NCT01453348

Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Meningococcal Disease
• Meningococcal Meningitis
• Hepatitis A
• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	MenACWY-CRM	Novartis meningococcal ACWY conjugate vaccine will be administered intramuscularly (IM) on day 1.
BIOLOGICAL	Combined inactivated hepatitis A & recombinant hepatitis B	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.
BIOLOGICAL	Recombinant hepatitis B vaccine	Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29
BIOLOGICAL	Inactivated hepatitis A vaccine	Inactivated hepatitis A will be administered intramuscularly on days 8 and 29.

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-10-17
• Last updated: 2017-06-08
• Results posted: 2014-03-10

Locations

4 sites across 1 country: Germany