Comparison of immunogenicity, safety and tolerability of Single Dose of Hepatitis A (Live) Vaccine obtained by Freeze-dried process from Sinopharm against BiovacTM-A (Freeze-dried Live Attenuated Vaccine from Wockhardt)in Healthy Indian Children.

Phase 3

Recruiting

• Conditions: Hepatitis A

• Registration Number: CTRI/2017/09/009760
• Lead Sponsor: Sinopharm India Private Limited

Brief Summary

This is a prospective, multicentre, randomized, double blind, parallel group, phase III study in which immunogenicity, safety, and tolerability of single dose of Hepatitis a (live) vaccine, freeze-dried from sinopharm versus is compared with BiovacTM a (freeze-dried live attenuated hepatitis a vaccine) from Wockhardt. The study involves approximately 176 healthy Indian children, who had not received hepatitis a vaccine and had anti-HAV ab levels of < 20 mIU/ml prior to enrolment into the study, after 8 weeks of immunization.

The study has to be conducted approximately at 5 sites in India with a primary objective of comparing the immune response of healthy Indian children treated with test drug/ vaccine versus reference drug/vaccine. The secondary objective of the study is to compare the safety and tolerability profile of test and reference drug/vaccine.

The study consists of 3 visits:

·         Visit 1 (Day -5)(Screening Visit)

·         Visit 2 (Day 0 + 2 days) (Baseline Visit)

·         Visit 3 (Week 8 +7 days) (End of Study [EOS] Visit)

At week 8, proportion of children with seroprotection (defined as an anti-HAV antibody (Ab) level ≥ 20 mIU/mL) will be assessed which is the primary endpoint of the study. Adverse events (AEs) and serious AEs (SAEs), Change in laboratory parameters (hematology and biochemistry) from baseline to 8 weeks, Change in brief clinical examination from baseline to 8 weeks, Vital signs, Immediate and delayed reaction post vaccination are to be assessed as secondary endpoints.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-28
• Last Update Posted: 2018-11-26

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

• Healthy children of either sex between the age range of 1-12 years 2.
• Subjects with negative anti-HAV antibodies (< 20mIU/ml) 3.
• Subjects’ parents/guardians willing to participate and who provide written informed consent (thumb impression for those who are not literate) for children.

Exclusion Criteria

• Subject with history of hypersensitivity to the vaccine or any of the ingredients of the vaccine, including subsidiary materials and kanamycin sulfate 2.
• Subject with previous history of Hepatitis A infection and subsequent jaundice manifested due to the infection 3.
• Subjects who have earlier received even a single dose of Hepatitis A vaccine 4.
• Subjects who were administered any live attenuated vaccine within 30 days.
• Subjects who were administered subunit or inactivated vaccines within 14 days 6.
• Subjects suffering from acute or chronic infections or any other serious liver, renal, cardiac, respiratory or metabolic disease 7.
• Subjects suffering from acute febrile illnesses 8.Subjects with a present or past history of allergic reactions.
• Subjects with clinically significant abnormal hematological and/or biochemical investigations.
• Subjects who have participated in an investigational study within the past 2 weeks 11.
• Subjects currently receiving immunosuppressant drugs 12.Subjects with uncontrolled epilepsy or other progressive diseases of nervous system 13.
• Subjects with any other illnesses which may impact the immune response or seroconversion as per investigator’s discretion 14.
• Subjects unwilling to comply with the study procedures 15.
• Subjects with immunodeficiency, HIV, and/or who are immunocompromised 16.
• Subjects with a history of administration of a single dose of Hepatitis A vaccine and/or any immunoglobulin at least 3 months prior to enrollment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of children with seroprotection (defined as an anti-HAV antibody (Ab) level ≥ 20 mIU/mL)	At 8 week from the day of immunization.

Secondary Outcome Measures

Name	Time	Method
• Adverse events (AEs) and serious AEs (SAEs)	• Change in laboratory parameters (hematology and biochemistry) from baseline to 8 weeks

Trial Locations

Locations (4)

All India Institute of Medical Sciences; 🇮🇳 South, DELHI, India

Institute of Child Health; 🇮🇳 Kolkata, WEST BENGAL, India

KEM Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Postgraduate Institute of Medical Education & Research; 🇮🇳 Chandigarh, CHANDIGARH, India

All India Institute of Medical Sciences

🇮🇳South, DELHI, India

Dr Puneet Misra

Principal investigator

91-9868397372

doctormisra@gmail.com