Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre Primary & Booster Vaccination Study of GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine When Given According to the 2-4-6 Month Schedule to Healthy Infants With Booster Dose at 12 to 15 Months
Brief Summary: This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4, 6, and 12 to 15 months of age. Co-administration with live, attenuated measles, mumps, and rubella combination vaccine; and with live, attenuated varicella vaccine will be assessed with administration of the booster dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.


Options:
A: 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®)
B: 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)
C: Phase A: Number of Subjects With Confirmed Varicella Case (From 42 days post dose 2 until the end of Phase A)
D: Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL) (One month after the 3-dose primary vaccination course); Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128 (One month after the 3-dose primary vaccination course); Number of Subjects Seroconverted for Anti-measles Antibodies (42 days after the fourth dose vaccination); Number of Subjects Seroconverted for Anti-mumps Antibodies (42 days after the fourth dose vaccination); Number of Subjects With an Anti-rubella Seroresponse (42 days after the fourth dose vaccination); Number of Subjects Seroconverted for Anti-varicella Antibodies (42 days after the fourth dose vaccination)

Answer: D