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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

Primary Purpose

Hepatitis A

Status

Completed

Phase

Phase 3

Locations

Israel

Study Type

Interventional

Intervention

Epaxal

Havrix 720

About this trial

This is an interventional prevention trial for Hepatitis A focused on measuring Hepatitis A Vaccine, Combined Vaccines, DTP Vaccine, MMR Vaccine

Eligibility Criteria

12 Months - 15 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

Epaxal + concomitant administration of DTPaHibIPV, MMR, OPV

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

Havrix 720 + concomitant administration of DTPaHibIPV, MMR

Outcomes

Primary Outcome Measures

Anti-hepatitis A virus (HAV) antibody concentrations

Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay

Anti-hepatitis A virus (HAV) antibody concentrations

Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay

Secondary Outcome Measures

Geometric mean concentrations (GMC)

GMCs of anti-HAV antibodies

Proportion of seroprotected subjects

Proportion of subjects seroprotected defined as anti-HAV antibody concentrations of at least 10 mIU/ml

Full Information

NCT ID

NCT01307436

First Posted

February 28, 2011

Last Updated

April 4, 2019

Sponsor

Crucell Holland BV

1. Study Identification

Unique Protocol Identification Number

NCT01307436

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

March 14, 2007 (Actual)

Primary Completion Date

July 8, 2013 (Actual)

Study Completion Date

July 8, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Crucell Holland BV

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis A

Keywords

Hepatitis A Vaccine, Combined Vaccines, DTP Vaccine, MMR Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

327 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Epaxal + concomitant administration of DTPaHibIPV, MMR, OPV

Arm Title

Group B

Arm Type

Experimental

Arm Description

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

Arm Title

Group C

Arm Type

Active Comparator

Arm Description

Havrix 720 + concomitant administration of DTPaHibIPV, MMR

Intervention Type

Biological

Intervention Name(s)

Epaxal

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Havrix 720

Intervention Description

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

Primary Outcome Measure Information:

Title

Anti-hepatitis A virus (HAV) antibody concentrations

Description

Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay

Time Frame

5.5 years

Title

Anti-hepatitis A virus (HAV) antibody concentrations

Description

Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay

Time Frame

7.5 years

Secondary Outcome Measure Information:

Title

Geometric mean concentrations (GMC)

Description

GMCs of anti-HAV antibodies

Time Frame

5.5 and 7.5 years

Title

Proportion of seroprotected subjects

Description

Proportion of subjects seroprotected defined as anti-HAV antibody concentrations of at least 10 mIU/ml

Time Frame

5.5 and 7.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Months

Maximum Age & Unit of Time

15 Months

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ron Dagan, MD

Organizational Affiliation

Soraka Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shai Ashkenazi, MD

Organizational Affiliation

Schneider Children's Medical Center, Israel

Official's Role

Principal Investigator

Facility Information:

City

Beer-Sheva

Country

Israel

City

Petach-Tikva

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

27093164

Citation

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.

Results Reference

result

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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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