New pneumonia vaccine put to the test in babies
NCT ID NCT07406347
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This early-stage study tests a new pneumococcal vaccine (Pn-MAPS30plus) in 60 healthy infants to see if it is safe and what side effects it may cause. Babies will receive three doses starting around 2 months old, followed by a booster at 12-15 months. The study compares the new vaccine to an existing one (PCV20) and focuses on reactions like tenderness, fever, and irritability.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jan 2027
An estimate. Start dates often move.
- Expected to finish
-
Oct 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
42 to 90 days
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants' parent(s)/Legally acceptable representative \[LAR(s)\] who, in the opinion of the investigator, can and will comply with all protocol requirements. 2. Written or witnessed/thumb printed informed consent obtained from the participants' parent(s)/LAR(s) prior to performance of any study-specific procedure. 3. Participant is approximately 2 Months of Age \[MOA (42 to 90 days, inclusive)\] at time of first study intervention administration. 4. Healthy participants as established by medical history and clinical examination before entering the trial. 5. Participant is a full-term infant (≥37 weeks gestation at birth) with a birth weight of \>2.5 kg. Exclusion Criteria: 1. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). 2. Hypersensitivity to latex. 3. History of microbiologically proven Invasive pneumococcal Disease (IPD). 4. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. 5. Major congenital defects, as assessed by the investigator. 6. Recurrent history or uncontrolled neurological disorders or any neuroinflammatory condition, congenital neurological conditions, encephalopathies, or seizures. 7. Condition that in the judgment of the investigator would make intramuscular injection unsafe. 8. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. 9. Use of any investigational or non-registered product (drug, vaccine, or invasive medical device in the country of enrollment) other than the study intervention(s) during the period beginning 30 days before the dose of study intervention(s), or their planned use during the trial period. 10. Previous vaccination with any pneumococcal vaccine. 11. Planned administration/administration of any inactivated or otherwise non live vaccine in the period starting 14 days before and ending 14 days after each dose of study intervention administration or planned administration/administration of any live vaccine in the period starting 28 days before and ending 28 days after each dose of study intervention(s) administration, with the exception of inactivated influenza vaccine which may be administered but must be given at least 7 days before or 15 days after receipt of any study intervention. 12. Receipt of blood or plasma products or immunoglobulins, since birth, or planned receipt during the trial up to 30 days after last study intervention administration. 13. Chronic administration of immune-modifying drugs and/or planned use of long-acting immune-modifying treatments at any time up to the end of the trial since birth. For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum of 20 mg/day. Inhaled and topical steroids are allowed. 14. Concurrent participation in another clinical study in which the participant has been or will be exposed to an investigational or non-investigational intervention. 15. Any child of trial personnel or their immediate dependents, family, or household members. 16. Child in care.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pneumonia - bacterial are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- AI could outsmart bacteria: a smarter way to choose antibiotics?
- Does the setting of care affect whether kids finish their antibiotics?
- Inhaled antibiotics aim to beat pneumonia in ECMO patients
- Which works better: one antibiotic or two for this superbug?
- One-Hour test could revolutionize pneumonia treatment in hospitals
- Are hidden immune defects causing your recurring infections? new study investigates.