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CTRI Number  CTRI/2023/05/052325 [Registered on: 04/05/2023] Trial Registered Prospectively
Last Modified On: 10/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to assess the efficacy and safety of Diphtheria and Tetanus vaccine in Healthy participants aged 10 t0 60 years. 
Scientific Title of Study   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. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PBL/21/01/Td Version No: 03, Dated: 04-10-22  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lalitendu Mohanty 
Designation  VP- Clinical Research 
Affiliation  Panacea Biotec Limited 
Address  B-1 Extn/G-3, Mohan Co-op, Indl. Estate, Mathura Road, South West, DELHI

South West
DELHI
110044
India 
Phone  011-41679000  
Fax  011-41578085  
Email  lalitendumohanty@panaceabiotec.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lalitendu Mohanty 
Designation  VP- Clinical Research 
Affiliation  Panacea Biotec Limited 
Address  B-1 Extn/G-3, Mohan Co-op, Indl. Estate, Mathura Road, South West, DELHI

South West
DELHI
110044
India 
Phone  011-41679000  
Fax  011-41578085  
Email  lalitendumohanty@panaceabiotec.com  
 
Details of Contact Person
Public Query  
Name  Dr Nidhi Singh 
Designation  Head Clinical Operations 
Affiliation  Clinical Research Network India 
Address  B-806,807, Advant Navis Business Park, Plot #7, Noida-Greater Noida Expressway, Sector 142, Gautam Buddha Nagar UTTAR PRADESH 201305 India

Gautam Buddha Nagar
UTTAR PRADESH
201305
India 
Phone  9695237796  
Fax    
Email  nidhisingh@crnindia.org  
 
Source of Monetary or Material Support  
Panacea Biotec Limited 
 
Primary Sponsor  
Name  Panacea Biotec Limited 
Address  B-1, Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road, New Delhi. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Clinical Research Network India   B-806,807, Advant Navis Business Park Plot 7, Noida-Greater Noida Expressway, Sector 142, Noida, Delhi, Uttar Pradesh 201305 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chandramani Singh  All India Institute of Medical Sciences  Room No. 17 Department of Community & Family Medicine All India Institute of Medical Sciences, Phulwari Sharif, Patna, Bihar-801507
Patna
BIHAR 		 9695237796

cmaiims57@gmail.com 
Dr Amit Suresh Bhate  Jeevan Rekha Hospital  3rd Floor Room No. 2 Jeevan Rekha Hospital,Dr B.R Ambedkar Road Belagavi
Belgaum
KARNATAKA 		 966717725

dr.amitsureshbhate@gmail.com 
Dr Dinesh HN  K.R. Hospital  Department of General Surgery, K.R. Hospital, Mysore Medical College and Research Institute, Irwin Road
Mysore
KARNATAKA 		 9448089501

drdinesh07@gmail.com 
Dr Jitender Singh Kushwaha  Prakhar Hospital Pvt Ltd.  Department of Medicine, Ground floor,8/219 Arya Nagar, KANPUR
Kanpur Nagar
UTTAR PRADESH 		 8448522450

dr.jskushwahacr@gmail.com 
Dr Ajeet Pratap Singh  Rana Hospital Pvt. Ltd.  Room No. 7 Rana Hospital Pvt. Ltd,Rail Vihar Medical College, Road Chargawa Gorakhpur
Gorakhpur
UTTAR PRADESH 		 07652456810

ajeetpsingh1177@gmail.com 
Dr Rajesh Kumar Yadav  Uttar Pradesh University of Medical Sciences  Department of Respiratory Medicine, UPUMS, Saifai
Etawah
UTTAR PRADESH 		 9026291170

drrajeshyadav39@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Commitee Prakhar Hospital, Prakhar Hospital Private Limited, 8/219, Arya Nagar, Kanpur (208002), Uttar Pradesh  Approved 
Institutional Ethics Commitee, All India Institute of Medical Sciences, Phulwarisharif, Patna-Bihar 801507  Approved 
Institutional Ethics Commitee, Jeevan Rekha Hospital, Dr B.R Ambedkar Road Belagavi-590002  Approved 
Institutional Ethics Commitee, Rana Hospital Pvt Ltd, Rail Vihar Medical College, Road Chargawa, Gorakhpur-273001  Approved 
Institutional Ethics Committee Mysore Medical College & Research Instiute and Associated hospitals   Approved 
Institutional Ethics Committee, Uttar Pradesh University of Medical Sciences, Saifai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Indian male and female adults (18-60 years) & adolescents (10-17 years) will be enrolled in the study. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Diphtheria And Tetanus vaccine (adsorbed) for adults and adolescents I.P. (BE Td®)  dose (0.5 ml) of the study vaccine will be administered as intramuscular (IM) injection in the upper arm. 
Intervention  Diphtheria and Tetanus vaccine (adsorbed) for adults and adolescents IP (Td)  dose (0.5 ml) of the study vaccine will be administered as intramuscular (IM) injection in the upper arm.  
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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
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 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Proportion (Number and percentage) of subjects achieving seroprotection levels of anti-diphtheria and anti-tetanus antibodies in both test and comparator groups).
2. Two sided 95% Cis for the difference in proportions of subjects achieving seroprotection rates of anti-Tetanus and anti-Diphtheria antibody titer.
 		 Day 28 post vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
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.
3. Incidence of solicited local and systemic reactions for 30 minutes post immunization and for the next 7 days
4. Unsolicited AEs will be recorded 28 days post vaccination.
5. SAEs will be recorded during the entire study period. 		 Day 28 post vaccination 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/05/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.
 
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