This study will compare the safety, tolerability, and immunogenicity of measles, mumps, rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with those of the 2006 process
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,412
Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
Measles, mumps, rubella, and VZV vaccine made with the 2006 manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL
Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Time frame: Six weeks after vaccination 1
Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL
Sera were tested for measles virus IgG antibody levels by an ELISA
Time frame: Six weeks after vaccination 1
Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL
Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)
Time frame: Six weeks after vaccination 1
Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)
Sera were tested for rubella virus IgG antibody levels by an ELISA
Time frame: Six weeks after vaccination 1
Geometric Mean Titer (GMT) of VZV Antibodies
Sera were tested for VZV IgG antibody levels by gpELISA
Time frame: Six weeks after vaccination 1
Geometric Mean Titer (GMT) of Measles Virus Antibodies
Sera were tested for measles virus IgG antibody levels by ELISA
Time frame: Six weeks after vaccination 1
Geometric Mean Titer (GMT) of Mumps Virus Antibodies
Sera were tested for mumps virus IgG antibody levels by ELISA
Time frame: Six weeks after vaccination 1
Geometric Mean Titer (GMT) of Rubella Virus Antibodies
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Sera were tested for rubella virus IgG antibody levels by ELISA
Time frame: Six weeks after vaccination 1
Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
Time frame: Up to 5 days after vaccination 1
Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
Time frame: Up to 42 days after each vaccination
Percentage of Participants With Zoster-like Rash
Time frame: Up to 42 days after each vaccination
Percentage of Participants With Mumps-like Symptoms
Time frame: Up to 42 days after each vaccination
Percentage of Participants With Measles-like Rash
Time frame: Up to 42 days after each vaccination
Percentage of Participants With Rubella-like Rash
Time frame: Up to 42 days after each vaccination
Percentage of Participants With Varicella-like Rash
Time frame: Up to 42 days after each vaccination
Percentage of Participants With an Injection-site Adverse Event
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs reported were solicited with a Vaccine Report Card.
Time frame: Up to 5 days after each vaccination