CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 433 enrolled
Drug / intervention
Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccinebiological
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.

Search/NCT01148017
NCT01148017Phase 3Completed
CompareCT.gov

A Phase IIIb, Open-Label, Controlled, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine

Novartis Vaccines·interventional·Posted Jun 22, 2010·Updated Aug 14, 2017

In Brief

A Phase 3 clinical trial evaluating Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine for Meningococcal Meningitis. Completed, enrolled 433 participants across 19 sites.

Detailed Summary

The primary objective was to evaluate the persistence of bactericidal antibodies in children 40 and 60 months of age previously enrolled in the V59P14 (NCT00474526) study who received Novartis MenACWY Conjugate Vaccine. The study also enrolled age-matched subjects who have never received any meningococcal vaccine (naïve subjects) to serve as a control group. In addition, the response of a booster dose at 60 months was evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Meningitis
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2010
Enrollment StartJul 1, 2010
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.0 years ago

Interventions

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccinebiological