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

NCT01536405 | Completed Phase 3 Results

• 2 other identifiers: V221-027P20930
• Study Type: interventional
• Target: 1,412
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• Geometric Mean Titer (GMT) of VZV Antibodies

  Sera were tested for VZV IgG antibody levels by gpELISA

  Six weeks after vaccination 1

• Geometric Mean Titer (GMT) of Measles Virus Antibodies

  Sera were tested for measles virus IgG antibody levels by ELISA

  Six weeks after vaccination 1

• Geometric Mean Titer (GMT) of Mumps Virus Antibodies

  Sera were tested for mumps virus IgG antibody levels by ELISA

  Six weeks after vaccination 1

• Geometric Mean Titer (GMT) of Rubella Virus Antibodies

  Sera were tested for rubella virus IgG antibody levels by ELISA

  Six weeks after vaccination 1

• Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)

  Up to 5 days after vaccination 1

Secondary Outcomes (7)

• Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)

  Up to 42 days after each vaccination

• Percentage of Participants With Zoster-like Rash

  Up to 42 days after each vaccination

• Percentage of Participants With Mumps-like Symptoms

  Up to 42 days after each vaccination

• Percentage of Participants With Measles-like Rash

  Up to 42 days after each vaccination

• Percentage of Participants With Rubella-like Rash

  Up to 42 days after each vaccination

Study Arms (2)

MMRV (AMP)

EXPERIMENTAL

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

Biological: MMRV (AMP)

MMRV (2006 process)

ACTIVE COMPARATOR

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

Biological: MMRV (2006 process)

Interventions

MMRV (AMP) BIOLOGICAL

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

MMRV (AMP)

MMRV (2006 process) BIOLOGICAL

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

Also known as: ProQuad™

MMRV (2006 process)

Eligibility Criteria

• Age: 12 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Negative clinical history for measles, mumps, rubella, varicella, and zoster

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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 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.

  PMID: 27149048 RESULT

MeSH Terms

Conditions

Measles; Mumps; Rubella; Chickenpox

Interventions

measles, mumps, rubella, varicella vaccine; Adenosine Monophosphate

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Rubulavirus Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Rubivirus Infections; Togaviridae Infections; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 22, 2012
• Study Start: June 5, 2012
• Primary Completion: July 2, 2013
• Study Completion: January 27, 2014
• Last Updated: October 31, 2018
• Results First Posted: July 2, 2014

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share