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临床试验/CTRI/2025/02/081285
CTRI/2025/02/081285已完成不适用

Persistence of Immunogenicity of a Single Dose of Live Attenuated Hepatitis A Vaccine: A Follow-up Study 20 Years After Vaccination

Dr. Reddys Laboratories Ltd1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2025年2月28日

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
109
试验地点
1
主要终点
1.To evaluate the seroprotection rate of a single dose of live attenuated hepatitis A vaccine- 20 years after vaccination amongst the subjects

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Received a single dose of the Hepatitis A vaccine in 2004
  • Assessed at any of the follow-up studies
  • Willingness to provide written informed consent for the current study.

排除标准

  • Refusal or inability to comply with the requirements of the protocol for any reason
  • Any other condition or concomitant medication that would make the patient, in the opinion of the Investigator, unsuitable for the study.

结局指标

主要结局

1.To evaluate the seroprotection rate of a single dose of live attenuated hepatitis A vaccine- 20 years after vaccination amongst the subjects

时间窗: Single visit (Baseline)

2. To evaluate the GMT of total anti-HAV antibody

时间窗: Single visit (Baseline)

次要结局

  • 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)

研究者

发起方
Dr. Reddys Laboratories Ltd
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Sagar Katare

Dr. Reddys Laboratories Ltd

研究点 (1)

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