Can a new vaccine shield older kids and adults from three deadly infections?
NCT ID NCT06056050
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This early-stage trial is testing an experimental vaccine designed to protect people aged 6 and older against diphtheria, tetanus, and pertussis (whooping cough). The study will enroll 180 participants to check the vaccine's safety and how well it triggers an immune response. Some participants will receive the new vaccine, while others will get a different vaccine for comparison. The goal is to see if this new option could help prevent these serious diseases in older age groups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp)
- What this could lead to
- If successful, this vaccine could provide a new option to protect older children, teens, and adults against three serious bacterial infections.
- What could go wrong
- This is an early-phase trial focused on safety and immune response, so the vaccine may not prove effective or may cause side effects. Results are not yet available.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
180 people
The number who actually took part.
- Started
-
Dec 2023
- Finished
-
Mar 2025
- 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 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * ≥ 6 years of age. * Willingness to provide proof of identity. * The informed consent of the volunteer and/or the guardian and/or the delegate must be obtained and the informed consent form must be signed. * Volunteers are able and willing to comply with the requirements of the clinical trial protocol and are able to complete the full study follow up. * Volunteers aged 6-11 years who have completed 4 doses of DPT-containing vaccine, but have not received the 5th dose, and have ≥3 years between the 4th dose. * Volunteers aged ≥12 years must not have received any of the components of the DPT-containing vaccine within 5 years. Exclusion Criteria: * Persons with fever prior to vaccination, with axillary temperature \> 37.0°C. * A female with a positive urine pregnancy test or a breastfeeding volunteer, where the volunteer or her partner has a plan to become pregnant within 180 days. * Adults with severe cardiovascular disease, hypertension (systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg) that cannot be controlled by medication, or other severe chronic diseases. * Abnormal and clinically significant results of preimmunization blood tests, blood biochemistry and urine tests. * Persons who have suffered from one of the diseases of diphtheria or tetanus, or who have suffered from whooping cough in the last three years. * Volunteers ≥12 years of age who have received pneumococcal polysaccharide/conjugate-containing vaccine within 4 years. * Individuals who have had household contact with individuals diagnosed with pertussis, diphtheria, tetanus in the past 30 days. * Individuals who are allergic to the components of the study vaccine or who have developed an allergy during previous administration of the same vaccine; individuals with a previous history of severe allergies, such as urticaria, anaphylaxis, respiratory distress, angioneurotic edema, or asthma. * History of convulsions, epilepsy, encephalopathy and serious neurological disorders (e.g., transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.), etc. * Individuals with primary and secondary immune impairment (history of thyroid, pancreas, liver, spleen, kidney disease or removal, or need for treatment due to thyroid disease within the past 12 months), who have received immunosuppressive therapy within 3 months. * Physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders. * Persons with acute febrile illnesses and current patients with infectious diseases who have had a history of moderately high fever (axillary temperature ≥38.0°C) or cardiopulmonary disease (frequent asthma attacks) within the past 3 days. * Has received another investigational drug or vaccine within 1 month prior to receiving the experimental drug, or is planning to participate or is participating in a clinical study of any other drug. * Received live attenuated vaccine within 14 days prior to receiving the test drug and subunit vaccine or inactivated vaccine within 7 days prior to receiving the test drug. * Any other factors that, in the judgment of the investigator, make the volunteer unsuitable for participation in a clinical trial.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diphtheria are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Shaanxi Center for Disease Control and Prevention
Xi'an, Shaanxi, 710054, 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 Five-Part vaccine bolster protection against three serious infections?