Status:
COMPLETED
Primary and Booster Vaccination Study With a Pneumococcal Vaccine in HIV Infected, HIV Exposed Uninfected and HIV Uninfected Children 6 to 10 Weeks of Age.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
6-10 years
Phase:
PHASE3
Brief Summary
The purposes of this study: * To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV infected infants, HIV exposed uninfected infants and HIV unexposed u...
Detailed Description
This protocol posting has been updated according to Protocol amendment 1, December 08
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 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).
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.
- A family history of hereditary immunodeficiency other than HIV infection.
- Major congenital defects or serious chronic illness other than HIV infection.
- For HIV infected infants: Moderately and severely symptomatic: stages III and IV according to latest version of WHO classification.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and/or Streptococcus pneumoniae.
- History of, or intercurrent, diphtheria, tetanus, pertussis, 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.
- Acute disease at the time of enrolment.
- Babies for which weight for age is \< 3rd percentile at Visit 1, using standard growth charts, with the exception of HIV infected infants for which the decision of enrolment was left to the investigator's discretion.
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator.
- Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of vaccination).
Key Trial Info
Start Date :
February 17 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2012
Estimated Enrollment :
489 Patients enrolled
Trial Details
Trial ID
NCT00829010
Start Date
February 17 2009
End Date
June 27 2012
Last Update
August 17 2018
Active Locations (1)
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1
GSK Investigational Site
Soweto, Gauteng, South Africa, 2013