Pneumococcal infection MedDRA version: 12.1 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: • Subjects who received all 4 assigned doses of the PnC vaccine as randomized and completed study 6096A1-008-EU. • Subjects are at least 24 months posttoddler dose and at least 3 years of age at visit 1. • Healthy as determined by medical history, physical examination, and judgment of the investigator. • Available for the entire study period and his or her parents/legal guardians must be able to complete all relevant study procedures during study participation and can be reached by telephone. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Vaccination with any licensed or investigational pneumococcal vaccine since completion of the 6096A1 008-EU study. • History of culture-proven invasive disease caused by S pneumoniae since the completion of study 6096A1 008-EU. • Previous anaphylactic reaction to any vaccine or vaccine-related component. • Contraindication to vaccination with pneumococcal conjugate vaccine. • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. • Known or suspected immune deficiency or suppression since participation in study 6096A1-008-EU. • Major known congenital malformation or serious chronic disorder. • Significant neurological disorder or history of seizure (excluding simple febrile seizure), or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. • Receipt of any blood products, including immunoglobulin, within 90 days before the study. • Current participation in another investigational or interventional trial. (Note: participation in purely observational studies is acceptable). • Received any live vaccine within 28 days before administration of the first study vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the antibody levels to the 13 pneumococcal vaccine serotypes not earlier than 24 months after the administration of the toddler dose in study 6096A1-008-EU, as measured by serotype-specific (immunoglobulin G) IgG concentrations. To evaluate the immune response to 13 pneumococcal vaccine serotypes 1 month after a dose of 13vPnC administered not earlier than 24 months after the toddler dose in study 6096A1-008-EU, as measured by serotype specific IgG concentrations. ;Secondary Objective: To evaluate the antibody levels to the 13 pneumococcal vaccine serotypes not earlier than 24 months after the administration of the toddler dose in study 6096A1-008-EU, as measured by serotype-specific opsonophagocytic activity (OPA). To evaluate the immune response to 13 pneumococcal vaccine serotypes 1 month after a dose of 13vPnC administered not earlier than 24 months after the toddler dose in study 6096A1-008-EU, as measured by serotype specific OPA antibody titers. ;Primary end point(s): The primary endpoint is the serotype-specific IgG concentration 1 month after the single dose of 13vPnC. | — |
Countries
France
Outcome results
None listed