Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 4, Randomized, Open-Label Study to Assess Humoral and Intestinal Polio Immunity Following a Three-Dose Trivalent Inactivated Polio Vaccine Schedule Relative to Two Sequential Schedules of IPV/Bivalent Oral Polio Vaccines
Brief Summary: The rationale for this study (IPV 002ABMG) is to evaluate and compare three doses of IPV, two doses of IPV plus one bOPV, and one dose of IPV plus two doses of bOPV in order to provide evidence for better immunization policy making in regions of the world that must switch to use of IPV/bOPV schedules in the 2014-2015 time frame. The goal is to identify the best option optimizing humoral immune responses, intestinal immunity and thereby prevent community transmission as well as preventing VAPP. Specifically, the study seeks to show that both of the sequential regimens are equivalent (not-inferior) to the 3-dose IPV regimen in the seroconversion rates to both type 1 and type 3 poliovirus such that not more than 10% of subjects fall below the 95% confidence interval observed for the 3-dose IPV alone regimen and the geometric mean titers (GMTs) are no more than 2/3 logs less than those for the 3-dose IPV regimen. In addition, the study will evaluate by a novel method (poliovirus shedding index), the adequacy of IPV vaccines in inducing intestinal immunity, specifically by reducing the shedding of poliovirus type 2 after an OPV challenge. The hypotheses of the study are:

* A 3-dose IPV/bOPV sequential schedule including 1 or 2 doses of bOPV is non-inferior in terms of types 1 and 3 seroconversion rates and GMTs to a 3-dose IPV schedule.
* Two and possibly 1 IPV dose(s) provides significant seroconversion rates and GMTs to type 2 poliovirus and sufficient priming to induce a rapid immune response in the context of an oral challenge at 7 months of age.
* Three, 2, and possibly 1 dose of IPV will induce intestinal immunity to poliovirus type 2 as measured by a combination of quantity of virus in stools and duration of shedding (shedding index).

In addition to these 3 hypotheses, the study will explore the following hypothesis:

• Co-administration of bOPV and rotavirus at 16 weeks of age (the second rotavirus dose) provides similar antirotavirus IgA seroconversion rates and GMCs compared to subjects receiving rotavirus vaccine together with IPV.


Options:
A: Arm Label: G1: Sanofi bOPV Control; Type: EXPERIMENTAL; Interventions: Biological: Bivalent Oral Polio Vaccine (bOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2) | Arm Label: G2: Sanofi bOPV Control; Type: EXPERIMENTAL; Interventions: Biological: Bivalent Oral Polio Vaccine (bOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2) | Arm Label: G3: Trivalent OPV Control; Type: EXPERIMENTAL; Interventions: Biological: Trivalent Oral Polio Vaccine (tOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2) | Arm Label: G4: Sanofi bOPV, Sanofi IPV; Type: EXPERIMENTAL; Interventions: Biological: Bivalent Oral Polio Vaccine (bOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2), Biological: Sanofi-Pasteur IPV (Sanofi IPV) | Arm Label: G5: Sanofi bOPV, Sanofi 2 IPV; Type: EXPERIMENTAL; Interventions: Biological: Bivalent Oral Polio Vaccine (bOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2), Biological: Sanofi-Pasteur IPV (Sanofi IPV) | Arm Label: G6: Sanofi bOPV, GSK IPV; Type: EXPERIMENTAL; Interventions: Biological: Bivalent Oral Polio Vaccine (bOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2), Biological: Glaxo SmithKline IPV (GSK IPV) | Arm Label: G7: Sanofi bOPV, GSK 2 IPV; Type: EXPERIMENTAL; Interventions: Biological: Bivalent Oral Polio Vaccine (bOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2), Biological: Glaxo SmithKline IPV (GSK IPV) | Arm Label: G8: Sanofi bOPV, SII IPV; Type: EXPERIMENTAL; Interventions: Biological: Bivalent Oral Polio Vaccine (bOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2), Biological: Serum Institute of India IPV (SII IPV) | Arm Label: G9: Sanofi bOPV, SII 2 IPV; Type: EXPERIMENTAL; Interventions: Biological: Bivalent Oral Polio Vaccine (bOPV), Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2), Biological: Serum Institute of India IPV (SII IPV) | Intervention Type: BIOLOGICAL; Name: Bivalent Oral Polio Vaccine (bOPV); Assigned to Arm(s): G1: Sanofi bOPV Control, G2: Sanofi bOPV Control, G4: Sanofi bOPV, Sanofi IPV, G5: Sanofi bOPV, Sanofi 2 IPV, G6: Sanofi bOPV, GSK IPV, G7: Sanofi bOPV, GSK 2 IPV, G8: Sanofi bOPV, SII IPV, G9: Sanofi bOPV, SII 2 IPV | Intervention Type: BIOLOGICAL; Name: Trivalent Oral Polio Vaccine (tOPV); Assigned to Arm(s): G3: Trivalent OPV Control | Intervention Type: BIOLOGICAL; Name: Monovalent Oral Polio Vaccine Type 2 (mOPV2); Assigned to Arm(s): G1: Sanofi bOPV Control, G2: Sanofi bOPV Control, G3: Trivalent OPV Control, G4: Sanofi bOPV, Sanofi IPV, G5: Sanofi bOPV, Sanofi 2 IPV, G6: Sanofi bOPV, GSK IPV, G7: Sanofi bOPV, GSK 2 IPV, G8: Sanofi bOPV, SII IPV, G9: Sanofi bOPV, SII 2 IPV | Intervention Type: BIOLOGICAL; Name: Sanofi-Pasteur IPV (Sanofi IPV); Assigned to Arm(s): G4: Sanofi bOPV, Sanofi IPV, G5: Sanofi bOPV, Sanofi 2 IPV | Intervention Type: BIOLOGICAL; Name: Glaxo SmithKline IPV (GSK IPV); Assigned to Arm(s): G6: Sanofi bOPV, GSK IPV, G7: Sanofi bOPV, GSK 2 IPV | Intervention Type: BIOLOGICAL; Name: Serum Institute of India IPV (SII IPV); Assigned to Arm(s): G8: Sanofi bOPV, SII IPV, G9: Sanofi bOPV, SII 2 IPV
B: Intervention Type: BIOLOGICAL; Name: Inactivated Polio Vaccine given at an accelerated schedule; Assigned to Arm(s): N/A
C: Arm Label: Poliorix Group; Type: EXPERIMENTAL; Interventions: Biological: Poliorix™ | Arm Label: Control Group; Type: ACTIVE_COMPARATOR; Interventions: Biological: Oral Poliovirus vaccine | Intervention Type: BIOLOGICAL; Name: Poliorix™; Assigned to Arm(s): Poliorix Group | Intervention Type: BIOLOGICAL; Name: Oral Poliovirus vaccine; Assigned to Arm(s): Control Group
D: Arm Label: IPV/IPV/IPV/Rotarix/mOPV type 2; Type: EXPERIMENTAL; Interventions: Biological: IPV, Biological: mOPV type 2, Biological: Rotarix | Arm Label: IPV/IPV/bOPV/Rotarix/mOPV type 2; Type: ACTIVE_COMPARATOR; Interventions: Biological: IPV, Biological: bOPV, Biological: mOPV type 2, Biological: Rotarix | Arm Label: IPV/bOPV/bOPV/Rotarix/mOPV type 2; Type: ACTIVE_COMPARATOR; Interventions: Biological: IPV, Biological: bOPV, Biological: mOPV type 2, Biological: Rotarix | Intervention Type: BIOLOGICAL; Name: IPV; Assigned to Arm(s): IPV/IPV/IPV/Rotarix/mOPV type 2, IPV/IPV/bOPV/Rotarix/mOPV type 2, IPV/bOPV/bOPV/Rotarix/mOPV type 2 | Intervention Type: BIOLOGICAL; Name: bOPV; Assigned to Arm(s): IPV/IPV/bOPV/Rotarix/mOPV type 2, IPV/bOPV/bOPV/Rotarix/mOPV type 2 | Intervention Type: BIOLOGICAL; Name: mOPV type 2; Assigned to Arm(s): IPV/IPV/IPV/Rotarix/mOPV type 2, IPV/IPV/bOPV/Rotarix/mOPV type 2, IPV/bOPV/bOPV/Rotarix/mOPV type 2 | Intervention Type: BIOLOGICAL; Name: Rotarix; Assigned to Arm(s): IPV/IPV/IPV/Rotarix/mOPV type 2, IPV/IPV/bOPV/Rotarix/mOPV type 2, IPV/bOPV/bOPV/Rotarix/mOPV type 2

Answer: D