CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 623 enrolled
Drug / intervention
MenACWY-CRM conjugate vaccine, adjuvanted +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.

Search/NCT00310817
NCT00310817Phase 2Completed
CompareCT.gov

A Phase II, Randomized, Observer Blind, Multi-Center, Active Controlled Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

Novartis Vaccines·interventional·Posted Apr 5, 2006·Updated Nov 6, 2015

In Brief

A Phase 2 clinical trial evaluating MenACWY-CRM conjugate vaccine, adjuvanted, MenACWY polysaccharide vaccine, and 1 other intervention for Meningococcal Meningitis. Completed, enrolled 623 participants across 2 sites in 2 countries.

Detailed Summary

To compare the functional immune response 28 days after administration of one dose of Men ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY polysaccharide (PS) vaccine

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Meningitis
CountriesFinland, Poland
CollaboratorsNovartis

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 5, 2006
Enrollment StartMar 1, 2005
Primary CompletionMay 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 20.2 years ago

Interventions

MenACWY-CRM conjugate vaccine, adjuvantedbiological

MenACWY polysaccharide vaccinebiological

MenACWY-CRM conjugate vaccine, unadjuvantedbiological