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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01307436
First received: February 28, 2011
Last updated: March 3, 2014
Last verified: August 2013
  Purpose

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).


Condition Intervention Phase
Hepatitis A
Biological: Epaxal
Biological: Havrix 720
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III Randomised, Open, Controlled Study to Assess the Safety and Immunogenicity of Concomitant Administration of Virosomal Hepatitis A Vaccine (Epaxal®) With DTPaHibIPV, OPV and MMR Vaccines vs. Non-concomitant Administration in 12-15 Month Old Children. Follow-up: Serological Long-term Follow-up of Subjects for up to 42 Months, 5.5 and 7.5 Years After the Second Dose.

Resource links provided by NLM:


Further study details as provided by Crucell Holland BV:

Primary Outcome Measures:
  • Anti-hepatitis A virus (HAV) antibody concentrations [ Time Frame: 5.5 years ] [ Designated as safety issue: No ]
    Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay

  • Anti-hepatitis A virus (HAV) antibody concentrations [ Time Frame: 7.5 years ] [ Designated as safety issue: No ]
    Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay


Secondary Outcome Measures:
  • Geometric mean concentrations (GMC) [ Time Frame: 5.5 and 7.5 years ] [ Designated as safety issue: No ]
    GMCs of anti-HAV antibodies

  • Proportion of seroprotected subjects [ Time Frame: 5.5 and 7.5 years ] [ Designated as safety issue: No ]
    Proportion of subjects seroprotected defined as anti-HAV antibody concentrations of at least 10 mIU/ml


Estimated Enrollment: 200
Study Start Date: March 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Epaxal + concomitant administration of DTPaHibIPV, MMR, OPV
Biological: Epaxal
0.25ml Epaxal: at least 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted influenza virosomes (IRIV)
Experimental: Group B
Epaxal, with administration of DTPaHibIPV, MMR, OPV one month later
Biological: Epaxal
0.25ml Epaxal: at least 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted influenza virosomes (IRIV)
Active Comparator: Group C
Havrix 720 + concomitant administration of DTPaHibIPV, MMR
Biological: Havrix 720
0.5ml Havrix 720: at least 720 EU hepatitis A antigen adsorbed onto aluminium hydroxide

  Eligibility

Ages Eligible for Study:   12 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Original study:

  • Written informed consent obtained 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.
  • At least 8 kg of body weight at age of 12 months.

Follow-up phase:

  • Subjects enrolled and randomised in the original study and having received two doses of the hepatitis A study vaccines.

Exclusion Criteria:

Original study:

  • Children not having received 3 documented doses of DTPaHib and polio vaccines during infancy
  • Children having received a documented dose of MMR during infancy
  • 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 the 30 days safety follow-up after the last dose.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Administration of systemic corticosteroids (inhaled and topical steroids are allowed).
  • 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.
  • 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.

Follow-up phase:

  • Children who had received a hepatitis A antigen containing vaccine since the last visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307436

Locations
Israel
Pediatric Infectious Diseases Unit, Soraka Medical Center
Beer Sheva, Israel, 84101
Schneider Children's Medical Center of Israel
Petah Tiqva, Israel, 49202
Sponsors and Collaborators
Crucell Holland BV
Investigators
Principal Investigator: Ron Dagan, MD Soraka Medical Center
Principal Investigator: Shai Ashkenazi, MD Schneider Children's Medical Center, Israel
  More Information

No publications provided

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01307436     History of Changes
Other Study ID Numbers: EPA 004 FU
Study First Received: February 28, 2011
Last Updated: March 3, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Crucell Holland BV:
Hepatitis A Vaccine
Combined Vaccines
DTP Vaccine
MMR Vaccine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on April 21, 2014