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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


Phase 1
18 Years
45 Years
Not Enrolling
Both
Pneumococcal Disease

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Trial Information

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


The safety profile of the PhtD vaccine will be assessed in comparison to a comparator
vaccine (Pneumovax 23TM). In order to further increase the immune response to vaccination, a
novel adjuvant system will also be examined.


Inclusion Criteria:



- 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
vaccination.

- 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.

Exclusion Criteria:

- 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
the vaccine.

- 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
temperature <37.5°C.

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

Occurrence, intensity and relationship of any solicited local and general signs and symptoms

Outcome Time Frame:

During a 7-day follow up period (i.e. Days 0-6) after each vaccine dose

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

100417

NCT ID:

NCT01767402

Start Date:

October 2003

Completion Date:

November 2004

Related Keywords:

  • Pneumococcal Disease
  • Safety
  • Pneumococcal Infections
  • Immunogenicity
  • PhtD vaccine
  • Healthy adults
  • Reactogenicity

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