Status:
COMPLETED
Evaluation of a Booster Dose of Pneumococcal Vaccine Formulations in Young Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
18-41 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of pneumococcal vaccines (GSK 2189242A) in young adults. This protocol posting deals with obje...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 18 and 41 years old at the time of vaccination.
- Subjects who previously participated in the study NCT00707798 and received one of the two investigational GSK2189242A vaccine formulations during the primary study.
- Written informed consent obtained from the subject.
- Free of obvious health problems as established by medical history, clinical examination and clinical laboratory assessment before entering into the study.
- Female subjects of non-childbearing potential (defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause) may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after vaccination.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the vaccination, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the vaccination and ending one month (minimum 30 days) after vaccination.
- Administration of any pneumococcal vaccine other than the study vaccine during the period between end of study NCT00707798 and study vaccination.
- Bacterial pneumonia within the period between end of study NCT00707798 and study vaccination.
- Invasive pneumococcal disease (IPD) within the period between end of study NCT00707798 and study vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection (no laboratory testing required).
- History of thrombocytopenia or bleeding disorder.
- Anaphylactic reaction following the previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
- Current serious neurologic or mental disorders.
- Inflammatory processes such as known chronic active infections (e.g. Hepatitis B, C).
- All past or current malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders.
- Acute disease at the time of enrolment/vaccination.
- Fever at the time of vaccination. Fever is defined as temperature \>= 37.5°C on oral setting.
- Physical examination positive for acrocyanosis, jaundice, splenomegaly.
- Acute or chronic, clinically significant anaemia, pulmonary, cardiovascular, hematologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator
- Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Other conditions that the principal investigator judges may interfere with study findings.
Key Trial Info
Start Date :
May 18 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2009
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00896064
Start Date
May 18 2009
End Date
August 5 2009
Last Update
August 17 2018
Active Locations (1)
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1
GSK Investigational Site
Ghent, Belgium, 9000