At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 324 enrolled
Drug / intervention
vaccine-13vPnC +1 morebiological
Likely dose
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.
A Phase 3, Open Label, Single Arm, Multicenter, Trial to Assess The Safety, Tolerability And Immunogenicity Of 13-Valent Pneumococcal Conjugate Vaccine In Healthy Adults Aged => 50 Years of Age Who Are Naive To 23-Valent Pneumococcal Polysaccharide Vaccine in Mexico.
In Brief
A Phase 3 clinical trial evaluating vaccine-13vPnC for Pneumococcal Infections. Completed, enrolled 324 participants across 4 sites.
Detailed Summary
The purpose of this study will be to assess the safety, tolerability, and immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) when given to healthy adults older than 50 years of age who haven't received 23-valent pneumococcal polysaccharide vaccine in Mexico.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumococcal Infections
CountriesMexico
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2011
First PostedSep 2011
Primary CompletionDec 2011
TodayJul 2026
First PostedSep 12, 2011
Enrollment StartJul 1, 2011
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.8 years ago
Interventions
vaccine-13vPnCbiological
Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)
vaccine-13vPnCbiological
Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)