Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Multinational Study, Double-blinded for the Immunogenicity and Consistency Evaluation of 3 Hib-MenCY-TT Vaccine Lots and Single-blinded and Controlled for the Evaluation of Safety and Immunogenicity of GSK Biologicals' Haemophilus Influenzae Type b and Neisseria Meningitidis Serogroups C and Y-tetanus Toxoid Conjugate Vaccine Combined (Hib-MenCY-TT) Compared to Monovalent Hib Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.
Brief Summary: This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. The study will also evaluate the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15 months of age.


Options:
A: 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)
B: Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV) (At Day 42 after vaccination); Concentration of Antibodies to Varicella Virus (VZV) (At Day 42 after vaccination); Number of Subjects With Seroresponse for Antibodies to Mumps Virus (At Day 42 after vaccination); Number of Subjects With Seroresponse for Antibodies to Measles Virus (At Day 42 after vaccination); Number of Subjects With Seroresponse for Antibodies to Rubella Virus (At Day 42 after vaccination); Concentration of Antibodies to Hepatitis A Virus (HAV) (At Day 42 after vaccination); Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (At Day 42 after vaccination)
C: Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups. (31 days following the second dose of Havrix®); Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups (31 days following the second dose of Havrix®); Number of Subjects Seroconverted for Anti-measle, Anti-mumps and Anti-varicella Antibodies in HAV+MMR+V and MMR+V→HAV Groups (42 days following the administration of M-M-R®II and VARIVAX®); Number of Subjects With Vaccine Response for Anti-rubella Antibodies in HAV+MMR+V and MMR+V→HAV Groups (42 days following administration of M-M-R®II and VARIVAX®)
D: Antibody Response to Hepatitis A - Participants With a Serological Response (4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)); Antibody Response to Varicella - Participants With a Serological Response (6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)); Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers (6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)); Participants With 1 or More Systemic Adverse Experience (6 weeks post dose 1); Participants With 1 or More Systemic Adverse Experience (4 weeks post dose 2); Participants With 1 or More Systemic Adverse Experience. (6 months); Participants With 1 or More Injection-site Adverse Experience (6 weeks post dose 1); Participants With 1 or More Injection-site Adverse Experience (4 weeks post dose 2); Participants With 1 or More Injection-site Adverse Experience (6 months); Participants With Elevated Temperature (≥102.2F/ ≥39.0C) (6 weeks post dose 1); Participants With Elevated Temperature (≥102.2F/ ≥39.0C) (4 weeks post dose 2); Participants With Elevated Temperature (≥102.2F/ ≥39.0C) (6 months); Participants With 1 or More Serious Vaccine-related Adverse Experience (6 weeks post dose 1); Participants With 1 or More Serious Vaccine-related Adverse Experience (4 weeks post dose 2); Participants With 1 or More Serious Vaccine-related Adverse Experience (6 months)

Answer: A