| CTRI Number |
CTRI/2025/07/090196 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate the safety and immunogenicity of tetanus vaccine in healthy pregnant women |
|
Scientific Title of Study
|
An open label multicentric clinical trial to evaluate the safety and immunogenicity of Tetanus vaccine (Adsorbed) I.P. (AbhayTOX® vaccine) in healthy pregnant women |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HBI/TOX4/23/02.2.0 Version 02 dated 20 January 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sai Krishna |
| Designation |
GM Medical Veterinary services |
| Affiliation |
Human Biologicals Institute |
| Address |
Medical and Veterinary Services department Human Biologicals institute A division of Indian Immunologicals Limited Gachibowli Hyderabad
Hyderabad
TELANGANA
500010
India |
| Phone |
8187836444 |
| Fax |
|
| Email |
s.saikrishna@indimmune.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sai Krishna |
| Designation |
GM Medical Veterinary services |
| Affiliation |
Human Biologicals Institute |
| Address |
Medical and Veterinary Services department Human Biologicals institute A division of Indian Immunologicals Limited Gachibowli Hyderabad
TELANGANA
500010
India |
| Phone |
8187836444 |
| Fax |
|
| Email |
s.saikrishna@indimmune.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sai Krishna |
| Designation |
GM Medical Veterinary services |
| Affiliation |
Human Biologicals Institute |
| Address |
Medical and Veterinary Services department Human Biologicals institute A division of Indian Immunologicals Limited Gachibowli Hyderabad
TELANGANA
500010
India |
| Phone |
8187836444 |
| Fax |
|
| Email |
s.saikrishna@indimmune.com |
|
|
Source of Monetary or Material Support
|
| Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli, Hyderabad – 500 032, Telangana, India. |
|
|
Primary Sponsor
|
| Name |
Human Biologicals Institute |
| Address |
Human Biologicals Institute Rakshapuram Gachibowli Hyderabad 500032 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neema Acharya |
Acharya Vinoba Bhave Rural Hospital |
Sawangi Wardha 442004 Maharashtra India
Wardha
MAHARASHTRA |
9326692511
neemasacharya@gmail.com |
| Dr Meenkshi Pranavi |
Aditya Multi Speciality Hospital |
3rd Line Gunturivari Thota
Kothapet Beside Peoples Trauma
Guntur 522001 Andhra Pradesh India
Guntur
ANDHRA PRADESH |
9392961355
drmeenakshipranavi@gmail.com |
| Dr Vibhavari Shrirang Solunke |
Baramati Hospital |
Behind Kavivarya Moropant Natyamandir New Indapur Ring Road Baramati 413102 Maharashtra India
Pune
MAHARASHTRA |
9823064597
vibhashrirang@yahoo.com |
| Dr Madhavender Jain |
Maharaja Agrasen Superspeciality Hospital |
Central Spine Sector 7 Vidyadhar Nagar Jaipur 302039 Rajasthan India
Jaipur
RAJASTHAN |
9413062961
madhvanderjain2@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee of Baramati Hospital Pvt.Ltd. |
Approved |
| IEC Maharaja Agrasen Hospital |
Approved |
| Institutional Ethics Committee Aditya Multi specialty Hospital |
Approved |
| Institutional Ethics Committee of DMIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of Tetanus in Pregnant women and in the newborn infants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
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 region. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
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 Outcome
|
| Outcome |
TimePoints |
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 delivery |
28 days after second dose of vaccination for the pregnant women
Within 48 hours of delivery for the new born child |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/07/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |