MMRV (AMP)
BiologicalMeasles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
NCT Number: NCT01536405
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
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Notify Me12 month–23 month
All sexes
Interventional
Phase 3
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
equivalent of 2 mg/kg total daily dose of prednisone] within 3 months prior to
entering the study, or 2) any dose of systemic immunomodulatory steroids within
7 days prior to entering study, or 3) is expected to require systemic immunomodulatory steroids through the course of the study
when the disease process has been stabilized
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.
Other names: ProQuad™
Time frame: Six weeks after vaccination 1
Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Time frame: Six weeks after vaccination 1
Sera were tested for measles virus IgG antibody levels by an ELISA
Time frame: Six weeks after vaccination 1
Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)
Time frame: Six weeks after vaccination 1
Sera were tested for rubella virus IgG antibody levels by an ELISA
Time frame: Six weeks after vaccination 1
Sera were tested for VZV IgG antibody levels by gpELISA
Time frame: Six weeks after vaccination 1
Sera were tested for measles virus IgG antibody levels by ELISA
Time frame: Six weeks after vaccination 1
Sera were tested for mumps virus IgG antibody levels by ELISA
Time frame: Six weeks after vaccination 1
Sera were tested for rubella virus IgG antibody levels by ELISA
Time frame: Up to 5 days after vaccination 1
Time frame: Up to 42 days after each vaccination
Time frame: Up to 42 days after each vaccination
Time frame: Up to 42 days after each vaccination
Time frame: Up to 42 days after each vaccination
Time frame: Up to 42 days after each vaccination
Time frame: Up to 42 days after each vaccination
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.
Merck Sharp & Dohme LLC
Industry
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 Alternative Manufacturing Process (AMP)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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