Status:
COMPLETED
Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Tetanus
Poliomyelitis
Eligibility:
All Genders
60-90 years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healt...
Detailed Description
This Protocol Posting has been updated following Protocol Amendment 1, February 2011, leading to the update of the exclusion criteria.
Eligibility Criteria
Inclusion
- A male or female between, and including, 60 and 90 days of age at the time of the first vaccination.
- Born after a gestation period of 37 to 42 weeks inclusive.
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral rotavirus vaccination which is allowed at any time during the study.
- 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.
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Hib and/or pneumococcal vaccination or disease, with the exception of hepatitis B vaccination at birth.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- History of any neurological disorders or seizures.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment.
Key Trial Info
Start Date :
December 9 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2012
Estimated Enrollment :
721 Patients enrolled
Trial Details
Trial ID
NCT01248884
Start Date
December 9 2010
End Date
January 5 2012
Last Update
August 20 2018
Active Locations (16)
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1
GSK Investigational Site
Santo Domingo, Dominican Republic
2
GSK Investigational Site
Santo Domingo, Distrito Nacional, Dominican Republic
3
GSK Investigational Site
Espoo, Finland, 02100
4
GSK Investigational Site
Helsinki, Finland, 00100