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New baby vaccine could fight pneumonia

NCT ID NCT07593924

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new vaccine to protect babies against pneumococcal infections, which can cause pneumonia and meningitis. About 500 healthy infants will receive either the new vaccine or an existing one. Researchers will check if the new vaccine triggers a strong immune response and is safe.

Why investors are watching

Sinovac Biotech Ltd. is running a Phase III trial of its 13-valent pneumococcal conjugate vaccine (PCV13) in 500 infants, testing whether two infant doses plus a toddler dose produce a strong immune response and are safe. For a small-cap company, this late-stage readout is a key step toward potential approval and commercialization of a vaccine that competes in a well-established market.

If it works: A positive result could support regulatory approval in China and other markets, giving Sinovac a new revenue source from a vaccine for a common bacterial infection. It could also strengthen the company's vaccine portfolio and credibility with regulators and partners.

If it fails: The trial could fail to show the vaccine is as immunogenic or safe as the active comparator, which would delay or block approval. Clinical trials fail often, and a negative outcome would hurt the company's prospects for this product.

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 3

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

Participants

About 500 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jul 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 to 89 days

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. Health infants aged approximately 2 months (42 to 89 days) 2. Have a parent/legal guardian who has provided written informed consent after being fully informed about the study. 3. Be able to provide the vaccination records since birth. 4. The infant's mother is tested negative for HIV, syphilis, hepatitis B, and hepatitis C before the infant's enrollment to this study (test results obtained during pregnancy are acceptable, if provided). Exclusion Criteria: 1. Previous vaccination of any licensed or investigational pneumococcal vaccine, or planned receipt during the study participation; 2. Previous vaccination of vaccines containing the component of diphtheria, tetanus, pertussis, poliomyelitis, and/or Hib vaccine. 3. Previous receipt of ≥2 doses of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at \>30 days old. 4. History of severe adverse reaction to previous vaccinations and/or serious allergic reactions (eg, anaphylaxis) to any vaccine component. 5. History of any laboratory confirmed pneumococcal bacterial pneumonia or invasive pneumococcal diseases caused by S pneumoniae. 6. Premature infants (born before week 37 of gestation). 7. Severe congenital malformations, developmental disorders, clinically significant genetic defects, malnutrition. 8. Autoimmune diseases or immunodeficiency/immunosuppression. 9. Serious chronic diseases such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders. 10. Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders). 11. Received immunosuppressive for ≥14 days (e.g., prednisone equivalent of ≥2 mg/kg), or cytotoxic drug before enrollment, or plans to receive these treatments during the study participation. 12. Received blood products before investigational vaccine inoculation, or plan to receive these treatments during study participation. 13. Received other investigational drugs/vaccines before enrollment, or plan to receive investigational drugs/vaccines during study participation. 14. Received live attenuated vaccines or nucleic-acid vaccines within 14 days before enrollment. 15. Received subunit or inactivated vaccines within 7 days before enrollment. 16. Acute diseases or acute exacerbations of chronic diseases within 7 days before enrollment. 17. Axillary temperature ≥ 37.5°C before enrollment. 18. Any other factors judged by the investigators as unsuitable for participation.

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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

  • Health Index Multispecialty Clinic (HIMC) Research and Development on Medical Sciences

    Imus, Cavite, Philippines