Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase IIIb, Partially Blind, Randomized, Placebo-controlled Study to Asses the Effect on Immunogenicity of Administration of Vaccine Without Buffering Agent and to Assess Heat Stability in Terms of Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Following a 0, 2 Month Schedule, in Healthy Infants Previously Uninfected With Human Rotavirus
Brief Summary: Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age. GSK Biologicals has developed a vaccine against human rotavirus gastroenteritis. In this study, the immunogenicity, reactogenicity and safety of the HRV vaccine will be evaluated when stored or reconstituted in circumstances different from the recommendations: i.e. when not reconstituted with a buffer or when stored for 7 days at 37°C before reconstitution. In addition, the effect of feeding will be explored for HRV vaccine reconstituted without buffer.


Options:
A: Intervention Type: BIOLOGICAL; Name: Live attenuated human rotavirus vaccine; Assigned to Arm(s): N/A
B: Arm Label: RotaTeq™ Experimental Formulation; Type: EXPERIMENTAL; Interventions: Biological: RotaTeq™ experimental formulation | Arm Label: RotaTeq™ Existing Formulation; Type: ACTIVE_COMPARATOR; Interventions: Biological: RotaTeq™ existing formulation | Intervention Type: BIOLOGICAL; Name: RotaTeq™ experimental formulation; Assigned to Arm(s): RotaTeq™ Experimental Formulation | Intervention Type: BIOLOGICAL; Name: RotaTeq™ existing formulation; Assigned to Arm(s): RotaTeq™ Existing Formulation
C: Arm Label: Rotarix Group; Type: EXPERIMENTAL; Interventions: Biological: GSK Biologicals' liquid human rotavirus vaccine 444563, Biological: Infanrix™, Biological: Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV) | Arm Label: Placebo Group; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo, Biological: Infanrix™, Biological: Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV) | Intervention Type: BIOLOGICAL; Name: GSK Biologicals' liquid human rotavirus vaccine 444563; Assigned to Arm(s): Rotarix Group | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo Group | Intervention Type: BIOLOGICAL; Name: Infanrix™; Assigned to Arm(s): Placebo Group, Rotarix Group | Intervention Type: BIOLOGICAL; Name: Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV); Assigned to Arm(s): Placebo Group, Rotarix Group
D: Arm Label: PLACEBO-ROTARIX-ROTARIX GROUP; Type: EXPERIMENTAL; Interventions: Biological: Rotarix™, Biological: Placebo | Arm Label: ROTARIX-PLACEBO-ROTARIX 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): PLACEBO-ROTARIX-ROTARIX GROUP, ROTARIX-PLACEBO-ROTARIX GROUP | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): PLACEBO GROUP, PLACEBO-ROTARIX-ROTARIX GROUP, ROTARIX-PLACEBO-ROTARIX GROUP

Answer: A