At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 180 enrolled
Drug / intervention
13-valent pneumococcal conjugate vaccine +1 morebiological
Likely dose
Not stated in 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.
Phase 2, Randomized, Active-Controlled, Double-Blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Healthy Infants Given With Routine Pediatric Vaccinations In Korea
Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Jun 3, 2008·Updated Jun 28, 2011
In Brief
A Phase 2 clinical trial evaluating 13-valent pneumococcal conjugate vaccine and 7-valent pneumococcal conjugate vaccine for Pneumococcal Vaccine. Completed, enrolled 180 participants across 6 sites.
Detailed Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumococcal Vaccine
CountriesSouth Korea
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedJun 2008
Primary CompletionDec 2009
TodayJul 2026
First PostedJun 3, 2008
Enrollment StartJun 1, 2008
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.1 years ago
Interventions
13-valent pneumococcal conjugate vaccinebiological
13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
7-valent pneumococcal conjugate vaccinebiological
7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.