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

NCT ID: NCT01536405

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1412 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-05
• Study Completion Date: 2014-01-27

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

Conditions

Measles; Mumps; Rubella; Varicella

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

MMRV (AMP)

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

Group Type: EXPERIMENTAL

MMRV (AMP)

Intervention Type: BIOLOGICAL

Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.

MMRV (2006 process)

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

Group Type: ACTIVE_COMPARATOR

MMRV (2006 process)

Intervention Type: BIOLOGICAL

Measles, mumps, rubella, and VZV vaccine made with the 2006 manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.

Interventions

MMRV (AMP)

Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

ProQuad™

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 27149048 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

P20930

Identifier Type: -

Identifier Source: secondary_id

V221-027

Identifier Type: -

Identifier Source: org_study_id