Status:
COMPLETED
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
12-23 years
Phase:
PHASE2
Brief Summary
This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-v...
Eligibility Criteria
Inclusion
- 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, 12 and 23 months of age at the time of the first vaccination.
- Written 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.
Exclusion
- 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).
- Previous vaccination against S. pneumoniae since birth.
- History of any hypersensitivity reaction following any previous vaccination.
- Eczema and any history of allergy
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus infection.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or any chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature \>= 37.5°C on oral or axillary setting, or \>= 38.0°C on rectal setting.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period.
- Child in care.
Key Trial Info
Start Date :
November 24 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2011
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT00985751
Start Date
November 24 2009
End Date
March 2 2011
Last Update
November 5 2020
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Chomutov, Czechia, 43003
2
GSK Investigational Site
Děčín, Czechia, 405 01
3
GSK Investigational Site
Náchod, Czechia, 547 01
4
GSK Investigational Site
Odolena Voda, Czechia, 25070