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

PHASE3CompletedINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2012

Conditions
Meningococcal DiseaseMeningococcal MeningitisHepatitis AHepatitis B
Interventions
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.

Trial Locations (4)

10117

03, Novartis Investigational Site, Berlin

18057

04, Novartis Investigational Site, Rostock

20359

02, Novartis Investigational Site, Hamburg

80802

01, Novartis Investigational Site, München

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Novartis Vaccines

INDUSTRY