Clinical trial NCT01536405: Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Measles
Mumps
Rubella
Varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 1412
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL
timeFrame: Six weeks after vaccination 1
measure: Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL
timeFrame: Six weeks after vaccination 1
measure: Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL
timeFrame: Six weeks after vaccination 1
measure: Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)
timeFrame: Six weeks after vaccination 1
measure: Geometric Mean Titer (GMT) of VZV Antibodies
timeFrame: Six weeks after vaccination 1
measure: Geometric Mean Titer (GMT) of Measles Virus Antibodies
timeFrame: Six weeks after vaccination 1
measure: Geometric Mean Titer (GMT) of Mumps Virus Antibodies
timeFrame: Six weeks after vaccination 1
measure: Geometric Mean Titer (GMT) of Rubella Virus Antibodies
timeFrame: Six weeks after vaccination 1
measure: Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
timeFrame: Up to 5 days after vaccination 1
Secondary outcomes:
measure: Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
timeFrame: Up to 42 days after each vaccination
measure: Percentage of Participants With Zoster-like Rash
timeFrame: Up to 42 days after each vaccination
measure: Percentage of Participants With Mumps-like Symptoms
timeFrame: Up to 42 days after each vaccination
measure: Percentage of Participants With Measles-like Rash
timeFrame: Up to 42 days after each vaccination
measure: Percentage of Participants With Rubella-like Rash
timeFrame: Up to 42 days after each vaccination
measure: Percentage of Participants With Varicella-like Rash
timeFrame: Up to 42 days after each vaccination
measure: Percentage of Participants With an Injection-site Adverse Event
timeFrame: Up to 5 days after each vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Marshall GS, Senders SD, Shepard J, Twiggs JD, Gardner J, Hille D, Hartzel J, Valenzuela R, Stek JE, Helmond FA. A double blind, randomized, active controlled study to assess the safety, tolerability and immunogenicity of measles, mumps rubella, and varicella vaccine (MMRV) manufactured using an alternative process. Hum Vaccin Immunother. 2016 Aug 2;12(8):2188-2196. doi: 10.1080/21645515.2016.1165374. Epub 2016 May 5.