New infant vaccine aims to shield against three serious diseases
NCT ID NCT05091619
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
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2,898 people
The number who actually took part.
- Started
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Oct 2021
- Expected to finish
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Sep 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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2 to 3 months
- 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: * 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
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Neihuang County Center for Disease Control and Prevention
Anyang, Henan, 456300, China
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Wen County Center for Disease Control and Prevention
Jiaozuo, Henan, 454850, China
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Wuyang County Center for Disease Control and Prevention
Luohe, Henan, 462400, China
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Yanjin County Center for Disease Control and Prevention
Xinxiang, Henan, 453200, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Tetanus immunity under the microscope: do antibodies hold up after 2.5 years?
- One shot, six protections: could a single vaccine replace multiple infant shots?
- Can one shot replace six? a new vaccine aims to protect infants from six diseases at once
- Can a Lab-Made antibody outperform standard tetanus shots?
- One shot, six protections: can a new vaccine match current standards?
- Can a new vaccine shield older kids and adults from three deadly infections?