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

Phase 3

Completed

• Conditions: Hepatitis A
• Interventions: Biological: Epaxal; Biological: Havrix 720

• Registration Number: NCT01307436
• Lead Sponsor: Crucell Holland BV

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-14
• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-03-01
• Study First Posted: 2011-03-03
• Primary Completion: 2013-07-08
• Study Completion: 2013-07-08
• Status Verified: 2019-03
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Epaxal	Epaxal, with administration of DTPaHibIPV, MMR, OPV one month later
Group C	Havrix 720	Havrix 720 + concomitant administration of DTPaHibIPV, MMR
Group A	Epaxal	Epaxal + concomitant administration of DTPaHibIPV, MMR, OPV

Primary Outcome Measures

Name	Time	Method
Anti-hepatitis A virus (HAV) antibody concentrations	7.5 years	Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay

Secondary Outcome Measures

Name	Time	Method
Geometric mean concentrations (GMC)	5.5 and 7.5 years	GMCs of anti-HAV antibodies
Proportion of seroprotected subjects	5.5 and 7.5 years	Proportion of subjects seroprotected defined as anti-HAV antibody concentrations of at least 10 mIU/ml