Study: NCT01266850

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Rotarix®
Description: Each 1-mL dose of Rotarix® contains a suspension of at least 10\^6 median Cell Culture Infective Dose (CCID50) of live, attenuated human G1P rotavirus after reconstitution. The lyophilized vaccine contains amino acids, dextran, Dulbecco's Modified Eagle Medium (DMEM), sorbitol, and sucrose. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the acid environment of the stomach. Rotarix® contains no preservatives. Once reconstituted, the vaccine will appear white and turbid.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: RotaTeq®
Description: 2-mL ready-to-use oral solution of live reassortant rotaviruses, containing G1, G2, G3, G4, and P1A, which contains a minimum of 2.0 to 2.8 x 10\^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10\^6 IU per aggregate dose. The buffered stabilizer solution contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq® contains no preservatives. RotaTeq® is a pale yellow clear liquid that may have a pink tint.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: RotaTeq®
Description: 2-mL ready-to-use oral solution of live reassortant rotaviruses, containing G1, G2, G3, G4, and P1A, which contains a minimum of 2.0 to 2.8 x 10\^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10\^6 IU per aggregate dose. The buffered stabilizer solution contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq® contains no preservatives. RotaTeq® is a pale yellow clear liquid that may have a pink tint.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: RotaTeq®
Description: 2-mL ready-to-use oral solution of live reassortant rotaviruses, containing G1, G2, G3, G4, and P1A, which contains a minimum of 2.0 to 2.8 x 10\^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10\^6 IU per aggregate dose. The buffered stabilizer solution contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq® contains no preservatives. RotaTeq® is a pale yellow clear liquid that may have a pink tint.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: RotaTeq®
Description: 2-mL ready-to-use oral solution of live reassortant rotaviruses, containing G1, G2, G3, G4, and P1A, which contains a minimum of 2.0 to 2.8 x 10\^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10\^6 IU per aggregate dose. The buffered stabilizer solution contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq® contains no preservatives. RotaTeq® is a pale yellow clear liquid that may have a pink tint.