A multicentric study, to assess the safety and efficacy of â??Inactivated Hepatitis A Vaccine, given to healthy adults.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/11/005184
• Date of registration: 07-11-2014
• Prospective Registration: No
• Primary sponsor: Prosper Channel Life Science India Pvt Ltd
• Public title: A multicentric study, to assess the safety and efficacy of â??Inactivated Hepatitis A Vaccine, given to healthy adults.
• Scientific title: A multicentric open label Phase-III Clinical trial to assess the immunogenicity and the safety of Inactivated Hepatitis-A vaccine (Healive®)â?? administered to healthy adults (PCL/H-AV/AD-002).
• Date of first enrolment: 27-10-2014
• Target sample size: 150
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9535
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Mr NC Sharma
• Affiliation: Prosper Channel Life sceince India Pvt Ltd

• Name: Mr NC Sharma
• Affiliation: Prosper Channel Life sceince India Pvt Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 1. Adults of 18-40 years of age who give written informed consent prior to the study

entry.

2. Subjects with good health as determined by:

• Medical history

• Physical examination

• Clinical judgment of the Investigator
Exclusion criteria: Presence of jaundice or any abnormal function as indicated by elevated Alanine

Aminotransferase (ALT) and/or HBsAg positive.

2. Subjects who are seropositive for Hepatitis A virus should be excluded (>=20 mIU/ml)

3. Subjects on treatment with any hepatotoxic drug before receiving the vaccine.

4. Fever > 38°C in past 3 days.

5. Any evidence of acute illness or infection requiring systemic antibiotic therapy within

past 7 days.

6. Subjects with a known or suspected impairment of the immune function, or those

receiving immunosuppressive therapy, or having received immunosuppressive therapy

within 1 month prior to study entry till completion (including systemic or inhaled

corticosteroids) or those who have received a parenteral immunoglobulin preparation.

7. Subjects who have received any blood or blood products, cytotoxic agents or

radiotherapy within last month.

8. Subjects with history of anaphylaxis, or any serious vaccine reaction, or allergy to any

vaccine component

9. Subjects with any serious chronic disease such as cardiac, renal, hematological,

hepatic, respiratory disease or autoimmune disease or with any condition that in the

opinion of the investigator might interfere with the evaluation of the study objectives.

10. Subjects who have participated in another trial of an investigational agent within 30

days of enrolment.

11. Subjects who are planning to leave the area of the study site before the end of the

study period.

12. Subjects who have received any live attenuated vaccines in past 30 days

Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: Hepatitis-A Vaccine.: Inactivated Hepatitis A vaccine is a liquid injection, packaged in vial or pre filled syringe, 1.0 ml per dose.
Intervention2: Inactivated Hepatitis A vaccine: (2 Dose) Healive® is a liquid injection, packaged in vial or pre-filled syringe, 1.0 ml per dose for adult (18-40 years) interval between 1st dose and 2nd dose is 6 months.
at deltoid region of right upper arm.
Control Intervention1: Inactivated Hepatitis A vaccine: Healive® is a liquid injection, packaged in vial or pre-filled syringe, 1.0 ml per dose for adult (18-40 years) at deltoid region of right upper arm.

Primary Outcome(s)

Primary Outcome/Efficacy Variable:

Immunogenicity 1 month after IInd dose vaccination (IInd dose of vaccination will be administered to subject after 6 months of Ist dose of vaccination).

â?? Anti-Hepatitis A virus antibody concentrations.

â?? Seroprotection status defined as anti-Hepatitis A antibody concentrations â?¥ 20

mIU/ml.Timepoint: Primary Outcome/Efficacy Variable:

Immunogenicity 1 month after IInd dose vaccination (IInd dose of vaccination will be administered to subject after 6 months of Ist dose of vaccination).

â?? Anti-Hepatitis A virus antibody concentrations.

â?? Seroprotection status defined as anti-Hepatitis A antibody concentrations â?¥ 20

mIU/ml.

Secondary Outcome(s)

Secondary Outcome/Efficacy Variable(s):

â?? Occurrence of solicited local adverse events during the 7-day (Days 0, 1, 2, 3, 4,

5, 6, 7) follow up period after vaccination.

â?? Occurrence of solicited general adverse events during the 7-day (Days 0, 1, 2, 3,

4, 5, 6, 7) follow up period after vaccination.

â?? Occurrence of unsolicited local and general adverse events on follows up.

â?? Occurrence of serious adverse events during the entire study period.Timepoint: 1. 7 days after 1st dose post vaccination.

2. 7 days after 2nd dose post vaccination.

Secondary ID(s)

PCL/H-AV/AD-002, amendment No.: PCL/H-AV-004,(08-11-2013)

Source(s) of Monetary Support

Sponsor by M/S. Prosper Channel Lifescience India Pvt. Ltd. , New Delhi

Ethics review

Status: Approved
Approval date: 06/09/2014
Contact:

Belle Vue Clinic Institutional Ethics Committee

Status: Approved
Approval date: 15/09/2014
Contact:

MAMC Institutional Ethics Committee

Status: Approved
Approval date: 05/11/2014
Contact:

Bombay Hospital and Medical Research Centre Institutional Ethics Committee

Status: Approved
Approval date: 03/01/2016
Contact:

Sri Ramachndra University Institutional Ethics Committee