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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Rubella; Varicella; Mumps; Measles

Treatments: Biological: MMRV (2006 process); Biological: MMRV (AMP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01536405

V221-027

P20930

Details and patient eligibility

About

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

Enrollment: 1,412 patients

Sex: All

Ages: 12 to 23 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,412 participants in 2 patient groups

MMRV (AMP)

Experimental group

Description:

Participants received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)

Treatment:

Biological: MMRV (AMP)

MMRV (2006 process)

Active Comparator group

Description:

Participants received two 0.5 mL subcutaneous injections of MMRV vaccine made with the 2006 manufacturing process

Treatment:

Biological: MMRV (2006 process)