CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,198 enrolled
Drug / intervention
CYD Dengue vaccine +1 morebiological
Likely dose
CYD Dengue vaccine 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00880893
NCT00880893Phase 2Completed
CompareCT.gov

Immunogenicity and Large-Scale Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Singapore

Sanofi Pasteur, a Sanofi Company·interventional·Posted Apr 14, 2009·Updated Mar 21, 2022

In Brief

A Phase 2 clinical trial evaluating CYD Dengue vaccine and NaCl + influenza virus or hepatitis A vaccine for Dengue Fever and 3 related conditions. Completed, enrolled 1,198 participants across 5 sites.

Detailed Summary

Primary Objectives: * To evaluate safety after each CYD Dengue vaccination in terms of injection site and systemic reactogenicity. * To evaluate the occurrence of Serious Adverse Events (SAEs) throughout the trial period. * To evaluate the humoral immune response to each CYD Dengue serotype after each vaccination in a subset of participants. Secondary Objectives: * To evaluate the persistence of the humoral immune response during 4 years after the last vaccination in a subset of participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue Fever, Dengue Hemorrhagic Fever, Dengue Virus, Dengue Diseases
CountriesSingapore
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 14, 2009
Enrollment StartApr 7, 2009
Primary CompletionOct 1, 2014
Study CompletionOct 14, 2014
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 17.2 years ago

Interventions

CYD Dengue vaccinebiological

0.5 mL, Subcutaneous on Day 0, Months 6 and 12

NaCl + influenza virus or hepatitis A vaccinebiological

0.5 mL, Subcutaneous (Intramuscular - Hepatitis A)