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View Clinical Trial (Medical Research Study)
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Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants - NCT01000974-44308 (Clinical Trial 379109)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy379109.aspx
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| City: |
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Akron |
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State:
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OH |
| Zip Code: |
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44308 |
| Conditions: |
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Haemophilus Influenzae Type B Related Disease - Pneumonia - Meningitis - Cellulitis - Osteomyelitis - Epiglottis |
| Purpose: |
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The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of
the vaccine, to address the relevant concomitant vaccine administrations and to provide a
comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib
vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6
and 15-18 months of age. This study is designed with a primary and a booster phase.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Subjects for whom the investigator believes that their parent(s)/Legally Acceptable
Representative(s) (LAR[s]) can and will comply with the requirements of the protocol
(e.g., completion of the diary card, return for follow-up visits).
- A male or female between, and including, 6 and 12 weeks of age at the time of the
first vaccination.
- Written informed consent obtained from the subject's parent/LAR.
- Healthy subjects as established by medical history and clinical examination before
entering into the study.
- Born after a gestation period of minimum 36 weeks.
- Infants who have not received a previous dose of hepatitis B vaccine or those who
have received only 1 dose of hepatitis B vaccine administered at least 30 days prior
to enrolment.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs since birth.
- Planned administration of a vaccine not foreseen by the study protocol within 30 days
of the first dose of study vaccine and until 30 days after the booster dose.
- Previous vaccination against Haemophilus influenzae type b, diphtheria, tetanus,
pertussis, Pneumococcus, rotavirus and/or poliovirus; more than one previous dose of
hepatitis B vaccine.
- History of Haemophilus influenzae type b, diphtheria, tetanus, pertussis,
pneumococcal, rotavirus, poliovirus, and hepatitis B diseases.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on
medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccines, including dry natural latex rubber.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at time of enrolment. All vaccines can be administered to persons with
a minor illness.
- Administration of immunoglobulins and/or any blood products since birth or planned
administration during the study period.
- Concurrent participation in another clinical study, up to 30 days prior to study
entry or 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 (pharmaceutical
product or device).
- Child in care. |
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| Study is available at: |
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GSK Investigational Site
Akron, OH 44308
United States
Primary Contact:
US GSK Clinical Trials Call Center
Phone: 877-379-3718 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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