Please select the outcome measures that correspond to the clinical trial below.
Title: An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of M-M-R™II Manufactured With Recombinant Human Albumin (rHA) and VARIVAX® When Administered Concomitantly by Intramuscular (IM) Route or Subcutaneous (SC) Route at Two Separate Injection Sites in Healthy Subjects 12 to 18 Months of Age
Brief Summary: Primary objective:

To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates to measles, mumps and rubella at 42 days following the vaccination.

AND/OR

To compare if, when given concomitantly with M-M-RTMII by the same route at 12-18 months of age using separate injection sites, a single dose of VARIVAX® administered by IM route is as immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate to varicella at 42 days following the vaccination

Secondary objectives:

* To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days following the vaccination in children immunised with M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC,
* To evaluate the safety profiles of M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC.


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: Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L). (At Month 30 after the first vaccination.); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 30 after the first vaccination); Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination)
C: 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
D: N/A

Answer: D