Status:
COMPLETED
Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety & Immunogenicity in Children & Infants
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
PATH
Department of State for Health and Social Welfare, The Gambia
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
56-4 years
Phase:
PHASE2
Brief Summary
This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and co-administered with ...
Detailed Description
There will be two cohorts in the study: Cohort 1 (children aged 2-4 years) and Cohort 2 (infants aged 8-10 weeks), and two steps in the study, Step 1 and Step 2. Step 1 will consist in a safety evalua...
Eligibility Criteria
Inclusion
- Inclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
- Male or female between, and including,
- 2 to 4 years of age at the time of the first vaccination for subjects in Cohort 1 (children).
- 8 to 10 weeks (56-76 days) of age at the time of the first vaccination for subjects in Cohort 2 (infants).
- Signed or thumb-printed informed consent obtained from the parents/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Permanent residence in the study area and no intention of leaving during the study period.
- Additional inclusion criteria for subjects in Cohort 1:
- • Previously completed three-dose primary course of diphtheria-tetanus-pertussis (DTP) vaccination.
Exclusion
- Exclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):
- Child in care.
- Use of any investigational or non-registered product 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 of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the exception of licensed flu vaccines.
- 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
- Previous vaccination against S. pneumoniae.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Malnutrition
- A 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 any chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease and/or fever at the time of enrolment.
- Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Contraindications to any co-administered vaccine.
- Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.
- Additional exclusion criteria for subjects in Cohort 1:
- • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b with the exception of vaccines where the first dose should be given within the first two weeks of life according to the national recommendations (for example Bacillus Calmette-Guérin \[BCG\] and hepatitis B vaccination).
Key Trial Info
Start Date :
February 9 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2013
Estimated Enrollment :
1320 Patients enrolled
Trial Details
Trial ID
NCT01262872
Start Date
February 9 2011
End Date
March 18 2013
Last Update
June 19 2019
Active Locations (1)
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1
GSK Investigational Site
Banjul, The Gambia