Safety and Immunogenicity of a Paediatric Dose of Virosomal Hepatitis A Vaccine

NCT01405677 | Completed Phase 2 DMC

• 1 other identifier: EPA 001 FU
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 2

Brief Summary

The primary purpose of the original study was to assess whether the protection afforded by the paediatric dose of Epaxal vaccine against hepatitis A was not inferior to the protection afforded by the standard dose of Epaxal. The aim of the follow-up phase was to perform a computer based modelling analysis of the long term protection afforded by the paediatric dose, and to compare this with the standard dose and also with an alternative hepatitis A vaccine (Havrix Junior).

Conditions

Hepatitis A

Keywords

Hepatitis A; Vaccination; Immunisation

Outcome Measures

Primary Outcomes (5)

• Individual anti-HAV titers

  Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection

  66 months post-booster

• Individual anti-HAV titers

  Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection

  18 months post-booster

• Individual anti-HAV titers

  Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection

  30 months post-booster

• Individual anti-HAV titers

  Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection

  42 months post-booster

• Individual anti-HAV titers

  Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection

  54 months post-booster

Secondary Outcomes (2)

• Geometric mean titers

  18, 30, 42, 54, 66 months post-booster

• Seroprotection

  18, 30, 42, 54, 66 months post-booster

Study Arms (3)

Epaxal 0.25 mL

EXPERIMENTAL

Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6

Biological: Epaxal 0.25 mL

Epaxal 0.5 mL

ACTIVE COMPARATOR

Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6

Biological: Epaxal 0.5 mL

Havrix Junior

ACTIVE COMPARATOR

Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6

Biological: Havrix Junior 0.5 mL

Interventions

Epaxal 0.25 mL BIOLOGICAL

12 IU hepatitis A antigen coupled to immunopotentiating reconstituted Influenza virosome (IRIV)

Epaxal 0.25 mL

Epaxal 0.5 mL BIOLOGICAL

24 IU hepatitis A antigen coupled to IRIV

Epaxal 0.5 mL

Havrix Junior 0.5 mL BIOLOGICAL

720 EU hepatitis A antigen absorbed onto aluminum hydroxide

Havrix Junior

Eligibility Criteria

• Age: 12 Months - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Original study:
• Males or females aged \>=12 months and 16 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject when applicable and from the parent/legal guardian of the subject. - Free of obvious health problems as established by medical history and/or clinical examination before entering the study.
• Follow up phase:
• Subjects enrolled and randomized in the primary study and having received two doses of the study vaccine

You may not qualify if:

• Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this means prednisone, or equivalent, \>=0.5 mg/kg/day. Inhaled and topical steroids were allowed.)
• Planned administration/administration of a vaccine not foreseen by the study protocol within 4 weeks prior to the first dose of study vaccine
• Previous vaccination against hepatitis A
• Seropositive for anti-HAV antibodies (\>=10 mIU/mL)
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness
• Acute disease at the time of enrolment

Sponsors & Collaborators

• Crucell Holland BV: lead

Study Sites (2)

Sint-Vincentiusziekenhuis

Antwerp, B-2018, Belgium

Location

Centre for the Evaluation of Vaccination, University of Antwerp

Antwerp, BE-2610, Belgium

Location

MeSH Terms

Conditions

Hepatitis A

Interventions

epaxal berna

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Pierre van Damme, MD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

• Andre Vertruyen, MD

  Sint-Vincentiusziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: July 29, 2011
• Study Start: June 1, 2004
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 29, 2014

Record last verified: 2013-12

Locations

BE (2)