At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,620 enrolled
Drug / intervention
Novartis Meningococcal ACWY Conjugate Vaccine +2 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.
A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine in Healthy Adolescents
In Brief
A Phase 3 clinical trial evaluating Novartis Meningococcal ACWY Conjugate Vaccine and Tdap Vaccine for Meningococcal Meningitis and 3 related conditions. Completed, enrolled 1,620 participants across 1 site.
Detailed Summary
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCosta Rica
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2007
First PostedAug 2007
Primary CompletionApr 2008
Study CompletionOct 2008
TodayJul 2026
First PostedAug 20, 2007
Enrollment StartJul 1, 2007
Primary CompletionApr 1, 2008
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.9 years ago
Interventions
Novartis Meningococcal ACWY Conjugate Vaccinebiological
One dose of vaccine administered intramuscularly
Tdap Vaccinebiological
One dose of vaccine administered intramuscularly
Novartis Meningococcal ACWY Conjugate Vaccinebiological
One dose of vaccine administered intramuscularly