CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 484 enrolled
Drug / intervention
Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV. +3 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/NCT01272180
NCT01272180Phase 2Completed
CompareCT.gov

Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents and Young Adults to Evaluate Safety and Immunogenicity of Two Different rMenB With OMV + MenACWY Combination Vaccination Formulations

Novartis Vaccines·interventional·Posted Jan 7, 2011·Updated Jun 16, 2020

In Brief

A Phase 2 clinical trial evaluating Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV., Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV., and 2 other interventions for Invasive Meningococcal Disease. Completed, enrolled 484 participants across 13 sites in 2 countries.

Detailed Summary

This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInvasive Meningococcal Disease
CountriesPoland, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 7, 2011
Enrollment StartAug 1, 2011
Primary CompletionOct 1, 2011
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.5 years ago

Interventions

Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV.biological

Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus OMV.

Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.biological

Two injections of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.

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

One injection of saline solution placebo and one of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.

Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV.biological

Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus a quarter dose of OMV.