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Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America

NCT00993447 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2022-03-24

Study results available
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Summary

Primary objectives:

* To describe the immune response to each dengue serotype before and after each vaccination with sanofi pasteur's CYD dengue vaccine.
* To evaluate the safety of each vaccination with sanofi pasteur's CYD dengue vaccine.

Conditions

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

Interventions

BIOLOGICAL

CYD Dengue Vaccine

0.5 mL, Subcutaneous at Day 0, 6 and 12 months

BIOLOGICAL

Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis

NaCl: 0.5 mL, Intramuscular at Day 0 and 6 months; Adacel®: 0.5 mL, Intramuscular at 12 months

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-09-30
Completion
2012-03-31

Countries

  • Colombia
  • Honduras
  • Mexico
  • Puerto Rico

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 NCT00993447 on ClinicalTrials.gov