CTRI/2025/05/086953 [Registered on: 14/05/2025] Trial Registered Prospectively
Last Modified On:
21/04/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine Biological Preventive
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical study to assess the immunogenicity & safety of Biological Es Polio vaccine in 6-8months old healthy infants.
Scientific Title of Study
A single blind, randomized, active-controlled, phase-III study to evaluate immunogenicity and safety of Biological E’s inactivated poliomyelitis vaccine, administered to 6-8 weeks old healthy infants in 6-10-14 weeks dosing schedule.
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Subhash Thuluva
Designation
Sr. Vice President- Clinical Development
Affiliation
Biological E.Limited
Address
Clinical Development Dept, 2nd floor, Room No:04,Road No.35,Jubilee Hills
Hyderabad TELANGANA 500033 India
Phone
04071216248
Fax
Email
subhash.thuluva@biologicale.com
Details of Contact Person Scientific Query
Name
Dr Subhash Thuluva
Designation
Sr. Vice President- Clinical Development
Affiliation
Biological E.Limited
Address
Clinical Development Dept, 2nd floor, Room No:04,Road No.35,Jubilee Hills
Hyderabad TELANGANA 500033 India
Phone
04071216248
Fax
Email
subhash.thuluva@biologicale.com
Details of Contact Person Public Query
Name
Mr Subba Reddy GV
Designation
Associate Vice President- Clinical Development
Affiliation
Biological E.Limited
Address
Clinical Development Dept, 2nd floor, Room No:03,Road No.35,Jubilee Hills
Hyderabad TELANGANA 500033 India
Phone
04071216240
Fax
Email
subbareddy.gunneri@biologicale.com
Source of Monetary or Material Support
Biological E.Limited, 18/1&3, Azamabad, Hyderabad - 500020, Telangana, India
Primary Sponsor
Name
Biological ELimited
Address
Plot No. 1, Biotech Park, Phase II, Kolthur Village, Shameerpet, Medchal-Malkajgiri District, Telangana, India -500 078
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
None
None
Countries of Recruitment
India
Sites of Study
No of Sites = 42
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Ravi B Nagarajaiah
Adichunchanagiri Hospital
Department of General Medicine,Clinical Trial Centre , OPD Block, Ground floor, B G Nagara, Nagamangala Taluk-571448 Mandya KARNATAKA
9448323893
ravibn972@yahoo.com
Dr Nagarjuna Chadalavada
Aditya Multispecialty Hospital
Department of Paediatrics, 13-3-52, 3rd Line, 1st floor,Gunturuvari Thota, Kothapet, Beside Peoples Trauma -522001 Guntur ANDHRA PRADESH
8500454689
researchaditya26@gmail.com
Dr Bhagirathi Dwibedi
All India Institute of Medical Sciences
Department of Paediatrics, All India Institute of Medical Sciences, OPD block, Ground floor, Sijua, Patrapada, Bhubaneswar-751019 Baleshwar ORISSA
09337908486
dr.dwibedi@gmail.com
Dr Atul Jindal
All India Institute Of Medical Sciences (AIIMS)
Department of Paediatrics,
Paediatric OPD, Consultant room, First floor, B block, Gate No-1, Great Eastern Road, opposite Gurudwara, AIIMS Campus, Tatibandh-492099 Raipur CHHATTISGARH
8224014667
dratuljindal@gmail.com
Dr Hira Lal Bhalla
All India Institute of Medical Sciences (AIIMS)
Department of Pharmacology & Therapeutics,
OPD block, 3rd floor, Kunraghat-273008 Gorakhpur UTTAR PRADESH
9761715236
hirabhalla@gmail.com
Dr Shailesh Patil
Belagavi Institute of Medical Sciences
Department of Paediatrics, 3rd floor, OPD block,BIMS Building, Dr. B. R. Ambedkar Road, Sadashiv Nagar-590001 Belgaum KARNATAKA
09480454944
bimsclinicalresearch@gmail.com
Dr RameshM
BGS Global Institute of Medical Sciences
Department of Paediatrics, No. 67, OPD block, 2nd floor, BGS Health and Education city, Uttarahalli Road, Kengeri -560060 Bangalore KARNATAKA
9741333320
drrameshm.research@gmail.com
Dr Sonali Hemant Palkar
Bharati Vidyapeeth (Deemed to be University) Medical College Hospital and Research Centre
Department of Paediatrics, Ground floor, OPD block, Pune-Satara Road, Dhankawadi-411043 Pune MAHARASHTRA
9881008717
sonali.palkar@bharatividyapeeth.edu
Dr PradeepN
Cheluvamba Hospital
Department of Paediatrics, Pediatric block, Ground floor,Sitharanga OPD, Unit B, Mysore Medical College & Research Institute, Irwin Road-570001 Mysore KARNATAKA
9611898080
drpradeepn80@yahoo.com
Dr Jaishree Vasudevan
Chettinad Hospital & Research Institute
Department of Paediatrics, Chettinad Academy of Research and Education,Chettinad Health City, Paediatric OPD,1st floor, SH 49A, Kelambakkam Dist.-603103 Chennai TAMIL NADU
9444362134
drjaishree.research@gmail.com
Dr Kishori Sharan Agarwal
Chirayu Hospital
Department of Paediatrics,
Ground Floor of OPD, Kalwar Road, Hathoj-302012 Jaipur RAJASTHAN
9116943306
Cr.chirayuhospital@gmail.com
Dr Deepshikha Kamra
Christian Medical College & Hospital
Department of Community Medicine, OPD Block, First floor, Brown Road, CMC Campus, -141008 Ludhiana PUNJAB
9463034958
deepshikhakamra@gmail.com
Dr Pankaj Kumar Gupta
ESIC Medical College & Hospital
Department of Pharmacology,
Clinical Trial Unit (MRU) Multidisplaniary Research Unit, Room No:341,OPD 3rd floor of Academic Building, NH-3, NIT-121001 Faridabad HARYANA
9654214386
drpankajgupta2000@yahoo.com
Dr Kompally Vasudev
Gandhi Hospital
Department of Paediatrics,
OPD block,1st Floor, Musheerabad, Secunderabad-500003, Hyderabad TELANGANA
7702694362
drvasudevkompally@gmail.com
Dr Nehal Suryakant Patel
GMERS Medical College and Civil Hospital
Department of Paediatrics, Block A, 1st floor, Near Gujarat High Court, S.G. Highway, Sola-380061, Ahmadabad GUJARAT
7567897517
nehal_pedia@yahoo.com
Dr B Vijai Anand Babu
Government General Hospital
Department of Paediatrics,
1st floor, Budhawara Peta, Alluri Sitarama Raju Nagar -518002, Kurnool ANDHRA PRADESH
900718884
vijaianandbangi@gmail.com
Dr Pareshkumar AThakkar
Govt Medical College Baroda and SSG General Hospital
Department of Paediatrics,
1st floor, Jail Road, Indira Avenue-390001 Vadodara GUJARAT
9426032150
drpareshresearchandtrials@gmail.com
Dr Monjori Mitra
Institute of Child Health
Department of Paediatrics, 11, OPD block, Ground floor, Room no 10, Dr Biresh Guha Street-700017 Kolkata WEST BENGAL
9831075730
monjorimr@gmail.com
Dr Mruthunjay Dash
Institute of Medical Science & SUM Hospital
Department of Paediatrics, Paediatric OPD, 3rd floor, Room no -2,K-8, Kalinga Nagar, Ghatikia,Bhubaneswar-751003 Baleshwar ORISSA
9437163601
m.dash74@gmail.com
Dr Jai Prakash Narayan
JLN Medical College
Department of Paediatrics,
OPD Block of Ground Floor, Kala Bagh-305001 Ajmer RAJASTHAN
9314294402
narayan_jaiprakash@yahoo.co.in
Dr Mandyam DhatiRavi
JSS Hospital
Department of Paediatrics,
1st Floor Paediatric OPD, Mahatma Gandhi Road, Fort Mohalla-570004 Mysore KARNATAKA
9880629506
ravimdped@gmail.com
Dr Janani Sankar
Kanchi Kamakoti Childs Trust Hospital
Department of Paediatrics, Room No-1, First floor, 12-A Nageswara Road, Nungambakkam, -600034 Chennai TAMIL NADU
9841078101
md@kkcth.org
Dr Anand Shantaram Kawade
KEM Hospital Research Centre
Department of Paediatrics,
Ground floor, Vadu Rural Health Program at Post Vadu (Budruk), Taluka Shirur, District -412216 Pune MAHARASHTRA
9850559983
anand.kawade@kemhrcvadu.org
Dr B S Chakravarthy
King George Hospital
Department of Paediatrics,
1st floor, Room no 9, Collectorate Junction, Maharanipeta– 530002 Visakhapatnam ANDHRA PRADESH
9848253535
chakravarthy.kghamc@gmail.com
Dr N S Mahantshetti
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre
Department of Paediatrics, 2nd floor, Sharawathi ward, opposite psychiatric ward, Nehru Nagar - 590010 Belgaum KARNATAKA
9448157237
niranjanakle@gmail.com
Dr Anju JK Mehrotra
Latha Mangeshkar Hospital
Department of Paediatrics,
OPD on Ground Floor, 5YMCA Complex Maharajbagh Road, Sitabuldi - 440012 Nagpur MAHARASHTRA
9325160804
mehrotraanju@gmail.com
Dr Mohit Poddar
Maharaja Agrasen Superspeciality Hospital
Department of Paediatrics,
Sec 7, Paediatric OPD, Second floor, Central Spin, Vidyadhar Nagar-302039 Jaipur RAJASTHAN
9829666655
drmohitpoddar@gmail.com
Dr Jog Pramod Prabhakar
Medipoint Hospitals Pvt. Ltd
Department of Paediatrics,
1st Floor of OPD, 241/1, New D.P.Road, Aundh-411007, Pune MAHARASHTRA
9422309677
drpramod.medipoint@gmail.com
Dr N Ravi Kumar
Niloufer Hospital for Women and Children
Department of Paediatrics,
Redhills, Paediatrics OPD 1st floor, Room No:1 Lakdikapool-500004 Hyderabad TELANGANA
9490919293
ravik1961@yahoo.com
Dr Girish Nanoti
NKP Salve Institute of Medical sciences & Research Centre & Lata Mangeshkar Hospital
Department of Paediatrics, 1st floor of OPD Building, Digdoh Hills, Hingna Road- 440019 Nagpur MAHARASHTRA
9422492050
girish.nanoti.gn@gmail.com
Dr Paruchuri Anil Kumar
Old Government General Hospital (Associated By Govt. Siddhartha Medical College)
Department of Paediatrics,
Two Town, 1st floor, Hanumanpet,Vijayawada - 520002 Krishna ANDHRA PRADESH
9848527270
paruchuriak70@gmail.com
Dr Ramanath Andy Karayalar
Panimalar Medical College Hospital & Research Institute
Department of Paediatrics,
OPD Room No: 240, 1st floor, Varadharajapuram, Poonamallee- 600123 Chennai TAMIL NADU
9884750160
chandra.ramanath82@gmail.com
Dr Savita Verma
PT. B D Sharma Post Graduate Institute of Medical Sciences
Department of Pharmacology, 2nd floor, University of Health Sciences, Room No:428 -124001 Rohtak HARYANA
9812283746
savita_verma@hotmail.com
Dr Dhongade Ramchandra Keshav
Sant Dnyaneshwar Medical Education & Research Centre
Department of Paediatrics, Ground floor, 695-A, Sadashiv Peth, Opp. Vijay Talkies, Laxmi Road-411030 Pune MAHARASHTRA
9822037483
ramdhongade@hotmail.com
Dr Pravakar Mishra
Sardar Vallabhbhai Patel Post Graduate Institute of Paediatrics and SCB Medical College and Hospital
Department of Paediatrics,
SCRC Building, Ground floor, Room no-9, Oriya Bazar-753002 Cuttack ORISSA
9437028882
drpravakar@yahoo.co.in
Dr Neeraj Kumar
Sarojini Naidu Medical College & Hospital
Department of Paediatrics,
Ground floor, Moti Katra, Mantola -282003 Agra UTTAR PRADESH
9756966669
neerajyadu18@gmail.com
Dr Madhukar Pandey
Shubham Sudbhawana Superspeciality Hospital
Department of Paediatrics, OPD 4th floor, B31/80-23B, Bhogabeer, Lanka-221005 Varanasi UTTAR PRADESH
9839439464
pandeymadhukar@gmail.com
Dr Patil Shyamkant Suresh
Signus Hospital
Department of Paediatrics, 5th Floor of OPD, Atlanta Shoppers, Pathardi Phata, Pathardi Road, -422010 Nashik MAHARASHTRA
8652606169
shyamkantspatil@gmail.com
Dr Javadekar Bakul Balchandra
Smt. B. K. Shah Medical Institute & Research Centre
Department of Paediatrics, OPD No:10, Ground Floor, Sumandeep Vidhyapeeth At & Po Piparia, Ta. Waghodia -391760 Vadodara GUJARAT
9925014448
dean.medical@sumandeepvidyapeethdu.edu.in
Dr Sarala Premkumar
Sri Ramachandra Hospital
Department of Paediatrics,
Dental College Basement No. 1, G-Block,Ramachandra Nagar, Porur-600116 Chennai TAMIL NADU
9840294333
premsarala@yahoo.com
Dr G Balakishor
St.Theresas Hospital
Department of Paediatrics,
1st Floor,Room no 5,Erragadda Main Road, Czech Colony Sanath Nagar-500018 Hyderabad TELANGANA
9949046236
drbalakishor@gmail.com
Dr Manish Narang
UCMS & GTB Hospital
Department of Paediatrics, MCH Block, Ground floor,Room no 605, Dilshad Garden -110095 New Delhi DELHI
PMCHRI-IHEC, Panimalar Medical College Hospital & Research Institute
Approved
Shubham Sudbhawana Super Hospital, Ethics Committee
Approved
Signus Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
vaccination against Polio diseases.
Patients
(1) ICD-10 Condition: Z23||Encounter for immunization,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Bio E’s Inactivated Poliomyelitis Vaccine, Adsorbed
Each 0.5 mL will be administered intramuscularly in the anterolateral aspect of mid or upper thigh (vastus lateralis muscle) in three dose schedule at 6, 10, 14 weeks of age.
Comparator Agent
Marketed Polio Vaccine
Each 0.5 mL will be administered intramuscularly in the anterolateral aspect of mid or upper thigh (vastus lateralis muscle) in three dose schedule at 6, 10, 14 weeks of age.
Inclusion Criteria
Age From
42.00 Day(s)
Age To
56.00 Day(s)
Gender
Both
Details
1. Subjects’ parent(s) or LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, with access to a consistent means of telephone contact, either residential land line or mobile).
2. Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the parent(s) or LAR(s) of the subject prior to performing any study specific procedure.
3. A male or female healthy infant of either gender between 6-8 weeks 42-56 days, both inclusive of age at the time of first vaccination.
4. Healthy infants with body weight 3300 gms at the time of first vaccination.
5. Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature) as judged by the principal investigator.
6. Subjects not participating in any other clinical trials.
7. Infants with a minimal vaccination status for their age at the time of enrolment (Receipt of single birth dose of BCG, OPV and HBV vaccines (within 14 days of birth)).
8. Infants without contraindications or precautionary circumstances for participating in the trial.
ExclusionCriteria
Details
1.Child in care
2. Prior immunization or intent to receive oralinjectable polio vaccine OPV or IPV within the study period with an exception of birth dose of oral polio vaccine.
3. Current illness (especially fever) or any acute or congenital illness or disability.
4. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the administration of study vaccine (Day -29 to Day 0), or planned use during the study period.
5. Subjects receiving immunosuppressive therapy
6. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
7. Known or suspected allergy to any of the vaccine components. History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity likely to be exacerbated by any component of the study vaccines.
8. Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS)
9. Known family history of SIDS (Sudden Infant Death Syndrome).
10. Planned or elective surgery during the course of the study.
11. Infants who have received any blood products, any dose of corticosteroids, cytotoxic agents or radiotherapy.
12. Subjects and or their mothers who have participated in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course.
13. Inability or unwillingness of the parent to abide by the requirements of the protocol.
14. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
15. Family history of congenital or hereditary immunodeficiency.
16. Administration of immunoglobulins and or any blood products during the period starting 30 days before the administration of study vaccine or planned administration during the study period.
17. Administration of long-acting immune-modifying drugs during the period starting 30 days prior to the proposed first vaccine dose or at any time during the study period.
18. Acute disease and or fever at the time of vaccination.
19. Infant is a direct descendant (child or grand-child) of any person employed by the Sponsor, the Contract Research Organization (CRO) or the Study Site (including the PI and study site personnel).
20. Any criteria, which in the judgement of the Investigator, suggests that the subject would not be compliant with the study protocol.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
To evaluate the proportion of subjects seroprotected with serotype specific anti-Polio antibodies among those vaccinated with either BE’s IPV or licensed comparator vaccine
At Day 84 (28 days’ post third dose).
Secondary Outcome
Outcome
TimePoints
Proportion of subjects with solicited local adverse reactions and systemic events
during first 30 minutes of vaccine administration after each dose
Proportion of subjects with solicited local and systemic adverse events
during 7-day post vaccination period
Proportion of subjects with unsolicited adverse events (AEs) during the subsequent follow up period
28 days after each dose.
Proportion of subjects seroconverted with anti-Polio antibodies
at Day 84 (28 days’ post third dose).
Rate of serious adverse events (SAEs) and medically attended AEs
for the total study period.
GMTs for serotype specific anti-Polio neutralizing antibody titres estimated
both at baseline and again at Day 84
Proportion of subjects achieving 2-fold and 4-fold rise in serotype specific anti-Polio neutralizing antibody titres
at Day 84 from baseline.
GMFR for serotype specific anti-Polio neutralizing antibody titres
at Day 84 from baseline.
Number and proportion of subjects seroprotected with anti-Polio neutralizing antibodies
at Day 84 from baseline in three lots of BE’s IPV.
Number and proportion of subjects seroconverted with anti-Polio neutralizing antibodies
at Day 84 from baseline in three lots of BE’s IPV.
Proportion of subjects with SAEs
during the 6 months follow up period after the third dose of the vaccination
Number and proportion of subjects seroconverted, in terms of serum IgG concentrations induced by 14 serotypes
at Day 84 from baseline.
Number and proportion of subjects seroconverted or seroprotected (IgG concentrations) against Pentavalent DTwP-rHepB-Hib vaccine
at Day 84 from baseline.
Target Sample Size
Total Sample Size="3875" Sample Size from India="3875" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a prospective, single blind, randomized, active-controlled, phase-III study to evaluate immunogenicity and safety of Biological E’sinactivated poliomyelitis vaccine, administered to 6-8 weeks old healthy infants in 6-10-14 weeks dosing schedule.
The target population for this study would be 6-8 weeks old healthy infants of either gender, at the time of first dose administration. The total sample size to be enrolled would be 3875 healthy eligible subjects wherein N=3175 to be enrolled under BE’s IPV and N=700 under licensed comparator.
The study will be conducted in compliance with New Drugs and Clinical Trials Rules, ICH and Indian good clinical practice guidelines in force at the time of study conduct.