CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,630 enrolled
Drug / intervention
MenACWY-CRM + MMRV +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/NCT00626327
NCT00626327Phase 3Completed
CompareCT.gov

A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity of MMRV Vaccine When Administered Concomitantly With Novartis Meningococcal ACWY Conjugate Vaccine to Healthy Toddlers

Novartis Vaccines·interventional·Posted Feb 29, 2008·Updated Apr 19, 2013

In Brief

A Phase 3 clinical trial evaluating MenACWY-CRM + MMRV, MMRV, and 1 other intervention for Meningococcal Infections. Completed, enrolled 1,630 participants across 90 sites.

Detailed Summary

Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Infections
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 29, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJul 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.3 years ago

Interventions

MenACWY-CRM + MMRVbiological

One injection of MenACWY-CRM vaccine at 7-9 months of age; the second injection of MenACWY-CRM vaccine concomitantly administered with MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age.

MMRVbiological

one injection of MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age

MenACWY-CRMbiological

Two injections of MenACWY-CRM at 7-9 months and 12 months of age; one injection of MMRV (Measles, Mumps, Rubella and Varicella) at 13.5 months of age