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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

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ClinicalTrials.gov Identifier: NCT01307436
Recruitment Status : Completed
First Posted : March 3, 2011
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Hepatitis A Biological: Epaxal Biological: Havrix 720 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Actual Study Start Date : March 14, 2007
Actual Primary Completion Date : July 8, 2013
Actual Study Completion Date : July 8, 2013

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Anti-hepatitis A virus (HAV) antibody concentrations [ Time Frame: 5.5 years ]
    Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay

  2. Anti-hepatitis A virus (HAV) antibody concentrations [ Time Frame: 7.5 years ]
    Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay


Secondary Outcome Measures :
  1. Geometric mean concentrations (GMC) [ Time Frame: 5.5 and 7.5 years ]
    GMCs of anti-HAV antibodies

  2. Proportion of seroprotected subjects [ Time Frame: 5.5 and 7.5 years ]
    Proportion of subjects seroprotected defined as anti-HAV antibody concentrations of at least 10 mIU/ml


Eligibility Criteria
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Ages Eligible for Study:   12 Months to 15 Months   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307436


Locations
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Israel
Beer-Sheva, Israel
Petach-Tikva, Israel
Sponsors and Collaborators
Crucell Holland BV
Investigators
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Principal Investigator: Ron Dagan, MD Soraka Medical Center
Principal Investigator: Shai Ashkenazi, MD Schneider Children's Medical Center, Israel
More Information
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Publications of Results:

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Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01307436    
Other Study ID Numbers: CR106637
EPA 004 FU ( Other Identifier: Crucell Holland BV )
First Posted: March 3, 2011    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: March 2019
Keywords provided by Crucell Holland BV:
Hepatitis A Vaccine
Combined Vaccines
DTP Vaccine
MMR Vaccine
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections