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Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore

NCT00880893 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1198

Last updated 2022-03-21

Study results available
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Summary

Primary Objectives:

* To evaluate safety after each CYD Dengue vaccination in terms of injection site and systemic reactogenicity.
* To evaluate the occurrence of Serious Adverse Events (SAEs) throughout the trial period.
* To evaluate the humoral immune response to each CYD Dengue serotype after each vaccination in a subset of participants.

Secondary Objectives:

* To evaluate the persistence of the humoral immune response during 4 years after the last vaccination in a subset of participants.

Conditions

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

Interventions

BIOLOGICAL

CYD Dengue vaccine

0.5 mL, Subcutaneous on Day 0, Months 6 and 12

BIOLOGICAL

NaCl + influenza virus or hepatitis A vaccine

0.5 mL, Subcutaneous (Intramuscular - Hepatitis A)

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-04-07
Primary Completion
2014-10-31
Completion
2014-10-14

Countries

  • Singapore

Study Locations

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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 NCT00880893 on ClinicalTrials.gov