Status:
COMPLETED
Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Streptococcus Pneumoniae Vaccines
Eligibility:
All Genders
16-18 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine co-administered with a boo...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 16-18 months of age at the time of the booster vaccination.
- A male or female who previously participated in study 107737 and received three doses of pneumococcal conjugate vaccine.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion
- Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up).
- Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccine.
- Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month (30 days) before the booster dose of study vaccines (Visit 1) and up to the follow-up visit (Visit 2).
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae other than the study vaccines from study 107737
- History of or intercurrent diphtheria, tetanus, hepatitis B, pertussis, polio, Haemophilus influenzae type b disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of seizures or progressive neurological disease
- Acute disease at the time of enrolment.
- Febrile illness defined as oral, axillary or tympanic temperature \< 37.5°C / rectal temperature \< 38°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- Administration of immunoglobulins, with the exception of monoclonal antibodies against RSV, and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.
Key Trial Info
Start Date :
January 3 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2009
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT00609492
Start Date
January 3 2008
End Date
March 30 2009
Last Update
January 3 2020
Active Locations (7)
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1
GSK Investigational Site
Athens, Greece, 115 27
2
GSK Investigational Site
Athens, Greece, 11527
3
GSK Investigational Site
Ioannina, Greece, 452 21
4
GSK Investigational Site
Thessaloniki, Greece, 54636