CTRI/2023/05/052325进行中（未招募）2 期
A randomized, single blind, multicenter, Phase II/III study to assess and compare the immunogenicity and safety of Diphtheria and Tetanus (Td) vaccine (adsorbed) of Panacea Biotec Ltd. with BE Td of M/s. Biological E Ltd in Healthy Adults & Adolescents.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（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 & female subjects aged 10 to 60 years.
- •2. Subjects in good health, based on medical history and physical examination.
- •3. Subject/Parent/LAR willing to participate throughout the study period.
- •4. Subject/Parent/LAR is willing to provide written Informed Consent/Assent form.
- •5. Past history of primary immunization with diphtheria and tetanus.
- •6. Inclusion criteria for females:
- •6.1 Female with non-child bearing potential (Females having documented history of surgical sterilization or are postmenopausal (12 months of amenorrhea after the last menstrual period) or are pre-menarche girls)
- •6.2 Female with child bearing potential is eligible if:
- •Subject has used an effective method of contraception or abstinence from at least 4 weeks prior to enrollment in the study
- •Subject is willing to avoid pregnancies throughout the study by use of an effective method of contraception or abstinence
- •Subject has negative urine pregnancy test on the day of vaccination
排除标准
- •1. Breast feeding women
- •2. Subjects who have any clinically significant chronic disease, which, in the opinion of the investigator would endanger the volunteer’s /subject’s well-being or interfere with the evaluation of the study objectives.
- •3. Known impairment of the immune function, including, but not limited to: Diabetes Mellitus, Cancer, Autoimmune diseases, Asthma, Asplenia etc. 4. Known history of HIV, hepatitis B, and hepatitis C reported by the subject.
- •5. History of any Bleeding Disorder.
- •6. History of severe allergic reactions or anaphylaxis. History of allergy to any of the component of Investigational product.
- •7. Any evidence of clinically significant acute illness or infection or fever within past 3 days of study participation.
- •8. Any evidence of clinically significant acute illness or infection or fever within past 3 days of vaccination. -Oral Temperature should not be = 37.8°C (100°F) on the day of vaccination.
- •9. Any major surgery within the past 90 days prior to vaccination.
- •10. Receipt of immunosuppressive therapy:
- •10.1) History of intake of anti-cancer chemotherapy or radiation therapy at any time in the past.
- •10.2) Systemic corticosteroid therapy (within the past 90 days prior to vaccination).
- •10.3) Received any other immunosuppressive therapy prior to study entry within a period that can interfere with study assessment in the clinical judgment of Investigator.
- •11. Have received blood products in the past 90 days prior to vaccination, including transfusions or immunoglobulin.
- •12. Use of anticoagulant medication in the past 90 days prior to vaccination.
- •13. Receipt of any vaccine in the past 4 weeks prior to study vaccination.
- •14. History of abusive usage of alcohol or drugs in the past 12 months that has caused medical problems.
- •15. Has participated in another clinical trial in the past 4 weeks prior to vaccination and planned participation in any other clinical trial during the present trial period.
- •16. Known tetanus or diphtheria disease/infection within 5 years of enrollment in the study.
- •17. Known or suspected acute respiratory illness at the time of study vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis or any other respiratory problems (e.g. asthma, wheezing, shortness of breath).
- •18. Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms.
- •19. Vaccinated with any diphtheria or tetanus containing vaccine within 5 years before inclusion.
- •20. History of recent contact with any confirmed case of COVID-19 or having tested positive for COVID-19 for less than a month.
- •21. Any other condition that might put in risk the safety/rights of a potential participant or hurdle his/her compliance with this protocol in investigator’s opinion.
研究者
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