Status:
COMPLETED
Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis A
Eligibility:
All Genders
12-13 years
Phase:
PHASE3
Brief 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)...
Detailed 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™ ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 6 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2009
Estimated Enrollment :
1474 Patients enrolled
Trial Details
Trial ID
NCT00197015
Start Date
October 6 2003
End Date
June 9 2009
Last Update
July 31 2018
Active Locations (42)
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1
GSK Investigational Site
Cabot, Arkansas, United States, 72023
2
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
3
GSK Investigational Site
North Little Rock, Arkansas, United States, 72117
4
GSK Investigational Site
Huntington Beach, California, United States, 92647