Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Infectious Disease, Infectious Disease, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 10/10/2018 |
Start Date: | November 20, 2007 |
End Date: | March 17, 2009 |
Immunogenicity of GlaxoSmithKline Biologicals' MMRV Vaccine (208136) vs. ProQuad®, When Coadministered With Hepatitis A and Pneumococcal Conjugate Vaccines to Children 12-14 Months of Age.
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.
immunogenicity and reactogenicity in comparison with the US standard of care (ProQuad®) when
administered with Hepatitis A vaccine and Pneumococcal vaccine.
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:
- 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®).
We found this trial at
128
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