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Efficacy and Safety of Dengue Vaccine in Healthy Children

NCT00842530 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4002

Last updated 2022-04-05

Study results available
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Summary

The primary objective of the study was to assess the efficacy of CYD dengue vaccine after three injections in preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the severity, due to any of the four serotypes in children aged 4 to 11 years at the time of inclusion.

Secondary objectives included to assess:

* Vaccine efficacy against severe VCD cases
* Vaccine efficacy against VCD cases following at least two injections with CYD dengue vaccine
* Immune response to CYD dengue vaccine
* Safety profile of CYD dengue vaccine. Safety assessments include solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.

Other objectives included:

* Vaccine efficacy against VCD cases following at least one injection with CYD dengue vaccine
* Vaccine efficacy against VCD cases due to each serotype
* Participants with clinical signs and symptoms for VCD

Conditions

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

Interventions

BIOLOGICAL

CYD Dengue Vaccine

0.5 mL, Subcutaneous

BIOLOGICAL

Inactivated rabies virus vaccine

0.5 mL, Subcutaneous

BIOLOGICAL

Placebo

Sodium chloride 0.9%

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2013-09-30
Completion
2014-02-28

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Drugs

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 NCT00842530 on ClinicalTrials.gov