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Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia

NCT01254422 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2022-03-25

Study results available
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Summary

The purpose of this study was to evaluate the safety and immunogenicity of Phase III lots of the CYD dengue vaccine in a pediatric population in Malaysia.

Primary Objectives:

* To describe the safety (in terms of solicited and unsolicited adverse events) of the CYD dengue vaccine in all participants after each injection.
* To describe the antibody response to each dengue virus serotype post-injection 2 and post-injection 3.

Conditions

  • Dengue Fever
  • Dengue Hemorrhagic Fever

Interventions

BIOLOGICAL

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

0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension

BIOLOGICAL

Placebo: NaCl 0.9%

0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Sanofi Pasteur Singapore

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-02
Primary Completion
2012-09-28
Completion
2013-01-31

Countries

  • Malaysia

Study Locations

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Entities

Companies

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 NCT01254422 on ClinicalTrials.gov