An open label multicentric clinical trial to evaluate the safety and immunogenicity of Tetanus vaccine (Adsorbed) I.P. (AbhayTOX® vaccine) in healthy pregnant women
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- Safety
研究概览
简要总结
This is an open label multicentric clinical trial to evaluate the safety and immunogenicity of Tetanus vaccine (Adsorbed) I.P. (AbhayTOX® vaccine) in healthy pregnant women The primary objectives are to evaluate the safety of AbhayTOX® vaccine when administered in healthy pregnant women, to evaluate proportion of the subjects experiencing local and/or systemic adverse events till 28 days after each dose of vaccination and to evaluate number of serious adverse events occurring till 28 days after second dose of vaccination.
The Secondary objective is to determine the Immunogenicity i.e., Humoral immune response after administration of AbhayTOX® vaccine in healthy pregnant women till 28 days after the second dose of vaccination and Exporatory objectives are to evaluate number of serious adverse events occurring till the delivery of the child, o To determine the Immunogenicity i.e., Humoral immune response after administration of AbhayTOX® vaccine in healthy pregnant women till 48 hours of delivery of child and to determine the immunogenicity in children born to the subjects by assessing the anti-tetanus antibody titres within 48 hours of delivery.
Blood samples for the anti-tetanus antibody titres estimation will be collected during the screening visit (Visit 1), 28 days after the second dose of vaccination (visit 4) and within 48 hours of delivery of child (Visit 5). The pre-vaccination and post-vaccination serum samples from the subjects will be tested for anti-tetanus antibodies in a central laboratory by using commercially available kits. Blood sample will also be collected from the child within 48 hours after birth for estimation of anti-tetanus antibodies. The study will be conducted in four sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Healthy pregnant women greater than or equals to 18 years of age with gestational age of 20 to 26 weeks.
- •2.Judged to be in good health based on reported medical history, physical examination, laboratory investigations and clinical judgement of the investigator.
- •3.Subject/ Legally acceptable representative (LAR) has understood and signed the written informed consent prior to the study inclusion.
- •4.Plans to remain in the study area for the entire length of the trial.
排除标准
- •1.Participation in any other clinical trial in the 4 weeks preceding the trial vaccination.
- •2.Planned participation/planning to participate in any other clinical trial during the present trial period.
- •3.Subjects with high obstetrical risk as assessed by the Obstetrician.
- •4.Pregnancy occurring within 3 years of last pregnancy.
- •6.History of major gynecologic or major abdominal surgery.
- •7.Subjects with Diabetes Mellitus and Hypertension.
- •8.Subject who has a known history of allergy to any component of the vaccine.
- •9.Allergy immunotherapy or receiving immunosuppressive therapy except for using topical steroids.
- •10.Known or suspected primary or acquired disease of the immune system.
- •11.Any serious mental illness (like Schizophrenia, psychosis, major depression).
- •12.Any fever with temperature greater than or equal to 38 C (100.4 F) in last 3 days.
- •14.Any unstable significant underlying chronic disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction.
- •15.History of recent contact with any confirmed case of COVID-19 or having tested positive for COVID-19 since less than a month.
- •16.Subjects on treatment with any hepatotoxic drug before receiving the vaccine during the last 90 days.
- •17.Prior stillbirth or neonatal death, or multiple spontaneous abortions.
- •19.Greater than three prior deliveries.
- •20.Primary genital Herpes simplex virus (HSV) infection during the current pregnancy.
- •21.History of vaccination against Tetanus within the past 3 years.
- •22.Previous evidence of Tetanus infection.
- •23.Receipt of any vaccine within the 30 days prior to enrollment or planning to receive any other vaccine within 28 days after receiving study vaccine.
- •24.Known or suspected acute infectious respiratory illness at the time of vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis and respiratory problems (e.g. wheezing, shortness of breath).
- •25.Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids.
- •26.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.
- •27.Known history or suspicion of HIV, Hepatitis B or Hepatitis C.
- •28.History of alcohol or drug abuse.
- •29.Pregnant women having the risk of Rh incompatibility with the baby during the second pregnancy.
- •30.Any history of receipt of blood products in last 3 months.
- •31.Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
结局指标
主要结局
Safety
时间窗: Safety | Solicited/unsolicited local adverse events till 28 (+7) days after each dose of vaccination. | Solicited/unsolicited systemic adverse events till 28 (+7) days after each dose of vaccination. | Number of serious adverse events till 28 (+7) days after second dose of vaccination.
Solicited/unsolicited local adverse events till 28 (+7) days after each dose of vaccination.
时间窗: Safety | Solicited/unsolicited local adverse events till 28 (+7) days after each dose of vaccination. | Solicited/unsolicited systemic adverse events till 28 (+7) days after each dose of vaccination. | Number of serious adverse events till 28 (+7) days after second dose of vaccination.
Solicited/unsolicited systemic adverse events till 28 (+7) days after each dose of vaccination.
时间窗: Safety | Solicited/unsolicited local adverse events till 28 (+7) days after each dose of vaccination. | Solicited/unsolicited systemic adverse events till 28 (+7) days after each dose of vaccination. | Number of serious adverse events till 28 (+7) days after second dose of vaccination.
Number of serious adverse events till 28 (+7) days after second dose of vaccination.
时间窗: Safety | Solicited/unsolicited local adverse events till 28 (+7) days after each dose of vaccination. | Solicited/unsolicited systemic adverse events till 28 (+7) days after each dose of vaccination. | Number of serious adverse events till 28 (+7) days after second dose of vaccination.
次要结局
- Immunogenicity(Proportion of subjects achieving seroprotection seroconversion at 28 days after second dose of vaccination)
研究者
Dr Sai Krishna
Human Biologicals Institute