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CTRI Number  CTRI/2025/02/081285 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A 20 year follow up study of a Single Dose of Live Attenuated Hepatitis A Vaccine 
Scientific Title of Study   Persistence of Immunogenicity of a Single Dose of Live Attenuated Hepatitis A Vaccine: A Follow-up Study 20 Years After Vaccination 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
DRL-IND-GGI-075-BIOV/2024 Version 1.0 dated 29 November 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sagar Katare 
Designation  Overall Responsible Person 
Affiliation  Dr. Reddys Laboratories Ltd 
Address  8-2-337, Road No. 3 Banjara Hills, Hyderabad Telangana – 500034, India

Hyderabad
TELANGANA
500034
India 
Phone  9223772427  
Fax    
Email  sagarkatare@drreddys.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhishek T 
Designation  Medical Expert 
Affiliation  Dr. Reddys Laboratories Ltd 
Address  8-2-337, Road No. 3 Banjara Hills, Hyderabad Telangana – 500034, India

Hyderabad
TELANGANA
500034
India 
Phone  7675817463  
Fax    
Email  abhishek.t@drreddys.com  
 
Details of Contact Person
Public Query  
Name  Dr Sagar Katare 
Designation  Overall Responsible Person 
Affiliation  Dr. Reddys Laboratories Ltd 
Address  8-2-337, Road No. 3 Banjara Hills, Hyderabad Telangana – 500034, India

Hyderabad
TELANGANA
500034
India 
Phone  9223772427  
Fax    
Email  sagarkatare@drreddys.com  
 
Source of Monetary or Material Support  
Dr. Reddys Laboratories Ltd 8-2-337, Road No. 3 Banjara Hills, Hyderabad Telangana – 500034, India 
 
Primary Sponsor  
Name  Dr. Reddys Laboratories Ltd 
Address  8-2-337, Road No. 3 Banjara Hills, Hyderabad Telangana – 500034, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sheila Bhave  KEM Hospital Research Centre  Room No 315, Paediatric Research Unit, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth, Pune 411011, Maharashtra, India
Pune
MAHARASHTRA 		 9823091871

s.bhave@kemhrcpune.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KEM Hospital Research Centre Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Received a single dose of the Hepatitis A vaccine in 2004 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Received a single dose of the Hepatitis A vaccine in 2004
2. Assessed at any of the follow-up studies
3. Willingness to provide written informed consent for the current study 
 
ExclusionCriteria 
Details  1. Refusal or inability to comply with the requirements of the protocol for any reason
2. Any other condition or concomitant medication that would make the patient, in the opinion of the Investigator, unsuitable for the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the seroprotection rate of a single dose of live attenuated hepatitis A vaccine- 20 years after vaccination amongst the subjects
2. To evaluate the GMT of total anti-HAV antibody 		 Single visit (Baseline) 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the proportion of subjects who are anti-HAV IgM antibody-positive
2. To evaluate the occurrence of clinical hepatitis-like illness during 20 years post vaccination with a single dose of live attenuated hepatitis A vaccine 		 Single visit (Baseline) 
 
Target Sample Size   Total Sample Size="109"
Sample Size from India="109" 
Final Enrollment numbers achieved (Total)= "99"
Final Enrollment numbers achieved (India)="99" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/02/2025 
Date of Study Completion (India) 17/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   It is a Single-center longitudinal cohort 20 year follow up study. Subjects who received a single dose of live attenuated Hepatitis A vaccine in 2004 will assessed in this study. Subjects who fulfill the eligibility criteria mentioned above will be intimated by post, phone call, or home visit by the social worker. The participant will be invited to KEMHRC for the 20th year follow-up visit. During the visit, after the informed consent, participants will be asked for the history of hepatitis-like illness (fever, anorexia, nausea, vomiting, and jaundice). The clinical examination will involve checking for hepatomegaly or splenomegaly, if any. The subjects will be clinically assessed for evidence of hepatitis (if any). After routine clinical assessments, blood samples (~10 mL of venous blood from each subject) will be collected and sent to the partner laboratory to estimate the total anti-HAV antibodies. Any local reactions while collecting venous blood will be captured and reported. Data will be entered in predesigned paper case report forms (CRFs). All study documents will be maintained in a dedicated study cupboard with restricted access. 
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