At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 104 enrolled
Drug / intervention
V114 +1 morebiological
Likely dose
V114 2 mcgfrom 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, Multicenter, Randomized, Double-blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (PNEU-SICKLE)
In Brief
A Phase 3 clinical trial evaluating V114 and Prevnar 13™ for Pneumococcal Infections. Completed, enrolled 104 participants across 19 sites in 7 countries.
Detailed Summary
This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumococcal Infections
CountriesBrazil, Colombia, Dominican Republic, Greece, Italy, Panama, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartJan 2019
Primary CompletionJun 2020
TodayJul 2026
First PostedNov 6, 2018
Enrollment StartJan 23, 2019
Primary CompletionJun 8, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.7 years ago
Interventions
V114biological
V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
Prevnar 13™biological
Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose