| CTRI Number |
CTRI/2018/06/014617 [Registered on: 26/06/2018] Trial Registered Prospectively |
| Last Modified On: |
12/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Safety and immunogenicity assessment of Tdap vaccine in healthy adults, adolescent and children. |
|
Scientific Title of Study
|
A Phase II/III, Multicenter, Randomized, Open Label, Active Controlled, Clinical Study to Assess the Immunogenicity and Safety of Tetanus Toxoid, Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccine Manufactured by Serum Institute of India Pvt. Ltd (SIIPL) in Comparison with Boostrix® Vaccine of GSK in Healthy Adults, Adolescents and Children in India. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| SII-Tdap/IN-02 Version: 3.0 Date: 24-Jun-2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hitt Sharma |
| Designation |
Additional Medical Director |
| Affiliation |
Serum Institute of India Pvt. Ltd. |
| Address |
Clinical Research and Pharmacovigilance
Serum Institute of India Pvt. Ltd. 212/ 2, Hadapsar, Pune
MAHARASHTRA
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
020-26602451 |
| Fax |
|
| Email |
drhjs@seruminstitute.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hitt Sharma |
| Designation |
Additional Medical Director |
| Affiliation |
Serum Institute of India Pvt. Ltd. |
| Address |
Clinical Research and Pharmacovigilance
Serum Institute of India Pvt. Ltd. 212/ 2, Hadapsar, Pune
MAHARASHTRA
411028
India
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 |
Clinical research and Pharmacovigilance,
Serum Institute of India Pvt. Ltd. 212/ 2, Hadapsar, Pune
MAHARASHTRA
411028
India
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, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Serum Institute of India Pvt Ltd |
| Address |
212/2, Hadapsar, Pune |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jitendra Oswal |
Bharti Vidyapeeth Deemed University Medical college & Hospital |
Department of pediatrics, Pune-Satara Road, Katraj Dhankawdi, Pune-411043
Pune
MAHARASHTRA |
020-24364308
researchpedpune@gmail.com |
| Dr Varughese PV |
Christian Medical College |
Dept of Peadiatrics, Christian Medical College, Brown Road, Ludhiana-141008, Punjab, India
Ludhiana
PUNJAB |
0161-2115644
drpvvarughese@yahoo.com |
| Dr A V Rao |
Gleneagles Global Hospitals |
Gleneagles Global Hospitals, 6-1-1070/1 to 4 Lakdikapul, Hyderabad -500004
Hyderabad
ANDHRA PRADESH |
040-30644444
venky_gmc@yahoo.co.in |
| Dr Apurba Ghosh |
Institute of Child Health |
Institute of Child Health, 11,Dr. Biresh Guha Street, Kolkata,700017
Kolkata
WEST BENGAL |
033-22905686
apurbaghosh@yahoo.com |
| Dr M D Ravi |
JSS Hospital |
Dept of Peadiatrics, Mahatma Gandhi Road, Mysore-570004
Mysore
KARNATAKA |
0821-2335555
ravimdped@gmail.com |
| Dr S Balasubramaniam |
Kanchi Kamakoti Childs Trust Hospital |
12A, Nageswara Road, Nungambakkam, Chennai-600034
Chennai
TAMIL NADU |
044-42001800
sbsped@gmail.com |
| Dr Anand Kawade |
KEM Hospital Research centre |
KEM Hospital Pune,
Ankit Shirdi Sai Baba Rural Hospital,A/P-Vadu Budruk, Taluka- Shirur, District Pune- 412216
Pune
MAHARASHTRA |
9850559983
askawade@yahoo.com |
| Dr N S Mahantshetti |
KLEs Dr Prabhakar Kore Hospital and Medical research Centre |
KLEs Dr Prabhakar Kore Hospital and MRC, Nehru Nagar, Belgavi-590010,Karnataka, India
Belgaum
KARNATAKA |
0831-2471350
niranjanasn@yahoo.com |
| Dr Somashekar A R |
M S Ramaiah Medical College and Hospital |
Department of Pediatrics,Romm No-104, M. S. Rmaiah Nagar,MSRIT Post , Bangalore -560054, Karnataka, India.
Bangalore
KARNATAKA |
080-23601923
s_arshekar2002@yahoo.com |
| Dr Saji James |
Sri Ramchandra Hospital |
Dept of Peadiatrics, No. 1 Ramchandranagar, Porur, Chennai-600116
Chennai
TAMIL NADU |
9841223038
dr.sajijames@gmail.com |
| Dr Renuka Munshi |
Topiwala National Medical College and BYL Nair Ch Hospital |
Dr. AL Nair Road, Mumbai Central, Mumbai – 400008
Mumbai
MAHARASHTRA |
022-23027204
renuka.munshi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee, M. S. Ramaiah Medical College and Hospital, Bangalore |
Approved |
| Institutional Ethics Committee, Bharati Vidyapeeth Deemed University, Pune |
Approved |
| Institutional Ethics Committee, Christian Medical College, Ludhiana |
Approved |
| Institutional Ethics Committee, Gleneagles Global Hospitals, Hyderabad |
Approved |
| Institutional Ethics Committee, JSS Medical College and Hospital, Mysore |
Approved |
| Institutional Ethics Committee, King Edward Memorial Hospital Research Centre Pune |
Approved |
| Institutional Ethics Committee, Sri Ramchandra Medical College and Research Institute, Chennai |
Approved |
| Institutional Ethics Committee, Topiwala National Medical College and BYL Nair Ch. Hospital, Mumbai |
Approved |
| Institutional Ethics Committee,, Institute of Child Health, Kolkata |
Approved |
| Institutional Eyhics Committee, KLE University, JN Medical college, Nehru Nagar, Belgavi |
Approved |
| Institutional Review Board, Ethics Committee of Kanchi Kamakoti Childs Trust Hospital and The Child Trust Medical Research Foundation, Chennai |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
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 |
BOOSTRIX® vaccine of GSK |
0.5 ml intramuscular, single dose |
| Intervention |
Tdap vaccine by SIIPL |
0.5 ml intramuscular, single dose |
|
|
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 years to 65 years on the day of enrollment
2 Healthy subjects as established by medical history, physical examination during screening and as per the clinical judgment of the Investigator
3 Sexually active participants to be using an effective method of contraception 30 days prior to the enrollment and throughout the study period
4 Subjects/ parent willing to provide assent or written informed consent
5 Subjects/ parent willingness and ability to comply with the requirements of the protocol
|
|
| 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 and/or for tetanus vaccination in pregnant women) in the past 5 yrs.
2.History of Tetanus, diphtheria or pertussis infection
3.History of administration of any vaccine within 30 days prior to administration of study vaccine or planned during the course of study participation.
4.History of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines.
5.History of anaphylactic shock.
6.History of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological functional abnormality, mental or physical disability or blood dyscrasias.
7.History of encephalopathy of unknown aetiology occurring within 7 days following a previous vaccination with a vaccine containing a pertussis component.
8.History of neurological complications following an earlier vaccination against diphtheria and/or tetanus.
9.Acute illness and/or fever at the time of vaccination or during the 7 days prior to the vaccination.
10.Receipt of any oral or injectable antibiotics 5 days before enrollment.
11.History of any cancer, HIV infection, organ transplant or any other immune system disorder.
12.Chronic administration of immunosuppressant or other immune modifying drugs during the period starting six months prior to the study vaccine dose.
13.History of receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior to study vaccination.
14.Females who are pregnant, breastfeeding or planning to become pregnant.
15.
15.Participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Percentage of subjects achieving the booster responses to diptheria toxoid 30 days after vaccination with Tdap and Boostrix
2)Percentage of subjects achieving the booster responses to tetanus toxoid 30 days after vaccination with Tdap and Boostrix
3)Percentage of subjects achieving booster response for PT, FHA and PRN 30 days after vaccination with Tdap and Boostrix
4)Anti-PT, anti-FHA and antiPRN antibody GMCs 30 days after vaccination with Tdap and Boostrix
|
One month after the vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Percentage of subjects with seroprotection against Diphteria and Tetanus 30 days after vaccination
2)Percentage of seropositive subjects against Pertussis antigens 30 days after vaccination
3)Antibody geometric mean concentrations for anti-diphtheria, anti-tetanus 30 days after vaccination in both the groups
4)Frequency of adverse event that occurred during the 30 days follow-up period after vaccination. |
One month after the vaccination |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
Final Enrollment numbers achieved (Total)= "1439"
Final Enrollment numbers achieved (India)="1439" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/07/2018 |
| Date of Study Completion (India) |
20/06/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a
multicenter, randomized, active controlled, open label Phase II/ III clinical
study to assess the immunogenicity and safety of Tdap vaccine manufactured by
SIIPL in comparison with Boostrix® vaccine of GSK. Healthy adults, adolescents
and children will be enrolled in the study. Eligible participants will be
randomized in a 1:1 ratio. A single 0.5 mL dose of the vaccine (Tdap
vaccine by SIIPL or Boostrix®) will be administered by intramuscular injection.
The objective of the trial is to demonstrate immunogenic non-inferiority of
Tdap vaccine compared to Boostrix® and to assess the reactogenicity and
safety of single dose of Tdap vaccine in comparison with Boostrix®. |