A Phase I Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age10+
SponsorChangchun BCHT Biotechnology Co.

About this trial

the safety and tolerability of different dosages of adsorbed acellular pertussis (two-component) diphtheria-tetanus combined vaccine

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

People aged 10 years or older;

Study participants and/or their guardians/authorized representatives are willing to provide valid identity certification documents of the study participants and/or their guardians/authorized representatives;

Informed consent of the study participants themselves and/or their guardians/authorized representatives shall be obtained, and informed consent forms shall be signed;

Study participants themselves and/or their guardians/authorized representatives are able and willing to comply with the requirements of the clinical trial protocol and complete all trial follow-up visits;

Disqualifiers

Axillary body temperature >37.0°C on the day of enrollment of trial participants;

Female trial participants who are breastfeeding or pregnant, or trial participants or their partners who plan to conceive within 6 months;

Persons with severe cardiovascular diseases, uncontrolled hypertension (e.g., systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg for trial participants aged 18-59 years before enrollment, or systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg for trial participants aged 60 years and above) or other severe chronic diseases (for persons aged 18 years and above);

Persons with clinically significant abnormal results of pre-vaccination tests of blood routine, blood biochemistry, urine routine, and coagulation function indicators who are deemed unsuitable for vaccination by the investigator after comprehensive evaluation;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tdap vaccine

    Biological/Vaccine

    intramuscular injection only, and the preferred inoculation site is the deltoid muscle of the upper arm.

Treatment groups

96 Participants
are divided into 3 treatment groups
Group A: BCHT Tdap vaccine (low dose)Experimental treatment 1 intervention
Group B: BCHT Tdap vaccine (high dose)Experimental treatment 1 intervention
Group C: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

adverse event

Time frame
14/30 days after injection

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: