Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Hepatitis A

Treatments: Biological: VARIVAX®; Biological: Havrix®; Biological: M-M-R®II

Study type: Interventional

Funder types: Industry

Identifiers

NCT00197015

208109/231

Details and patient eligibility

About

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.

Full description

An open, controlled comparison of Havrix™ administered alone or with MMR II and Varivax™. The three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + MMR II and Varivax™ and 3) MMR II and Varivax™ followed by Havrix™ one month later.

Enrollment: 1,474 patients

Sex: All

Ages: 12 to 13 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,474 participants in 3 patient groups

HAV Group

Active Comparator group

Description:

Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)

Treatment:

Biological: Havrix®

HAV+MMR+V Group

Experimental group

Description:

Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Treatment:

Biological: M-M-R®II

Biological: VARIVAX®

Biological: Havrix®

MMR+V→HAV Group

Active Comparator group

Description:

Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)

Treatment:

Biological: M-M-R®II

Biological: VARIVAX®

Biological: Havrix®