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Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US

NCT00617344 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2019-06-11

Study results available
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Summary

This study used 3 different formulations of tetravalent CYD dengue vaccine.

The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and Month 6.

The secondary objectives were:

* To evaluate the safety of the 3 formulations of tetravalent CYD dengue vaccine.
* To describe the neutralizing antibody responses to each of the 3 vaccine formulations.
* To describe vaccine viremia after the first and second dose of each of the 3 vaccine formulations in a subset of participants.

Conditions

  • Dengue Fever
  • Dengue Hemorrhagic Fever
  • Dengue Virus

Interventions

BIOLOGICAL

Tetravalent CYD Dengue Vaccine , 5555 formulation

A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively.

BIOLOGICAL

Tetravalent CYD Dengue Vaccine , 5553 formulation

A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively

BIOLOGICAL

Tetravalent CYD Dengue Vaccine, 4444 formulation

A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-04-17
Primary Completion
2009-12-31
Completion
2010-02-28

Countries

  • United States

Study Locations

More Related Trials

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 NCT00617344 on ClinicalTrials.gov