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A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines

NCT01064141 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2013-02-06

No results posted yet for this study

Summary

The purpose of this study is to investigate the potential for co-administration of the first dose of CYD Dengue vaccine with childhood vaccination.

Primary Objectives:

* To describe the safety of CYD Dengue vaccine after each dose; first dose given alone or coadministered with childhood vaccines.

Secondary Objectives:

* To describe the immunogenicity of CYD Dengue vaccine after each dose; first dose given alone or co-administered with childhood vaccines.

Conditions

  • Dengue Fever
  • Dengue Hemorrhagic Fever

Interventions

BIOLOGICAL

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

0.5 mL, Subcutaneous

BIOLOGICAL

OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines

0.5 mL, Subcutaneous and 0.5 mL, Intravascular

BIOLOGICAL

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

0.5 mL, Subcutaneous and 0.5 mL, Subcutaneous

BIOLOGICAL

Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)

0.5 mL Subcutaneous and 0.5 mL Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
15 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-09-30
Completion
2012-11-30

Countries

  • Philippines

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 NCT01064141 on ClinicalTrials.gov