ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)

Measles Clinical Trial

Official title:

A Pilot Study to Compare the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine and the Concomitant Administration of the Currently Licensed VARIVAX™ and M-M-R II™ in Healthy Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975507
• Other study ID #: V221-009
• Secondary ID: 2009_660
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2009
• Last updated: October 5, 2015
• Start date: March 1998
• Est. completion date: June 1999

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 compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: June 1999
• Est. primary completion date: January 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 23 Months

Eligibility

Inclusion Criteria:

• In good health

• Negative clinical history of varicella, shingles, measles, mumps, and rubella

Exclusion Criteria:

• Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination

• Any immune impairment or deficiency

• Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination

• Vaccination with an inactive vaccine with in the past 14 days

• Vaccination with a live vaccine within the past 30 days

• Immune globulin or any blood product administered in the past 3 months

Study Design

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

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Measles
• Mumps
• Rubella
• Varicella

Intervention

Biological:
• Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90
• Comparator: Placebo
a single 0.5 mL subcutaneous placebo injection at Day 0
• Comparator: Varivax
a single 0.5 mL subcutaneous injection of Varivax at Day 0
• Comparator: M-M-R II
a single 0.5 mL subcutaneous injection of M-M-R II at Day 0

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Shinefield H, Black S, Digilio L, Reisinger K, Blatter M, Gress JO, Brown ML, Eves KA, Klopfer SO, Schödel F, Kuter BJ. Evaluation of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):665-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Postvaccination Varicella Antibody Titer =5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline	Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline	6 weeks Postvaccination	No
Secondary	Number of Participants With Postvaccination Measles ELISA Antibody Titer =207.8 mIU/mL	Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline	6 weeks Postvaccination	No
Secondary	Number of Participants With Postvaccination Varicella Antibody Titer =5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline	Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline	6 weeks Postvaccination	No
Secondary	Number of Participants With Postvaccination Mumps ELISA Antibody Titer =2.0 Ab Units/mL	Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline	6 weeks Postvaccination	No
Secondary	Number of Participants With Postvaccination Rubella ELISA Antibody Titer =10 IU/mL	Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline	6 weeks Postvaccination	No

External Links

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