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CTRI Number  CTRI/2024/06/068559 [Registered on: 07/06/2024] Trial Registered Prospectively
Last Modified On: 13/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Other 
Public Title of Study   To Evaluate the efficacy and Safety of a test vaccine (Tetanus, diphtheria, pertussis) in comparison to a marketed vaccine in healthy Subjects Aged 4-65 years. 
Scientific Title of Study   A Multicenter, Randomized, Observer-blind, Non-inferiority, Phase III Study to Evaluate the Immunogenicity and Safety of BoostagenRED TM (combined tetanus toxoid, reduced diphtheria toxoid, reduced recombinant pertussis vaccine) by BioNet-Asia compared to ADACEL® vaccine by Sanofi Pasteur Limited in Healthy Subjects Aged 4-65 years 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CRNI/CTP/009 version 1.0 dated 17 Nov 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hari Shanker Joshi 
Designation  Dean Academics and Professor & Head Department of Community Medicine & Family Medicine 
Affiliation  All India Institute of Medical Sciences, gorakhpur 
Address  Department of Community & Family Medicine All India Institute of Medical Sciences, Kunraghat, Gorakhpur, Uttar Pradesh


UTTAR PRADESH
273008
India 
Phone  9415833751  
Fax    
Email  drjoshiharish@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nidhi Singh 
Designation  Head Clinical operations  
Affiliation  Clinical Research Network India Pvt. Ltd. 
Address  B-806,807 Advant Navis Business Park, Plot #7, Noida-Greater Noida Expressway, Sector 142, Noida, Delhi NCR Gautam Buddha Nagar UTTAR PRADESH 201305 India

Gautam Buddha Nagar
UTTAR PRADESH
201305
India 
Phone  9695237796  
Fax    
Email  nidhisingh@crnindia.org  
 
Details of Contact Person
Public Query  
Name  Dr Nidhi Singh 
Designation  Head Clinical operations  
Affiliation  Clinical Research Network India Pvt. Ltd. 
Address  B-806,807 Advant Navis Business Park, Plot #7, Noida-Greater Noida Expressway, Sector 142, Noida, Delhi NCR Gautam Buddha Nagar UTTAR PRADESH 201305 India


UTTAR PRADESH
201305
India 
Phone  9695237796  
Fax    
Email  nidhisingh@crnindia.org  
 
Source of Monetary or Material Support  
Techinvention Lifecare Pvt. Ltd. #1004, The Summit Business Park, Off WEH Metro Station, Andheri Kurla Road, Andheri East, Mumbai 400093. India 
 
Primary Sponsor  
Name  Techinvention Lifecare Pvt Ltd  
Address  #1004, The Summit Business Park, Off WEH metro station, Andheri kurla road, Andheri east, Mumbai 400093 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hari Shanker Joshi  All India Institute of Medical Sciences  Kunraghat Gorakhpur Uttar Pradesh 273008
Gorakhpur
UTTAR PRADESH 		 9415833751

drjoshiharish@gmail.com 
Dr Santosh Kumar Nirala  All India Institute of Medical Sciences  Department of Community & Family Medicine All India Institute of Medical Sciences, Phulwari Sharif, Patna, Bihar 801507
Patna
BIHAR 		 7783892746

drsantoshkaiims@gmail.com 
Dr Shrikanth Tripathy   Dr. D.Y. Patil Medical College, Hospital & Research Centre  Dr. D.Y. Patil Medical College, Hospital & Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA 		 9500779797

director.medicalresearch@dpu.edu.in 
Dr Amit S Bhate  Jeevan Rekha Hospital   Dr. B.R. Ambedkar Road, Opp. Civil Hospital, Belagavi, Karnataka 590002
Belgaum
KARNATAKA 		 9667177125

dr.amitsureshbhate@gmail.com 
Dr Vinod Kumar Kapoor  New Leelamani Hospital Pvt. Ltd.  14/116, C-1, Parade Churaha, Civil Lines Kanpur, Uttar Pradesh 208001
Kanpur Nagar
UTTAR PRADESH 		 09555989176

drvinodkumarkapoor@gmail.com 
Dr Vijaykumar Bhagwan Barge  Rajashree Chhatrapati Shahu Maharaj Govt. Medical College and General Hospital  Medicine Department, CPR Hospital, Dasara Chowk, Bhausinghaji Road, Kolhapur, Town Hall, Maharashtra 416012
Kolhapur
MAHARASHTRA 		 7969792775

drvijaybarge12@gmail.com 
Dr Manish Narang  UCMS & Guru Teg Bahadur Hospital   Guru Teg Bahadur Hospital & UCMS, Dilshad Garden, Delhi-110095
East
DELHI 		 9811036569

manish_2710@yahoo.com 
Dr Ramesh Chand  Uttar Pradesh University of Medical Sciences  Saifai, Etawah, Uttar Pradesh, India, 206130
Etawah
UTTAR PRADESH 		 8319572549

drrameshc64@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Guru Teg Bahadur Hospital Ethics Committee  Approved 
Institutional Ethics Committe Dr. D.Y. Patil Vidyapeeth  Approved 
Institutional Ethics Committee All India Institute of Medical Sciences Patna  Approved 
Institutional Ethics Committee All India Institute Of Medical Sciences, Gorakhpur  Approved 
Institutional Ethics committee Jeevan Rekha Hospital, Belagavi  Approved 
Institutional Ethics Committee RCSMGMC and CPR Hospital  Approved 
Institutional Ethics Committee Uttar Pradesh University of Medical Sciences, Saifai, Etawah, UP  Approved 
Institutional Ethics Committee, Dr. Ram Manohar lohia Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy male or female subjects aged 4-65 years will be enrolled. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ADACEL®  (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) vaccine by Sanofi Pasteur Limited. A single dose (0.5 mL) of the vaccine will be administered by deep intramuscular injection, in the deltoid muscle of the non-dominant upper arm. 
Intervention  BoostagenREDTM   (combined tetanus toxoid, reduced diphtheria toxoid, reduced recombinant pertussis vaccine) by BioNet-Asia Co. Ltd. Thaialand. A single dose (0.5 mL) of the vaccine will be administered by deep intramuscular injection, in the deltoid muscle of the non-dominant upper arm. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Healthy male or female subjects aged 4-65 years at the time of enrolment.
2. Subjects with good health as determined by personal medical history and physical examination during screening as determined by the investigator.
3. Subjects who require booster vaccination against diphtheria, tetanus, and pertussis and have previously received at least 4 doses of DPT within the first 2 years of life (inclusive of 3 primary vaccinations and 1 booster
dose of DPT)
4. Subject and/or his/her parent/LAR who are willing to give written informed consent/assent before any study procedure
5. Female subjects (subjects of childbearing potential and married or sexually active) must have a negative urine pregnancy test at enrollment and be willing to take reliable birth control measures for 1 month after vaccination
6. Able to attend all scheduled visits and to understand and comply with the study procedures in the investigator’s judgment 
 
ExclusionCriteria 
Details  1. Subjects with a history of previous vaccination against diphtheria, tetanus, and pertussis with either study vaccine or another licensed vaccine in the past 12 months in subjects aged 4-7 years of age
2. Subjects with a history of previous vaccination against diphtheria, tetanus, and pertussis with either study vaccine or another vaccine (except tetanus-prone wound management for adults and/or for tetanus vaccination in pregnant women) in the past 5 years in subjects aged ≥ 8 years
3. Subjects who have a history of a previous disease potentially related to any of the agents targeted by the DPT vaccine
4. Subjects with known hypersensitivity to any component of the study vaccine (including excipients) or a history of life threatening local or systemic reactions after previous administration of the vaccine or a vaccine containing the same substances
5. Subject with acute severe febrile illness on the day of the vaccination and/ or with evidence of acute illness within the past 7 days requiring systemic antibiotic or antiviral therapy.
6. Pregnant or lactating women should be excluded by performing urine pregnancy test during screening
7. Subjects with any confirmed or suspected
immunosuppressive or immunodeficient condition based on medical history and physical examination
8. Subjects who have experienced transient
thrombocytopenia or neurological complications following an earlier immunization
9. If the subject has experienced any of the following events in temporal relationship to previous vaccination with pertussis-containing vaccine:
a. Temperature of greater than or equals to
40.0 degree Celsius within 48 hours of
vaccination, not due to another identifiable cause
b. Collapse or shock-like state (hypotonic – hypo - responsiveness episode) within 48 hours of
vaccination
c. Convulsions with or without fever, occurring
within 3 days of vaccination
d. Encephalopathy of unknown origin occurring
within 7 days of vaccination
10. Subjects with any chronic or active neurologic disorder, including seizures and epilepsy
11. Presence of significant cardiovascular, hepatic, renal, pulmonary (including respiratory depression or diseases involving obstruction/narrowing of airways), gastrointestinal, endocrine, dermatological, neurological, or psychiatric disease or disorder, cancer, or autoimmune disease under treatment that in the opinion of the investigator, are likely to interfere with study outcome or study subject safety
12. Chronic administration (defined as more than 14 days) of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins, immunosuppressants, or other immune-modifying drugs in the past or any time
during the study or intake of any other medications which may interfere with study volunteers’ self-assessing ability/safety
13. Known history of administration of blood or blood-derived products in the past 3 months
14. Significant alcoholism or drug abuse which may interfere with study volunteers’ self- assessing ability/safety
15. Subjects with a known history of Guillain-Barré syndrome
16. Subjects who have received any other vaccines within 28 days before recruitment (3 months for live attenuated vaccines)
17. Planned participation in another clinical study during the study period
18. Subjects planning to leave the area of the study site before completion of the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentages of subjects achieving a significant booster
response in anti-PT IgG and anti-FHA IgG antibody
concentrations at Day 29 after vaccination in BoostagenREDTM and ADACEL® vaccine groups. 		 at Day 29 after vaccination. 
 
Secondary Outcome  
Outcome  TimePoints 
1 GMCs of anti-PT IgG & anti-FHA IgG antibody concentrations as measured by ELISA.
2 Percentage of subjects with seroprotection against DT as defined by anti-DT IgG antibody concentrations ≥ 0.1 IU/mL measured by ELISA
3 Percentage of subjects with seroprotection against TT as defined by anti-TT IgG antibody concentrations ≥ 0.1 IU/mL measured by ELISA
4 GMCs of anti-DT IgG & anti-TT IgG antibody concentrations as measured by ELISA
5 GMTs of PT-neutralizing antibodies as assessed by PT neutralization assay in CHO cells
6 Percentage of subjects achieving a booster response against PT as assessed by PT neutralization assay in CHO cells
Safety endpoints
7 Percentage of subjects with solicited local & systemic ADRs reported within 7 days after vaccination
8 Percentage of subjects with unsolicited AEs & SAEs from study vaccine administration until Day 29  		 at pre vaccination & Day 29 after vaccination. 
 
Target Sample Size   Total Sample Size="534"
Sample Size from India="534" 
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 3 
Date of First Enrollment (India)   15/06/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Pertussis is a highly infectious disease and remains an important worldwide public health problem, even in countries with sustained high vaccination coverage. Despite established infant immunization programmes, pertussis continues to circulate.The need to maintain antibody levels against pertussis beyond childhood, through booster vaccines is therefore increasingly recognized. Vaccination against pertussis using available pediatric formulation was not recommended to immunize adolescent and adult population therefore reduced-antigen content combined diphtheria-tetanus-acellular pertussis (Tdap) vaccine has been specifically developed.

ADACEL® is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis (whooping cough) in persons 4 years of age and older.

Techinvention Lifecare Pvt. Ltd. plans to conduct a multicenter, Randomized, Observer-blind, Non-inferiority, Phase III Study to Evaluate the Immunogenicity and Safety of BoostagenRED TM (combined tetanus toxoid, reduced diphtheria toxoid, reduced recombinant pertussis vaccine) by BioNet-Asia compared to ADACEL® by Sanofi Pasteur Ltd. in Healthy Subjects Aged 4-65 years. The study vaccine will be given to 534 subjects (267 subjects per vaccine group) as a single dose of 0.5 mL by deep intramuscular injection in the deltoid region of the non-dominant upper arm.
 
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