Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)
- Conditions
- MeaslesMumpsVaricellaRubella
- Interventions
- Biological: MMRV (AMP)Biological: MMRV (2006 process)
- Registration Number
- NCT01536405
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1412
- Negative clinical history for measles, mumps, rubella, varicella, and zoster
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MMRV (AMP) MMRV (AMP) Participants received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP) MMRV (2006 process) MMRV (2006 process) Participants received two 0.5 mL subcutaneous injections of MMRV vaccine made with the 2006 manufacturing process
- Primary Outcome Measures
Name Time Method Geometric Mean Titer (GMT) of Measles Virus Antibodies Six weeks after vaccination 1 Sera were tested for measles virus IgG antibody levels by ELISA
Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL Six weeks after vaccination 1 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 Six weeks after vaccination 1 Sera were tested for measles virus IgG antibody levels by an ELISA
Geometric Mean Titer (GMT) of VZV Antibodies Six weeks after vaccination 1 Sera were tested for VZV IgG antibody levels by gpELISA
Geometric Mean Titer (GMT) of Mumps Virus Antibodies Six weeks after vaccination 1 Sera were tested for mumps virus IgG antibody levels by ELISA
Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL Six weeks after vaccination 1 Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)
Geometric Mean Titer (GMT) of Rubella Virus Antibodies Six weeks after vaccination 1 Sera were tested for rubella virus IgG antibody levels by ELISA
Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL) Six weeks after vaccination 1 Sera were tested for rubella virus IgG antibody levels by an ELISA
Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent) Up to 5 days after vaccination 1
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Measles-like Rash Up to 42 days after each vaccination 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 Varicella-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 Zoster-like Rash Up to 42 days after each vaccination Percentage of Participants With an Injection-site Adverse Event 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.
Percentage of Participants With Rubella-like Rash Up to 42 days after each vaccination