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Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children

NCT00621764 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2014-10-02

Study results available
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Summary

Safety:

To describe the safety profiles following vaccination.

Immunogenicity:

To describe the immune response after a single dose of vaccine.

Conditions

  • Japanese Encephalitis
  • Hepatitis A

Interventions

BIOLOGICAL

Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)

≥4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28)

BIOLOGICAL

Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)

0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)

BIOLOGICAL

Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)

≥4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28)

BIOLOGICAL

Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)

0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)

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
CROSSOVER

Eligibility

Min Age
12 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-12-31
Completion
2013-05-31

Countries

  • Thailand

Study Locations

More Related Trials

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 NCT00621764 on ClinicalTrials.gov