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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-10

Study Completion Date

2016-08-31

Brief Summary

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

The Objectives:

* 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).

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Detailed Description

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This study was a passive surveillance of hospitalized dengue cases in participants who participated in study CYD23 (NCT00842530) where participants 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) were reported to the Sponsor.

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

No study vaccinations were administered.

Conditions

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Dengue Dengue Fever Dengue Hemorrhagic Fever

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CYD Dengue Vaccine Group

Participants who received 3 injections of 0.5 milliliter (mL) CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.

No interventions assigned to this group

Control Group

Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively in the study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Ongoing participation in study CYD23 at the time of enrolment.
* Assent form was signed and dated by the participant (for participants \>= 7 years old), and informed consent form was signed and dated by the parent(s) or another legally accepted representative and by 2 independent witnesses.
* Participant and parent/legally accepted representative were able to attend all scheduled visits 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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No