Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)

Varicella Clinical Trial

Official title:

Safety, Tolerability, and Immunogenicity of VARIVAX (2007 Commercial VZV Bulk Process) Administered Concomitantly With M-M-R II in Healthy Children 12-to-23 Months of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822237
• Other study ID #: V210-057
• Secondary ID: 2009_510
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2009
• Last updated: October 29, 2015
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

This treatment has been approved for sale to the public.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 23 Months

Eligibility

Inclusion Criteria:

• Subject is in good health based on medical history

• Subject has no history of measles, mumps, rubella, chickenpox, or shingles

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Varicella

Intervention

Biological:
• Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)
VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart
• Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)
VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart
• Measles, Mumps, and Rubella Virus Vaccine Live (MMR)
M-M-R II in two 0.5 mL doses by injection ~6 weeks apart

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site