New vaccine aims to shield toddlers from 24 pneumonia strains
NCT ID NCT06800261
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new vaccine (PCV24) designed to protect children aged 2 to 23 months against 24 types of pneumococcal bacteria, which can cause serious infections like pneumonia and meningitis. Around 180 healthy children will receive either the new vaccine or an existing one to compare safety and immune response. The goal is to see if the vaccine is safe and triggers strong protection.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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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
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42 days to 23 months
- Sex
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Anyone
- Healthy volunteers
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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. Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months; 2. Participants' guardian provides legal identity document and participants' vaccination record; 3. Participants' guardian understands and voluntarily signs the informed consent form; 4. Follow all study procedures and stay in contact during the study. Exclusion Criteria: 1. Received any pneumococcal vaccine prior to enrollment; 2. History of invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests; 3. History of severe adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock; 4. Low birth weight (\<2.5kg), or premature infant (gestation weeks \< 37 weeks) (applies to infants younger than 12 months); 5. History of abnormal labor during delivery (planned cesarean section is excluded), history of asphyxia rescue and nervous system damage (applies to infants younger than 12 months); 6. Congenital malformations or developmental disorders, genetic defects, severe malnutrition; 7. Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases (e.g. congenital heart disease), hematological diseases (e.g. severe anemia), liver and kidney diseases, digestive diseases, respiratory diseases (such as active tuberculosis), malignant tumors and major functional organ transplantation history; 8. Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection); 9. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), potential bleeding (history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture). 10. Have/have suffered from a serious neurological disorder (epilepsy or convulsions, but febrile convulsion is not an exclusion criteria ) or mental illness or have a family history of such diseases. 11. Consecutively received immunosuppressive therapy (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or other immunoregulatory therapies, or cytotoxic therapy over 14 days within 6 months before vaccination, or plans to receive such therapies during the study. 12. Received blood products prior to enrollment within 3 months prior to enrollment, or plans to receive such therapies during the study. Receipt of Hepatitis B immunoglobulin one month prior to enrollment is an exception. 13. Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study; 14. Received live attenuated vaccine within 14 days prior to enrollment; 15. Received subunit or inactivated vaccine within 7 days prior to enrollment; 16. Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, known or potentially active infection; 17. Axillary temperature≥ 37.3 Degree Celsius before vaccination; 18. In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.
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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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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Shandong Provincial Center for Disease Control and Prevention
NOT_YET_RECRUITINGJinan, Shandong, 250014, China
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Shanxian Center for Disease Control and Prevention
RECRUITINGShancheng, Shandong, 250014, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New vaccine aims to shield against 24 pneumonia strains
- New pneumonia vaccine trial aims to shield 3,000 kids from deadly infection
- New pneumonia vaccine shows promise in early trial for kids
- New 24-Valent pneumonia vaccine shows promise in kids trial
- New 24-Strain pneumonia vaccine trial launches for kids
- New vaccine targets 24 pneumococcal strains in major trial