Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase I/II Double-blind, Randomized, Placebo-controlled, Descending Age, Dose-escalation Study of the Safety, and Immunogenicity of the Trivalent P2-VP8 Subunit Rotavirus Vaccine in Healthy South African Adults, Toddlers and Infants
Brief Summary: This is is a study of a parenteral trivalent rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study examined the safety and immunogenicity of three dose levels of this vaccine in healthy South African adults, toddlers and infants. Progression from one dose level to another and to the next age group population was based on the assessment of safety information from the lowest dose and older age group.

The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and well-tolerated. The primary immunogenicity hypothesis is that the trivalent P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an immune response to at least 2 of the 3 strains in 60% or more of participants in at least one of the study groups.


Options:
A: Arm Label: measles-rubella and rotavirus vaccines; Type: EXPERIMENTAL; Interventions: Biological: Rotarix vaccine, Biological: measles-rubella vaccine | Arm Label: measles-rubella vaccine; Type: ACTIVE_COMPARATOR; Interventions: Biological: measles-rubella vaccine | Intervention Type: BIOLOGICAL; Name: Rotarix vaccine; Assigned to Arm(s): measles-rubella and rotavirus vaccines | Intervention Type: BIOLOGICAL; Name: measles-rubella vaccine; Assigned to Arm(s): measles-rubella and rotavirus vaccines, measles-rubella vaccine
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Biological: Rotavirus Vaccine (ROTARIX) | Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BIOLOGICAL; Name: Rotavirus Vaccine (ROTARIX); Assigned to Arm(s): 1
C: 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
D: Arm Label: Adults: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Arm Label: Adults: 30 µg P2-VP8; Type: EXPERIMENTAL; Interventions: Biological: Trivalent P2-VP8 Subunit Rotavirus Vaccine | Arm Label: Adults: 90 µg P2-VP8; Type: EXPERIMENTAL; Interventions: Biological: Trivalent P2-VP8 Subunit Rotavirus Vaccine | Arm Label: Toddlers: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Arm Label: Toddlers: 30 µg P2-VP8; Type: EXPERIMENTAL; Interventions: Biological: Trivalent P2-VP8 Subunit Rotavirus Vaccine | Arm Label: Toddlers: 90 µg P2-VP8; Type: EXPERIMENTAL; Interventions: Biological: Trivalent P2-VP8 Subunit Rotavirus Vaccine | Arm Label: Infants: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Arm Label: Infants: 15 µg P2-VP8; Type: EXPERIMENTAL; Interventions: Biological: Trivalent P2-VP8 Subunit Rotavirus Vaccine | Arm Label: Infants: 30 µg P2-VP8; Type: EXPERIMENTAL; Interventions: Biological: Trivalent P2-VP8 Subunit Rotavirus Vaccine | Arm Label: Infants: 90 µg P2-VP8; Type: EXPERIMENTAL; Interventions: Biological: Trivalent P2-VP8 Subunit Rotavirus Vaccine | Intervention Type: BIOLOGICAL; Name: Trivalent P2-VP8 Subunit Rotavirus Vaccine; Assigned to Arm(s): Adults: 30 µg P2-VP8, Adults: 90 µg P2-VP8, Infants: 15 µg P2-VP8, Infants: 30 µg P2-VP8, Infants: 90 µg P2-VP8, Toddlers: 30 µg P2-VP8, Toddlers: 90 µg P2-VP8 | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Adults: Placebo, Infants: Placebo, Toddlers: Placebo

Answer: D