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: 2-dose oral live attenuated G1P[8] human rotavirus vaccine; Assigned to Arm(s): N/A
B: Intervention Type: BIOLOGICAL; Name: Live attenuated human rotavirus vaccine; Assigned to Arm(s): N/A
C: Arm Label: V260 with staggered EPI; Type: EXPERIMENTAL; Interventions: Biological: V260, Biological: OPV, Biological: DTaP | Arm Label: Placebo with staggered EPI; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo to V260, Biological: OPV, Biological: DTaP | Arm Label: V260 with concomitant EPI; Type: EXPERIMENTAL; Interventions: Biological: V260, Biological: OPV, Biological: DTaP | Arm Label: Placebo with concomitant EPI; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo to V260, Biological: OPV, Biological: DTaP | Intervention Type: BIOLOGICAL; Name: V260; Assigned to Arm(s): V260 with concomitant EPI, V260 with staggered EPI | Intervention Type: BIOLOGICAL; Name: Placebo to V260; Assigned to Arm(s): Placebo with concomitant EPI, Placebo with staggered EPI | Intervention Type: BIOLOGICAL; Name: OPV; Assigned to Arm(s): Placebo with concomitant EPI, Placebo with staggered EPI, V260 with concomitant EPI, V260 with staggered EPI | Intervention Type: BIOLOGICAL; Name: DTaP; Assigned to Arm(s): Placebo with concomitant EPI, Placebo with staggered EPI, V260 with concomitant EPI, V260 with staggered EPI
D: Arm Label: Rotavirus Vaccine at age 6 & 10 weeks; Type: ACTIVE_COMPARATOR; Interventions: Biological: Human Rotavirus Vaccine | Arm Label: Rotavirus vaccine at age 10 & 14 weeks; Type: EXPERIMENTAL; Interventions: Biological: Human Rotavirus Vaccine | Arm Label: Rotavirus vaccine at age 6,10,&14 weeks; Type: EXPERIMENTAL; Interventions: Biological: Human Rotavirus Vaccine | Intervention Type: BIOLOGICAL; Name: Human Rotavirus Vaccine; Assigned to Arm(s): Rotavirus Vaccine at age 6 & 10 weeks, Rotavirus vaccine at age 10 & 14 weeks, Rotavirus vaccine at age 6,10,&14 weeks

Answer: B