Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase I/II Descending Age Double-blinded Randomized Placebo-controlled Dose Escalation Study to Examine the Safety Reactogenicity Tolerability & Immunogenicity of the P2-VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers & Infants
Brief Summary: This is is a study of a parenteral rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study will examine the safety and immunogenicity of this vaccine first in healthy South African toddlers. If the safety profile is deemed appropriate, the study will continue to explore the safety and immunogenicity of the vaccine in healthy South African infants.

The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and well-tolerated in healthy toddlers and infants. The primary immunogenicity hypothesis is that the P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an immune response in at least 80% of participants in at least one of the study groups.


Options:
A: Intervention Type: BIOLOGICAL; Name: Rotavirus; Assigned to Arm(s): N/A
B: Arm Label: Cohort A P2-VP8 30 mcg; Type: EXPERIMENTAL; Interventions: Biological: P2-VP8 Subunit Vaccine 30 mcg | Arm Label: Cohort A Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: Cohort A P2-VP8 60 mcg; Type: EXPERIMENTAL; Interventions: Biological: P2-VP8 Subunit Vaccine 60mcg | Arm Label: Cohort B P2-VP8 10mcg; Type: EXPERIMENTAL; Interventions: Biological: P2-VP8 Subunit Vaccine 10mcg | Arm Label: Cohort B placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: Cohort B P2-VP8 30mcg; Type: EXPERIMENTAL; Interventions: Biological: P2-VP8 Subunit Vaccine 30 mcg | Arm Label: Cohort B1 P2-VP8 60mcg; Type: EXPERIMENTAL; Interventions: Biological: P2-VP8 Subunit Vaccine 60mcg | Arm Label: Cohort A P2-VP8 10mcg; Type: EXPERIMENTAL; Interventions: Biological: P2-VP8 Subunit Vaccine 10mcg | Intervention Type: BIOLOGICAL; Name: P2-VP8 Subunit Vaccine 10mcg; Assigned to Arm(s): Cohort A P2-VP8 10mcg, Cohort B P2-VP8 10mcg | Intervention Type: BIOLOGICAL; Name: P2-VP8 Subunit Vaccine 30 mcg; Assigned to Arm(s): Cohort A P2-VP8 30 mcg, Cohort B P2-VP8 30mcg | Intervention Type: BIOLOGICAL; Name: P2-VP8 Subunit Vaccine 60mcg; Assigned to Arm(s): Cohort A P2-VP8 60 mcg, Cohort B1 P2-VP8 60mcg | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Cohort A Placebo, Cohort B placebo
C: Arm Label: Bivalent OPV 2 week interval; Type: ACTIVE_COMPARATOR; Interventions: Biological: Bivalent OPV 2 week interval | Arm Label: Bivalent OPV 4 week interval; Type: ACTIVE_COMPARATOR; Interventions: Biological: Bivalent OPV 4 week interval | Arm Label: Monovalent OPV 2week interval; Type: ACTIVE_COMPARATOR; Interventions: Biological: Monovalent OPV 2 week interval | Arm Label: Monovalent OPV 4 week interval; Type: ACTIVE_COMPARATOR; Interventions: Biological: Monovalent OPV 4 week interval | Arm Label: Trivalent OPV 4 week interval; Type: ACTIVE_COMPARATOR; Interventions: Biological: Trivalent OPV 4 week interval | Intervention Type: BIOLOGICAL; Name: Bivalent OPV 2 week interval; Assigned to Arm(s): Bivalent OPV 2 week interval | Intervention Type: BIOLOGICAL; Name: Bivalent OPV 4 week interval; Assigned to Arm(s): Bivalent OPV 4 week interval | Intervention Type: BIOLOGICAL; Name: Monovalent OPV 2 week interval; Assigned to Arm(s): Monovalent OPV 2week interval | Intervention Type: BIOLOGICAL; Name: Monovalent OPV 4 week interval; Assigned to Arm(s): Monovalent OPV 4 week interval | Intervention Type: BIOLOGICAL; Name: Trivalent OPV 4 week interval; Assigned to Arm(s): Trivalent OPV 4 week interval
D: Arm Label: Rotarix 3-Dose Group; Type: EXPERIMENTAL; Interventions: Biological: Rotarix™ | Arm Label: Rotarix 2-Dose Group; Type: EXPERIMENTAL; Interventions: Biological: Rotarix™, Biological: Placebo | Arm Label: Placebo Group; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: Rotarix™; Assigned to Arm(s): Rotarix 2-Dose Group, Rotarix 3-Dose Group | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo Group, Rotarix 2-Dose Group

Answer: B