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CTRI Number  CTRI/2017/03/008003 [Registered on: 03/03/2017] Trial Registered Prospectively
Last Modified On: 20/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine
Preventive 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to assess safety and tolerability of tetanus, diptheria, and pertussis vaccine in adults. 
Scientific Title of Study   A phase-I, open label clinical trial to assess the safety of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine manufactured by Serum Institute of India Pvt. Ltd. in healthy Indian adults 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SII-Tdap/IN-01 Version no. 2 dated 30th May 2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anil K 
Designation  Head, Human Pharmacology Unit 
Affiliation  Syngene International Limited, Bangalore, Karnataka 
Address  Human Pharmacology Unit, Syngene International Limited Clinical Development Tower-1, Semicon Park Electronics City Phase II Bangalore India.

Bangalore
KARNATAKA
560100
India 
Phone  080-28082771  
Fax  080-28082722  
Email  Anil.Dr@syngeneintl.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hitt Sharma 
Designation  Additional Medical Director 
Affiliation  Serum Institute Of India Pvt Ltd 
Address  Department of Clinical Trials and Pharmacovigilance, SEZ-1B, Building 9, 212/ 2, Hadapsar, Pune

Pune
MAHARASHTRA
411028
India 
Phone  020-26602451  
Fax    
Email  drhjs@seruminstitute.com  
 
Details of Contact Person
Public Query  
Name  Dr Hitt Sharma 
Designation  Additional Medical Director 
Affiliation  Serum Institute Of India Pvt Ltd 
Address  Department of Clinical Trials and Pharmacovigilance, SEZ-1B,Building 9, 212/ 2, Hadapsar, Pune

Pune
MAHARASHTRA
411028
India 
Phone  020-26602451  
Fax    
Email  drhjs@seruminstitute.com  
 
Source of Monetary or Material Support  
Serum Institute of India Pvt. Ltd. 212/2, Hadapsar, Pune-411028, Maharshtra, India 
 
Primary Sponsor  
Name  Serum Institute of India Pvt Ltd 
Address  212/2, Hadapsar, Pune, Maharashtra 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anil K  Syngene International Limited  Human Pharmacology Unit, Syngene International Limited, Clinical Development Tower–1, Semicon Park Electronics City Phase II Bangalore–560100, India
Bangalore
KARNATAKA 		 080-28082780

Anil.Dr@syngeneintl.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Venkateshwara Hospital ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z23||Encounter for immunization,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NOT APPLICABLE 
Intervention  Tetanus, Reduced Diptheria and Acellular Pertussis vaccine  A single 0.5 ml intramuscular dose in the deltoid region of the upper arm 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Healthy adult male or female aged between 18-45 years and normal
Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg
weight.
2. Healthy subjects as established by personal medical history, physical
examination, laboratory investigation during screening and as per the
clinical judgment of the Investigator.
3. Sexually active participants to be using an effective method of
contraception (i.e. intrauterine device or hormonal contraception or
condom, diaphragm, cervical cap).
4. Subject’s willingness and ability to comply with the requirements of
the protocol.
5. Subject willing to sign a written informed consent. 
 
ExclusionCriteria 
Details  1. History of previous vaccination against diphtheria, tetanus and pertussis with either the trial vaccine or another vaccine (except
Tetanus-prone wound management for adults) in the past 5 years.
2. History of Tetanus, diphtheria or pertussis infection.
3. Female participant who is pregnant or breast-feeding, or wanting to fall pregnant during study.
4. History of any major illness.
5. History of major congenital defects or illness.
6. Investigator, site personnel directly affiliated with this study and their immediate families.
7. Acute illness and/or fever at the time of vaccination or during the past 7 days.
8. Chronic administration high doses of
corticosteroids, cytotoxic agents or radiotherapy or immune-modifying drugs in last 3 months.
9. Receipt of any oral or injectable antibiotics and/or antiviral from 5 days before screening through to enrollment.
10. History of receipt a blood transfusion or other blood products in the past one year.
11. Use of any investigational or non-registered drug.
12. History of administration of any vaccine within past 30 days or during the study
13. History of any major illness.
14. Participant having any allergies to medication and food.
15. History of anaphylactic shock
16. History or presence of significant alcoholism or drug abuse in the past one year.
18. History or presence of significant smoking.
19. Reactive serology for HIV, hepatitis B and hepatitis C viruses
20. Abnormal ECG and chest X-ray
21. Participation in a drug research study within past 3 months or planned participation during the study.
22. Participant has any plans to relocate from the area prior to the completion of the study.
23. Any other condition which in the opinion of the investigator will
jeopardize the safety of the subject due to participation in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Occurrence of immediate adverse events after single dose.
2. Occurrence of solicited adverse reactions within 7-day post-vaccination
follow-up period.
3. Occurrence of solicited adverse events, including serious adverse
events within 30 days after vaccination. 		 1. Blood and Urine samples for safety assessment to be drawn at screening, day 7 and day 30. 
 
Secondary Outcome  
Outcome  TimePoints 
Occurrence of unsolicited adverse events, including serious adverse
events within 30 days after vaccination. 		 Blood and Urine samples for safety assessment to be drawn at screening, day 7 and day 30. 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="23" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   14/03/2017 
Date of Study Completion (India) 02/06/2017 
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   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
The study is designed as a single center trial to access safety and tolerability of SIIPLs Tdap vaccine in healthy adults. A single dose of Tdap vaccine will be administered in adult volunteers. Active follow up for vaccine reactogenicity (solicited reactions) over the 7-day period after vaccination will be conducted on all subjects. In addition, follow up for unsolicited AEs and SAEs will be carried out over the period between enrollment and 30 days after vaccination on all subjects by using a diary card. Independent oversight of this study will be provided by a DSMB. 
 
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