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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:
Full 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.
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260 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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