Status:
COMPLETED
Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
The purposes of this study are: To demonstrate the immunogenicity in terms of antibody response following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A co...
Detailed Description
Vaccination course at 2, 4, 6 months of age.
Eligibility Criteria
Inclusion
- Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- Written and signed informed consent obtained from the parent(s)/guardian(s) of the child/ward.
- Free of any known or suspected health problems as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks inclusive, with a birth weight of at least 2.5 kilogram.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, 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 (pharmaceutical product or device).
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/administration of a vaccine not allowed by the study protocol during the study period. Vaccines included in the Korean routine immunization schedule can be administered at least one week before or at least one month after the administration of the study vaccines. Recommended live vaccines not included in the Korean routine immunization schedule can be given at least one month before or at least one month after the administration of the study vaccines.
- A family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
- Previous vaccination against Streptococcus pneumoniae and/or Haemophilus influenzae type b.
- History of, or intercurrent Streptococcus pneumoniae and/or Haemophilus influenzae type b disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of any neurological disorders or seizures.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment. Study entry should be delayed until the illness has improved.
Key Trial Info
Start Date :
June 10 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2009
Estimated Enrollment :
503 Patients enrolled
Trial Details
Trial ID
NCT00680914
Start Date
June 10 2008
End Date
May 8 2009
Last Update
June 8 2018
Active Locations (14)
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1
GSK Investigational Site
Ansan, South Korea, 425-707
2
GSK Investigational Site
Bucheon-si, South Korea, 420-767
3
GSK Investigational Site
Daejeon, South Korea, 301-723
4
GSK Investigational Site
Gyeongnam, South Korea, 641-560