A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy In… (NCT06720038) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants
United States905 participantsStarted 2024-11-25
Plain-language summary
The objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 4 dose levels) compared to PCV20 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll approximately 352 subjects. Stage 3 of the study will enroll approximately 500 subjects.
Who can participate
Age range42 Days – 89 Days
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy male or female infant ≥42 days to ≤89 days.
✓. Full-term infant at least 37 weeks gestational age at birth.
✓. Afebrile for ≥72 hours with an tympanic or rectal temperature \<38.0°C (\<100.4°F) before receipt of study vaccine.\*Criterion applies to each vaccination. If not met, visit may be rescheduled for a time when no longer febrile for ≥72 hours.
✓. Able to attend all scheduled visits and comply with the study procedures.
✓. Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent.
✓. Subject's parent/legal guardian is able to fill out an eDiary of solicited AE and take daily tympanic temperature and measurements of local injection site reactions for the 7 days after each study vaccination.
✓. Subject's parent/legal guardian has an email address and access to a computer or smartphone with internet to complete the eDiary.
Exclusion criteria
✕. History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
✕. Previous receipt of a licensed or investigational vaccine (excluding 1 dose of hepatitis B vaccine).
✕. Known hypersensitivity to any vaccine.
What they're measuring
1
Percentage of subjects with any solicited local injection site adverse events (AE) within 7 days after each vaccination
Timeframe: 7 days after each vaccination
2
Percentage of subjects with any solicited systemic AE within 7 days after each vaccination
Timeframe: 7 days after each vaccination
3
Percentage of subjects with any unsolicited AE within 1 month after each vaccination
Timeframe: 1 months after each vaccination
4
Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination
Timeframe: 6 months after last vaccination
5
Percentage of subjects with any Serious Adverse Events (SAE) within 6 months after last vaccination
Timeframe: 6 months after last vaccination
6
Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination
. Known or suspected impairment of immunological function (e.g., asplenia, human immunodeficiency virus, primary immunodeficiency).
✕. Use of any immunosuppressive therapy or planned use through the last blood draw (Visit 6). Receipt of a \<14-day course of systemic corticosteroids is not exclusionary if completed ≥1 month prior to first study vaccination. Topical and inhaled/nebulized steroids are also permitted.
✕. History of failure to thrive or prior hospitalization for any chronic condition.
✕. Subject has a bleeding disorder contraindicating IM vaccination.
✕. Subject or his/her mother has documented hepatitis B surface antigen-positive test.