeding female. 13. Participation in another investigational trial from 28 days before enrollment until the end of the study. (Note: participation in purely observational studies is acceptable.) 14. Subject is a direct descendant (child or grandchild) of a member of site study personnel or is study personnel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immune response 1 month after 2 doses of 13vPnC given 6 months apart compared to 1 month after 1 dose of 13vPnC as measured by fold rise in serotype specific IgG geometric mean concentrations (GMCs) in children with SCD who have previously been vaccinated with at least 1 dose of 23vPS.;Secondary Objective: To evaluate the immune response 1 month after 2 doses of 13vPnC given 6 months apart compared to 1 month after 1 dose of 13vPnC as measured by serotype-specific IgG GMC in children with SCD who have previously been vaccinated with at least 1 dose of 23vPS.;Primary end point(s): The geometric mean fold rise (GMFR) in IgG is the primary analysis endpoint following dose 2 relative to dose 1 for each serotype. | — |
Countries
France, Italy, United Kingdom
Outcome results
None listed