CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 662 enrolled
Drug / intervention
MenACWY-CRM197 (two doses) +4 morebiological
Likely dose
MenACWY-CRM197 (two doses) 0.5mLfrom 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/NCT00667602
NCT00667602Phase 3Completed
CompareCT.gov

A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Toddlers

Novartis Vaccines·interventional·Posted Apr 28, 2008·Updated Nov 7, 2013

In Brief

A Phase 3 clinical trial evaluating MenACWY-CRM197 (two doses), MenC, and 3 other interventions for Meningococcal Meningitis. Completed, enrolled 662 participants across 28 sites.

Detailed Summary

The primary immunogenicity objective is to assess and compare the immunogenicity of one dose of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured by the percentage of subjects with serum bactericidal titers directed against N. meningitidis serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Meningitis
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 28, 2008
Enrollment StartMar 1, 2008
Primary CompletionJul 1, 2009
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.2 years ago

Interventions

MenACWY-CRM197 (two doses)biological

Two 0.5mL doses of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.

MenCbiological

One 0.5mL dose of MenC vaccine was administered by intramuscular injection.

PCV7biological

One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.

DTPa-IPV-HepB-Hibbiological

One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.

MenACWY-CRM197 (one dose)biological

One 0.5mL dose of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.