Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Double-Blind Randomized Placebo-Controlled Dose Escalating Phase Ib/IIa Study to Evaluate the Safety and Immunogenicity of Live Attenuated Oral Rotavirus Vaccine 116E in Healthy Non-Malnourished Infants 8 to 20 Weeks of Age
Brief Summary: This study will be a Phase I, randomized, double blind, safety and immunogenicity trial of the Vero cell based 116E neonatal rotavirus vaccine candidate strain in healthy non-malnourished infants aged 8-20 weeks at three different dosage levels i.e.10\^4.0, 10\^5.0 and 10\^6.0 FFU and for three administrations of each of these dosages given to infants at 4-week intervals. 180 infants (90 vaccinees/90 placebo) will be enrolled for each of the three dosage levels. The progression from the lower to the next higher dosage will be based on approval by the Data Safety Monitoring Board (DSMB) to be constituted by the Department of Biotechnology, New Delhi.


Options:
A: Arm Label: Primary 1: Rotavirus vaccine 6 and 10 weeks; Type: ACTIVE_COMPARATOR; Interventions: Biological: Rotavirus vaccine | Arm Label: Primary 1: Rotavirus vaccine 6, 10 and 14 weeks; Type: EXPERIMENTAL; Interventions: Biological: Rotavirus vaccine | Arm Label: Primary 1: Rotavirus vaccine 10 and 14 weeks; Type: EXPERIMENTAL; Interventions: Biological: Rotavirus vaccine | Arm Label: Primary 2: Rotavirus vaccine withholding breast feeding; Type: EXPERIMENTAL; Interventions: Biological: Rotavirus vaccine | Arm Label: Primary 2: Rotavirus vaccine with immediate breast feeding; Type: EXPERIMENTAL; Interventions: Biological: Rotavirus vaccine | Arm Label: Baseline seroconversion for rotavirus; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BIOLOGICAL; Name: Rotavirus vaccine; Assigned to Arm(s): Primary 1: Rotavirus vaccine 10 and 14 weeks, Primary 1: Rotavirus vaccine 6 and 10 weeks, Primary 1: Rotavirus vaccine 6, 10 and 14 weeks, Primary 2: Rotavirus vaccine with immediate breast feeding, Primary 2: Rotavirus vaccine withholding breast feeding
B: Arm Label: Study Group 1: DAPTACEL®, ActHIB®, and IPOL®; Type: EXPERIMENTAL; Interventions: Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®. | Arm Label: Study Group 2: Pentacel®; Type: EXPERIMENTAL; Interventions: Biological: Pentacel®: DTaP-IPV/Hib combined | Arm Label: Study Group 3: DTaP-IPV and ActHIB®; Type: EXPERIMENTAL; Interventions: Biological: DTaP-IPV and ActHIB® | Arm Label: Study Group 4: Pentacel®; Type: EXPERIMENTAL; Interventions: Biological: Pentacel®: DTaP-IPV/Hib combined | Intervention Type: BIOLOGICAL; Name: DAPTACEL®. (DTaP), IPOL®., and ActHIB®.; Assigned to Arm(s): Study Group 1: DAPTACEL®, ActHIB®, and IPOL® | Intervention Type: BIOLOGICAL; Name: Pentacel®: DTaP-IPV/Hib combined; Assigned to Arm(s): Study Group 2: Pentacel® | Intervention Type: BIOLOGICAL; Name: DTaP-IPV and ActHIB®; Assigned to Arm(s): Study Group 3: DTaP-IPV and ActHIB® | Intervention Type: BIOLOGICAL; Name: Pentacel®: DTaP-IPV/Hib combined; Assigned to Arm(s): Study Group 4: Pentacel®
C: Arm Label: rotavirus vaccine 116E 1 X 10(4); Type: EXPERIMENTAL; Interventions: Biological: Oral Rotavirus Vaccine 116E Live Attenuated | Arm Label: rotavirus vaccine 116E 1 X 10(5); Type: EXPERIMENTAL; Interventions: Biological: Oral Rotavirus Vaccine 116E Live Attenuated | Intervention Type: BIOLOGICAL; Name: Oral Rotavirus Vaccine 116E Live Attenuated; Assigned to Arm(s): rotavirus vaccine 116E 1 X 10(4), rotavirus vaccine 116E 1 X 10(5)
D: Arm Label: Rotavin; Type: EXPERIMENTAL; Interventions: Drug: Rotavin | Intervention Type: DRUG; Name: Rotavin; Assigned to Arm(s): Rotavin

Answer: C