Can a Five-Part vaccine bolster protection against three serious infections?
NCT ID NCT06708286
First seen Aug 06, 2026 · Last updated Aug 27, 2026 · Updated 3 times
Summary
This trial evaluates a new five-component vaccine (Tdcp) designed to protect against diphtheria, tetanus, and pertussis (whooping cough). It includes about 1,820 participants aged 7 and older, who receive either the experimental vaccine or a control vaccine. The study measures how well the vaccine triggers an immune response and monitors for any side effects, aiming to see if this new formulation is safe and effective for 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
- Tdcp vaccine (tetanus, reduced diphtheria, and acellular pertussis, five components)
- What this could lead to
- If successful, this vaccine could offer stronger or longer-lasting protection against diphtheria, tetanus, and whooping cough for older children and adults.
- What could go wrong
- The trial is in early-to-mid stages, so the vaccine may not prove more effective than existing ones. As with any vaccine, there is a risk of side effects like injection-site reactions or fever.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
1,820 people
The number who actually took part.
- Started
-
Dec 2024
- Finished
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Mar 2026
- 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: * Phase II : People ≥ 7 years old * Phase II : Willing to provide identification documents * Phase II : Volunteers must obtain informed consent from the volunteers themselves and/or their guardians/ or delegates, sign the informed consent form and be willing to comply with the requirements of the clinical trial protocol, and be able to complete the full study follow-up * Phase II : Volunteers aged 7\~11 years have completed 4 doses of vaccine containing DPT * Phase II : ≥12 years old volunteers need to have not received any component vaccine containing DPT within 5 years * Phase III : People ≥6 years old * Phase III : Willing to provide identification documents * Phase III : Volunteers must obtain informed consent from themselves and/or their guardians/ or delegates, sign the informed consent form and be willing to comply with the requirements of the clinical trial protocol, and be able to complete the full study follow-up * Phase III : Volunteers aged 6\~11 years old have completed 4 doses of DPT-containing vaccine in the past * Phase III : Volunteers aged ≥12 years should not have received any vaccine containing any component of DPT within 5 years Exclusion Criteria: * Those who have fever before vaccination, with axillary temperature \>37.0℃; * Females with a positive urine pregnancy test or breastfeeding volunteers, volunteers or their partners who have a pregnancy plan within 6 months; * Suffering from hypertension (systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg) that cannot be controlled by medication (applicable to people aged 18 years and above); * Those who have already suffered from one of the diphtheria or tetanus diseases, those who have suffered from whooping cough in the last 3 years; or those who have had persistent cough for 14 days or more in the last 6 months; * Those who have received vaccine containing pneumococcal polysaccharide/conjugate component within 5 years (applicable to those aged 7 years and above); * Individuals who have had household contact with an individual with a confirmed diagnosis of pertussis, diphtheria, or tetanus disease in the past 30 days; * Individuals who are allergic to the components of the test vaccine (e.g., aluminum adjuvant, sodium dihydrogen phosphate, sodium chloride, etc.) or who have developed an allergy to the same type of vaccine previously; individuals with a previous history of severe allergy, e.g., recurrent generalized urticaria, anaphylactic shock, respiratory distress, angioneurotic edema, or a history of asthma; * Those with encephalopathy, uncontrolled epilepsy and other progressive neurological disorders (e.g., transverse myelitis, Guillain-Barre syndrome, demyelinating diseases) * Persons with primary and secondary impaired immune function, receiving immunosuppressive therapy * Doctor-diagnosed coagulation abnormalities (e.g. coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders * Currently suffering from severe chronic diseases, acute exacerbation of chronic diseases, acute infectious diseases; * Have received another investigational drug or vaccine within 1 month prior to receiving the experimental vaccine, or have plans to participate or are participating in a clinical study of any other drug; * Have received an injectable live attenuated vaccine within 14 days prior to receiving the experimental vaccine, or any other vaccine within 7 days prior to receiving the experimental vaccine; * In the judgment of the investigator, the volunteer has any other factors that make him/her unsuitable for participation 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
-
Kaihua County Center for Disease Control and Prevention
Kaihua, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new vaccine shield older kids and adults from three deadly infections?