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Clinical Trials/CTRI/2017/02/007837
CTRI/2017/02/007837
Not yet recruiting
Phase 4

Multicentric Study onPersistence of Immune Responses of anti-HAV in Children vaccinated with live attenuated Hepatitis A vaccine Biovac-A TM Upto 9 years

Wockhardt Ltd0 sites150 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Wockhardt Ltd
Enrollment
150
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
Wockhardt Ltd

Eligibility Criteria

Inclusion Criteria

  • 1\. Subjects who were enrolled for the Multi\-centric Trial on Immunogenecity of single dose of Biovac\-ATM Live Attenuated Hepatitis\-A Vaccine (MC/Vaccine/2006/CT\-01\) in 2007 would be considered
  • 2\. Subjects who had a baseline anti\-HAV antibody titre \<20mIU/mL in the initial phase of the study (MC/Vaccine/2006/CT\-01\).
  • 3\. Written informed consent from the parent or guardian of the subjects.

Exclusion Criteria

  • 1\. Subjects who had a baseline anti\-HAV antibody titre \>20mIU/mL(i.e these subjects are considered to be seroprotected prior to vaccination)

Outcomes

Primary Outcomes

Not specified

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