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

NCT01453348 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2017-06-08

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01453348 on ClinicalTrials.gov