Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity & Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With Merck & Company, Inc. Measles-Mumps-Rubella Vaccine (M-M-RII) & Merck & Co Varicella Vaccine (VARIVAX™) to Children 15 Months of Age
Brief Summary: This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a varicella (chickenpox) vaccine in children as young as 15 months of age.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: N/A
B: 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®)
C: Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) (Baseline and ~28 days after Vaccination 4 (~Day 118)); GMFR in VZV Antibody Response Measured by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay (Baseline and ~28 days after Vaccination 4 (~Day 118)); Percentage of Participants With a Serious Adverse Event (Up to ~28 days after Vaccination 4 (~Day 118))
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: B