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

Hepatitis A Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307436
• Other study ID #: CR106637
• Secondary ID: EPA 004 FU
• Status: Completed
• Phase: Phase 3
• Start date: March 14, 2007
• Est. completion date: July 8, 2013

Study information

• Verified date: March 2019
• Source: Crucell Holland BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: July 8, 2013
• Est. primary completion date: July 8, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 15 Months

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A

Intervention

Biological:
• Epaxal
0.25ml Epaxal: at least 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted influenza virosomes (IRIV)
• Havrix 720
0.5ml Havrix 720: at least 720 EU hepatitis A antigen adsorbed onto aluminium hydroxide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Crucell Holland BV

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Dagan R, Ashkenazi S, Livni G, Go O, Bagchi P, Sarnecki M. Long-term Serologic Follow-up of Children Vaccinated with a Pediatric Formulation of Virosomal Hepatitis A Vaccine Administered With Routine Childhood Vaccines at 12-15 Months of Age. Pediatr Infe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-hepatitis A virus (HAV) antibody concentrations	Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay	5.5 years
Primary	Anti-hepatitis A virus (HAV) antibody concentrations	Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay	7.5 years
Secondary	Geometric mean concentrations (GMC)	GMCs of anti-HAV antibodies	5.5 and 7.5 years
Secondary	Proportion of seroprotected subjects	Proportion of subjects seroprotected defined as anti-HAV antibody concentrations of at least 10 mIU/ml	5.5 and 7.5 years