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

Condition(s) targeted: Hepatitis A

Intervention: Epaxal (Biological); Havrix 720 (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Crucell Holland BV

Official(s) and/or principal investigator(s):
Ron Dagan, MD, Principal Investigator, Affiliation: Soraka Medical Center
Shai Ashkenazi, MD, Principal Investigator, Affiliation: Schneider Children's Medical Center, Israel

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).

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Anti-hepatitis A virus (HAV) antibody concentrations

Anti-hepatitis A virus (HAV) antibody concentrations

Secondary outcome:

Geometric mean concentrations (GMC)

Proportion of seroprotected subjects

Minimum age: 12 Months. Maximum age: 15 Months. Gender(s): Both.

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

Pediatric Infectious Diseases Unit, Soraka Medical Center, Beer Sheva 84101, Israel

Schneider Children's Medical Center of Israel, Petah Tiqva 49202, Israel

Starting date: March 2011
Last updated: July 28, 2014