At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 389 enrolled
Drug / intervention
MenACWY-CRM 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.
An Open-Label, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Adolescents Who Previously Received Novartis MenACWY Conjugate Vaccine or Commercially Available MenACWY Conjugate Vaccine
In Brief
A Phase 3 clinical trial evaluating MenACWY-CRM conjugate vaccine and Licensed comparator for Meningococcal Meningitis. Completed, enrolled 389 participants across 32 sites.
Detailed Summary
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Meningitis
CountriesUnited States
CollaboratorsGlaxoSmithKline
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedMar 2009
Primary CompletionNov 2012
TodayJul 2026
First PostedMar 5, 2009
Enrollment StartFeb 1, 2009
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.3 years ago
Interventions
MenACWY-CRM conjugate vaccinebiological
Licensed comparatorbiological