Immunogenicity and safety of GlaxoSmithKline Biologicals' Havrix administered on a 0, 6-month schedule concomitantly with Merck and Company, Inc. M-M-R II and Merck and Company, Inc. VARIVAX to healthy children 15 months of age

• Conditions: Active immunization against hepatitis A of healthy children 15 months of age at the time of the first study vaccination.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-001509-15-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-25
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1474

Inclusion Criteria

Only subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol should be enrolled in the study.
A male or female child 12 to 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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 1474
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Use of any investigational or non-registered drug or vac-cine other than the study vaccines within 42 days preceding the first dose of study vaccine, or planned use during the study period,
Chronic administration of immunosuppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period.,
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 vaccines.
For subjects in the HAV Group ONLY, the first dose of M-M-RII and VARIVAX must be administered during the Enrollment Phase and >= 42 days prior to administration of study vaccine(s) at Day 0.]
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 im-munodeficient condition, including human immunodeficiency virus 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 Havrix, M-M-RII or VARIVAX, 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 Havrix needle-less pre-filled syringes contain dry natural latex rubber.
Major congenital defects or serious chronic illness,
Active untreated tuberculosis,
History of significant blood dyscrasias, e.g., leukemia, lymphomas, etc.
History of any neurologic disorder
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, i.e., the Enrollment, Active and Extended Safety Follow-up Phases of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified