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Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

NCT00735644 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2015-04-21

Study results available
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Summary

This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in toddlers aged 12-18 months.

Primary objective:

To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi pasteur.

Secondary objective:

To describe the safety of vaccination in all subjects

Conditions

  • Japanese Encephalitis
  • Hepatitis A

Interventions

BIOLOGICAL

Japanese encephalitis vaccine

0.5 mL, Subcutaneous

BIOLOGICAL

Japanese encephalitis vaccine

0.5 mL, Subcutaneous

BIOLOGICAL

Japanese encephalitis vaccine

0.5 mL, Subcutaneous

BIOLOGICAL

Japanese encephalitis vaccine (Acambis)

0.5 mL, Subcutaneous

BIOLOGICAL

Hepatitis A vaccine

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-05-31
Completion
2009-08-31

Countries

  • Philippines
  • Thailand

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 NCT00735644 on ClinicalTrials.gov