At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 4,545 enrolled
Drug / intervention
Meningococcal ACWY Conjugate Vaccine +7 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, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
In Brief
A Phase 3 clinical trial evaluating Meningococcal ACWY Conjugate Vaccine, DTaP-IPV-HBV, and 6 other interventions for Meningitis, Meningococcal. Completed, enrolled 4,545 participants across 63 sites in 3 countries.
Detailed Summary
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningitis, Meningococcal
CountriesArgentina, Colombia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedMay 2007
Primary CompletionSep 2008
Study CompletionNov 2009
TodayJul 2026
First PostedMay 17, 2007
Enrollment StartMar 1, 2007
Primary CompletionSep 1, 2008
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.1 years ago
Interventions
Meningococcal ACWY Conjugate Vaccinebiological
DTaP-IPV-HBVbiological
Hibbiological
Rotavirusbiological
Pneumococcal 7-valent Conjugate Vaccinebiological
HAVbiological
MMR-Vbiological
DTaPbiological