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 States, Puerto Rico900 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 range
42 Days – 89 Days
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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.