Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
Brief Summary: The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC.


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: 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)
C: Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year; Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination
D: Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations (One month after primary vaccination); Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers (One month after primary vaccination); Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers (One month after primary vaccination); hSBA-MenC Antibody Titers (Prior to the fourth dose vaccination and 42 days after the fourth dose); hSBA-MenY Antibody Titers (Prior to the fourth dose vaccination and 42 days after the fourth dose); Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) (One month after primary vaccination); Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8 (42 days after the fourth dose); Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8 (42 days after the fourth dose); Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML) (42 days after the fourth dose); Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (42 days after the fourth dose); Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50) (42 days after the fourth dose); Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL) (42 days after the fourth dose); Number of Subjects With Anti-varicella Titer Equal to or Above 1:5 (42 days after the fourth dose)

Answer: A