Clinical trial NCT03239873: Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)
Official title: A Phase 3, Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Passage Extension 34 (PE34) Process Administered Concomitantly With M-M-R™ II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2017-08-04
Enrollment: 600
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Negative clinical history for varicella, herpes zoster, measles, mumps, and rubella

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
timeFrame: 6 weeks (43 days) after vaccination 1
measure: Geometric Mean Titer of VZV Antibodies
timeFrame: 6 weeks (43 days) after vaccination 1
Secondary outcomes:
measure: Percentage of Participants With Fever (≥102.2 °F Oral Equivalent)
timeFrame: Up to 42 days after vaccination 1; Up to 42 days after vaccination 2
measure: Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence > 0%)
timeFrame: Up to 42 days after vaccination 1
measure: Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 2 (Incidence > 0%)
timeFrame: Up to 42 days after vaccination 2
measure: Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, or Injection-site Pain/Tenderness After Vaccination 1
timeFrame: Up to 5 days after vaccination 1
measure: Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2
timeFrame: Up to 5 days after vaccination 2
measure: Percentage of Participants With One or More Adverse Events
timeFrame: Up to 42 days after vaccination 1 and up to 42 days after vaccination 2
measure: Percentage of Participants With One or More Serious Adverse Events
timeFrame: Up to ~180 days after vaccination 2 (Up to ~285 days)
measure: Percentage of Participants With One or More Vaccine-Related Adverse Events
timeFrame: Up to 42 days after vaccination 1 and up to 42 days after vaccination 2
measure: Percentage of Participants With One or More Systemic Adverse Events After Vaccination 1 (Incidence ≥ 4)
timeFrame: Up to 42 days after vaccination 1
measure: Percentage of Participants With One or More Systemic Adverse Events After Vaccination 2 (Incidence > 0)
timeFrame: Up to 42 days after vaccination 2
measure: Percentage of Participants With Immunogenicity to Varicella Zoster Virus in Participants Initially Seropositive to Varicella Zoster Virus Antibody (≥ 5gpELISA Units/mL)
timeFrame: 6 weeks (~43 days) after vaccination 1
measure: Geometric Mean Fold Rise From Baseline in Varicella Zoster Virus Antibody Titer in Participants Initially Seropositive to Varicella Zoster Virus Antibody
timeFrame: Baseline and 6 weeks (~43 days) after vaccination 1
measure: Percentage of Participants With a ≥4-fold Rise From Baseline in Varicella Zoster Virus Antibody Titers in Participants Initially Seropositive to Varicella Zoster Virus Antibody
timeFrame: Baseline and 6 weeks (~43 days) after vaccination 1
measure: Percentage of Participants With One or More Vaccine-Related Serious Adverse Events
timeFrame: Up to ~180 days after vaccination 2
measure: Percentage of Participants Who Discontinued From the Study Due to an Adverse Event
timeFrame: Up to 42 days after vaccination 1 and up to 42 days after vaccination 2
measure: Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 1 (Incidence > 0%)
timeFrame: Up to 42 days after vaccination 1
measure: Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 2 (Incidence > 0%)
timeFrame: Up to 42 days after vaccination 2
measure: Percentage of Participants With Medically-Attended Adverse Events (Incidence ≥5%)
timeFrame: Up to ~180 days after vaccination 2 (Up to ~285 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics ( Site 0018)
state: Alabama
city: Jonesboro
country: United States
facility: Children's Clinic of Jonesboro, PA ( Site 0030)
state: Arkansas
city: Anaheim
country: United States
facility: Southland Clinical Research Center ( Site 0017)
state: California
city: Downey
country: United States
facility: Premier Health Research Center, LLC ( Site 0044)
state: California
city: San Diego
country: United States
facility: California Research Foundation ( Site 0003)
state: California
city: Thornton
country: United States
facility: IMMUNOe Research Centers ( Site 0046)
state: Colorado
city: Lake Mary
country: United States
facility: Children's Research at Altamonte Pediatric Associates ( Site 0040)
state: Florida
city: Tampa
country: United States
facility: University of South Florida ( Site 0042)
state: Florida
city: Meridian
country: United States
facility: Advanced Clinical Research ( Site 0038)
state: Idaho
city: Augusta
country: United States
facility: Heartland Research Associates, LLC ( Site 0029)
state: Kansas
city: Newton
country: United States
facility: Heartland Research Associates, LLC ( Site 0015)
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Research Center ( Site 0014)
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research Inc ( Site 0012)
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville: Pediatric Clinical Trials Unit ( Site 0025)
state: Kentucky
city: Haughton
country: United States
facility: ACC Pediatric Research ( Site 0041)
state: Louisiana
city: Kansas City
country: United States
facility: The Center For Pharmaceutical Research PC ( Site 0011)
state: Missouri
city: East Syracuse
country: United States
facility: Child Health Care Associates ( Site 0045)
state: New York
city: Boone
country: United States
facility: Blue Ridge Pediatric & Adolescent Medicine ( Site 0001)
state: North Carolina
city: Winston-Salem
country: United States
facility: Ford, Simpson, Lively & Rice Pediatrics, PLLC ( Site 0037)
state: North Carolina
city: Cleveland
country: United States
facility: Senders Pediatrics ( Site 0034)
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association ( Site 0035)
state: Ohio
city: Hermitage
country: United States
facility: Kid's Way Pediatrics ( Site 0047)
state: Pennsylvania
city: Charleston
country: United States
facility: Palmetto Pediatrics, PA ( Site 0023)
state: South Carolina
city: Charleston
country: United States
facility: Coastal Pediatric Research ( Site 0006)
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group Pediatrics ( Site 0024)
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research ( Site 0005)
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston ( Site 0032)
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research Services ( Site 0009)
state: Texas
city: Tomball
country: United States
facility: Pediatric Healthcare of Northwest Houston ( Site 0027)
state: Texas
city: Layton
country: United States
facility: Tanner Clinic ( Site 0010)
state: Utah
city: Roy
country: United States
facility: Wee Care Pediatrics-Roy ( Site 0043)
state: Utah
city: Salt Lake City
country: United States
facility: J Lewis Research Inc / Foothill Family Clinic ( Site 0016)
state: Utah
city: Salt Lake City
country: United States
facility: J Lewis Research Inc/Foothill Family Clinic South ( Site 0004)
state: Utah
city: South Jordan
country: United States
facility: J Lewis Research Inc/Jordan River Family Medicine ( Site 0019)
state: Utah
city: Syracuse
country: United States
facility: Wee Care Pediatrics ( Site 0036)
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research ( Site 0020)
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC ( Site 0039)
state: Virginia
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.