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OpenTrials
Completed

NCT Number: NCT01536405

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

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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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MMRV (AMP)

Biological

Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.

MMRV (2006 process)

Biological

Measles, mumps, rubella, and VZV vaccine made with the 2006 manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.

Other names: ProQuad™

Primary outcomes

  1. Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL

    Time frame: Six weeks after vaccination 1

    Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)

  2. Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL

    Time frame: Six weeks after vaccination 1

    Sera were tested for measles virus IgG antibody levels by an ELISA

  3. Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL

    Time frame: Six weeks after vaccination 1

    Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)

  4. Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)

    Time frame: Six weeks after vaccination 1

    Sera were tested for rubella virus IgG antibody levels by an ELISA

  5. Geometric Mean Titer (GMT) of VZV Antibodies

    Time frame: Six weeks after vaccination 1

    Sera were tested for VZV IgG antibody levels by gpELISA

  6. Geometric Mean Titer (GMT) of Measles Virus Antibodies

    Time frame: Six weeks after vaccination 1

    Sera were tested for measles virus IgG antibody levels by ELISA

  7. Geometric Mean Titer (GMT) of Mumps Virus Antibodies

    Time frame: Six weeks after vaccination 1

    Sera were tested for mumps virus IgG antibody levels by ELISA

  8. Geometric Mean Titer (GMT) of Rubella Virus Antibodies

    Time frame: Six weeks after vaccination 1

    Sera were tested for rubella virus IgG antibody levels by ELISA

  9. Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)

    Time frame: Up to 5 days after vaccination 1

Secondary outcomes

  1. Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)

    Time frame: Up to 42 days after each vaccination

  2. Percentage of Participants With Zoster-like Rash

    Time frame: Up to 42 days after each vaccination

  3. Percentage of Participants With Mumps-like Symptoms

    Time frame: Up to 42 days after each vaccination

  4. Percentage of Participants With Measles-like Rash

    Time frame: Up to 42 days after each vaccination

  5. Percentage of Participants With Rubella-like Rash

    Time frame: Up to 42 days after each vaccination

  6. Percentage of Participants With Varicella-like Rash

    Time frame: Up to 42 days after each vaccination

  7. Percentage of Participants With an Injection-site Adverse Event

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Feb 22, 2012
Registry last updated
Oct 31, 2018

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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