Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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.
Exclusion criteria
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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.
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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.
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Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
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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.
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Previous vaccination against measles, mumps, rubella and/or varicella.
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Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
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History of measles, mumps, rubella and/or varicella/zoster diseases.
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Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
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Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination, including human immunodeficiency virus infection.
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A family history of congenital or hereditary immunodeficiency.
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History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
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Major congenital defects or serious chronic illness.
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History of any neurologic disorders or seizures. Uncomplicated febrile convulsions are not an exclusion criterion.
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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.
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Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness.
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Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
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Contra-indications to commercially available vaccines used in this study (Havrix®, Prevnar®, ProQuad®).
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,851 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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