At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,072 enrolled
Drug / intervention
Meningococcal ACWY conjugate vaccine (MenACWY-CRM) +2 morebiological
Likely dose
saline placebo 4.5 mgfrom 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, Multi-Center, Observer Blind, Controlled, Randomized Study to Compare the Immunogenicity and Safety of the Concomitant Administration of a Combined Tetanus, Reduced Diphtheria, and Acellular Pertussis (Tdap) Vaccine and Chiron (Now Novartis) Meningococcal ACWY Conjugate Vaccine, With Either One Dose of Acellular Pertussis (Tdap) Vaccine, or One Dose of Chiron (Now Novartis) Meningococcal ACWY Conjugate Vaccine, in Healthy Subjects Aged 11-25 Years
In Brief
A Phase 3 clinical trial evaluating Meningococcal ACWY conjugate vaccine (MenACWY-CRM), Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap), and 1 other intervention for Meningococcal Disease and Meningococcal Meningitis. Completed, enrolled 1,072 participants across 14 sites.
Detailed Summary
Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease, Meningococcal Meningitis
CountriesItaly
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2006
First PostedMay 2006
Primary CompletionMay 2007
Study CompletionDec 2007
TodayJul 2026
First PostedMay 25, 2006
Enrollment StartApr 1, 2006
Primary CompletionMay 1, 2007
Study CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 20.1 years ago
Interventions
Meningococcal ACWY conjugate vaccine (MenACWY-CRM)biological
Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)biological
saline placebobiological
4.5 mg sodium chloride per 0.5 ml dose