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Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study

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ClinicalTrials.gov Identifier: NCT01983553
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The purpose of this study is to conduct a passive surveillance of hospitalized dengue cases in subjects who participated in study CYD23 (NCT00842530).

The Objectives are:

  • To describe the incidence of virologically-confirmed hospitalized dengue cases.
  • To characterize hospitalized dengue cases.
  • To evaluate the occurrence of related and fatal serious adverse events (SAEs).

Condition or disease
Dengue Dengue Fever Dengue Hemorrhagic Fever

Detailed Description:

This study will be a passive surveillance of hospitalized dengue cases in subjects who participated in study CYD23 (NCT00842530) where subjects were initially randomized to receive 3 injections of either CYD dengue vaccine or control at 6 month intervals. Any SAE related to a study procedure or related to a previous injection from study CYD23, or any fatal SAEs (even if unrelated) will be reported to the Sponsor.

An Independent Data Monitoring Committee (IDMC) will also be involved in the regular review of virologically-confirmed hospitalized dengue cases. Any fatal outcome or related SAE will be promptly reviewed by the IDMC.

No study vaccinations will be administered in this protocol.


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Study Type : Observational
Actual Enrollment : 3203 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Follow-Up of Hospitalized Dengue and Safety in Thai Children Who Were Included in an Efficacy Study of a Tetravalent Dengue Vaccine
Study Start Date : November 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

Group/Cohort
Study Group
Participants in study CYD23 (NCT00842530) with hospitalized dengue cases



Primary Outcome Measures :
  1. Number of hospitalized, virologically confirmed dengue case following participation in Study CYD23 [ Time Frame: Up to 5 years post vaccination in subjects who participated in study CYD23 ]
    Case are defined as (1) An acute febrile illness with fever lasting for at least 1 day (temperature 37.5 C measured at least twice with an interval of at least 4 hours) (2) Virologically confirmed by reverse transcriptase polymerase chain reaction (RT PCR) or dengue non structural protein 1 (NS1) enzyme linked immunosorbent assay (ELISA) Antigen (Ag) test with the addition of serotype strain specific analyses where appropriate and (3) In patient hospitalization


Secondary Outcome Measures :
  1. Classification of dengue cases following participation in Study CYD23 [ Time Frame: Up to 5 years post vaccination in subjects who participated in study CYD23 ]
    Classification will be based on: (1) Detection of dengue viremia, clinical signs and symptoms, duration of clinical syndrome, duration of hospitalization, neutralizing antibody titers and other pertinent criteria (2) A severity assessment using the World Health Organization (WHO) 1997 severity definition and the IDMC severity definition and (3) A dengue serological profile based on immunoglobulin G (IgG) and IgM ELISA results in all acute febrile episodes. Neutralizing antibody titers will be assessed in all virologically confirmed dengue cases

  2. Number and nature of reported serious adverse events following vaccination in study CYD23 [ Time Frame: Up to 5 years post vaccination in subjects who participated in Study CYD23 ]
    This include the occurrence, nature (MedDRA preferred term), seriousness criteria, relationship, outcome, and whether the SAE led to early termination from the study of SAEs related to study procedures or to previous injection from study CYD23 and fatal (even if unrelated) SAEs in all subjects



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants in study CYD23 (NCT00842530) that are hospitalized with dengue cases.
Criteria

Inclusion Criteria:

  • Ongoing participation in study CYD23 at the time of enrollment
  • Assent form has been signed and dated by the subject (for subjects ≥ 7 years old), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by 2 independent witnesses.
  • Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures.

Exclusion Criteria:

  • Planned participation in another dengue clinical trial during the present study
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.

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): NCT01983553


Locations
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Thailand
Ratchaburi, Muang District, Thailand
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur SA

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01983553     History of Changes
Other Study ID Numbers: CYD57
U1111-1127-7380 ( Other Identifier: WHO )
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
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 Virus
Dengue Fever
Dengue Hemorrhagic Fever
CYD Dengue Vaccine

Additional relevant MeSH terms:
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Fever
Dengue
Hemorrhagic Fevers, Viral
Severe Dengue
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs