Dengue Fever Clinical Trial
Official title:
Immunogenicity and Safety of Three Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Adults Aged 18 to 45 Years in the US
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.
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.
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