New pneumonia vaccine shows promise in early trial
NCT ID NCT05092386
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a new 13-valent pneumococcal conjugate vaccine in 310 healthy volunteers ranging from 6-week-old infants to adults up to 49 years old. The goal was to check the vaccine's safety and how well it triggers the immune system to fight pneumococcal bacteria, which can cause pneumonia and other serious infections. Results will help decide if larger studies are warranted.
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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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310 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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May 2024
- 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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6 weeks to 49 years
- 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: * Healthy infants aged 2 months (minimum 6 weeks), healthy infants aged 3 months, healthy infants aged 7 \~ 11 months, healthy infants aged 12\~ 23 months, healthy children aged 2\~ 5 years, healthy adolescent and children aged 6\~ 17 years, healthy adults aged 18\~ 49 years; * Proven legal identification and vaccination certificate (vaccination certificate is required for those aged 5 and below); * The subject and/or guardian can understand and voluntarily sign the informed consent form. Exclusion Criteria: * Have received pneumococcal polysaccharide vaccine or pneumococcal polysaccharide conjugate vaccine; * Have Bacterial pneumonia or invasive pneumococcal infectious disease (IPD) caused by pneumococcus confirmed by sputum culture; * History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema; * Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; * Autoimmune disease or immunodeficiency / immunosuppression; * Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.; * Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; * History of thyroidectomy, absence of spleen, functional absence of spleen, and absence of spleen or splenectomy due to any circumstance; * Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation; * Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; * History of alcohol or drug abuse; * Receipt of blood products within in the past 3 months; * Receipt of other investigational drugs in the past 30 days; * Receipt of attenuated live vaccines in the past 14 days; * Receipt of inactivated or subunit vaccines in the past 7 days; * Acute diseases or acute exacerbation of chronic diseases in the past 7 days; * Axillary temperature \>37.0°C; * 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
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Henan Center for Diseases Control and Prevention
Zhengzhou, Henan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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