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Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America

NCT01187433 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-03-21

Study results available
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Summary

The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America.

Primary Objectives:

* To describe the immune response to dengue viruses before and after each vaccination with CYD dengue vaccine.
* To evaluate the safety of each vaccination with CYD dengue vaccine.

Conditions

  • Dengue
  • Dengue Hemorrhagic Fever

Interventions

BIOLOGICAL

Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus

0.5 mL, Subcutaneous (SC)

BIOLOGICAL

NaCl 0.9%

0.5 mL, Subcutaneous

BIOLOGICAL

Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed

0.5 mL, Intramuscular

BIOLOGICAL

Meningococcal A+C vaccine

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-10-31
Completion
2012-12-31

Countries

  • Brazil

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 NCT01187433 on ClinicalTrials.gov