At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 89 enrolled
Drug / intervention
13-valent pneumococcal conjugate vaccine (13vPnC) +1 morebiological
Likely dose
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
REVACCINATION WITH PREVENAR 13 - CHARACTERIZATION OF THE LATE IMMUNE RESPONSE AFTER POLYSACCHARIDE (REPLAY).
Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Mar 2, 2009·Updated Nov 11, 2021
In Brief
A Phase 3 clinical trial evaluating 13-valent pneumococcal conjugate vaccine (13vPnC) and Blood draw for Invasive Pneumococcal Disease. Completed, enrolled 89 participants across 2 sites.
Detailed Summary
The primary purpose of this study is to evaluate the immune response to 13-valent pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine (PSV). This study is also intended to evaluate the safety of the 13vPnC.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInvasive Pneumococcal Disease
CountriesIceland
CollaboratorsPfizer
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2009
Enrollment StartMay 2009
Primary CompletionDec 2009
TodayJul 2026
First PostedMar 2, 2009
Enrollment StartMay 5, 2009
Primary CompletionDec 16, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.3 years ago
Interventions
13-valent pneumococcal conjugate vaccine (13vPnC)biological
0.5 mL intramuscular injection
Blood drawprocedure
Collection of 10 mL of blood