Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of Kinrix® Co-administered With Varivax®
Brief Summary: The purpose of the study is to evaluate the immunogenicity and safety of Kinrix when co-administered with varicella (Varivax® \[varicella virus vaccine live\], Merck and Company) and (measles mumps rubella) MMR vaccines, compared to Kinrix co-administered with MMR vaccine alone. Both Kinrix and the second dose of Varivax are indicated in children 4-6 years of age, and there is great potential for the vaccines to be given concurrently. The aim of this trial is to demonstrate that co-administered Varivax does not negatively affect the immunogenicity or reactogenicity of Kinrix.


Options:
A: Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations (At Month 1, one month post-vaccination); Anti-poliovirus Types 1, 2 and 3 Antibody Titres (At Month 1, one month post-vaccination); Number of Seroprotected Subjects Against Polio Types 1, 2 and 3 (At Month 1, one month post-vaccination); Number of Seropositive Subjects for Anti-D and Anti-T Antibodies (At Month 1, one month post-vaccination)
B: Number of Subjects With Booster Responses to Diphteria and Tetanus (One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.); Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (Anti-PRN) Booster Responses, Measured in Enzyme-Linked Immunosorbent Assay Units Per Milliliter (EL.U/mL) (One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.); Geometric Mean Titers (GMTs) for Antibodies to Poliovirus Types 1, 2 and 3 (One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.)
C: 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)
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: B