A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in I… (NCT07406347) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose Primary Dosing Series Followed by a Booster Dose at 12 to 15 Months of Age
60 participantsStarted 2026-07-10
Plain-language summary
The main purpose of this study is to evaluate safety and reactogenicity of the investigational pneumococcal vaccine (called Pn-MAPS30plus). PCV20 will be used as a comparator for this study
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
. Participants' parent(s)/Legally acceptable representative \[LAR(s)\] who, in the opinion of the investigator, can and will comply with all protocol requirements.
. Written or witnessed/thumb printed informed consent obtained from the participants' parent(s)/LAR(s) prior to performance of any study-specific procedure.
. Participant is approximately 2 Months of Age \[MOA (42 to 90 days, inclusive)\] at time of first study intervention administration.
. Healthy participants as established by medical history and clinical examination before entering the trial.
. Participant is a full-term infant (≥37 weeks gestation at birth) with a birth weight of \>2.5 kg.
Exclusion criteria
. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
. Hypersensitivity to latex.
. History of microbiologically proven Invasive pneumococcal Disease (IPD).
. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
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
Number of participants with solicited administration site adverse events (AEs)
Timeframe: Day 1 to Day 7
2
Number of participants with solicited systemic adverse events (AEs)
Timeframe: Day 1 to Day 7
3
Number of participants with unsolicited AEs
Timeframe: Day 1 to Day 30
4
Number of Participants with Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Withdrawal
. Major congenital defects, as assessed by the investigator.
. Recurrent history or uncontrolled neurological disorders or any neuroinflammatory condition, congenital neurological conditions, encephalopathies, or seizures.
. Condition that in the judgment of the investigator would make intramuscular injection unsafe.
. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.