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 |
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Recruitment Status :
Completed
First Posted : November 14, 2013
Last Update Posted : September 28, 2016
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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 |
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| Dengue Dengue Fever Dengue Hemorrhagic Fever |
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.
| 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 |
| Group/Cohort |
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Study Group
Participants in study CYD23 (NCT00842530) with hospitalized dengue cases
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- 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
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 7 Years to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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
| Thailand | |
| Ratchaburi, Muang District, Thailand | |
| Study Director: | Medical Director | Sanofi Pasteur SA |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 ):
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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 |