Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis Among Infants in Niger
Brief Summary: The study is a double-blinded, randomized, placebo-controlled, trial with two groups of infants receiving vaccine or placebo to assess the efficacy and safety of BRV-PV. Three doses of BRV-PV containing ≥ Log10 5.6 FFU/Dose of each serotype G1, G2, G3, G4 and G9 will be administered at 4 week intervals between doses. The first administration will occur at 6-8 weeks of age.

We hypothesize a difference in vaccine efficacy of three doses of BRV-PV vaccine vs. placebo against severe rotavirus gastroenteritis in healthy infants in Niger.

Active surveillance for gastroenteritis episodes will be conducted throughout the trial. Surveillance for adverse events will be carried out among all children from the time of first vaccination and 28 days post-Dose 3. Surveillance for all serious adverse events, including intussusception and death, will be conducted on all participants until they each reach two years of age.

To assess the effect of prenatal nutrition supplementation on infant immune response to the BRV-PV vaccine, study villages in the immunogenicity sub-cohort will be randomized in a 1:1:1 ratio to provide pregnant women with daily iron-folate, multiple micronutrients or a lipid-based nutrition supplement. Infants of participating women, if eligible at 6-8 weeks of age, will be randomized in a 1:1 ratio to receive three doses of vaccine or placebo and enter the main trial as part of the immunogenicity sub-cohort.


Options:
A: Arm Label: Rotavirus vaccine (BRV-PV); Type: EXPERIMENTAL; Interventions: Biological: Rotavirus vaccine (BRV-PV) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: Rotavirus vaccine (BRV-PV); Assigned to Arm(s): Rotavirus vaccine (BRV-PV) | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Group 1: Concomitant Administration; Type: EXPERIMENTAL; Interventions: Biological: RotaTeq®, Biological: NeisVac-C® | Arm Label: Group 2: Sequential Administration; Type: ACTIVE_COMPARATOR; Interventions: Biological: RotaTeq®, Biological: NeisVac-C® | Intervention Type: BIOLOGICAL; Name: RotaTeq®; Assigned to Arm(s): Group 1: Concomitant Administration, Group 2: Sequential Administration | Intervention Type: BIOLOGICAL; Name: NeisVac-C®; Assigned to Arm(s): Group 1: Concomitant Administration, Group 2: Sequential Administration
C: Arm Label: Rotarix Group; Type: EXPERIMENTAL; Interventions: Biological: Rotarix, Biological: Tritanrix-HB+Hib, Biological: Polio Sabin | Arm Label: Placebo Group; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo, Biological: Tritanrix-HB+Hib, Biological: Polio Sabin | Intervention Type: BIOLOGICAL; Name: Rotarix; Assigned to Arm(s): Rotarix Group | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo Group | Intervention Type: BIOLOGICAL; Name: Tritanrix-HB+Hib; Assigned to Arm(s): Placebo Group, Rotarix Group | Intervention Type: BIOLOGICAL; Name: Polio Sabin; Assigned to Arm(s): Placebo Group, Rotarix Group
D: Arm Label: Group 1, RotaTeq® x 3; Type: ACTIVE_COMPARATOR; Interventions: Biological: RotaTeq® | Arm Label: Group 5, Rotarix®, RotaTeq® x2; Type: EXPERIMENTAL; Interventions: Biological: Rotarix®, Biological: RotaTeq® | Arm Label: Group 4, Rotarix® x 2; Type: ACTIVE_COMPARATOR; Interventions: Biological: Rotarix® | Arm Label: Group 2, RotaTeq®, Rotarix® x 2; Type: EXPERIMENTAL; Interventions: Biological: Rotarix®, Biological: RotaTeq® | Arm Label: Group 3, RotaTeq® x 2, Rotarix®; Type: EXPERIMENTAL; Interventions: Biological: Rotarix®, Biological: RotaTeq® | Intervention Type: BIOLOGICAL; Name: Rotarix®; Assigned to Arm(s): Group 2, RotaTeq®, Rotarix® x 2, Group 3, RotaTeq® x 2, Rotarix®, Group 4, Rotarix® x 2, Group 5, Rotarix®, RotaTeq® x2 | Intervention Type: BIOLOGICAL; Name: RotaTeq®; Assigned to Arm(s): Group 1, RotaTeq® x 3, Group 2, RotaTeq®, Rotarix® x 2, Group 3, RotaTeq® x 2, Rotarix®, Group 5, Rotarix®, RotaTeq® x2

Answer: A