New 24-Strain pneumonia vaccine enters human trials
NCT ID NCT07600983
First seen Jun 24, 2026 · Last updated Aug 06, 2026 · Updated 3 times
Summary
This study tests a new vaccine (PCV24) designed to protect against 24 types of pneumococcal bacteria, which can cause pneumonia, meningitis, and ear infections. The trial includes 854 healthy people aged 2 months and older, split into two phases to check safety and immune response. Participants will receive either the new vaccine or an existing one, and researchers will monitor for side effects and antibody levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 24-valent pneumococcal polysaccharide conjugate vaccine (PCV24)
- What this could lead to
- If successful, this could lead to a vaccine that protects against 24 types of pneumococcal bacteria, potentially preventing serious infections like pneumonia and meningitis.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with only 854 participants, so the vaccine may not prove safe or effective in larger studies. Side effects are possible, and the immune response may not be strong enough.
Why investors are watching
CanSino Biologics is testing a 24-valent pneumococcal vaccine in a Phase 1 and Phase 2 trial with 854 participants, ranging from infants to older adults. For a small company, this readout matters because it tests whether the vaccine is safe and triggers an immune response, which could determine if the product advances to later-stage studies.
If it works: A positive result could show the vaccine is safe and immunogenic, potentially allowing CanSino to move it into larger trials. That progress could strengthen the company's pipeline and its position in the pneumococcal vaccine market.
If it fails: The trial could fail to show adequate safety or immune response, or face delays in enrollment or analysis. Trials at this stage often fail, and a negative result would likely set back the program and hurt the company's prospects.
AI-written from the trial record. Speculative, and not investment advice.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 854 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2027
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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6 weeks and older
- 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: Phase I: * Individuals aged 2 months (minimum 6 weeks), 7 months to 5 years, and 18 years and older who are willing to provide identification * The trial participant and/or guardian (legal representative) has voluntarily signed the informed consent form after providing informed consent * Children aged 5 and under who have not previously received a pneumococcal vaccine * People aged 18 and older who have not received a pneumonia vaccine in the past five years Phase II (age ≥50 group): * People aged 50 and older who are willing to provide identification documents * The trial participants voluntarily signed the informed consent form after providing their informed consent * People aged 50 and older who have not received a pneumonia vaccine in the past five years Phase II (2-month-old group (minimum 6 weeks)): * Individuals aged 2 months or older (minimum 6 weeks) who are willing to provide identification documents * The guardian (authorized representative) of the trial participant has voluntarily signed the informed consent form after providing informed consent. * Infants aged 2 months (minimum 6 weeks) who have not previously received a pneumococcal vaccine Exclusion Criteria: * Exclusion criteria for the first dose: * Preterm birth (delivery before 37 weeks of gestation), low birth weight (\<2500 g at birth), history of labor abnormalities or resuscitation due to asphyxia; (Applicable to individuals in Phase I and Phase II who are 2 months of age or older (minimum 6 weeks)) * Patients with abnormal results in pre-vaccination blood tests (including complete blood count, blood chemistry, and coagulation function) or urinalysis, which the investigator determines to be clinically significant; (Applicable only to Phase I participants aged 2 years (or 7 months) and older) * Individuals who are allergic to the active ingredient of the vaccine, any of its inactive ingredients, or substances used in the manufacturing process; or those who have previously experienced an allergic reaction after receiving a similar vaccine; Individuals with a history of severe allergic reactions to vaccines (such as acute allergic reactions, angioedema, or difficulty breathing), or a history of severe allergic reactions to any vaccine, food, or medication, including urticaria, anaphylactic shock, eczema, allergic respiratory distress, angioedema, or a history of asthma * Individuals with uncontrolled hypertension (as measured on-site: systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg); (Applicable to Stage II participants aged 50 and older and Stage I participants aged 18 and older) * Women of childbearing age with a positive urine pregnancy test; participants who are breastfeeding; or participants or their partners who plan to become pregnant within the next 6 months; (Applicable to the Phase II group aged 50 or older and the Phase I group aged 18 or older) * History of epilepsy, seizures (excluding febrile seizures), convulsions, or brain disorders \[such as congenital brain malformations, traumatic brain injury, brain tumors, cerebral hemorrhage, cerebral infarction (excluding cerebral infarctions without sequelae and lacunar infarctions), brain infections, chemical poisoning, and other conditions causing damage to brain neural tissue\], or a history of mental illness or a family history thereof; or those with other progressive neurological diseases * Have been diagnosed with a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases * Known or suspected acute illness or severe chronic disease (including severe respiratory disease, severe cardiovascular disease, liver or kidney disease, severe skin disease, malignant tumors, etc.); or currently experiencing an acute exacerbation of a chronic condition * Clinically diagnosed coagulation disorders (such as coagulation factor deficiencies, coagulation disorders, or platelet abnormalities) or significant bruising or bleeding disorders * Asplenia, functional asplenia, and asplenia or splenectomy resulting from any cause * Patients who have received immunosuppressive therapy within 6 months prior to vaccination or who are scheduled to receive such therapy between enrollment and 1 month after completion of the vaccination series (e.g., long-term systemic corticosteroid use for ≥14 days at a dose \>2 mg/kg/day or ≥20 mg/day of prednisone or prednisone-equivalent dose) (excluding topical corticosteroids such as inhaled, nasal spray, intra-articular, eye drops, or ointments; topical use must not exceed the dose recommended in the product label or result in any signs of systemic exposure). Individuals who have used long-acting immunomodulatory drugs (e.g., infliximab) within 6 months prior to the first dose or who plan to use such drugs during the trial (applicable to the Phase II group aged ≥50 years and the Phase I group aged 7 months and older) * Received blood products (excluding hepatitis B immunoglobulin) within 3 months prior to receiving the investigational drug * Participation in any other clinical trial involving a drug or vaccine within the 6 months prior to enrollment, or currently participating in such a trial, or plans to participate in such a trial during the study period * Received an injectable live attenuated vaccine within 14 days prior to receiving the investigational drug, or received any other vaccine within 7 days * Underarm temperature of 37.3°C or higher prior to vaccination * According to the researchers' assessment, the trial participants had other factors that made them unsuitable for participation in the clinical trial Exclusion criteria for the 2nd, 3rd, and 4th doses: * Individuals who experienced a severe allergic reaction following the previous dose of the vaccine * Individuals who experienced a serious adverse reaction causally related to a previous dose of the vaccine * Other potential causes ruled out by the researchers
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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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Ningling County Center for Disease Control and Prevention
NOT_YET_RECRUITINGShangqiu, China
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Xiangcheng County Center for Disease Control and Prevention
RECRUITINGXuchang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.