At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 449 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.
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 a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain
Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted May 17, 2007·Updated Mar 5, 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 449 participants across 27 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 Spain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaccines, Pneumococcal
CountriesSpain
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2007
Enrollment StartJul 2007
Primary CompletionMar 2009
TodayJul 2026
First PostedMay 17, 2007
Enrollment StartJul 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.1 years ago
Interventions
13-valent pneumococcal conjugate vaccinebiological
1 dose at 2,4,6 and 15 months of age
7-valent pneumococcal conjugate vaccinebiological
1 dose at 2,4,6 and 15 months of age