A Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine

Официальное название

Phase I Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine

Обзор

This clinical trial will enroll 160 participants who previously took part in the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combination vaccine (for individuals aged 6 years and older) (Protocol No.: CTP-Tdcp-001). Approximately 3-4 mL of venous blood will be collected from each participant 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.

Вмешательства

• Другое Previously received the Tdcp vaccine at age 18 and older
  Approximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
• Другое Previously received the Tdcp vaccine at age 12-17
  Approximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
• Другое Previously received the Tdcp vaccine at age 6-11
  Approximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
• Другое Previously received the DT vaccine at age 6-11
  Approximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.

Первичные конечные точки

• Seropositivity rates of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3 [Срок оценки: 2.5, 5, and 10 years post-vaccination]
• Geometric mean concentrations (GMC) of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3 [Срок оценки: 2.5, 5, and 10 years post-vaccination]
• Proportions of serum anti-PRN antibody levels ≥5 and ≥10 IU/mL [Срок оценки: 2.5, 5, and 10 years post-vaccination]
• Proportions of anti-FIM 2&3 antibody levels ≥5 and ≥10 EU/mL [Срок оценки: 2.5, 5, and 10 years post-vaccination]
• Proportions of serum anti-DT and anti-TT antibody levels ≥0.1 IU/mL and ≥1.0 IU/mL [Срок оценки: 2.5, 5, and 10 years post-vaccination]

Критерии участия

Критерии включения

• Participants in the 6-11-year-old, 12-17-year-old, and ≥18-year-old groups from the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combined vaccine (for individuals aged 6 and older) (Protocol No.: CTP-Tdcp-001) who were included in the protocol-defined analysis set;
• Willingness to provide identification documents;
• Informed consent must be obtained from the trial participant and/or guardian and/or authorized representative, and the informed consent form must be signed;
• The trial participant and/or guardian and/or authorized representative must be able and willing to comply with the requirements of the clinical study protocol and be able to complete the full course of study follow-up.

Критерии исключения

• Received another DTP-type vaccine after completing the CTP-Tdcp-001 study;
• Developed a DTP-related illness since the completion of the CTP-Tdcp-001 study;
• Has a coagulation disorder;
• In the investigator's judgment, the participant has any other factors that make them unsuitable for participation in the clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07744347 · CTP-Tdcp-005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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