At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 84,496 enrolled
Drug / intervention
VACCINE: placebo +1 morebiological
Likely dose
VACCINE: placebo 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 4, Randomized, Placebo-Controlled Clinical Trial of 13-valent Pneumococcal Conjugate Vaccine Efficacy in Prevention of Vaccine-Serotype Pneumococcal Community-Acquired Pneumonia and Invasive Pneumococcal Disease
In Brief
A Phase 4 clinical trial evaluating VACCINE: placebo and VACCINE: 13-valent pneumococcal conjugate vaccine for Pneumonia, Pneumococcal and 2 related conditions. Completed, enrolled 84,496 participants across 159 sites.
Detailed Summary
The purpose of this study is to assess the efficacy of 13-valent pneumococcal conjugate vaccine in the prevention of the first episode of vaccine-type pneumococcal community-acquired pneumonia in adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2008
Enrollment StartSep 2008
Primary CompletionOct 2013
TodayJul 2026
First PostedAug 29, 2008
Enrollment StartSep 1, 2008
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 17.8 years ago
Interventions
VACCINE: placebobiological
0.5 mL, single intra-muscular injection
VACCINE: 13-valent pneumococcal conjugate vaccinebiological
0.5 mL, single intra-muscular injection