Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age

Completed · Phase 2

Conditions studied: Varicella, Rubella, Mumps, Measles

In brief

The purpose of this observer blinded study is to provide information on vaccine immunogenicity and reactogenicity in comparison with the US standard of care (ProQuad®) when administered with Hepatitis A vaccine and Pneumococcal vaccine.

Key facts

Study ID

NCT00578175

Run by

GlaxoSmithKline

People needed

1851

Starts

2007-11-20

Expected to finish

2009-03-17

Last updated by the study team

2018-10-09

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol.
• Male or female between 12 and 14 months of age at the time of first vaccination.
• Written informed consent obtained from the parent/guardian of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Have previously received 3 doses of 7-valent pneumococcal conjugate vaccine within the first year of life.

You may not qualify if…

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine.
• Previous vaccination against measles, mumps, rubella and/or varicella.
• Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
• History of measles, mumps, rubella and/or varicella/zoster diseases.
• Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination, including human immunodeficiency virus infection.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures. Uncomplicated febrile convulsions are not an exclusion criterion.
• Residence in the same household as the following persons:
• New-born infants (0-4 weeks of age).
• Pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox.
• Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella disease history.
• Persons with known immunodeficiency.
• Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness.
• Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
• Contra-indications to commercially available vaccines used in this study (Havrix®, Prevnar®, ProQuad®).

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Tuscaloosa, Alabama, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Benton, Arkansas, United States
• GSK Investigational Site — Jonesboro, Arkansas, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Anaheim, California, United States
• GSK Investigational Site — Anaheim, California, United States
• GSK Investigational Site — Buena Park, California, United States
• GSK Investigational Site — Downey, California, United States
• GSK Investigational Site — Fountain Valley, California, United States
• GSK Investigational Site — Fremont, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Hayward, California, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Lakewood, California, United States
• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — Paramount, California, United States
• GSK Investigational Site — Pleasanton, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — San Jose, California, United States
• GSK Investigational Site — Torrance, California, United States
• GSK Investigational Site — Vacaville, California, United States
• GSK Investigational Site — West Covina, California, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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