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Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With JE-CV

NCT01190228 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2022-03-28

Study results available
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Summary

The aim of the study is to investigate the memory immune response and the yearly persistence of the immunity against Japanese Encephalitis (JE) after vaccination with Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in participants previously vaccinated with JE-CV vaccine.

Objectives:

* To describe JE immune status before and after JE-CV vaccination in subjects previously vaccinated with JE-CV vaccine
* To describe the immune status before and after JE-CV vaccination in JE-naïve control subjects.
* To describe the safety (in terms of solicited and unsolicited adverse events) of a single dose of JE-CV vaccine up to 6 months after the last vaccination.
* To describe all related serious adverse events (SAEs) and related deaths from 6 months to 5 years after vaccination in JE-CV-primed subjects.

Conditions

  • Japanese Encephalitis
  • Varicella

Interventions

BIOLOGICAL

JE-CV Vaccine

0.5 mL (single dose), Subcutaneous

BIOLOGICAL

Varicella Vaccine

0.5 mL (single dose), Subcutaneous

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur SA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
36 Months
Max Age
42 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-25
Primary Completion
2010-10-29
Completion
2015-10-12
FDA Drug
Yes

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01190228 on ClinicalTrials.gov