CTRI/2024/06/068559尚未招募3 期
A Multicenter, Randomized, Observer-blind, Non-inferiority, Phase III Study to Evaluate the Immunogenicity and Safety of BoostagenREDTM (combined tetanus toxoid, reduced diphtheria toxoid, reduced recombinant pertussis vaccine) by BioNet-Asia compared to ADACEL® vaccine by Sanofi Pasteur Limited in Healthy Subjects Aged 4-65 years - NI
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Healthy male or female subjects aged 4-65 years at the time of enrolment.
- •2. Subjects with good health as determined by personal medical history and physical examination during screening as determined by the investigator.
- •3. Subjects who require booster vaccination against diphtheria, tetanus, and pertussis and have previously received at least 4 doses of DPT within the first 2 years of life (inclusive of 3 primary vaccinations and 1 booster
- •dose of DPT)
- •4. Subject and/or his/her parent/LAR who are willing to give written informed consent/assent before any study procedure
- •5. Female subjects (subjects of childbearing potential and married or sexually active) must have a negative urine pregnancy test at enrollment and be willing to take reliable birth control measures for 1 month after vaccination
- •6. Able to attend all scheduled visits and to understand and comply with the study procedures in the investigator’s judgment
排除标准
- •1. Subjects with a history of previous vaccination against diphtheria, tetanus, and pertussis with either study vaccine or another licensed vaccine in the past 12 months in subjects aged 4-7 years of age
- •2. Subjects with a history of previous vaccination against diphtheria, tetanus, and pertussis with either study vaccine or another vaccine (except tetanus-prone wound management for adults and/or for tetanus vaccination in pregnant women) in the past 5 years in subjects aged = 8 years
- •3. Subjects who have a history of a previous disease potentially related to any of the agents targeted by the DPT vaccine
- •4. Subjects with known hypersensitivity to any component of the study vaccine (including excipients) or a history of life threatening local or systemic reactions after previous administration of the vaccine or a vaccine containing the same substances
- •5. Subject with acute severe febrile illness on the day of the vaccination and/ or with evidence of acute illness within the past 7 days requiring systemic antibiotic or antiviral therapy.
- •6. Pregnant or lactating women should be excluded by performing urine pregnancy test during screening
- •7. Subjects with any confirmed or suspected
- •immunosuppressive or immunodeficient condition based on medical history and physical examination
- •8. Subjects who have experienced transient
- •thrombocytopenia or neurological complications following an earlier immunization
- •9. If the subject has experienced any of the following events in temporal relationship to previous vaccination with pertussis-containing vaccine:
- •a. Temperature of greater than or equals to
- •40.0 degree Celsius within 48 hours of
- •vaccination, not due to another identifiable cause
- •b. Collapse or shock-like state (hypotonic – hypo - responsiveness episode) within 48 hours of
- •vaccination
- •c. Convulsions with or without fever, occurring
- •within 3 days of vaccination
- •d. Encephalopathy of unknown origin occurring
- •within 7 days of vaccination
- •10. Subjects with any chronic or active neurologic disorder, including seizures and epilepsy
- •11. Presence of significant cardiovascular, hepatic, renal, pulmonary (including respiratory depression or diseases involving obstruction/narrowing of airways), gastrointestinal, endocrine, dermatological, neurological, or psychiatric disease or disorder, cancer, or autoimmune disease under treatment that in the opinion of the investigator, are likely to interfere with study outcome or study subject safety
- •12. Chronic administration (defined as more than 14 days) of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins, immunosuppressants, or other immune-modifying drugs in the past or any time
- •during the study or intake of any other medications which may interfere with study volunteers’ self-assessing ability/safety
- •13. Known history of administration of blood or blood-derived products in the past 3 months
- •14. Significant alcoholism or drug abuse which may interfere with study volunteers’ self- assessing ability/safety
- •15. Subjects with a known history of Guillain-Barré syndrome
- •16. Subjects who have received any other vaccines within 28 days before recruitment (3 months for live attenuated vaccines)
- •17. Planned participation in another clinical study during the study period
- •18. Subjects p
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