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New 24-Valent vaccine aims to shield children from more pneumonia strains

NCT ID NCT07300644

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a new vaccine called PCV24 in 420 healthy children aged 2 months to 5 years. The vaccine targets 24 types of pneumococcal bacteria, which can cause pneumonia, meningitis, and ear infections. Researchers will compare it to an existing vaccine to see if it is safe and triggers a strong immune response.

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 conjugate vaccine (PCV24)
What this could lead to
If successful, this vaccine could protect children against 24 types of pneumococcal bacteria, potentially preventing more infections than current vaccines.
What could go wrong
This is an early phase 2 trial with only 420 children, so results may not apply to all kids. The vaccine may not work as well as expected or could cause side effects.
Why investors are watching

Sinovac Biotech Ltd. is a small publicly traded company, and its unit Sinovac Life Sciences Co., Ltd. runs this Phase 2 trial of a 24-valent pneumococcal conjugate vaccine in children aged 2 months to 5 years. The trial tests whether the vaccine is safe and produces an immune response, comparing it against an existing positive control in 420 participants. For a company this size, a vaccine that covers more pneumococcal strains than current options would matter because pediatric vaccines sell in large, recurring public health markets.

If it works: If the vaccine proves safe and immunogenic, Sinovac could move it into later-stage trials and toward a product that competes in the pediatric pneumococcal vaccine market. A strong result may also draw partner or public health interest that a small company cannot generate on its own.

If it fails: Phase 2 trials often fail on safety or immune response, and a negative readout would end this program's path forward. A delay or weak result would cost the company time and money it may struggle to replace at its size.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 420 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

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

42 days to 5 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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, and 2-5 years; 2. The participants' guardian provides a legal identity document and the participants' vaccination record; 3. The participant's 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. Severe congenital malformations or developmental disorders, genetic defects, or 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 platelet levels); 10. Have/have suffered from a serious neurological disorder (epilepsy or convulsions, but a 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. Receipt of immunoglobulins or other blood products within 3 months prior to administration of the investigational vaccine (except for hepatitis B immunoglobulin or rabies immunoglobulin used within 1 month), or planned use of such products during the study period; 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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Qichun District Center for Disease Prevention and Control

    RECRUITING

    Huanggang, Hubei, China

  • Xian'an District Center for Disease Prevention and Control

    RECRUITING

    Xianning, Hubei, China

  • Xiangzhou District Center for Disease Prevention and Control

    RECRUITING

    Xiangyang, Hubei, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.