At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,200 enrolled
Drug / intervention
13 valent pneumococcal conjugate vaccinebiological
Likely dose
13 valent pneumococcal conjugate vaccine 0.5mLfrom 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 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Aged 15 Months to 17 Years in the United States
In Brief
A Phase 3 clinical trial evaluating 13 valent pneumococcal conjugate vaccine for Healthy Subjects. Completed, enrolled 1,200 participants across 31 sites.
Detailed Summary
This open-label, multicenter study is designed to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than 15 months up to less than 18 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2008
Enrollment StartDec 2008
Primary CompletionJul 2010
TodayJul 2026
First PostedSep 29, 2008
Enrollment StartDec 1, 2008
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.8 years ago
Interventions
13 valent pneumococcal conjugate vaccinebiological
Intramuscular injection of 0.5mL at visit 1 and visit 2 for group 1 and and visit 1 for groups 2, 3, and 4.