Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study
Launched by SANOFI PASTEUR, A SANOFI COMPANY · Nov 7, 2013
Trial Information
Current as of May 14, 2025
Completed
Keywords
ClinConnect Summary
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 wer...
Gender
ALL
Eligibility criteria
- 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.
About Sanofi Pasteur, A Sanofi Company
Sanofi Pasteur, a subsidiary of Sanofi, is a global leader in the development and production of vaccines. With a rich heritage in vaccine innovation, the company is dedicated to advancing public health by providing safe, effective, and accessible immunizations for a wide range of infectious diseases. Sanofi Pasteur invests significantly in research and development to address evolving health challenges and to enhance vaccine coverage worldwide. Committed to collaboration with health organizations and communities, the company strives to protect individuals and populations through its comprehensive portfolio of vaccines, contributing to the prevention of diseases and the promotion of healthier lives globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ratchaburi, Muang District, Thailand
Patients applied
Trial Officials
Medical Director
Study Director
Sanofi Pasteur SA
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials