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 Immunogenicity of Three Lots of 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
Brief Summary: The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine.


Options:
A: 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))
B: Percentage of Participants in Arm 2 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2 (Day 132 (6 weeks after ProQuad® Dose 2)); Percentage of Participants in Arm 1 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2 (Day 132 (6 weeks after ProQuad® Dose 2)); Percentage of Participants With Solicited Injection-site Adverse Reactions (Day 1 to Day 4 (up to 4 days after ProQuad® Dose 1)); Percentage of Participants Experiencing Unsolicited Injection-site Adverse Reactions (Up to Day 28 (up to 28 days after ProQuad® Dose 1)); Percentage of Participants Experiencing a Systemic Adverse Event After ProQuad® Dose 1 (Up to Day 28 (up to 28 days after ProQuad® Dose 1)); Percentage of Participants With Rectal (or Rectal Equivalent) Temperature ≥ 39.4°C (Up to Day 28 (up to 28 days after ProQuad® Dose 1))
C: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series (1 Month after the infant series (7 Months of age)); Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series (1 month after the infant series (7 months of age)); Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series (1 month after the infant series (7 months of age)); Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series (1 month after the infant series (7 months of age))
D: 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

Answer: C