Please select the outcome measures that correspond to the clinical trial below.
Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine
Brief Summary: An observer-blind study to evaluate GlaxoSmithKline Biologicals' live attenuated varicella vaccine and GlaxoSmithKline Biologicals' combined measles-mumps-rubella-varicella vaccine in the prevention of varicella disease in children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series (One month after the 3-dose infant series (7 months of age)); Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose (1 Month After the Toddler Dose); Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series (One Month After the Infant Series (7 months of age)); Percentage of Participants Reporting Pre-specified Systemic Events (Within 7 days after each dose); Percentage of Participants Reporting Pre-specified Local Reactions (Within 7 days after each dose)
B: Phase A: Number of Subjects With Confirmed Varicella Case (From 42 days post dose 2 until the end of Phase A)
C: Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2 (Up to Day 46 (for 4 days following ProQuad® Dose 2)); Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2 (Up to Day 84 (up to 42 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2 (Up to Day 84 (up to 42 days after ProQuad® Dose 2))
D: compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children (Day 42)

Answer: B