NCT02012998

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
751

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

1.1 years

First QC Date

December 11, 2013

Last Update Submit

September 8, 2017

Conditions

Virus DiseasesHepatitis B

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL

    One month after the challenge dose

Secondary Outcomes (4)

  • Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL

    Prior to challenge dose (At Day 0 prior to administration of the challenge dose)

  • Solicited injection-site adverse reactions and pyrexia

    Day 0 to day 4 after vaccination

  • Unsolicited injection-site adverse reactions and systemic adverse events

    Day 0 to day 14 after vaccination

  • Serious adverse events

    From signature of the informed consent to the last visit of the subject, an expected average of one month

Study Arms (1)

HBVAXPRO Challenge dose

EXPERIMENTAL

HBVAXPRO 5µg

Biological: HBVAXPRO 5µg

Interventions

HBVAXPRO 5µgBIOLOGICAL

0.5mL intramuscular injection

Also known as: Hepatitis B vaccine (rDNA)
HBVAXPRO Challenge dose

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Sanofi Pasteur MSD Investigational Site 004

Bologna, Italy

Location

Sanofi Pasteur MSD Investigational Site 009

Cagliari, Italy

Location

Sanofi Pasteur MSD Investigational Site 005

Capannori, Italy

Location

Sanofi Pasteur MSD Investigational Site 003

Chiavari, Italy

Location

Sanofi Pasteur MSD Investigational Site 002

Latisana, Italy

Location

Sanofi Pasteur MSD Investigational Site 008

Massafra, Italy

Location

Sanofi Pasteur MSD Investigational Site 006

Nocera Inferiore, Italy

Location

Sanofi Pasteur MSD Investigational Site 010

Ragusa, Italy

Location

Sanofi Pasteur MSD Investigational Site 007

Salerno, Italy

Location

Sanofi Pasteur MSD Investigational Site 001

Sassari, Italy

Location

Related Publications (1)

  • Zanetti A, Desole MG, Romano L, d'Alessandro A, Conversano M, Ferrera G, Panico MG, Tomasi A, Zoppi G, Zuliani M, Thomas S, Soubeyrand B, Eymin C, Lockhart S. Safety and immune response to a challenge dose of hepatitis B vaccine in healthy children primed 10years earlier with hexavalent vaccines in a 3, 5, 11-month schedule: An open-label, controlled, multicentre trial in Italy. Vaccine. 2017 Jul 13;35(32):4034-4040. doi: 10.1016/j.vaccine.2017.05.047. Epub 2017 Jun 16.

    PMID: 28624307DERIVED

MeSH Terms

Conditions

Virus DiseasesHepatitis B

Interventions

Hepatitis B VaccinesDNA, Ribosomal

Condition Hierarchy (Ancestors)

InfectionsBlood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex MixturesDNANucleic AcidsNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Medical Director

    Sanofi Pasteur, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2013

First Posted

December 17, 2013

Study Start

January 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations

IT(10)