At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 193 enrolled
Drug / intervention
13vPnCbiological
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.
A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Japan
Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Dec 17, 2007·Updated Aug 8, 2012
In Brief
A Phase 3 clinical trial evaluating 13vPnC for Vaccines, Pneumococcal Conjugate Vaccine. Completed, enrolled 193 participants across 24 sites.
Detailed Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaccines, Pneumococcal Conjugate Vaccine
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedDec 2007
Primary CompletionAug 2008
TodayJul 2026
First PostedDec 17, 2007
Enrollment StartSep 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.5 years ago
Interventions
13vPnCbiological
"First dose during 2 to 6 months of age Second dose at least 28 days after the first dose Third dose at least 28 days after the second dose Forth dose during 12 to 15 months of age"