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. 2009 Jan 21;2009(1):CD000977. doi: 10.1002/14651858.CD000977.pub2

Wright 2008.

Methods Design: double‐blind randomized placebo controlled study conducted in two phases (Phase 1:a first dose of vaccine or placebo administered to participants; Phase 2: a second dose of vaccine or placebo admnistered to participants)
Length of follow up: 180 days for Phase 1 and Phase 2 studies
Participants Number: 28 healthy adult volunteers
Interventions Vaccine: live‐attenuated Langat/dengue 4 chimeric virus vaccine
Placebo: vaccine diluent
Schedule: 2 x 0.5 mL/dose (Phase 1: first dose; Phase 2: second dose) subcutaneously in the deltoid region
Outcomes 1. Seroconversion defined as a serum neutralizing antibody titer of at least 1:20 compared with prevaccination titre < 1:5
2. Geometric mean titre
3. LGT/DEN4 virus infection; vaccine related meningoencephalitic‐like syndrome
4. Local reactogenicity
5. Headache, rash, fever, neutropenia, elevated ALT level
5. Serious adverse events (hospitalization, congenital anomaly or birth defect, disability, death)
Notes Location: Nashville area (USA)