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Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India

NCT01550289 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2022-04-05

Study results available
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Summary

The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine in India adult subjects.

Primary Objectives:

* To describe the neutralizing antibody response to each dengue virus serotype before the first vaccination and after each vaccination with CYD dengue vaccine in all subjects.
* To describe the safety of the CYD dengue vaccine after each dose in all subjects.

Secondary Objective:

* To detect symptomatic dengue cases occurring at any time in the trial.

Conditions

  • Dengue
  • Dengue Fever
  • Dengue Hemorrhagic Fever

Interventions

BIOLOGICAL

Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus

0.5 mL, Subcutaneous

BIOLOGICAL

Placebo: NaCl 0.9% solution

0.5 ml, Subcutaneous

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur India Pvt Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-12-31
Completion
2014-02-28

Countries

  • India

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 NCT01550289 on ClinicalTrials.gov