Study: NCT03621670

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)
Description: Bexsero is to be administered intramuscularly on upper side of the right thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the MenB+PCV group.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Prevnar13
Description: Prevnar13 (PCV13) is to be administered intramuscularly on upper side of the left thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Prevnar13
Description: Prevnar13 (PCV13) is to be administered intramuscularly on upper side of the left thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pediarix
Description: Pediarix (DTPa-HBV-IPV) is to be administered intramuscularly on lower side of the left thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Pediarix
Description: Pediarix (DTPa-HBV-IPV) is to be administered intramuscularly on lower side of the left thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Hiberix
Description: Hiberix (Hib) is to be administered intramuscularly on lower side of the right thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Hiberix
Description: Hiberix (Hib) is to be administered intramuscularly on lower side of the right thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Rotarix
Description: Rotarix (HRV) is to be administered orally as a 2-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) to all subjects in the MenB+PCV group and Placebo+PCV group.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Rotarix
Description: Rotarix (HRV) is to be administered orally as a 2-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) to all subjects in the MenB+PCV group and Placebo+PCV group.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: M-M-R II
Description: M-M-R II (MMR) is to be administered subcutaneously on upper side of the right arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: M-M-R II
Description: M-M-R II (MMR) is to be administered subcutaneously on upper side of the right arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Varivax
Description: Varivax (VV) is to be administered subcutaneously on upper side of the left arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Varivax
Description: Varivax (VV) is to be administered subcutaneously on upper side of the left arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo (saline water)
Description: Placebo is to be administered intramuscularly on upper side of the right thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the Placebo+PCV group.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Prevnar 20
Description: Prevnar 20 (PCV13) is to be administered intramuscularly as a booster dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Prevnar 20
Description: Prevnar 20 (PCV13) is to be administered intramuscularly as a booster dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose.