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

NCT ID: NCT01307436

Last Updated: 2019-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 327 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-14
• Study Completion Date: 2013-07-08

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).

Conditions

Hepatitis A

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

Epaxal + concomitant administration of DTPaHibIPV, MMR, OPV

Group Type: EXPERIMENTAL

Epaxal

Intervention Type: BIOLOGICAL

0.25ml Epaxal: at least 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted influenza virosomes (IRIV)

Group B

Epaxal, with administration of DTPaHibIPV, MMR, OPV one month later

Group Type: EXPERIMENTAL

Epaxal

Intervention Type: BIOLOGICAL

0.25ml Epaxal: at least 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted influenza virosomes (IRIV)

Group C

Havrix 720 + concomitant administration of DTPaHibIPV, MMR

Group Type: ACTIVE_COMPARATOR

Havrix 720

Intervention Type: BIOLOGICAL

0.5ml Havrix 720: at least 720 EU hepatitis A antigen adsorbed onto aluminium hydroxide

Interventions

Epaxal

0.25ml Epaxal: at least 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted influenza virosomes (IRIV)

Intervention Type: BIOLOGICAL

Havrix 720

0.5ml Havrix 720: at least 720 EU hepatitis A antigen adsorbed onto aluminium hydroxide

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 15 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Crucell Holland BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ron Dagan, MD

Role: PRINCIPAL_INVESTIGATOR

Soraka Medical Center

Shai Ashkenazi, MD

Role: PRINCIPAL_INVESTIGATOR

Schneider Children's Medical Center, Israel

Locations

Beersheba, , Israel

Petah Tikva, , Israel

Countries

Israel

References

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 Infect Dis J. 2016 Jul;35(7):e220-8. doi: 10.1097/INF.0000000000001176.

Reference Type: RESULT

PMID: 27093164 (View on PubMed)

Other Identifiers

EPA 004 FU

Identifier Type: OTHER

Identifier Source: secondary_id

CR106637

Identifier Type: -

Identifier Source: org_study_id