Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA

September 8, 2017 updated by: Sanofi Pasteur, a Sanofi Company

An Open-label, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO to Explore the Anamnestic Immune Response in Healthy Children Vaccinated 10 Years Ago With a Primary Series (3 Doses) of Either HEXAVAC or INFANRIX HEXA

To evaluate the immune response to Hepatitis B virus in children who have been primed with HEXAVAC or INFANRIX HEXA 10 years ago.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

751

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy
        • Sanofi Pasteur MSD Investigational Site 004
      • Cagliari, Italy
        • Sanofi Pasteur MSD Investigational Site 009
      • Capannori, Italy
        • Sanofi Pasteur MSD Investigational Site 005
      • Chiavari, Italy
        • Sanofi Pasteur MSD Investigational Site 003
      • Latisana, Italy
        • Sanofi Pasteur MSD Investigational Site 002
      • Massafra, Italy
        • Sanofi Pasteur MSD Investigational Site 008
      • Nocera Inferiore, Italy
        • Sanofi Pasteur MSD Investigational Site 006
      • Ragusa, Italy
        • Sanofi Pasteur MSD Investigational Site 010
      • Salerno, Italy
        • Sanofi Pasteur MSD Investigational Site 007
      • Sassari, Italy
        • Sanofi Pasteur MSD Investigational Site 001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy child
  • Child vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX HEXA as infant
  • Child vaccinated with the third dose of HEXAVAC or INFANRIX HEXA at least 10 years prior to challenge dose

Exclusion Criteria:

  • Receipt of more than 3 doses of any Hepatitis B containing vaccine
  • History of clinical diagnosis of infection due to Hepatitis B
  • History or current close contact with known carriers of Hepatitis B virus
  • Prior known sensitivity or allergy to any component of HBVAXPRO
  • Chronic illness / medical condition that could interfere with study conduct or completion
  • Coagulation disorder that would contraindicate intramuscular injection
  • Subject is pregnant
  • Receipt of corticosteroids for more than 14 days in the 30 days prior to study
  • Receipt of Immunoglobulins, blood or blood-derived products in the 3 months prior to study
  • Planned participation in another clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HBVAXPRO Challenge dose
HBVAXPRO 5µg
Biological: HBVAXPRO 5µg
0.5mL intramuscular injection
Other Names:
  • Hepatitis B vaccine (rDNA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
Time Frame: One month after the challenge dose
One month after the challenge dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
Time Frame: Prior to challenge dose (At Day 0 prior to administration of the challenge dose)
Prior to challenge dose (At Day 0 prior to administration of the challenge dose)
Solicited injection-site adverse reactions and pyrexia
Time Frame: Day 0 to day 4 after vaccination
Day 0 to day 4 after vaccination
Unsolicited injection-site adverse reactions and systemic adverse events
Time Frame: Day 0 to day 14 after vaccination
Day 0 to day 14 after vaccination
Serious adverse events
Time Frame: From signature of the informed consent to the last visit of the subject, an expected average of one month
From signature of the informed consent to the last visit of the subject, an expected average of one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

December 11, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (ESTIMATE)

December 17, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 8, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HXV02C
  • 2013-001602-28 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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