Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children
Condition: Hepatitis A
MeSH terms: Hepatitis A; Chickenpox; Rubella; Hepatitis
Intervention: Havrix®; M-M-R®II; VARIVAX®
Intervention description: 2 doses administered intramuscularly; 1 dose administered subcutaneously; 1 dose administered subcutaneously
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1474.0
Sex: All
Minimum age: 12 Months
Maximum age: 13 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose
      inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a
      varicella (chickenpox) vaccine in children as young as 15 months of age.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects whose parents/guardians are believed by the investigator to be willing to
             comply with the requirements of the protocol

          -  A male or female child 12 and 13 months of age at the time of entry into the
             Enrollment Phase

          -  Written informed consent obtained from the parents or guardian of the subject,

          -  Free of obvious health problems as established by medical history and history-directed
             physical examination before entering into the study, and

          -  Parents/guardian of the subject must have a telephone or be able to be contacted by
             telephone

        Exclusion Criteria:

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccine(s) within 42 days preceding the first dose of study vaccine, or planned use
             during the study period, Chronic administration (defined as more than 14 days) of
             immuno-suppressant or other immune-modifying drugs within six months prior to
             vaccination or planned administration at any time during the study period. (For
             corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled,
             nasal and topical steroids are allowed.) Planned administration or administration of
             any vaccine not foreseen by the study protocol during the period 31 days before and 31
             days after each dose of study vaccine(s).

          -  Previous vaccination against hepatitis A,

          -  History of hepatitis A,

          -  Known exposure to hepatitis A,

          -  Previous vaccination against measles, mumps, rubella and/or varicella,

          -  History of measles, mumps, rubella and/or varicella,

          -  Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the
             start of the study,

          -  Planned chronic use of salicylates during the 6-week period following administration
             of the doses of study vaccine(s),

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection,

          -  A family history of congenital, hereditary or infectious immunodeficiency or parental
             risk factors for HIV infection,

          -  History of allergic disease/reactions or hypersensitivity likely to be exacerbated by
             any component of HavrixTM, M-M-RII or VARIVAXTM, including 2-phenoxyethanol, neomycin
             and gelatin,

          -  History of anaphylactic or anaphylactoid reactions to egg proteins,

          -  History of hypersensitivity/allergic reaction to latex. Note: The tip cap and the
             rubber plunger of the HavrixTM needleless pre-filled syringes contain dry natural
             latex rubber.

          -  Major congenital defects or serious chronic illness,

          -  Active untreated tuberculosis,

          -  History of significant blood dyscrasias

          -  History of any neurologic disorder (a history of febrile seizures not associated with
             an underlying neurological disorder does not exclude the subject)

          -  Acute disease at the time of vaccination

          -  Administration of immunoglobulins and/or any blood products within three months prior
             to the first dose of study vaccine or planned administration at any time during the
             entire study period