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

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