None listed
Conditions
Interventions
Intervention1: Tetanus vaccine (Adsorbed) I.P. (AbhayTOX® vaccine): Study participants will receive two doses (0.5 ml each) of AbhayTOX® vaccine at 4 weeks interval intramuscularly at the deltoid re
Sponsors
Human Biologicals Institute
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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. 5.Subjects having abnormal findings in Targeted Imaging for Foetal Anomalies (TIFFA) Scan/ Fetal Anomaly Scan. 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. 13.Any known history or suspicion of thrombocytopenia or a bleeding disorder. 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. 18.Previous infant with a known genetic disorder or major congenital anomaly. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity Proportion of subjects achieving seroprotection seroconversion at 28 days after second dose of vaccination Geometric mean titres of antibodies in subjects at 28 days after second dose of vaccination Exploratory Number of serious adverse events during the study duration till the delivery of the child Proportion of subjects achieving seroprotection and seroconversion after delivery of child within 48 hours of delivery Proportion of children achieving seroprotection within 48 hours of delivery Geometric mean titres of antibodies in subjects after delivery of child within 48 hours of delivery Geometric mean titres of antibodies in children within 48 hours of deliveryTimepoint: 28 days after second dose of vaccination for the pregnant women Within 48 hours of delivery for the new born child | — |
Countries
India
Contacts
Public ContactDr Sai Krishna
Human Biologicals Institute
Outcome results
None listed