A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in H… (NCT05412030) | Clinical Trial Compass
CompletedPhase 2
A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants
United States, Puerto Rico388 participantsStarted 2022-06-16
Plain-language summary
This is a Phase 2 clinical study to support the use of AFX3772 in healthy infants for the prevention of pneumococcal disease. The purpose of this study is to determine the safety, tolerability, and immunogenicity of 3 different formulations of AFX3772 compared with Prevnar 13 (PCV13) and Prevnar 20 (PCV).
Part 1 is the dose escalation, lead-in portion of the study in which infants at each dose level will be randomized 3:1 in sequential cohorts of increasing doses of AFX3772 or PCV13.
In Part 2, infants will be randomized to receive either one of two dose levels of AFX3772 or PCV20.
Who can participate
Age range
42 Days – 90 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:
• Is a full-term infant approximately 2 months of age at time of obtaining the informed consent.
Exclusion Criteria:
* Had prior administration of any pneumococcal vaccine.
* Has a known or suspected hypersensitivity to AFX3772, PCV13, PCV20 or any components of the formulations used.
* Has a known or suspected immunodeficiency or other conditions associated with immunosuppression that may require immunosuppressive drugs. In addition, the participant's biological mother has known HIV infection or known to be hepatitis B surface antigen positive.
* Has any clinically significant allergic condition or history prior to the first vaccination for primary immunization series.
* Has a history of microbiologically proven invasive disease caused by S. pneumoniae.
* Has received immunoglobulins.
* Has a bleeding diathesis or condition associated with prolonged bleeding that would contraindicate intramuscular injection.
* Has received systemic corticosteroids for a period of more than 14 days and has not completed the treatment for at least 30 days before study vaccine.
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 participants with solicited injection site events
Timeframe: Day 1 through Day 7 post-vaccination
2
Percentage of participants with solicited systemic events
Timeframe: Day 1 through Day 7 post-vaccination
3
Percentage of participants with AEs
Timeframe: Day 1 through Day 30
4
Percentage of participants with serious adverse events (SAEs)