Clinical Trial: Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase III Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, Varicella (MMRV) Vaccine Made With an Alternati

Brief Summary: 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

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL [ Time Frame: Six weeks after vaccination 1 ]
    Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)
  • Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL [ Time Frame: Six weeks after vaccination 1 ]
    Sera were tested for measles virus IgG antibody levels by an ELISA
  • Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL [ Time Frame: Six weeks after vaccination 1 ]
    Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)
  • Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL) [ Time Frame: Six weeks after vaccination 1 ]
    Sera were tested for rubella virus IgG antibody levels by an ELISA
  • Geometric Mean Titer (GMT) of VZV Antibodies [ Time Frame: Six weeks after vaccination 1 ]
    Sera were tested for VZV IgG antibody levels by gpELISA
  • Geometric Mean Titer (GMT) of Measles Virus Antibodies [ Time Frame: Six weeks after vaccination 1 ]
    Sera were tested for measles virus IgG antibody levels by ELISA
  • Geometric Mean Titer (GMT) of Mumps Virus Antibodies [ Time Frame: Six week

    Original Primary Outcome:

    • Percent of participants with varicella zoster virus (VZV) antibody levels ≥ 5 units/mL [ Time Frame: Week 6 postvaccination ]
    • Percent of participants with measles antibody levels ≥ 255 mIU/mL [ Time Frame: Week 6 postvaccination ]
    • Percent of participants with mumps antibody levels ≥ 10 units/mL [ Time Frame: Week 6 postvaccination ]
    • Percent of participants with rubella antibody levels ≥ 10 IU/mL [ Time Frame: Week 6 postvaccination ]


    Current Secondary Outcome:

    • 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 [ Time Frame: Up to 5 days after each vaccination ]
      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.


    Original Secondary Outcome:

    • Percent of participants with elevated body temperature [ Time Frame: Day 1 to Day 42 postvaccination ]
    • Percent of participants with measles-like, rubella-like, varicella-like, or zoster-like rash, or symptoms resembling mumps [ Time Frame: Day 1 to Day 42 postvaccination ]
    • Percent of participants with injection-site reactions [ Time Frame: Day 1 to Day 5 postvaccination ]


    Information By: Merck Sharp & Dohme Corp.

    Dates:
    Date Received: February 16, 2012
    Date Started: June 2012
    Date Completion:
    Last Updated: March 15, 2017
    Last Verified: March 2017