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

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Measles, Mumps, Rubella, Varicella

Intervention / Treatment
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* Biological: MMRV (AMP)
* Biological: MMRV (2006 process)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 23 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMRV (AMP)<br>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)<br>* Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.<br>|
| Active Comparator: MMRV (2006 process)<br>Participants received two 0.5 mL subcutaneous injections of MMRV vaccine made with the 2006 manufacturing process | Biological: MMRV (2006 process)<br>* Measles, mumps, rubella, and VZV vaccine made with the 2006 manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.<br>* Other names: ProQuad™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL | Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA) | Six weeks after vaccination 1 | 
| Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL | Sera were tested for measles virus IgG antibody levels by an ELISA | Six weeks after vaccination 1 | 
| Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL | Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA) | Six weeks after vaccination 1 | 
| Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL) | Sera were tested for rubella virus IgG antibody levels by an ELISA | Six weeks after vaccination 1 | 
| Geometric Mean Titer (GMT) of VZV Antibodies | Sera were tested for VZV IgG antibody levels by gpELISA | Six weeks after vaccination 1 | 
| Geometric Mean Titer (GMT) of Measles Virus Antibodies | Sera were tested for measles virus IgG antibody levels by ELISA | Six weeks after vaccination 1 | 
| Geometric Mean Titer (GMT) of Mumps Virus Antibodies | Sera were tested for mumps virus IgG antibody levels by ELISA | Six weeks after vaccination 1 | 
| Geometric Mean Titer (GMT) of Rubella Virus Antibodies | Sera were tested for rubella virus IgG antibody levels by ELISA | Six weeks after vaccination 1 | 
| Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent) |  | Up to 5 days after vaccination 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent) |  | Up to 42 days after each vaccination | 
| Percentage of Participants With Zoster-like Rash |  | Up to 42 days after each vaccination | 
| Percentage of Participants With Mumps-like Symptoms |  | Up to 42 days after each vaccination | 
| Percentage of Participants With Measles-like Rash |  | Up to 42 days after each vaccination | 
| Percentage of Participants With Rubella-like Rash |  | Up to 42 days after each vaccination | 
| Percentage of Participants With Varicella-like Rash |  | Up to 42 days after each vaccination | 
| Percentage of Participants With an Injection-site Adverse Event | 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. | Up to 5 days after each vaccination |