CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 851 enrolled
Drug / intervention
Bexsero® vaccine (1 dose at study month zero) +1 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/NCT01894919
NCT01894919Phase 3Completed

A Phase IIIb, Open Label, Multi Center Extension Study of V72_28 to Assess Antibody Persistence, and the Safety and Tolerability of a Booster Dose After the Completion of the Vaccination Course in Study V72_28

Novartis Vaccines·interventional·Posted Jul 10, 2013·Updated Nov 30, 2021

In Brief

A Phase 3 clinical trial evaluating Bexsero® vaccine (1 dose at study month zero) and Bexsero® vaccine (2 doses 1 month apart) for Meningoccocal Disease and Meningococcal Meningitis. Completed, enrolled 851 participants across 17 sites in 2 countries.

Detailed Summary

The aim of this extension study is to explore the antibody persistence 24 to 36 months after the last dose of vaccine, in infants that received a two or three dose primary series plus a booster dose at 11 months of age, of the Novartis meningococcal B vaccine (Bexsero®) in groups I to III of the parent V72\_28 study. This study will also explore the antibody persistence 24 to 36 months after two catch-up doses of the Novartis meningococcal B vaccine (Bexsero®) administered in children (2 to 10 years old) in group IV of the parent V72\_28 study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHungary, Spain
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 10, 2013
Enrollment StartJun 1, 2013
Primary CompletionSep 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.0 years ago

Interventions

Bexsero® vaccine (1 dose at study month zero)biological

Bexsero® vaccine (2 doses 1 month apart)biological