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

2014-07-23 21:10:46 | BioPortfolio

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.

Description

Participants will be enrolled in a 3-step enrollment and randomized to 1 of 4 treatment groups. Groups 1 and 2 will receive 5 vaccinations, and Groups 3 and 4 will received 6 vaccinations (childhood vaccines or placebo co-administered with the first dose of CYD Dengue vaccine in 2 separate arms). All toddlers will receive a pentavalent acellular pertussis combination vaccine or Combo (PENTAXIM®), planned approximately 10 months after enrollment.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Dengue Fever

Intervention

Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus, OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines, Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines, Li

Location

San Pablo City
Philippines

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:10:46-0400

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