Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants
Brief Summary: This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus vaccine \[OPV\] and diphtheria, tetanus, and acellular pertussis vaccine \[DTaP\]) either staggered or concomitantly with V260 or placebo. All participants will be followed for efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of participants. The primary hypothesis of the study states that V260 will be efficacious in preventing any severity of rotavirus gastroenteritis as compared with placebo.


Options:
A: Arm Label: Rotavirus vaccine (BRV-PV); Type: EXPERIMENTAL; Interventions: Biological: Rotavirus vaccine (BRV-PV) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: Rotavirus vaccine (BRV-PV); Assigned to Arm(s): Rotavirus vaccine (BRV-PV) | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo
B: Intervention Type: BIOLOGICAL; Name: HRV 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: Heat Stable Rotavirus (HSRV) Vaccine; Type: EXPERIMENTAL; Interventions: Biological: Heat Stable Rotavirus (HSRV) Vaccine | Arm Label: Placebo for Heatstable Rotavirus vaccine; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo for Heatstable Rotavirus vaccine | Arm Label: Heat Stable Rotavirus Vaccine; Type: EXPERIMENTAL; Interventions: Biological: Heat Stable Rotavirus (HSRV) Vaccine | Arm Label: RotaTeq; Type: ACTIVE_COMPARATOR; Interventions: Biological: RotaTeq® | Intervention Type: BIOLOGICAL; Name: Heat Stable Rotavirus (HSRV) Vaccine; Assigned to Arm(s): Heat Stable Rotavirus (HSRV) Vaccine, Heat Stable Rotavirus Vaccine | Intervention Type: BIOLOGICAL; Name: Placebo for Heatstable Rotavirus vaccine; Assigned to Arm(s): Placebo for Heatstable Rotavirus vaccine | Intervention Type: BIOLOGICAL; Name: RotaTeq®; Assigned to Arm(s): RotaTeq

Answer: C