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Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule

NCT02623725 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2022-03-24

Study results available
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Summary

The aim of the study was to assess and describe the booster effect of a CYD dengue vaccine dose administered 4 to 5 years after the completion of a 3-dose vaccination schedule.

Primary Objective

\- To demonstrate the non-inferiority, in terms of geometric mean of titer ratios (GMTRs), of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD13 - NCT00993447 and CYD30 - NCT01187433 trials (participants from Group 1 only).

Secondary Objectives:

* If the primary objective of non-inferiority was achieved: To demonstrate the superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD13 and CYD30 trials.
* To describe the immune responses elicited by a CYD dengue vaccine booster and placebo injection in participants who received 3 doses of the CYD dengue vaccine in the CYD13 and CYD30 trials in all participants.
* To describe the neutralizing antibody levels of each dengue serotype post-dose 3 (CYD13 and CYD30 participants) and immediately prior to booster or placebo injection in all participants.
* To describe the neutralizing antibody persistence 6 months, 1 year, and 2 years post booster or placebo injection in all participants.
* To evaluate the safety of booster vaccination with the CYD dengue vaccine in all participants.

Conditions

  • Dengue Fever
  • Dengue Hemorrhagic Fever

Interventions

BIOLOGICAL

CYD Dengue Vaccine (5-dose formulation)

0.5 mL, Subcutaneous

BIOLOGICAL

Placebo, NaCl 0.9%

0.5 mL, Subcutaneous

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-14
Primary Completion
2016-11-23
Completion
2018-10-28
FDA Drug
Yes

Countries

  • Brazil
  • Colombia
  • Honduras
  • Mexico
  • Puerto Rico

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 NCT02623725 on ClinicalTrials.gov