CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 440 enrolled
Drug / intervention
Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine +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/NCT01367158
NCT01367158Phase 2Completed
CompareCT.gov

Phase 2, Observer-Blind, Controlled, Randomized, Multi-Center Extension Study to Evaluate Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY in Adolescents Who Previously Received the Same Study Vaccines

Novartis Vaccines·interventional·Posted Jun 6, 2011·Updated Nov 19, 2014

In Brief

A Phase 2 clinical trial evaluating Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine, Meningococcal (group B) multicomponent recombinant adsorbed vaccine, and 1 other intervention for Meningococcal Disease and Meningococcal Meningitis. Completed, enrolled 440 participants across 7 sites in 3 countries.

Detailed Summary

This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a meningococcal vaccine formulation in adolescents.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease, Meningococcal Meningitis
CountriesChile, Colombia, Panama
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 6, 2011
Enrollment StartJul 1, 2011
Primary CompletionJan 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.1 years ago

Interventions

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccinebiological

The lyophilized Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine reconstituted with one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

Meningococcal (group B) multicomponent recombinant adsorbed vaccinebiological

Liquid Meningococcal (group B) multicomponent recombinant adsorbed vaccine

Tdapbiological

Sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection