A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine Without or With Adjuvant, Administered at 2 Different Concentrations According to a 0-2 Month Schedule, in Healthy Adults
- 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 45 years at the time of the first
- Written informed consent obtained from the subject.
- Free of obvious health problems as established by medical history and clinical
examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential, i.e., either
surgically sterilized or one year post-menopausal; or, if of childbearing potential,
she must be abstinent or have used adequate contraceptive precautions for 30 days
prior to vaccination, have a negative pregnancy test and must agree to continue such
precautions for two months after completion of the vaccination series.
- 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 or participation to another pharmaceutical/vaccine study.
- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the first vaccine dose.
- Use of any anticoagulants.
- Planned administration/ administration of a vaccine not foreseen by the study
protocol within 2 weeks of the first dose of vaccines.
- Previous vaccination against Streptococcus pneumoniae.
- Bacterial pneumonia within 3 years prior to 1st vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus (HIV) infection.
- History of allergic disease or reactions likely to be exacerbated by any component of
- Current serious neurologic or mental disorders.
- Inflammatory processes such as known chronic active infections.
- All malignancies (excluding non-melanic skin cancer) and lymphoproliferative
disorders diagnosed or treated actively during the past 5 years.
- History of administration of an experimental vaccine containing 3-deacylated
Monophosphoryl Lipid A (MPL) or Quillaja saponaria 21 (QS21).
- Acute disease at the time of enrolment. All vaccines can be administered to persons
with a minor illness such as diarrhea, mild upper respiratory infection with or
without low-grade febrile illness, i.e., Oral temperature <37.5°C or Axillary
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or laboratory screening
tests, at the discretion of the investigator.
- Pregnant or lactating female.
- History of chronic alcohol consumption and/or intravenous drug abuse.