Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01536405
First received: February 16, 2012
Last updated: February 11, 2014
Last verified: February 2014

February 16, 2012
February 11, 2014
June 2012
July 2013   (final data collection date for primary outcome measure)
  • Percent of participants with varicella zoster virus (VZV) antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL [ Time Frame: Six weeks after vaccination 1 ] [ Designated as safety issue: No ]
  • Percent of participants with measles antibody levels ≥ 255 mIU/mL [ Time Frame: Six weeks after vaccination 1 ] [ Designated as safety issue: No ]
  • Percent of participants with mumps antibody levels ≥ 10 units/mL [ Time Frame: Six weeks after vaccination 1 ] [ Designated as safety issue: No ]
  • Percent of participants with rubella antibody levels ≥ 10 IU/mL [ Time Frame: Six weeks after vaccination 1 ] [ Designated as safety issue: No ]
  • Geometric mean titer of VZV antibodies [ Time Frame: Six weeks after vaccination 1 ] [ Designated as safety issue: No ]
  • Geometric mean titer of measles antibodies [ Time Frame: Six weeks after vaccination 1 ] [ Designated as safety issue: No ]
  • Geometric mean titer of mumps antibodies [ Time Frame: Six weeks after vaccination 1 ] [ Designated as safety issue: No ]
  • Geometric mean titer of rubella antibodies [ Time Frame: Six weeks after vaccination 1 ] [ Designated as safety issue: No ]
  • Percent of participants with fever (≥102.2°F [39.0°C] oral equivalent) [ Time Frame: Days 1 to 5 after vaccination 1 ] [ Designated as safety issue: Yes ]
  • Percent of participants with varicella zoster virus (VZV) antibody levels ≥ 5 units/mL [ Time Frame: Week 6 postvaccination ] [ Designated as safety issue: No ]
  • Percent of participants with measles antibody levels ≥ 255 mIU/mL [ Time Frame: Week 6 postvaccination ] [ Designated as safety issue: No ]
  • Percent of participants with mumps antibody levels ≥ 10 units/mL [ Time Frame: Week 6 postvaccination ] [ Designated as safety issue: No ]
  • Percent of participants with rubella antibody levels ≥ 10 IU/mL [ Time Frame: Week 6 postvaccination ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01536405 on ClinicalTrials.gov Archive Site
  • Percent of participants with fever (≥102.2°F [39.0°C] oral equivalent) temperature [ Time Frame: Days 1 to 42 after each vaccination ] [ Designated as safety issue: Yes ]
  • Percent of participants with measles-like, rubella-like, varicella-like, or zoster-like rash, or symptoms resembling mumps [ Time Frame: Days 1 to 42 after each vaccination ] [ Designated as safety issue: Yes ]
  • Percent of participants with injection-site reactions [ Time Frame: Days 1 to 5 after each vaccination ] [ Designated as safety issue: Yes ]
  • Percent of participants with elevated body temperature [ Time Frame: Day 1 to Day 42 postvaccination ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Percent of participants with injection-site reactions [ Time Frame: Day 1 to Day 5 postvaccination ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027 AM1)
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)

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Measles
  • Mumps
  • Rubella
  • Varicella
  • Biological: MMRV (AMP)
    Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
  • Biological: MMRV (2006 process)
    Measles, mumps, rubella, and VZV vaccine made with the 2006 manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
    Other Name: ProQuad™
  • Experimental: MMRV (AMP)
    Intervention: Biological: MMRV (AMP)
  • Active Comparator: MMRV (2006 process)
    Intervention: Biological: MMRV (2006 process)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1413
January 2014
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Negative clinical history for measles, mumps, rubella, varicella, and zoster

Exclusion Criteria:

  • Received any measles, mumps, rubella, or varicella vaccine, either alone or in any combination at any time prior to the study, or is anticipated to receive any of these vaccines outside of study protocol, either alone or in any combination, during the study
  • Received immune globulin, a blood transfusion or blood-derived products (does not include autologous blood/blood products) within 5 months (150 days) prior to any dose of the study vaccines or plans to receive these products while enrolled in this study
  • Exposed to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination
  • Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity, including that resulting from steroid use or other immunosuppressive therapy
  • Received 1) systemic immunomodulatory steroids [greater than the

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

  • History of allergy or anaphylactoid reaction to gelatin, sorbitol, neomycin, egg proteins (eggs or egg products), chicken proteins, or any component of the study vaccines
  • Received salicylates (eg, aspirin or aspirin-containing products) within 14 days prior to study vaccination
  • Diagnosis of an active neurological disorder. Enrollment may be considered

when the disease process has been stabilized

  • History of seizure disorder, including single febrile seizure
  • Diagnosis of active untreated tuberculosis
  • History of thrombocytopenia
  • Born to a human immunodeficiency virus (HIV) infected mother
Both
12 Months to 23 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01536405
V221-027, P20930
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP