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Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects

NCT00875524 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-04-05

Study results available
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Summary

This trial evaluated the use of a tetravalent vaccine against dengue.

Primary objectives:

* To describe the humoral immune response to dengue before and after each vaccination with tetravalent dengue vaccine in adults, adolescents, and children.
* To evaluate the safety of each vaccination with tetravalent dengue vaccine in the 4 age cohorts.
* To evaluate the persistence of antibodies against dengue during 5 years after the first vaccination with tetravalent dengue vaccine in the 4 age cohorts.

Conditions

  • Dengue Virus
  • Dengue Fever
  • Dengue Hemorrhagic Fever
  • Dengue Disease

Interventions

BIOLOGICAL

CYD dengue vaccine serotypes (1, 2, 3, 4).

0.5 mL, Subcutaneous

BIOLOGICAL

Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide

Each at 0.5 mL, Subcutaneous, respectively

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2014-08-31
Completion
2014-12-31

Countries

  • Vietnam

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 NCT00875524 on ClinicalTrials.gov