A Multicenter, Randomized, Observer-blind, Non-inferiority, Phase III Study to Evaluate the Immunogenicity and Safety of BoostagenRED TM (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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 534
- 试验地点
- 8
- 主要终点
- Percentages of subjects achieving a significant booster
研究概览
简要总结
Pertussis is a highly infectious disease and remains an important worldwide public health problem, even in countries with sustained high vaccination coverage. Despite established infant immunization programmes, pertussis continues to circulate.The need to maintain antibody levels against pertussis beyond childhood, through booster vaccines is therefore increasingly recognized. Vaccination against pertussis using available pediatric formulation was not recommended to immunize adolescent and adult population therefore reduced-antigen content combined diphtheria-tetanus-acellular pertussis (Tdap) vaccine has been specifically developed.
ADACEL® is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis (whooping cough) in persons 4 years of age and older.
Techinvention Lifecare Pvt. Ltd. plans to conduct a multicenter, Randomized, Observer-blind, Non-inferiority, Phase III Study to Evaluate the Immunogenicity and Safety of BoostagenRED TM (combined tetanus toxoid, reduced diphtheria toxoid, reduced recombinant pertussis vaccine) by BioNet-Asia compared to ADACEL® by Sanofi Pasteur Ltd. in Healthy Subjects Aged 4-65 years. The study vaccine will be given to 534 subjects (267 subjects per vaccine group) as a single dose of 0.5 mL by deep intramuscular injection in the deltoid region of the non-dominant upper arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male or female subjects aged 4-65 years at the time of enrolment.
- •Subjects with good health as determined by personal medical history and physical examination during screening as determined by the investigator.
- •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)
- •Subject and/or his/her parent/LAR who are willing to give written informed consent/assent before any study procedure
- •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
- •Able to attend all scheduled visits and to understand and comply with the study procedures in the investigator’s judgment.
排除标准
- •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
- •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
- •Subjects who have a history of a previous disease potentially related to any of the agents targeted by the DPT vaccine
- •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
- •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.
- •Pregnant or lactating women should be excluded by performing urine pregnancy test during screening
- •Subjects with any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- •Subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization
- •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
- •Subjects with any chronic or active neurologic disorder, including seizures and epilepsy
- •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
- •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
- •Known history of administration of blood or blood-derived products in the past 3 months
- •Significant alcoholism or drug abuse which may interfere with study volunteers’ self- assessing ability/safety
- •Subjects with a known history of Guillain-Barré syndrome
- •Subjects who have received any other vaccines within 28 days before recruitment (3 months for live attenuated vaccines)
- •Planned participation in another clinical study during the study period
- •Subjects planning to leave the area of the study site before completion of the study.
结局指标
主要结局
Percentages of subjects achieving a significant booster
时间窗: at Day 29 after vaccination.
response in anti-PT IgG and anti-FHA IgG antibody
时间窗: at Day 29 after vaccination.
concentrations at Day 29 after vaccination in BoostagenREDTM and ADACEL® vaccine groups.
时间窗: at Day 29 after vaccination.
次要结局
- 1 GMCs of anti-PT IgG & anti-FHA IgG antibody concentrations as measured by ELISA.(2 Percentage of subjects with seroprotection against DT as defined by anti-DT IgG antibody concentrations ≥ 0.1 IU/mL measured by ELISA)
研究者
Dr Hari Shanker Joshi
All India Institute of Medical Sciences, gorakhpur