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Long Term Follow-up of a Study to Assess the Safety and Immunogenicity of a Hepatitis A Vaccine Administered With and in the Absence of DTPaHibIPV, OPV and MMR Vaccines

NCT01307436 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2019-04-08

No results posted yet for this study

Summary

The primary purpose of this study was to assess whether the protection afforded by Epaxal vaccine co-administered with diphtheria, tetanus, Bordetella pertussis, Haemophilus influenzae type b, and inactivated polio vaccine(DTPaHibIPV), oral polio vaccine (OPV) and (measles mumps and rubella) MMR vaccines against hepatitis A was not inferior to the protection afforded by Epaxal administered alone. The aim of the follow-up phase is to obtain information on the long term protection afforded by Epaxal, and to compare this with an alternative hepatitis A vaccine (Havrix).

Conditions

  • Hepatitis A

Interventions

BIOLOGICAL

Epaxal

0.25ml Epaxal: at least 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted influenza virosomes (IRIV)

BIOLOGICAL

Havrix 720

0.5ml Havrix 720: at least 720 EU hepatitis A antigen adsorbed onto aluminium hydroxide

Sponsors & Collaborators

  • Crucell Holland BV

    lead INDUSTRY

Principal Investigators

  • Ron Dagan, MD · Soraka Medical Center

  • Shai Ashkenazi, MD · Schneider Children's Medical Center, Israel

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
15 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-14
Primary Completion
2013-07-08
Completion
2013-07-08

Countries

  • Israel

Study Locations

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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 NCT01307436 on ClinicalTrials.gov