NL-OMON51807
Completed
Not Applicable
A controlled human pneumococcal infection model - Controlled human pneumococcal infection model (PIM) study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- nasal carriage of Streptococcus pneumoniae
- Sponsor
- Radboud Universitair Medisch Centrum
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant is:
- •\- Aged \>\= 18 and \< 50 years on the day of screening.
- •\- In good health as confirmed by review of medical history and physical
- •examination.
- •\- Able to arrive within 3h at the Radboudumc at any time during the study
- •participation, and participant is able to arrive within 1h at the Radboudumc
- •from his/her home address.
- •\- Willing to take a curative antibiotic course after inoculation with S.
- •pneumoniae, according to the study protocol.
Exclusion Criteria
- •\- Any history, or evidence at screening, of clinically significant symptoms,
- •physical signs or abnormal laboratory values suggestive of systemic conditions
- •which could compromise the health of the volunteer during the study or
- •interfere with the interpretation of the study results.
- •\- Previous pneumococcal vaccination or infection with the pneumococcus at
- •screening or inclusion visit
- •\- Close physical contact with at risk individuals (\>15 min within 1\.5m distance)
- •\- For female participants: pregnancy, lactation or intention to become pregnant
- •during the study.
- •\- Known hypersensitivity to or contra\-indications (including co\-medication) for
Outcomes
Primary Outcomes
Not specified
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