NCT00822237

Brief Summary

This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly administered with M-M-R II in healthy children.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
598

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

January 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 21, 2011

Completed
Last Updated

April 12, 2017

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

January 9, 2009

Results QC Date

October 28, 2010

Last Update Submit

March 14, 2017

Conditions

Varicella

Outcome Measures

Primary Outcomes (1)

  • Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).

    Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer \< 1.25 gpELISA units/mL. Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only.

    6 weeks following first vaccination

Study Arms (2)

VARIVAX 2007 process + M-M-R II

EXPERIMENTAL
Biological: Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)

VARIVAX 1999 process + M-M-R II

ACTIVE COMPARATOR
Biological: Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)

Interventions

Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)BIOLOGICAL

VARIVAX (2007 process) in two 0.5 mL doses by injection \~6 weeks apart

VARIVAX 2007 process + M-M-R II
Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)BIOLOGICAL

VARIVAX (1999 process) in two 0.5 mL doses by injection \~6 weeks apart

VARIVAX 1999 process + M-M-R II
Measles, Mumps, and Rubella Virus Vaccine Live (MMR)BIOLOGICAL

M-M-R II in two 0.5 mL doses by injection \~6 weeks apart

VARIVAX 1999 process + M-M-R IIVARIVAX 2007 process + M-M-R II

Eligibility Criteria

Age12 Months - 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Subject is in good health based on medical history
  • Subject has no history of measles, mumps, rubella, chickenpox, or shingles

You may not qualify if:

  • Subject has previously received measles, mumps, rubella, and/or varicella vaccine either alone or in combination
  • Subject has history of immune disorders
  • Subject has been exposed to chickenpox/shingles, measles, mumps, rubella or varicella within 4 weeks of study start
  • Subject has received an inactivated vaccine within 14 days of first dose of study vaccine
  • Subject has received a live vaccine within 30 days of first dose of study vaccine
  • Subject has received a blood transfusion or blood-derived products within 3 months of receiving study vaccine
  • Subject has had a fever within 72 hours of study start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chickenpox

Interventions

Herpes Zoster VaccineMeasles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Chickenpox VaccineHerpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex MixturesVaccines, CombinedMeasles VaccineMumps 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 Monitor

    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, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 14, 2009

Study Start

January 1, 2009

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

April 12, 2017

Results First Posted

April 21, 2011

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php