PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE, Prevention of Pneumococcal-induced Acute Otitis Media
Conditions
Brief summary
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.
Interventions
BIOLOGICALInactivated whole-cell Streptococcus pneumoniae vaccine
Single intramuscular injection of 1 mg protein/0.5 mL wSp vaccine
DRUGPlacebo
Single intramuscular injection of 0.5 mL placebo
Sponsors
Serum Life Science Europe GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult aged \> 18 and \< 49 years at screening. * Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2, with a maximum body weight of 120 kg at screening. * Good general health, without significant medical illness or abnormal physical examination, or laboratory findings per PI discretion. * If female, not breastfeeding, not pregnant, and not planning pregnancy during study period. * If female of child-bearing potential, willing to use acceptable method of contraception. * Willing and able to comply with all study activities, assessments, and restrictions through 30 days of follow-up. Willing and able to be contacted reliably by phone, and willing for the study team to record phone voice messages as needed. * Provided written informed consent to participate in the clinical trial before any study-related activities are carried out and, in the PI's opinion, must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
Exclusion criteria
In addition to meeting the inclusion criteria, individuals will be excluded from this trial if they meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability outcome | within 7 days post-vaccination//through Day 30 | 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. |
Countries
United States
Outcome results
None listed