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

Measles Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536405
• Other study ID #: V221-027
• Secondary ID: P20930
• Status: Completed
• Phase: Phase 3
• Start date: June 5, 2012
• Est. completion date: January 27, 2014

Study information

• Verified date: October 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1412
• Est. completion date: January 27, 2014
• Est. primary completion date: July 2, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 23 Months

Eligibility

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

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Measles
• Mumps
• Rubella
• Varicella

Intervention

Biological:
• MMRV (AMP)
Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
• MMRV (2006 process)
Measles, mumps, rubella, and VZV vaccine made with the 2006 manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 varic — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL	Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)	Six weeks after vaccination 1
Primary	Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL	Sera were tested for measles virus IgG antibody levels by an ELISA	Six weeks after vaccination 1
Primary	Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL	Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)	Six weeks after vaccination 1
Primary	Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)	Sera were tested for rubella virus IgG antibody levels by an ELISA	Six weeks after vaccination 1
Primary	Geometric Mean Titer (GMT) of VZV Antibodies	Sera were tested for VZV IgG antibody levels by gpELISA	Six weeks after vaccination 1
Primary	Geometric Mean Titer (GMT) of Measles Virus Antibodies	Sera were tested for measles virus IgG antibody levels by ELISA	Six weeks after vaccination 1
Primary	Geometric Mean Titer (GMT) of Mumps Virus Antibodies	Sera were tested for mumps virus IgG antibody levels by ELISA	Six weeks after vaccination 1
Primary	Geometric Mean Titer (GMT) of Rubella Virus Antibodies	Sera were tested for rubella virus IgG antibody levels by ELISA	Six weeks after vaccination 1
Primary	Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)		Up to 5 days after vaccination 1
Secondary	Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)		Up to 42 days after each vaccination
Secondary	Percentage of Participants With Zoster-like Rash		Up to 42 days after each vaccination
Secondary	Percentage of Participants With Mumps-like Symptoms		Up to 42 days after each vaccination
Secondary	Percentage of Participants With Measles-like Rash		Up to 42 days after each vaccination
Secondary	Percentage of Participants With Rubella-like Rash		Up to 42 days after each vaccination
Secondary	Percentage of Participants With Varicella-like Rash		Up to 42 days after each vaccination
Secondary	Percentage of Participants With an Injection-site Adverse Event	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.	Up to 5 days after each vaccination