At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 605 enrolled
Drug / intervention
13-valent pneumococcal conjugate vaccine +1 morebiological
Likely dose
13-valent pneumococcal conjugate vaccine 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.
A Phase 3, 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 Paediatric Vaccinations in Italy
Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Aug 21, 2006·Updated Feb 22, 2013
In Brief
A Phase 3 clinical trial evaluating 13-valent pneumococcal conjugate vaccine and 7 valent pneumococcal conjugate vaccine for Vaccines, Pneumococcal. Completed, enrolled 605 participants across 13 sites.
Detailed Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Italy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaccines, Pneumococcal
CountriesItaly
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2006
Enrollment StartOct 2006
Primary CompletionJul 2008
TodayJul 2026
First PostedAug 21, 2006
Enrollment StartOct 1, 2006
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.9 years ago
Interventions
13-valent pneumococcal conjugate vaccinebiological
Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.
7 valent pneumococcal conjugate vaccinebiological
Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age.