Study: NCT04563533

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: High-dose vaccine
Description: Active ingredients: recombinant ReNoV GI.1-VP1 protein, recombinant ReNoV GII.3-VP1 protein, recombinant ReNoV GII.4-VP1 protein and recombinant ReNoV GII.17-VP1 protein each 25μg.~Other ingredients: aluminum hydroxide adjuvant 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: High-dose vaccine
Description: Active ingredients: recombinant ReNoV GI.1-VP1 protein, recombinant ReNoV GII.3-VP1 protein, recombinant ReNoV GII.4-VP1 protein and recombinant ReNoV GII.17-VP1 protein each 25μg.~Other ingredients: aluminum hydroxide adjuvant 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: High-dose vaccine
Description: Active ingredients: recombinant ReNoV GI.1-VP1 protein, recombinant ReNoV GII.3-VP1 protein, recombinant ReNoV GII.4-VP1 protein and recombinant ReNoV GII.17-VP1 protein each 25μg.~Other ingredients: aluminum hydroxide adjuvant 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: High-dose vaccine
Description: Active ingredients: recombinant ReNoV GI.1-VP1 protein, recombinant ReNoV GII.3-VP1 protein, recombinant ReNoV GII.4-VP1 protein and recombinant ReNoV GII.17-VP1 protein each 25μg.~Other ingredients: aluminum hydroxide adjuvant 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo (containing aluminum)
Description: Active ingredients: none Other ingredients: aluminum hydroxide adjuvant: 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo (containing aluminum)
Description: Active ingredients: none Other ingredients: aluminum hydroxide adjuvant: 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo (containing aluminum)
Description: Active ingredients: none Other ingredients: aluminum hydroxide adjuvant: 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo (containing aluminum)
Description: Active ingredients: none Other ingredients: aluminum hydroxide adjuvant: 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo (containing aluminum)
Description: Active ingredients: none Other ingredients: aluminum hydroxide adjuvant: 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo (without aluminum)
Description: Active ingredients: none Other ingredients: L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.