This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be non-inferior to the antibody response rates after vaccination with concomitant M-M-R™ II and Varivax™.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
Single administration of 0.5 mL subcutaneous injection
Single administration of 0.5 mL subcutaneous injection
Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL
Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (\<255 mIU/mL) to measles at baseline
Time frame: 6 weeks postvaccination
Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL
Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (\<10 units/mL) to mumps at baseline
Time frame: 6 weeks postvaccination
Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL
Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (\<10 IU/mL) to rubella at baseline
Time frame: 6 weeks postvaccination
Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (\<5 gpELISA units/mL) to VZV at baseline
Time frame: 6 weeks postvaccination
Geometric Mean Titer of Measles Antibodies
Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (\<255 mIU/mL) to measles at baseline
Time frame: 6 weeks postvaccination
Geometric Mean Titer of Mumps Antibodies
Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (\<10 Units/mL) to mumps at baseline
Time frame: 6 weeks postvaccination
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Geometric Mean Titer of Rubella Antibodies
Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (\<10 IU/mL) to rubella at baseline
Time frame: 6 weeks postvaccination
Geometric Mean Titer of VZV (gpELISA) Antibodies
Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (\<5 gpELISA Units/mL) to VZV at baseline
Time frame: 6 weeks postvaccination