Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Safety and Immunogenicity of a Live, Attenuated Rotavirus Vaccine (RotaTeq™) in HIV-1 Infected and Uninfected Children Born to HIV-1-Infected Mothers
Brief Summary: Rotavirus is the leading cause of severe diarrhea in infants and young children, accounting for 45% of severe diarrhea disease in both developed and developing countries. Annually, rotavirus causes approximately 111 million episodes of gastroenteritis requiring home care, 25 million clinic visits, 2 million hospitalizations, and approximately 440,000 deaths in children less than 5 years of age, of which approximately 90% of hospitalizations and 99% of deaths occur in developing countries. Although rotavirus infection is not more common in HIV-infected children, it complicates their care and interferes with their nutrition. Chances of death by these infections can be greater in HIV-infected children when they also suffer from wasting, malnutrition, and/or opportunistic infections. The primary purpose of this study was to evaluate the safety and immunogenicity of the Rotavirus vaccine candidate, RotaTeq, in HIV-infected and uninfected children born to HIV-infected mothers.


Options:
A: Arm Label: Rotarix 3-Dose Group; Type: EXPERIMENTAL; Interventions: Biological: Rotarix™ | Arm Label: Rotarix 2-Dose 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): Rotarix 2-Dose Group, Rotarix 3-Dose Group | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo Group, Rotarix 2-Dose Group
B: Arm Label: HIV-uninfected RotaTeq; Type: EXPERIMENTAL; Interventions: Biological: RotaTeq | Arm Label: HIV-uninfected Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Arm Label: HIV-infected RotaTeq; Type: EXPERIMENTAL; Interventions: Biological: RotaTeq | Arm Label: HIV-1 infected Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: RotaTeq; Assigned to Arm(s): HIV-infected RotaTeq, HIV-uninfected RotaTeq | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): HIV-1 infected Placebo, HIV-uninfected Placebo
C: 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
D: 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)

Answer: B