CTRI/2023/05/052325进行中（未招募）2/3 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
- 2/3 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- 1. Proportion (Number and percentage) of subjects achieving seroprotection levels of anti-diphtheria and anti-tetanus antibodies in both test and comparator groups).
研究概览
简要总结
This is a Randomized, Multicenter, Single Blind, Active controlled, Non-Inferiority Phase II/III Study. In this study a minimum of 500 subjects aged between 10 to 60 years will be enrolled and randomized to one of the two study arms (A and B), upon receipt of written informed consent form.
The primary objective of the study is to evaluate the seroprotective immune response of Diphtheria and Tetanus vaccine (adsorbed) IP (Td, test vaccine ) in comparison to reference vaccine when administered as the booster dose in healthy adults & adolescents at day 28 after vaccination. Secondary objectives of the study is to assess the GMT and two fold/ four fold rise in anti-tetanus and anti-diphtheria antibody titers and compare the safety and reactogenicity throughout the study.
Subjects will receive 0.5 ml of single dose of test or comparator vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 10.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male & female subjects aged 10 to 60 years.
- •Subjects in good health, based on medical history and physical examination.
- •Subject/Parent/LAR willing to participate throughout the study period.
- •Subject/Parent/LAR is willing to provide written Informed Consent/Assent form.
- •Past history of primary immunization with diphtheria and tetanus.
- •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 AND • Subject is willing to avoid pregnancies throughout the study by use of an effective method of contraception or abstinence AND • Subject has negative urine pregnancy test on the day of vaccination.
排除标准
- •Breast feeding women
- •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.
- •Known impairment of the immune function, including, but not limited to: Diabetes Mellitus, Cancer, Autoimmune diseases, Asthma, Asplenia etc.
- •Known history of HIV, hepatitis B, and hepatitis C reported by the subject.
- •History of any Bleeding Disorder.
- •History of severe allergic reactions or anaphylaxis.
- •History of allergy to any of the component of Investigational product.
- •Any evidence of clinically significant acute illness or infection or fever within past 3 days of study participation.
- •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.
- •Any major surgery within the past 90 days prior to vaccination.
- •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.
- •Have received blood products in the past 90 days prior to vaccination, including transfusions or immunoglobulin.
- •History of abusive usage of alcohol or drugs in the past 12 months that has caused medical problems.
- •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.
- •Known tetanus or diphtheria disease/infection within 5 years of enrollment in the study.
- •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).
- •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.
- •Vaccinated with any diphtheria or tetanus containing vaccine within 5 years before inclusion.
- •History of recent contact with any confirmed case of COVID-19 or having tested positive for COVID-19 for less than a month.
- •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.
结局指标
主要结局
1. Proportion (Number and percentage) of subjects achieving seroprotection levels of anti-diphtheria and anti-tetanus antibodies in both test and comparator groups).
时间窗: Day 28 post vaccination
2. Two sided 95% Cis for the difference in proportions of subjects achieving seroprotection rates of anti-Tetanus and anti-Diphtheria antibody titer.
时间窗: Day 28 post vaccination
次要结局
- 1. Comparison of the geometric mean titer (GMT) and geometric mean titer ratio (GMR) of antibodies against diphtheria and tetanus toxoids between subjects who received the study vaccine and the comparator vaccine.(2. Two fold and four fold rise in anti-Tetanus and anti-Diphtheria antibody titers.)
研究者
研究点 (6)
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