CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,630 enrolled
Drug / intervention
Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1) +5 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/NCT00657709
NCT00657709Phase 3Completed
CompareCT.gov

A Phase 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Novartis Vaccines·interventional·Posted Apr 14, 2008·Updated Oct 10, 2017

In Brief

A Phase 3 clinical trial evaluating Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1), Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2), and 4 other interventions for Serogroup B Meningococcal Meningitis. Completed, enrolled 3,630 participants across 66 sites in 5 countries.

Detailed Summary

The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSerogroup B Meningococcal Meningitis
CountriesAustria, Czechia, Finland, Germany, Italy
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 14, 2008
Enrollment StartMar 1, 2008
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.2 years ago

Interventions

Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)biological

One dose of rMenB Lot concomitantly with the routinely administered infant vaccines

Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)biological

One dose of rMenB concomitantly with the routinely administered infant vaccines

Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)biological

One dose of rMenB concomitantly with the routinely administered infant vaccines

Infanrix Hexabiological

Routine vaccination

Menjugatebiological

One dose of the routinely administered infant vaccines + MenC vaccine

Prevenarbiological

Routine vaccination