Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027 AM1)
This study is ongoing, but not recruiting participants.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01536405
First received: February 16, 2012
Last updated: April 30, 2013
Last verified: April 2013
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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:
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 ]
| Estimated Enrollment: | 1400 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | May 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 |
| ClinicalTrials.gov Identifier: | NCT01536405 History of Changes |
| Other Study ID Numbers: | V221-027, P20930 |
| Study First Received: | February 16, 2012 |
| Last Updated: | April 30, 2013 |
| 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 May 23, 2013