Status:
COMPLETED
Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Tetanus
Acellular Pertussis
Eligibility:
All Genders
8-12 years
Phase:
PHASE3
Brief Summary
DTPa and IPV vaccines are recommended for immunization of infants in Korea. The use of combination vaccines simplifies routine paediatric vaccination. The Protocol Posting has been updated in order to...
Detailed Description
Participants in this Phase IIIb study will either receive GSK Biologicals' combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus (DTPa-IPV) vaccine or co-administration of GSK Biologi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol .
- A male or female between, and including, 8 and 12 weeks (56-90 days) of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks inclusive.
- 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.
- Administration of any vaccine within 30 days (i.e.30 days to 1 day) before the first dose of the study vaccine.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the study period (i.e. Day 0 to Month 7), with the exception of Bacille Calmette-Guérin (BCG) vaccine, hepatitis B vaccine, pneumococcal vaccine, flu vaccine and Hib vaccine.
- Planned administration/ administration of a vaccine foreseen by the study protocol (i.e. BCG vaccine, hepatitis B vaccine, pneumococcal, flu vaccine and Hib vaccine) during the period 30 days before and one week after the study vaccine dose.
- 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 (pharmaceutical product or device).
- Previous vaccination against diphtheria, tetanus, pertussis and/or poliovirus disease.
- History of diphtheria, tetanus, pertussis and/or poliovirus diseases.
- Known exposure to diphtheria, tetanus, pertussis and/or poliovirus before the study period.
- Any anaemia/ thrombocytopenia or blood clot that leads to prohibition from intramuscular injection.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2007
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT00290342
Start Date
January 1 2006
End Date
January 23 2007
Last Update
October 29 2018
Active Locations (9)
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1
GSK Investigational Site
Bucheon-si, South Korea, 420-767
2
GSK Investigational Site
Daegu, South Korea, 700-712
3
GSK Investigational Site
Gwangju, South Korea
4
GSK Investigational Site
Incheon, South Korea, 400-711