| CTRI Number |
CTRI/2019/01/017155 [Registered on: 18/01/2019] Trial Registered Prospectively |
| Last Modified On: |
30/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
|
A Phase 3 clinical study of 6-in-1 vaccine (SHAN6™) to check immunity equivalence of 3 different batches and immunity non-inferiority to 5-in-1 vaccine (SHAN 5®) PLUS SHANIPV™, when given as 3 doses schedule at 6-8, 10-12 and 14-16 weeks of age along with Oral Rotavirus Vaccine |
Scientific Title of Study
Modification(s)
|
Immune Lot-to-Lot Consistency and Non-Inferiority of SHAN6™ Vaccine in Comparison to SHAN 5® + SHANIPV™ When Administered as Three Doses at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Infants, Concomitantly with Oral Rotavirus Vaccine |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Registry |
| SH600003 Version 2.0 dated 26 March 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Somnath Mangarule |
| Address |
Clinical Research Department
3rd and 4th Floor,
Vasantha Chambers,5-10-173, Fateh Maidan Road,Basheer Bagh, Hyderabad
Hyderabad
TELANGANA
500004
India |
| Phone |
04066301502 |
| Fax |
04023234133 |
| Email |
Somnath.Mangarule@sanofi.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Dr Somnath Mangarule |
| Address |
Clinical Research Department
3rd and 4th Floor,
Vasantha Chambers,5-10-173, Fateh Maidan Road,Basheer Bagh, Hyderabad
Hyderabad
TELANGANA
500004
India |
| Phone |
04066301502 |
| Fax |
04023234133 |
| Email |
Somnath.Mangarule@sanofi.com |
|
|
Source of Monetary or Material Support
|
| Shantha Biotechnics Pvt Limited |
|
|
Primary Sponsor
|
| Name |
Shantha Biotechnics Pvt Limited |
| Address |
3rd and 4th Floor,
Vasantha Chambers, 5-10-173, Fateh Maidan Road
Basheer Bagh, Hyderabad 500004. Telangana, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonali Hemant Palkar |
Bharati Vidyapeeth Deemed University Medical College and Hospital |
Department of Pediatrics
Bharati Vidyapeeth Deemed University Medical College and Hospital
Pune-411043,India
Pune
|
02024364308
palkarsh@gmail.com |
| Dr Rajeev Zachariah Kompithra |
Christian Medical College |
Department of Child Health Unit-I, Christian Medical College,
Vellore, Tamilnadu-632004
Vellore
|
09843321529
0416-2232130
rajeev.k_zachariah@yahoo.in |
| Dr E Venkata Rao |
IMS and SUM Hospital |
Department of Community Medicine
I.M.S & SUM Hospital
Kalinga Nagar, Shampur, Bhubaneswar, Odisha-751003
Khordha
|
7853889552
06742386910
evenkatarao@soa.ac.in |
| Dr Ashwani Kumar Sood |
Indira Gandhi Medical College |
Department of Pediatrics and Adolescent Medicine,
I G Medical College, Shimla-171001,
Himachal Pradesh.
Shimla
|
94183008880
01772651616
doc.aksood@gmail.com |
| Dr Monjori Mitra |
Institute of Child Health |
Department of Pediatric Medicine
Institute of Child Health, Kolkata
Kolkata
|
033-22905686
monjorimr@gmail.com |
| Dr M D Ravi |
JSS Hospital |
Department of Pediatrics
JSS Hospital
Mysore-570 004, India
Mysore
|
08212548363
ravimdped@yahoo.co.in |
| Dr S M Dhaded |
K.L.E.S.Dr. Prabhakar Kore Hospital and JN Medical College |
Department of Pediatrics,
K.L.E.S.Dr. Prabhakar Kore
Hospital and JN Medical College Nehru Nagar,
Belagavi, Karnataka 590010
Belgaum
|
8762762586
drdhadedsm@gmail.com |
| Dr Ranjitha Shetty |
Kasturba Medical College |
Department of Community Medicine,
Kasturba Medical College,
Manipal Academy of Higher Education,
Manipal, Udupi, Karnataka - 576104
Udupi
|
9110401395
08202922275
ranjitha.shetty@manipal.edu |
| Dr Anand kawade |
King Edward Memorial Hospital Research Centre |
Department of Paediatrics
King Edward Memorial Hospital Research Centre
Vadu Rural Health Program
Village-vadu (Budruk), Tal-Shirur, Pune-412216
Pune
|
02026065603
askawade@yahoo.com |
| Dr Raghvendra Singh |
Maulana Azad Medical College |
Department of Pediatrics
Maulana Azad Medical College
New Delhi
|
01123234845
drraghvendrasingh@gmail.com |
| Dr Prashanth S |
Mysore Medical College and Research Institute and Cheluvamba Hospital |
Department of Pediatrics
Mysore Medical College
& Research Institute and Cheluvamba Hospital
Irwin Road, Mysore
Karnataka – 570 021
Mysore
|
9606352062
08212520803
drprashanths10@gmail.com |
| Dr Virendra Nath Tripathi |
Prakhar Hospital Pvt Ltd |
Department of PEdiatrics
Prakhar Hospital Pvt Ltd,
Arya Nagar, Kanpur,UP
208002
Kanpur Nagar
|
9415050777
Pi.clintrial@gmail.com |
| Dr Madhu Gupta |
School of Public Health, Post Graduate Institute of Medical Education & Research (PGIMER) |
Department of Community Medicine
School of Public Health,
Post Graduate Institute of Medical Education
& Research (PGIMER)
Chandigarh - 160 012
Chandigarh
|
7087008223
01722744401
madhugupta21@gmail.com |
| Dr Nithya Gogtay |
Seth GS Medical College and KEM Hospital |
Department of Clinical Pharmacology Seth GS Medical College and KEM Hospital Mumbai
Mumbai
|
9820495836
02224112871
njgogtay@hotmail.com |
| Dr Padmavathi IV |
Victoria Government Hospital |
Department of Paediatrics,
Victoria Government Hospital
Chengala Rao Peta, Purna market,
Visakhapatnam-530001
Andhra Pradesh
Visakhapatnam
|
9666140568
padmavathi.vgh@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Ethics committee ,KEM hospital Research centre,Pune |
Approved |
| Ethics Committee of the Prakhar Hospital |
Approved |
| Ethics committee sliver, Christian Medical College, Vellore |
Approved |
| Ethics Committee, Indira Gandhi Medical College, Shimla – 171001, |
Not Applicable |
| IEC IMS and SUM hospital, IMS and SUM hospital |
Approved |
| Institutional Ethic Committee, King George Hospital, Visakhapatnam |
Approved |
| Institutional Ethics Committee KLE Academy of Higher Education and Research, Belgavi |
Approved |
| Institutional Ethics Committee, Institute of Child Health Kolkata-700017 |
Approved |
| Institutional Ethics Committee, JSS Medical college & Hospital, Mysore |
Approved |
| Institutional Ethics Committee, Maulana Azad Medical College,New Delhi |
Approved |
| Institutional Ethics Committee, Mysore Medical College & Research Institute and Associated Hospitals, Department of Pathology, K.R. Hospital, Irwin Road, Mysuru-570021. |
Approved |
| Institutional Ethics Committee, Bharati Vidyapeeth (Deemed to be University) Medical College ,Pune |
Approved |
| Institutional Ethics Committee, Post Graduate Institute of Medical Education, Chandigarh – 160012, India |
Approved |
| Institutional Ethics Committee-I, Seth GS Medical College and KEM hospital,Mumbai |
Approved |
| MAHE Ethics Committee, Mezzanine Floor KMC old Library building, Madhava Nagar Manipal 576104 |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Vaccination for the prevention of Tetanus, Diphtheria, Pertussis (whooping cough), Poliomyelitis, Hepatitis B (Hep B) and invasive Haemophilus influenzae type b (Hib) diseases. |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
SHAN 5® (DTwP-HepB-Hib) |
0.5 mL administered intramuscularly, 3 doses at an interval of 4 weeks in between |
| Intervention |
SHAN6™ (DTwP-HepB-Hib-IPV) |
0.5 mL administered intramuscularly, 3 doses at an interval of 4 weeks in between |
| Comparator Agent |
SHANIPV™ |
0.5 mL administered intramuscularly, 3 doses at an interval of 4 weeks in between |
|
|
Inclusion Criteria
|
| Age From |
42.00 Day(s) |
| Age To |
56.00 Day(s) |
| Gender |
Both |
| Details |
1. Infants between 6-8 weeks of age (42 to 56 days, both days inclusive)
2. Infants, born at full term of pregnancy (≥ 37 weeks) with a birth
Weight ≥ 2.5 kg.
3. Infants who have received the birth dose of Oral Polio Vaccine
(OPV), Hep B vaccine and Bacillus Calmette-Guérin vaccine
(BCG) vaccine.
4. Informed consent form (ICF) signed by one or both parents or by
the LAR as per local requirements.
5. Subjects and parents/LAR are able to attend all scheduled visits
|
|
| ExclusionCriteria |
| Details |
1. Participation in another clinical trial in the 4 weeks preceding the trial inclusion.
2. Known systemic hypersensitivity to any of the vaccine components
3. Chronic illness at a stage that could interfere with trial conduct or completion,
4. Blood or blood-derived products received in the 30 days
5. Documented history of diphtheria, pertussis, tetanus, Haemophilus influenzae type b invasive disease, hepatitis B, poliomyelitis or rotavirus infection.
6. Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C seropositivity.
7. Known thrombocytopenia
8. Bleeding disorder or receipt of anticoagulants
9. Moderate or severe acute illness/infection on the day of vaccination
10. Identified as a natural or adopted child of the Investigator, relatives or employee.
11. History of seizures or encephalopathy.
12. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy,
13. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
14. Planned receipt of any other vaccine within the period from 7 days before to 7 days after each trial vaccination.
15. Previous vaccination or planned receipt of any vaccine against diphtheria, tetanus, pertussis, hepatitis B (except the birth dose of Hep B vaccine) disease, Haemophilus influenzae type b infection poliomyelitis (except the OPV) or rotavirus, apart from trial vaccines
16. History of intussusception.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Immunogenicity (Seroprotection rates/ GMCs) |
Baseline and 28 days post-Dose 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Immunogenicity (Descriptive) |
Baseline and 28 days post-Dose 3 |
| Safety |
Immediate systemic adverse events with in 30 min, Solicited reactions with in 7 days and unsolicited events within 28 days of each vaccination, SAEs and AESI through out the subject participation |
|
|
Target Sample Size
|
Total Sample Size="1280"
Sample Size from India="1280" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
21/01/2019 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
Brief Summary
Modification(s)
|
Background: Shantha have developed Shan6, a hexavalent
vaccine, considering advantages of combination vaccine versus 2 separate
vaccines. Vaccine was found safe and immunogenic in Phase I/II clinical
studies.
Purpose: Current study is designed to demonstrate
immune lot consistency of 3 different lots of Shan6 and to demonstrate non-inferiority
verses Shan5 + ShanIPV. Study will also evaluate safety in larger infants. Summary: This will be Multi-center, randomized, active-controlled, open-label, four-arm, Phase III study of SHAN6™ vaccine in 1280 infants followed up for immunogenicity and safety for 28 days after receipt of three-doses of primary immunization at 6-8, 10-12 and 14-16 weeks of age, using SHAN 5® + SHANIPV™ as control vaccine, when co-administered with oral Rotavirus vaccine |
