Completed PHASE3 INTERVENTIONAL 2-arm NCT01374516

Study of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America

Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions Dengue Dengue Fever Dengue Hemorrhagic Fever

Interventions Live, attenuated, dengue serotype 1, 2, 3, 4 virus Placebo: (NaCl) 0.9% solution

Updated 11 times since 2017 Last updated: Mar 10, 2022 Started: Jun 8, 2011 Primary completion: Nov 30, 2014 Completion: Mar 5, 2018

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Dengue and Dengue Fever and is currently completed. Sanofi Pasteur, a Sanofi Company leads this study, which shows 11 recorded versions since 2011 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

11 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Apr 2022 — Jul 2024 [monthly]

Completed PHASE3
Jan 2021 — Apr 2022 [monthly]

Completed PHASE3

▶ Show 6 earlier versions

May 2019 — Jan 2021 [monthly]

Completed PHASE3
Apr 2019 — May 2019 [monthly]

Completed PHASE3

Status: Unknown Status → Completed
Jun 2018 — Apr 2019 [monthly]

Unknown Status PHASE3
May 2018 — Jun 2018 [monthly]

Unknown Status PHASE3

Status: Active Not Recruiting → Unknown Status
Feb 2017 — May 2018 [monthly]

Active Not Recruiting PHASE3
Jan 2017 — Feb 2017 [monthly]

Active Not Recruiting PHASE3

First recorded

Jun 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Sanofi Pasteur, a Sanofi Company

Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Acacías, Colombia , Aguazul, Colombia , Armenia, Colombia , Bucaramanga, Colombia , Calarcá, Colombia , Campo Grande, Brazil , Fortaleza, Brazil , Girardot City, Colombia , Goiânia, Brazil , Guayama, Puerto Rico and 12 more locations