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
  Purpose

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


Condition Intervention Phase
Measles
Mumps
Rubella
Varicella
Biological: MMRV (AMP)
Biological: MMRV (2006 process)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Alternative Manufacturing Process (AMP)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 1412
Study Start Date: June 2012
Study Completion Date: January 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Biological: MMRV (AMP)
Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
Active Comparator: MMRV (2006 process)
Participants received two 0.5 mL subcutaneous injections of MMRV vaccine made with the 2006 manufacturing process
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™

  Eligibility

Ages Eligible for Study:   12 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536405

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01536405     History of Changes
Other Study ID Numbers: V221-027, P20930
Study First Received: February 16, 2012
Results First Received: May 30, 2014
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rubella
Chickenpox
Herpes Zoster
Measles
Mumps
Parotitis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Rubulavirus Infections
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on August 01, 2014