Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)

NCT03239873 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: V210-A032017-001910-27
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 37

Brief Summary

This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX® (Varicella Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with the VARIVAX® 2016 commercial process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX® PE34 Process are non-inferior to those induced by VARIVAX® 2016 commercial process, and that antibody response rate induced by VARIVAX® PE34 Process is acceptable.

Conditions

Varicella

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL

  The varicella zoster virus (VZV) antibody response rate was defined as the percentage of participants with VZV antibody titer ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL among participants who were seronegative to VZV (titers \<1.25 gpELISA units/mL) at baseline.

  6 weeks (43 days) after vaccination 1

• Geometric Mean Titer of VZV Antibodies

  The geometric mean titer (GMT) of VZV antibodies after vaccination 1 was assessed. Antibody titers were measured with gpELISA.

  6 weeks (43 days) after vaccination 1

Secondary Outcomes (18)

• Percentage of Participants With Fever (≥102.2 °F Oral Equivalent)

  Up to 42 days after vaccination 1; Up to 42 days after vaccination 2

• Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence > 0%)

  Up to 42 days after vaccination 1

• Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 2 (Incidence > 0%)

  Up to 42 days after vaccination 2

• Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, or Injection-site Pain/Tenderness After Vaccination 1

  Up to 5 days after vaccination 1

• Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2

  Up to 5 days after vaccination 2

Study Arms (2)

VARIVAX® PE34 Process + Measles, Mumps, Rubella (M-M-R) II®

EXPERIMENTAL

VARIVAX® Passage Extension (PE34) Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II® vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91

Biological: VARIVAX® PE34 Process; Biological: M-M-R II®

VARIVAX® 2016 Commercial Process + M-M-R II®

ACTIVE COMPARATOR

VARIVAX® 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II® vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91

Biological: VARIVAX® 2016 Commercial Process; Biological: M-M-R II®

Interventions

VARIVAX® PE34 Process BIOLOGICAL

Varicella virus vaccine live manufactured with a new passage extension process (PE34)

VARIVAX® PE34 Process + Measles, Mumps, Rubella (M-M-R) II®

VARIVAX® 2016 Commercial Process BIOLOGICAL

Varicella virus vaccine live manufactured with the 2016 commercial process

VARIVAX® 2016 Commercial Process + M-M-R II®

M-M-R II® BIOLOGICAL

Measles, Mumps, and Rubella virus vaccine live

VARIVAX® 2016 Commercial Process + M-M-R II®; VARIVAX® PE34 Process + Measles, Mumps, Rubella (M-M-R) II®

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 varicella, herpes zoster, measles, mumps, and rubella

You may not qualify if:

• Received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study
• Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity
• Received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to receive them during the course of the study
• History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of VARIVAX® or M-M-R II®
• Has any blood dyscrasias, leukemia, lymphoma, or other malignant neoplasm affecting the bone marrow or lymphatic systems
• Received salicylates within 14 days prior to study vaccination
• Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior to study vaccination
• Received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to study vaccination
• History of seizure disorder, including febrile seizure
• Fever illness (\>=102.2 °F \[39.0 °C\] within 72 hours prior to study vaccination
• History of thrombocytopenia
• Born to a human immunodeficiency virus (HIV)-infected mother
• Has a diagnosis of active untreated tuberculosis
• Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (37)

Alabama Clinical Therapeutics ( Site 0018)

Birmingham, Alabama, 35205, United States

Location

Children's Clinic of Jonesboro, PA ( Site 0030)

Jonesboro, Arkansas, 72401, United States

Location

Southland Clinical Research Center ( Site 0017)

Anaheim, California, 92804, United States

Location

Premier Health Research Center, LLC ( Site 0044)

Downey, California, 90240, United States

Location

California Research Foundation ( Site 0003)

San Diego, California, 92123, United States

Location

IMMUNOe Research Centers ( Site 0046)

Thornton, Colorado, 80233, United States

Location

Children's Research at Altamonte Pediatric Associates ( Site 0040)

Lake Mary, Florida, 32746, United States

Location

University of South Florida ( Site 0042)

Tampa, Florida, 33606, United States

Location

Advanced Clinical Research ( Site 0038)

Meridian, Idaho, 83642, United States

Location

Heartland Research Associates, LLC ( Site 0029)

Augusta, Kansas, 67010, United States

Location

Heartland Research Associates, LLC ( Site 0015)

Newton, Kansas, 67114, United States

Location

Cotton O'Neil Research Center ( Site 0014)

Topeka, Kansas, 66604, United States

Location

Kentucky Pediatric/Adult Research Inc ( Site 0012)

Bardstown, Kentucky, 40004, United States

Location

University of Louisville: Pediatric Clinical Trials Unit ( Site 0025)

Louisville, Kentucky, 40202, United States

Location

ACC Pediatric Research ( Site 0041)

Haughton, Louisiana, 71037, United States

Location

The Center For Pharmaceutical Research PC ( Site 0011)

Kansas City, Missouri, 64114, United States

Location

Child Health Care Associates ( Site 0045)

East Syracuse, New York, 13057, United States

Location

Blue Ridge Pediatric & Adolescent Medicine ( Site 0001)

Boone, North Carolina, 28607, United States

Location

Ford, Simpson, Lively & Rice Pediatrics, PLLC ( Site 0037)

Winston-Salem, North Carolina, 27103, United States

Location

Senders Pediatrics ( Site 0034)

Cleveland, Ohio, 44121, United States

Location

Ohio Pediatric Research Association ( Site 0035)

Dayton, Ohio, 45414, United States

Location

Kid's Way Pediatrics ( Site 0047)

Hermitage, Pennsylvania, 16148, United States

Location

Palmetto Pediatrics, PA ( Site 0023)

Charleston, South Carolina, 29406, United States

Location

Coastal Pediatric Research ( Site 0006)

Charleston, South Carolina, 29414, United States

Location

Holston Medical Group Pediatrics ( Site 0024)

Kingsport, Tennessee, 37660, United States

Location

Benchmark Research ( Site 0005)

Austin, Texas, 78705, United States

Location

University of Texas Medical Branch at Galveston ( Site 0032)

Galveston, Texas, 77555, United States

Location

West Houston Clinical Research Services ( Site 0009)

Houston, Texas, 77055, United States

Location

Pediatric Healthcare of Northwest Houston ( Site 0027)

Tomball, Texas, 77375, United States

Location

Tanner Clinic ( Site 0010)

Layton, Utah, 84041, United States

Location

Wee Care Pediatrics-Roy ( Site 0043)

Roy, Utah, 84067, United States

Location

J Lewis Research Inc / Foothill Family Clinic ( Site 0016)

Salt Lake City, Utah, 84109, United States

Location

J Lewis Research Inc/Foothill Family Clinic South ( Site 0004)

Salt Lake City, Utah, 84121, United States

Location

J Lewis Research Inc/Jordan River Family Medicine ( Site 0019)

South Jordan, Utah, 84095, United States

Location

Wee Care Pediatrics ( Site 0036)

Syracuse, Utah, 84075, United States

Location

Advanced Clinical Research ( Site 0020)

West Jordan, Utah, 84088, United States

Location

Pediatric Research of Charlottesville, LLC ( Site 0039)

Charlottesville, Virginia, 22902, United States

Location

Related Publications (1)

• Silas PE, Zissman EN, Gardner J, Helian S, Lee AW, Platt HL. A double-blind, randomized, multicenter, controlled study to evaluate the immunogenicity, safety, and tolerability of varicella vaccine (VARIVAX) passage extension 34 (PE34) process administered concomitantly with measles, mumps, and rubella vaccine (M-M-R II). Hum Vaccin Immunother. 2020 Nov 1;16(11):2634-2640. doi: 10.1080/21645515.2020.1743122. Epub 2020 May 19.

  PMID: 32429738 RESULT

MeSH Terms

Conditions

Chickenpox

Interventions

Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 4, 2017
• Study Start: October 17, 2017
• Primary Completion: August 14, 2018
• Study Completion: April 2, 2019
• Last Updated: January 27, 2021
• Results First Posted: August 26, 2019

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

US (37)