New vaccine targets 26 pneumococcal strains in early trial
NCT ID NCT06703203
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase I/II trial tested a new 26-valent pneumococcal conjugate vaccine in 450 people aged 2 months and older. The goal was to check safety and how well the vaccine triggers an immune response compared to existing vaccines. Researchers monitored side effects and antibody levels after vaccination.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 26-valent pneumococcal conjugate vaccine
- What this could lead to
- If successful, this vaccine could protect against more types of pneumococcal bacteria than current vaccines, potentially reducing pneumonia and ear infections.
- What could go wrong
- This is an early-phase trial focused on safety and immune response, not yet proven to prevent disease. Side effects like injection site pain or fever are possible.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
450 people
The number who actually took part.
- Started
-
Jul 2025
- Finished
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Feb 2026
- 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
-
2 months and older
- 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: * The subject is 2-3 months old (minimum 6 weeks old), 7 months old and above at the time of enrollment, and the legal guardian and/or the subject can provide legal identification certificate; * The subjects themselves and/or their legal guardians understand the vaccination and trial procedures, voluntarily participate in the trial and sign the informed consent form; * The subject and/or legal guardian can comply with the clinical trial protocol, have the ability to use thermometer, scale and fill in diary card and contact card as required; * Female subjects of childbearing potential agree to take effective contraceptive measures from enrollment to 6 months after vaccination. * For calibration group subjects: 18 to 55 years of age, ≥ 50 kg for males or ≥ 45 kg for females. Exclusion Criteria: * Axillary body temperature ≥ 37.3 ℃ on the day of enrollment; * History of infectious diseases caused by Streptococcus pneumoniae confirmed by bacterial culture within 3 years; * Have received or plan to receive a Streptococcus pneumoniae vaccine outside the trial protocol, including marketed or other investigational Streptococcus pneumoniae vaccines; * Pregnant or lactating women; Previous history of severe allergy to any vaccine or drug, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock, Henoch-Schonlein purpura, thrombocytopenic purpura; * Allergic to any component of the investigational vaccine; * Suffering from severe respiratory diseases (such as severe asthma), heart diseases, liver diseases, kidney diseases, congenital malformations, developmental disorders and genetic defects (including but not limited to: down syndrome, thalassemia major, etc.) that may interfere with the conduct or completion of the trial; * Diagnosed with congenital or acquired immunodeficiency, or suspected to have serious chronic disease or systemic disease that may interfere with the conduct or completion of the trial, such as: active tuberculosis, human immunodeficiency virus (HIV) infection, etc.; * Encephalopathy, uncontrolled epilepsy, convulsion and other progressive neurological diseases, or a history or family history of mental illness; * Contraindications for intramuscular injection such as thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy; * Asplenia or splenectomy, functional asplenia due to any condition; * Immunosuppressant therapy, cytotoxic therapy or corticosteroid therapy within 3 months prior to vaccination, such as systemic glucocorticoid therapy for more than 2 consecutive weeks, such as prednisone or similar drugs \> 5 mg/day (excluding corticosteroid spray therapy for allergic rhinitis, surface corticosteroid therapy for acute non-complicated dermatitis); * Received blood products or immunoglobulins within 3 months prior to enrollment (hepatitis B immunoglobulin is acceptable), or planned to be used during the trial (before the last immunogenicity blood sample collection); * Within 3 days before the first dose of vaccine, the patient has acute illness or is in acute attack of chronic disease, or has used antipyretic, analgesic or anti-allergic drugs (such as: acetaminophen, ibuprofen, aspirin, etc.); * Received non-live vaccine within 7 days (≤ 7 days) or live attenuated vaccine within 14 days (≤ 14 days) prior to enrollment; * Hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg, applicable to adults); * Abnormal and clinically significant laboratory test results, which are not suitable for enrollment as determined by the investigator (applicable to subjects aged 2 years and older in Phase I); * Birth weight \< 2.5 kg, premature delivery (gestational age \< 37 weeks), history of abnormal labor process, history of asphyxia rescue, history of nerve organ damage, history of pathological jaundice confirmed by diagnosis; * For Standardised Subjects: ① Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 50 U/L; Or hemoglobin ≤ 115 g/L (female)/120g/L (male); Any positive serology for hepatitis B, hepatitis C, HIV, or syphilis. * Plans to move before the end of the trial or leave the area for an extended period of time during scheduled trial visits; * Ongoing participation or planning to participate in other clinical trials (vaccines, drugs, medical devices, etc.) in the near future; * Subject has any condition that, in the opinion of the investigator, may interfere with the evaluation of the objectives of the 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
-
Henan Provincial Center for Disease Control and Prevention
Shangqiu, Henan, 476700, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New 25-Valent pneumonia vaccine shows promise in phase 2 trial
- New pneumonia vaccine VAX-31 aims to boost protection in older adults
- New combo shot study: could VAX-31 plus flu vaccine be a Game-Changer for seniors?
- Can a pneumonia vaccine protect the most vulnerable children?
- New vaccine aims to outsmart pneumonia bacteria
- New baby vaccine aims to beat pneumonia: VAX-31 trial underway