Clinical trial NCT06708286: A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component)
Official title: A Randomized, Blinded, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Adsorbed Cell-free DTP Vaccine (Five-component)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Keywords: Vaccine
Five Components
Immunogenicity
Safety
Acellular
Lead sponsor: CanSino Biologics Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-27
Enrollment: 1820
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized, blinded, controlled phase II and III clinical trial evaluating the immunogenicity and safety of adsorbed cell-free DPT vaccine. 320 subjects aged 7 years and older in the phase II were divided into two age groups, the ≥18 years group and the 7-17 years group, and randomized 3:1 to receive the trial vaccine Tdcp versus the control vaccine PPV23. 1500 subjects in the phase III were divided into 3 age subgroups. 780 subjects were planned to be enrolled in the 6-year-old group and randomized 1:1 to receive the experimental vaccine Tdcp versus the control vaccine DTaP, and 360 subjects were planned to be enrolled in each of the 7-17 and ≥18 age groups and randomized 3:1 to receive the experimental vaccine Tdcp versus the control vaccine PPV23.


Eligibility criteria: 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.

Primary outcomes:
measure: Phase II: Incidence of adverse reactions
timeFrame: Within 0-30 days after vaccination
measure: Phase III: Geometric mean concentration (GMC) of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
timeFrame: Pre-vaccination and 30 days post-vaccination
measure: Phase III: Proportion of serum anti-DT and TT antibodies ≥ 0.1IU/ml
timeFrame: 30 days after vaccination
measure: Phase III: Incidence of adverse reactions
timeFrame: Within 0-30 days after vaccination
Secondary outcomes:
measure: Phase II: Incidence of adverse events/reactions
timeFrame: Within 30 minutes of vaccination
measure: Phase II: Incidence of adverse events/reactions
timeFrame: 0-7 days after vaccination
measure: Phase II: Incidence of adverse events
timeFrame: 0-30 days after vaccination
measure: Phase II: Incidence of serious stadverse events
timeFrame: Within 6 months of vaccination
measure: Phase III: Positive rate of serum anti-Pertussis Toxoid (PT), Filamentous hemagglutmin (FHA), Pertactin (PRN), FIM 2&3, Diphtheria Toxoid (DT), Tetanus Toxoid (TT) antibodies
timeFrame: 30 days after vaccination
measure: Phase III: Positive transfer rate of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
timeFrame: 30 days after vaccination
measure: Phase III: Geometric Mean Increase (GMI) of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
timeFrame: 30 days after vaccination
measure: Phase III: Incidence of adverse events/reactions
timeFrame: Within 30 minutes of vaccination
measure: Phase III: Incidence of adverse events/reactions
timeFrame: 0-7 days after vaccination
measure: Phase III: Incidence of adverse events
timeFrame: 0-30 days after vaccination
measure: Phase III: Incidence of SAEs in subjects aged 7 years and older
timeFrame: Within 6 months of vaccination
measure: Phase III: Incidence of SAEs in subjects aged 6 years
timeFrame: Within 12 months of vaccination
Other outcomes:
Locations:
city: Kaihua
country: China
facility: Kaihua County Center for Disease Control and Prevention
Study officials:
affiliation: Ethical Review Committee for Clinical Trials of Zhejiang Center for Disease Control and Prevention
name: Hanqing He
role: PRINCIPAL_INVESTIGATOR
References: