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New pneumonia vaccine trial aims to shield 3,000 kids from deadly infection

NCT ID NCT06617715

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 time

Summary

This Phase 3 trial is testing a new 13-valent pneumococcal conjugate vaccine (PCV13) in over 3,000 healthy infants and children aged 6 weeks to 5 years. The goal is to see if the vaccine is safe and triggers a strong immune response compared to an existing vaccine. If it works, it could help prevent serious diseases like pneumonia and meningitis in young children.

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 conjugate vaccine (PCV13)
What this could lead to
If successful, this could provide a new option to protect infants and children from serious pneumococcal infections like pneumonia and meningitis.
What could go wrong
This is a large Phase 3 trial, but the vaccine may not prove as effective or safe as existing ones. Results are still pending.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 3,080 people

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

Started

Oct 2024

Expected to finish

Jul 2026

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

6 weeks 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 or children who are aged 2 months (at least 6 weeks), 7-11 months, 12-23 months and 2-5 years (before the 6th birthday); 2. Participants' guardians provide legal identity document and participants' vaccination record; 3. Participants' guardians understand and voluntarily sign the informed consent form; 4. Participants' guardians can follow all study procedures and stay in contact during the study. Exclusion Criteria: 1. Received any pneumococcal vaccine prior to enrollment; 2. History of bacterial pneumonia or invasive pneumococcal diseases (IPDs) caused by Streptococcus pneumoniae, as confirmed by laboratory tests; 3. History of allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and abdominal pain; 4. History of dystocia, asphyxia rescue and nervous system damage at birth for infants under 2 years of age; 5. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, history of asthma; 6. Autoimmune diseases (such as systemic lupus erythematosus), immunodeficiency diseases or immunosuppressive diseases (such as AIDS, organ transplantation); 7. Severe cardiovascular diseases, diabetes, liver diseases, kidney diseases, malignant tumours. 8. Have/have suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases. 9. History of thyroidectomy, asplenia, functional asplenia; asplenia or splenectomy caused by any reasons; 10. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture. 11. Consecutively received ≥14 days of corticosteroid, any other immunosuppressive therapy (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or cytotoxic therapy prior to enrollment for infants aged 6 weeks to 2 months or within 6 months prior to enrollment for children aged 7 months to 5 years. 12. Received blood products prior to enrollment for children aged 2 months or within 3 months prior to enrollment for children aged 7 months to 5 years. Receipt of Hepatitis B immunoglobulin one month prior to enrollment is an exception. 13. Received other investigational drugs within 60 days prior to enrollment, or plan to receive such drugs during the study; 14. Received live attenuated vaccine within 14 days prior to enrollment; 15. Received subunit or inactivated or other vaccine within 7 days prior to enrollment; 16. Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment; 17. Had fever (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

    1 site. 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

  • Henan Provincial Center for Disease Control and Prevention

    RECRUITING

    Zhengzhou, Henan, China

More trials for these conditions

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