Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)

Overview

This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™ 2007 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™ NSP are non-inferior to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by VARIVAX™ NSP is acceptable.

Full Title of Study: “A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ New Seed Process (NSP) Administered Concomitantly With M-M-R™ II”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: February 24, 2015

Interventions

  • Biological: VARIVAX™ New Seed Process
    • Varicella virus vaccine live manufactured with a new seed process
  • Biological: VARIVAX™ 2007 process
    • Varicella virus vaccine live manufactured with the 2007 process
  • Biological: M-M-R II™
    • Measles, Mumps, and Rubella virus vaccine live

Arms, Groups and Cohorts

  • Experimental: VARIVAX™ NSP + M-M-R II™
    • VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91
  • Active Comparator: VARIVAX™ 2007 Process + M-M-R II™
    • VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
    • Time Frame: 6 weeks (43 days) after vaccination 1
  • Geometric Mean Titer of VZV Antibodies
    • Time Frame: 6 weeks (43 days) after vaccination 1
    • Antibody titers were measured with gpELISA.

Secondary Measures

  • Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)
    • Time Frame: Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)
  • Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1
    • Time Frame: Up to 42 days after Vaccination 1
  • Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2
    • Time Frame: Up to 42 days after Vaccination 2
  • Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1
    • Time Frame: 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
    • Time Frame: Up to 5 days after Vaccination 2

Participating in This Clinical Trial

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™ – 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 – Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.

Gender Eligibility: All

Minimum Age: 12 Months

Maximum Age: 23 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Merck Sharp & Dohme LLC

Citations Reporting on Results

Senders SD, Bundick ND, Li J, Zecca C, Helmond FA. Evaluation of immunogenicity and safety of VARIVAX New Seed Process (NSP) in children. Hum Vaccin Immunother. 2018 Feb 1;14(2):442-449. doi: 10.1080/21645515.2017.1388479. Epub 2017 Dec 11.

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