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Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Gardasil®

NCT02993757 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 528

Last updated 2022-03-25

Study results available
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Summary

The aim of the study was to assess the safety and immunogenicity of the CYD dengue vaccine and Gardasil (Human Papillomavirus Quadrivalent \[Types 6, 11, 16, and 18\] Vaccine, Recombinant) when administered concomitantly or sequentially.

Primary objectives:

* To demonstrate that the humoral immune response (in terms of geometric mean titers \[GMTs\]) to Gardasil after concomitant administration was non-inferior to sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Gardasil.
* To demonstrate that the humoral immune response to the CYD dengue vaccine after concomitant administration was non-inferior to sequential administration with Gardasil measured 28 days after the last dose of the CYD dengue vaccine.

Secondary Objectives:

* To demonstrate that the humoral immune response (in terms of seroconversion) to Gardasil vaccine after concomitant administration was non-inferior to sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Gardasil.
* To describe the humoral immune response to Gardasil at baseline and after each dose of Gardasil in each and any group.
* To describe the humoral immune response to the CYD dengue vaccine at baseline and after each dose of the CYD dengue vaccine in each and any group.
* To describe the safety of Gardasil and the CYD dengue vaccine after each and any dose in each group.

Conditions

  • Dengue Fever
  • Dengue Hemorrhagic Fever
  • Human Papillomavirus Disease

Interventions

BIOLOGICAL

CYD Dengue Vaccine

0.5 mL, SC injection at Day 0, Month 6 and 12, respectively.

BIOLOGICAL

CYD Dengue Vaccine

0.5 mL, SC injection at Month 1, 7 and 13, respectively.

BIOLOGICAL

Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant.

0.5 mL, IM injection at Day 0 and Month 6, respectively.

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur SA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-12-01
Primary Completion
2019-05-27
Completion
2019-05-27
FDA Drug
Yes

Countries

  • Malaysia

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 NCT02993757 on ClinicalTrials.gov