CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 252 enrolled
Drug / intervention
MenACWY-CRM +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/NCT01453348
NCT01453348Phase 3Completed
CompareCT.gov

A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine When Administered Concomitantly With Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults

Novartis Vaccines·interventional·Posted Oct 17, 2011·Updated Jun 8, 2017

In Brief

A Phase 3 clinical trial evaluating MenACWY-CRM, Combined inactivated hepatitis A & recombinant hepatitis B, and 2 other interventions for Meningococcal Disease and 3 related conditions. Completed, enrolled 252 participants across 4 sites.

Detailed Summary

This study compares the safety and immunogenicity profile of combined hepatitis A/B vaccine given alone or concomitantly with MenACWY-CRM to healthy adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease, Meningococcal Meningitis, Hepatitis A, Hepatitis B
CountriesGermany
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2011
Enrollment StartOct 1, 2011
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.7 years ago

Interventions

MenACWY-CRMbiological

Novartis meningococcal ACWY conjugate vaccine will be administered intramuscularly (IM) on day 1.

Combined inactivated hepatitis A & recombinant hepatitis Bbiological

Combined inactivated hepatitis A and recombinant hepatitis B vaccine will be administered by IM on days 1, 8 \& 29 for subjects unprimed with hepatitis A and B; and a single booster injection on day 1 for primed subjects.

Recombinant hepatitis B vaccinebiological

Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29

Inactivated hepatitis A vaccinebiological

Inactivated hepatitis A will be administered intramuscularly on days 8 and 29.