Status:
COMPLETED
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Streptococcus Pneumoniae
Eligibility:
All Genders
6-10 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events followin...
Eligibility Criteria
Inclusion
- Male or female subjects between, and including 6-10 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.
- Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
- Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).
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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- 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 (with the exception of hepatitis B immunoglobulins at birth).
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject's first study visit).
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and 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.
- Babies for which birth weight is \< 2 kilogram.
Key Trial Info
Start Date :
March 7 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2009
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00814710
Start Date
March 7 2009
End Date
November 13 2009
Last Update
January 3 2020
Active Locations (4)
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1
GSK Investigational Site
Kolkata, India, 700073
2
GSK Investigational Site
Ludhiana, India, 141 008
3
GSK Investigational Site
Pune, India
4
GSK Investigational Site
Vellore, India, 632004