New pneumonia vaccine shows promise in early trial for kids
NCT ID NCT06183216
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed phase 1b trial tested a new 13-valent pneumococcal conjugate vaccine (PCV13) in 140 healthy infants (2 months old) and children (2-5 years). The goal was to check safety and immune response compared to an existing vaccine. Researchers monitored side effects and antibody levels to see if the new vaccine could protect against pneumococcal diseases like pneumonia and meningitis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13)
- What this could lead to
- If successful, this could lead to a new vaccine option to protect children against pneumococcal infections like pneumonia and meningitis.
- What could go wrong
- This is an early phase 1 trial with only 140 participants, so results may not confirm broad effectiveness or safety. The vaccine may not trigger a strong enough immune response or could cause side effects.
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
-
140 people
The number who actually took part.
- Started
-
Jan 2024
- Finished
-
Mar 2025
- 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
-
6 weeks to 5 years
- Sex
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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. Healthy infants aged 2 months (42-89 days); Healthy children aged 2-5 years. 2. Proven vaccination certificate, birth certificate and legal identification documents 3. The participants' guardians can understand and voluntarily sign the informed consent form. 4. Participants and their guardians can obey requirements of the protocol. Exclusion Criteria: 1. Received any pneumococcal vaccine prior to enrollment. 2. History of culture confirmed bacterial pneumonia or invasive pneumococcal disease (IPD) caused by Streptococcus pneumoniae. 3. History of allergy to the vaccine or vaccine components, including pneumococcal polysaccharide for each serotype, diphtheria CRM197, aluminum phosphate, succinic acid, polysorbate 80 and sodium chloride; or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and asthma. 4. History of dystocia, asphyxia rescue, nervous system damage at birth (only applicable to infants aged 2 months (42-89 days)) 5. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, asthma etc. 6. Autoimmune disease (such as systemic lupus erythematosus) or immunodeficiency/ immunosuppression (such as HIV, organ transplantation) 7. Severe cardiovascular diseases, such as diabetes, liver diseases, kidney diseases, malignant tumors. 8. Family history of mental illness, severe neurological disease (epilepsy or convulsions) or mental illness. 9. History of thyroidectomy, asplenia, functional asplenia; and asplenia or splenectomy resulting from any condition. 10. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets), history of obvious bleeding or bruising after intramuscular injection or venipuncture. 11. Infants 2 months of age (42-89 days) prior to enrollment/children 2 to 5 years of age 6 months prior to enrollment had been treated with corticosteroids, other immunosuppressive agents (excluding corticosteroid spray therapy for allergic rhinitis, superficial corticosteroid therapy for acute non-concurrent dermatitis) or cytotoxic therapy for ≥14 days 12. Infants 2 months of age (42-89 days) prior to enrollment/children 2 to 5 years of age 3 months prior to enrollment received blood products within the past 3 months (excluding hepatitis B immunoglobulin within 1 month). 13. Receipt of other investigational drugs in the past 60 days or have the plan to participate in other clinical trials during this study. 14. Receipt of attenuated live vaccines in the past 14 days. 15. Receipt of inactivated or subunit vaccines in the past 7 days. 16. Acute diseases or acute exacerbation of chronic diseases in the past 7 days. 17. Axillary temperature ≥37.3 °C. 18. According to the investigator's judgment, the subject has any other factors that are not suitable for participating 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.
Contacts and locations
Locations
-
Binchuan County Center for Diseases Control and Prevention
Dali, Yunnan, 671600, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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