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

Phase 2

Completed

• Conditions: Dengue Fever; Dengue Hemorrhagic Fever
• Interventions: Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus; Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines; Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)

• Registration Number: NCT01064141
• Lead Sponsor: Sanofi

Brief 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.

Detailed 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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-05
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-08
• Primary Completion: 2012-09
• Study Completion: 2012-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-05
• Last Update Posted: 2013-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Dengue Vaccine Group	Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus	Participants will receive CYD Dengue vaccine as Visits 1 and 2.
Group 3: Co-administration Group	Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines	Participants will receive CYD Dengue vaccine and childhood vaccines at Visit 1 and CYD Dengue vaccine at Visit 2.
Group 4: Sequential Administration Group	Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)	Participants will receive CYD Dengue vaccine and a Placebo vaccine at Visit 1 and CYD Dengue vaccine at Visit 2.

Primary Outcome Measures

Name	Time	Method
To provide information concerning the safety in terms of solicited and unsolicited adverse events after primary administration of CYD Dengue vaccine.	28 days after each Dengue vaccination and entire study duration

Secondary Outcome Measures

Name	Time	Method
To provide information concerning the immunogenicity of CYD Dengue vaccine after each dose of primary vaccination.	Day 28 after each Dengue vaccination
To provide information concerning the immunogenicity of childhood vaccines after primary vaccination.	Day 28 after post-vaccination