A phase-I clinical study to assess the safety of Biological Es Inactived Polio vaccine in 18-45 yearold healthy male adults.

Phase 1

Completed

• Conditions: Health Condition 1: Z23- Encounter for immunization

• Registration Number: CTRI/2019/04/018474
• Lead Sponsor: Biological ELimited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-01-24
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

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;

Exclusion Criteria

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;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Proportion of subjects with solicited adverse reactions. <br/ ><br>2.Proportion of subjects with local and systemic adverse events (AEs). <br/ ><br>3. Medically attended and serious adverse events (SAEs), if any <br/ ><br>4. Any clinically significant abnormal haematology and biochemistry laboratory parameters <br/ ><br>5. Clinically significant abnormal vital signs (Pulse, oral body temperature, Respiratory rate and Blood pressure)Timepoint: 1.During first 60 minutes of post vaccination observation period and for subsequent 7 consecutive days (Day 0-6) captured through subject diary. <br/ ><br>2.During the post vaccination follow up period till day 28. <br/ ><br>3. During the post vaccination 28 day follow up period. <br/ ><br>4.Any clinically significant abnormal haematology and biochemistry laboratory parameters - At visit-1 & Visit-3. <br/ ><br>5. At all visits.

Secondary Outcome Measures

Name	Time	Method
Geometric mean fold rise (GMFR)Timepoint: At day 28 as measured from baseline.;Geometric mean titre (GMT)Timepoint: At day 28 post vaccination.;Proportion of subjects achieving =2-fold and =4-fold increase in anti-Polio serotype specific antibody titreTimepoint: At 28 days after single dose.;Proportion of subjects achieving seroconversion.Timepoint: At day 28 post vaccination