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

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

Treatments tested in this trial

  • Tdap vaccine

Treatment groups

96 Participants
are divided into 3 treatment groups

Locations

This trial has no locations