NCT00617344

Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US

Immunogenicity and Safety of Three Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Adults Aged 18 to 45 Years in the US

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study used 3 different formulations of tetravalent CYD dengue vaccine. The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and Month 6. The secondary objectives were: * To evaluate the safety of the 3 formulations of tetravalent CYD dengue vaccine. * To describe the neutralizing antibody responses to each of the 3 vaccine formulations. * To describe vaccine viremia after the first and second dose of each of the 3 vaccine formulations in a subset of participants.

Detailed description

All participants provided blood samples for immunogenicity assessments, while vaccine viremia was assessed in a subset of participants in each group. Safety was assessed in all participants as follows: solicited adverse event (AE) prelisted in the diary card were collected for 7 days after vaccination for solicited injection site reactions and 14 days for solicited systemic reactions , unsolicited AEs were collected for 28 days after vaccination, and serious adverse event (SAE) information collected throughout the study up to 6 months after vaccination.

Conditions

• Dengue Fever
• Dengue Hemorrhagic Fever
• Dengue Virus

Interventions

Type	Name	Description
BIOLOGICAL	Tetravalent CYD Dengue Vaccine , 5555 formulation	A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively.
BIOLOGICAL	Tetravalent CYD Dengue Vaccine , 5553 formulation	A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
BIOLOGICAL	Tetravalent CYD Dengue Vaccine, 4444 formulation	A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively

Timeline

• Start date: 2008-04-17
• Primary completion: 2009-12-01
• Completion: 2010-02-01
• First posted: 2008-02-18
• Last updated: 2019-06-11
• Results posted: 2019-06-11

Locations

5 sites across 1 country: United States