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: 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
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Biological: Comparator: Placebo | Intervention Type: BIOLOGICAL; Name: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent; Assigned to Arm(s): 1 | Intervention Type: BIOLOGICAL; Name: Comparator: Placebo; Assigned to Arm(s): 2
C: 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
D: Arm Label: Rotarix Group; Type: EXPERIMENTAL; Interventions: Biological: Rotarix™ | Arm Label: Placebo Group; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: Rotarix™; Assigned to Arm(s): Rotarix Group | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo Group

Answer: C