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

NCT02979535 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2022-03-25

Study results available
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Summary

The aim of this study was to investigate the immunogenicity and safety of CYD dengue vaccine and Cervarix when administered concomitantly or sequentially in healthy female participants aged 9-14 years of age.

Primary objectives:

* To demonstrate that the humoral immune response (in terms of geometric mean titers \[GMTs\]) to Cervarix after concomitant administration with the CYD dengue vaccine is non-inferior to the humoral immune response (in terms of GMTs) after sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Cervarix.
* To demonstrate that the humoral immune response (in terms of GMTs) to the CYD dengue vaccine after concomitant administration with Cervarix is non-inferior to the humoral immune response (in terms of GMTs) to the CYD dengue vaccine after sequential administration with Cervarix 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 Cervarix after concomitant administration with the CYD dengue vaccine is non-inferior to the humoral immune response (in terms of seroconversion) to Cervarix sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Cervarix.
* To describe the humoral immune response to Cervarix at baseline and after each dose of Cervarix 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 Cervarix and 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 at Day 0, Months 6 and 12

BIOLOGICAL

CYD Dengue Vaccine

0.5 mL, SC at Months 1, 7, and 13

BIOLOGICAL

Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant

0.5 mL, IM at Day 0 and Month 6

BIOLOGICAL

Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant

0.5 mL, IM at Day 0 and Month 6

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
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-16
Primary Completion
2019-03-25
Completion
2019-03-25

Countries

  • Mexico

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 NCT02979535 on ClinicalTrials.gov