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Trials - SLCTR/2016/019

Protocol Change

Date

2021-03-30


Protocol

Protocol changed


Item Changed

Target number/sample size


Previous Version

2100 subjects in Sri Lanka (Ratio 2:1: 1400 in TDV arm, 700 in placebo arm), 20100 subjects globally


Next Version

2100 subjects in Sri Lanka (Ratio 2:1: 1400 in TDV arm, 700 in placebo arm), 20100 subjects globally 10500 globally for booster phase