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Cohort Event Monitoring for Dengvaxia®, CYD-TDV Dengue Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02948933
Recruitment Status : Active, not recruiting
First Posted : October 31, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The aim of this study is to evaluate the safety profile of Dengvaxia® when used in the real-world immunization setting

Primary Objective:

  • To measure the incidence of selected adverse events (AEs) and serious AEs (SAEs) occurring over a period of six (6) months after each Dengvaxia® dose administration;
  • To quantify the association between Dengvaxia® and each of the selected AEs and SAEs for which a risk window after vaccination can be defined, using estimates of relative risk
  • To monitor the occurrence and frequency of hospitalized dengue disease as well as any other SAEs leading to hospitalization or death, including new and previously unrecognized SAEs, following Dengvaxia® administration on a longer term (up to 5 years after the first Dengvaxia® dose administration.

Secondary objectives:

  • To identify risk factors for hospitalized dengue disease (severe or not) among subjects vaccinated with Dengvaxia®;
  • To describe the frequency of hospitalized dengue disease and/or other SAEs or selected AEs according to the number of Dengvaxia® doses and/or interval between doses.

Condition or disease
Dengue Fever Dengue Hemorrhagic Fever

Detailed Description:

This is a prospective multi-national non-interventional study that includes two components of Cohort Event Monitoring (i) Short-term safety surveillance with a follow-up of 6 months after each Dengvaxia® dose administration and (ii) a long-term safety surveillance with a follow-up of five years after the first dose.

No vaccine will be provided as part of this study.

Study population will be identified in a convenient sample of sites as representative as possible of vaccination centers in each country. Subjects who received their first dose of Dengvaxia® at participating sites during the recruitment period and who meet the eligibility criteria will be asked to participate. After enrollment, vaccinees will be contacted periodically by telephone, e-mail, or Short Message Service (SMS) during follow-up for the identification of outcomes and Dengvaxia® vaccination status.


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Study Type : Observational
Actual Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Authorization Safety Study: Cohort Event Monitoring for Dengvaxia®, CYD-TDV Dengue Vaccine
Actual Study Start Date : December 14, 2016
Estimated Primary Completion Date : December 18, 2024
Estimated Study Completion Date : December 18, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever




Primary Outcome Measures :
  1. Percentage of subjects with selected adverse events leading to a medical consultation, emergency room visit or hospitalization occurring during the short term surveillance period of 6 months after each dose of Dengvaxia® [ Time Frame: 6 months post-vaccination ]
  2. Percentage of subjects hospitalized with dengue disease (regardless of severity and laboratory confirmation of diagnosis) after each dose of Dengvaxia®. [ Time Frame: 6 months post-vaccination ]
  3. Percentage of subjects with any other serious adverse events (SAEs) occurring during the short term surveillance, and SAEs leading to hospitalization or death occurring during the long term surveillance [ Time Frame: Up to 5 years post-vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study population will be identified in a convenient sample of sites as representative as possible of vaccination centers in each country. Subjects who received their first dose of Dengvaxia® across all age groups at participating sites during the recruitment period and who meet the eligibility criteria will be enrolled.
Criteria

Inclusion Criteria:

  • Subjects who received the first dose of Dengvaxia® across all age groups, even if vaccination was given outside of local specific label indications or recommendations
  • Informed consent form (ICF) or Assent form (AF) has been signed and dated by the subject (based on local regulations), and/or ICF has been signed and dated by the parent(s) or another legal acceptable representative (and by an independent witness if required by local regulations)
  • Subjects for whom a telephone contact or an e-mail address is available.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948933


Locations
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Brazil
Alta, Brazil, CEP: 59025-050
Brasilia, Brazil, CEP: 70390-108
Campo Grande, Brazil, CEP: 79002-230
Curitiba, Brazil, CEP: 80.250-060
Jundiai, Brazil, CEP: 75110-810
Largo De Roma, Brazil, CEP: 40420-000
Macae, Brazil, CEP: 27920-180
Nova Iguacu, Brazil, CEP: 26030-380
Santo Amaro, Brazil, CEP: 50100-130
São Marcos, Brazil, CEP: 41953-190
Mexico
Investigational Site 2008-001
Cuernavaca, Mexico
Investigational Site 2011-001
Guerrero, Mexico, 39670
Investigational Site 2001-001
Mexico, Mexico, 11590
Investigational Site 2002-001
Monterrey, Mexico, 66260
Investigational Site 2007-001
Mérida, Mexico, 97130
Investigational Site 2003-001
Puerto Vallarta, Mexico, 48310
Investigational Site 2004-001
Veracruz, Mexico, 91910
Investigational Site 2006-001
Villahermosa, Mexico, 86035
Investigational Site 2010-001
Zapopan, Mexico, 45116
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Ltd.

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02948933     History of Changes
Other Study ID Numbers: DNG15
U1111-1143-8608 ( Other Identifier: WHO )
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at www.clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: Clinicalstudydatarequest.com/Sanofi.
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Dengue Fever
Dengue Hemorrhagic Fever
Dengvaxia®
Additional relevant MeSH terms:
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Severe Dengue
Dengue
Hemorrhagic Fevers, Viral
Fever
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs