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New infant vaccine aims to shield against three serious diseases

NCT ID NCT05091619

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 study tests a new vaccine (DTacP) that protects infants from diphtheria, tetanus, and whooping cough. Around 2,900 healthy babies aged 2-3 months will receive the vaccine to check its safety and how well it triggers immunity. The trial compares different schedules and vaccine batches to ensure consistent protection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Diphtheria, tetanus, and acellular pertussis (three-component) combined vaccine (DTacP)
What this could lead to
If successful, this could provide a safe and effective option to protect infants from whooping cough, diphtheria, and tetanus.
What could go wrong
This is a late-stage trial, but results may vary by schedule or lot. Common vaccine side effects like fever or injection-site reactions 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 3

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

Participants

2,898 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Sep 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

2 to 3 months

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: * Healthy subjects aged 2months (60-89 days) and 3months (90-119 days) ; * Willing to provide proof of identity * Subjects aged 2 months have not been vaccinated with DTaP, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine; * Subjects of 3 months have not been inoculated with DTaP vaccine, and IPV (only group A3); * Subjects'guardians or trustees are able to understand and sign the informed consent voluntarily, comply with the requirements of the clinical study plan. Exclusion Criteria: * With temperature \>37.0°C on axillary setting before vacciation; * With a medical history of diphtheria, pertussis or tetanus; * Had contact with individuals with confirmed pertussis, diphtheria and tetanus diseases in their families in the past 30 days; * Premature birth (delivery before the 37th week of pregnancy)or low birth weight (birth weight\< \<2500g); * History of dystocia, suffocation rescue, neurological damage; * With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. * History of epilepsy, convulsions or convulsions, or have a family history of mental illness; * History of abnormal blood coagulation (such as coagulation factor deficiency, coagulopathy); * Had received immune enhancement or inhibitor therapy (continuous oral or instillation for more than 14 days); * History of severe allergic reactions to vaccination, such as difficulty breathing, urticaria; * Any prior administration of blood products in last 3 month; * Any prior administration of attenuated live vaccine in last 14 days; * Any prior administration of subunit or inactivated vaccines in last 7 days; * Plans to participate in or is participating in any other drug clinical study; * Has any other factors judged by investigators that make them 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.

Contacts and locations

Locations

  • Neihuang County Center for Disease Control and Prevention

    Anyang, Henan, 456300, China

  • Wen County Center for Disease Control and Prevention

    Jiaozuo, Henan, 454850, China

  • Wuyang County Center for Disease Control and Prevention

    Luohe, Henan, 462400, China

  • Yanjin County Center for Disease Control and Prevention

    Xinxiang, Henan, 453200, China

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