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CTRI Number  CTRI/2019/04/018474 [Registered on: 08/04/2019] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine
Biological
Preventive 
Study Design  Single Arm Study 
Public Title of Study   A phase-I clinical study to assess the safety of Biological Es Inactived Polio vaccine in 18-45 year old healthy male adults.  
Scientific Title of Study   An open label single centre phase-I study to evaluate safety, reactogenicity and immunogenicity of a single intramuscular dose of an inactivated poliomyelitis vaccine (adsorbed) of Biological E Limited in 18-45 year old healthy adults. 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
BECT054/IPV-S19-Phase-I/CTP-01 Version :1.0 Dated:13.08.18  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrTSA Kishore 
Designation  Associate Vice President - Clinical Development 
Affiliation  Biological E.Limited 
Address  Clinical affairs & Pharmacovigilance Dept, 2nd floor, Road No.35,Jubilee Hills,

Hyderabad
TELANGANA
500033
India 
Phone  04071216247  
Fax  04027675309  
Email  kishore.turaga@biologicale.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subhash Thuluva 
Designation  Vice President- Clinical Development 
Affiliation  Biological E.Limited 
Address  Clinical affairs & Pharmacovigilance Dept, 2nd floor, Road No.35,Jubilee Hills,

Hyderabad
TELANGANA
500033
India 
Phone  04071216000  
Fax  04027675309  
Email  subhash.thuluva@biologicale.com  
 
Details of Contact Person
Public Query  
Name  Dr Subhash Thuluva 
Designation  Vice President- Clinical Development 
Affiliation  Biological E.Limited 
Address  Clinical affairs & Pharmacovigilance Dept, 2nd floor, Road No.35,Jubilee Hills,

Hyderabad
TELANGANA
500033
India 
Phone  04071216000  
Fax  04027675309  
Email  subhash.thuluva@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  18/1&3, Azamabad, Hyderabad-500020, Telangana, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr A Venkateshwar Rao  St. Theresa’s Hospital  Department of General Medicine,Room no:05, ground floor, Sanathnagar, Hyderabad, 500018-India
Hyderabad
TELANGANA 		 09440040662

venky_gmc@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, St. Theresa’s Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Preventive protection against Polio  
Patients  (1) ICD-10 Condition: Z23||Encounter for immunization,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Biological Es Inactivated poliomyelitis Vaccine (Adsorbed)  1. Dose: 0.5 mL single dose 2. Frequency: one dose only 3. Route of administration: intramuscular injection in deltoid muscle of the non-dominant arm. 4. Total duration of therapy: 35 days (28 days for post vaccination safety follow up and additional 7 days for subject visit compliance time window).  
Comparator Agent  None  None 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1. Healthy adult male volunteers ≥18 to ≤45 years of age at the time of vaccination;
2. Must have received primary polio vaccination series according to the Indian National Immunization Programme based on vaccination card or verbal information given by subjects during interview with investigator.
3. Subject’s ability to understand information relevant to participation in the study and abide with the requirements of the subject diary and other study procedures;
4. Signed informed consent obtained prior to screening from subject;
5. Free of obvious health problems [with no significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, mental or haematological functional abnormalities or illness that require medical therapy] as established by medical history, routine haematology and biochemistry parameters and clinical assessment;
 
 
ExclusionCriteria 
Details  1. Received IPV or OPV booster dose after the age of 12 years;
2. Sero-positive for HIV, Hepatitis B or Hepatitis C infections;
3. Abnormal pre-treatment laboratory haematology and biochemistry parameters which are clinically significant according to the investigator;
4. Known or suspected allergy against any of the vaccine components;
5. History of unusual or severe reactions to any previous vaccination;
6. Known or suspected immune deficiency either congenital or hereditary;
7. Systemic treatment with corticosteroids within one month before screening;
8. Blood donation within one month before screening;
9. History of any neurological disorder including epilepsy or febrile seizures or a family history of mental illness;
10. Evidence of excessive alcohol use or drug abuse;
11. Any infectious disease or acute condition at the time of screening and/or inclusion;
12. Individuals with body temperature ≥100.4°F (≥38.0°C) within 3 days prior of intended study immunization;
13. Participation in another clinical trial within three months before screening;
14. Bleeding disorders or the usage of anticoagulants in the past 3 weeks;
15. History of any blood disorder (e.g. thalassemia, thrombocytopenia, disorders of the lymphocytes, anaemias, etc.) in the past 3 weeks;
16. Subjects who have received any blood products, cytotoxic agents or radiotherapy within the last 3 months;
17. Any licensed or investigational drug or vaccine administered within 30 days prior to receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine;
18. An employee (or first-degree relative of employee) of the Sponsor, the CRO, or any investigator or site personnel.
19. Inability or unwillingness to abide by the requirements of the study:
• Participant is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study;

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Proportion of subjects with solicited adverse reactions.
2.Proportion of subjects with local and systemic adverse events (AEs).
3. Medically attended and serious adverse events (SAEs), if any
4. Any clinically significant abnormal haematology and biochemistry laboratory parameters
5. Clinically significant abnormal vital signs (Pulse, oral body temperature, Respiratory rate and Blood pressure)  		 1.During first 60 minutes of post vaccination observation period and for subsequent 7 consecutive days (Day 0-6) captured through subject diary.
2.During the post vaccination follow up period till day 28.
3. During the post vaccination 28 day follow up period.
4.Any clinically significant abnormal haematology and biochemistry laboratory parameters - At visit-1 & Visit-3.
5. At all visits.  
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of subjects achieving seroconversion.  At day 28 post vaccination  
Proportion of subjects achieving ≥2-fold and ≥4-fold increase in anti-Polio serotype specific antibody titre   At 28 days after single dose.  
Geometric mean titre (GMT)   At day 28 post vaccination.  
Geometric mean fold rise (GMFR)   At day 28 as measured from baseline.  
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   09/04/2019 
Date of Study Completion (India) 24/01/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is a single arm, open label Phase-I study to demonstrate safety, reactogenicity & Immunogenicity of Biological E’s Inactivated poliomyelitis vaccine (adsorbed) in 18-45 year-old adult male subjects. A total of 24 adult male subjects will be administered a single 0.5 mL dose of the test vaccine by Intra-muscular injection in deltoid muscle of the non-dominant arm. 

Blood sample will be collected once at screening and again 28 days after the single dose, for routine haematology, biochemistry parameters and serotype specific anti-Polio antibody assay. Vital signs will be recorded at all protocol specified visits for all subjects.

The total duration of the study is 35 days for each subject (7 days for screening time and 28 days for follow up post single dose).This study will be conducted in compliance with schedule Y, ICH and Indian good clinical practice guidelines in force. 

 
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