The goal of this clinical trial is to learn if whole-cell Streptococcus pneumoniae (wSp) vaccination is safe and tolerated in healthy adults. The main aim is to evaluate the safety and tolerability of wSp vaccine. Researchers will compare wSp vaccinated participants with placebo-treated participants. Participants will be administered once with 1mg wSp vaccine or placebo. After dosing, they will be followed up for 30 days. In addition to the screening and enrollment visits, each participant will come to the study site for scheduled study visits on Days 14 and 30 to undergo study evaluations and measurements and to monitor safety. Each participant also will receive scheduled phone calls on Days 3 and 7 to monitor safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
30
Single intramuscular injection of 1 mg protein/0.5 mL wSp vaccine
Single intramuscular injection of 0.5 mL placebo
Rochester Clinical Research
Rochester, New York, United States
Safety and tolerability outcome
Occurrence and severity of local reactogenicity (injection site pain, tenderness, redness, swelling, itching, local lymphadenopathy) and systemic reactogenicity (headache, muscle pain, fever, nausea, vomiting, excessive fatigue, and diarrhea) within 7 days post-vaccination. Occurrence, severity, and relatedness of solicited AEs and SAEs through Day 30. Occurrence, severity, and relatedness of unsolicited AEs and SAEs through Day 30.
Time frame: within 7 days post-vaccination//through Day 30
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