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
  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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1413
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) 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) 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
No Contacts or Locations Provided
  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
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Measles
Mumps
Parotitis
Rubella
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 April 17, 2014