Date

2021-03-30

Protocol

Protocol changed

Item Changed

Primary outcome(s)

Previous Version

1.Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine Candidate (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype VE defined as 1 - (?v/?c), where ?v and ?c denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature >38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR). [Time Frame: 30 days post-second vaccination (Day 120) until the end of Part 1 (120 cases of dengue fever are confirmed and minimum duration of subject follow-up of 12 months post-second vaccination) ]

Next Version

Vaccine Efficacy (VE) of 2 doses of TDV in preventing virologically confirmed dengue fever induced by any dengue serotype occurring from 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 1, with VE defined as 1 – (?V/?C) (where ?V and ?C denote the hazard rates for the TDV and placebo arms, respectively).