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

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: May 30, 2014
Last verified: May 2014

February 16, 2012
May 30, 2014
June 2012
July 2013   (final data collection date for primary outcome measure)
  • Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL [ Time Frame: Six weeks after vaccination 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Sera were tested for measles virus IgG antibody levels by ELISA
  • Geometric Mean Titer (GMT) of Mumps Virus Antibodies [ Time Frame: Six weeks after vaccination 1 ] [ Designated as safety issue: No ]
    Sera were tested for mumps virus IgG antibody levels by ELISA
  • Geometric Mean Titer (GMT) of Rubella Virus Antibodies [ Time Frame: Six weeks after vaccination 1 ] [ Designated as safety issue: No ]
    Sera were tested for rubella virus IgG antibody levels by ELISA
  • Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent) [ Time Frame: Up to 5 days 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
  • Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent) [ Time Frame: Up to 42 days after each vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Zoster-like Rash [ Time Frame: Up to 42 days after each vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Mumps-like Symptoms [ Time Frame: Up to 42 days after each vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Measles-like Rash [ Time Frame: Up to 42 days after each vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Rubella-like Rash [ Time Frame: Up to 42 days after each vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Varicella-like Rash [ Time Frame: Up to 42 days after each vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With an Injection-site Adverse Event [ Time Frame: Up to 5 days after each vaccination ] [ Designated as safety issue: Yes ]
    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.
  • 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)
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)
    Participants received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
    Intervention: Biological: MMRV (AMP)
  • Active Comparator: MMRV (2006 process)
    Participants received two 0.5 mL subcutaneous injections of MMRV vaccine made with the 2006 manufacturing 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
1412
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
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2014

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