At a glance
ClinicalIndex Comparison Record- ✓Had received all 3 doses of CYD dengue vaccine in the prior CYD28 trial
- ✓Aged 9 to 45 years at first injection in CYD28 trial
- ✓Good health based on medical history and physical examination
- ✓Post-dose 3 serum sample available from prior trial
- ✕Received any dengue vaccination outside of CYD28 trial
- ✕Pregnant, lactating, or of childbearing potential without effective contraception
- ✕Concurrent or recent participation (within 4 weeks) in another vaccine or drug trial
- ✕Other vaccines received within 4 weeks before or planned within 4 weeks after
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Given as a Booster Injection in Adolescents and Adults Who Previously Completed the 3-dose Schedule in a Study Conducted in Singapore
In Brief
A Phase 2 clinical trial evaluating CYD Dengue Vaccine (5 dose formulation) and Placebo, NaCl 0.9% for Dengue Fever and Dengue Hemorrhagic Fever. Completed, enrolled 118 participants across 3 sites.
Detailed Summary
The aim of the study was to assess and describe the booster effect of a tetravalent CYD dengue vaccine dose administered about 5 years or more after the completion of a 3-dose vaccination schedule in Singapore. Primary Objective: * To demonstrate the non-inferiority in terms of geometric mean of titer ratios (GMTRs) of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD28 trial (participants from Group 1 only). Secondary Objectives: * If the primary objective of non-inferiority achieved: To demonstrate the superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD28 trial (participants from Group 1 only). * To describe the immune responses elicited by the CYD dengue vaccine booster or placebo injection in participants who received three doses of the CYD dengue vaccine in the CYD28 trial in all participants. * To describe the neutralizing antibody levels of each dengue serotype Post Dose 3 (CYD28 participants) and immediately prior to booster or placebo injection in all participants. * To describe the neutralizing antibody persistence 6 months, 1 year and 2 years post booster or placebo injection in all study participants. * To evaluate the safety of booster vaccination with CYD dengue vaccine in all participants.
Study Details
Timeline
Interventions
0.5 mL, Subcutaneous
0.5 mL, Subcutaneous