NCT02062502

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
611

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

March 7, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2015

Completed
5 months until next milestone

Results Posted

Study results publicly available

March 1, 2016

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

12 months

First QC Date

February 12, 2014

Results QC Date

February 2, 2016

Last Update Submit

October 1, 2018

Conditions

Varicella

Outcome Measures

Primary Outcomes (2)

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

    6 weeks (43 days) after vaccination 1

  • Geometric Mean Titer of VZV Antibodies

    Antibody titers were measured with gpELISA.

    6 weeks (43 days) after vaccination 1

Secondary Outcomes (5)

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

    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

    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

    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

    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™ NSP + M-M-R II™

EXPERIMENTAL

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

Biological: VARIVAX™ New Seed ProcessBiological: M-M-R II™

VARIVAX™ 2007 Process + M-M-R II™

ACTIVE COMPARATOR

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

Biological: VARIVAX™ 2007 processBiological: M-M-R II™

Interventions

VARIVAX™ New Seed ProcessBIOLOGICAL

Varicella virus vaccine live manufactured with a new seed process

VARIVAX™ NSP + M-M-R II™
VARIVAX™ 2007 processBIOLOGICAL

Varicella virus vaccine live manufactured with the 2007 process

VARIVAX™ 2007 Process + M-M-R II™
M-M-R II™BIOLOGICAL

Measles, Mumps, and Rubella virus vaccine live

VARIVAX™ 2007 Process + M-M-R II™VARIVAX™ NSP + M-M-R II™

Eligibility Criteria

Age12 Months - 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (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™
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29087781RESULT

MeSH Terms

Conditions

Chickenpox

Interventions

Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesMeasles VaccineViral VaccinesMumps VaccineRubella 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

February 12, 2014

First Posted

February 13, 2014

Study Start

March 7, 2014

Primary Completion

February 24, 2015

Study Completion

October 13, 2015

Last Updated

October 30, 2018

Results First Posted

March 1, 2016

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

More information