A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)

Measles Clinical Trial

Official title:

Administration of Frozen Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine to Healthy Children at 4 to 6 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985166
• Other study ID #: V221-014
• Secondary ID: 2009_668
• Status: Completed
• Phase: Phase 3
• First received: September 24, 2009
• Last updated: July 16, 2015
• Start date: August 2000
• Est. completion date: May 2003

Study information

• Verified date: July 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

The study was conducted to determine if ProQuad may be used in place of the second dose of M-M-R II routinely given to children 4 to 6 years old who were previously immunized with M-M-R II and Varivax.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: May 2003
• Est. primary completion date: May 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria:

• In good health

• Received primary dose of M-M-R II at less than or equal to 12 months of age

• Received primary dose of Varivax at less than or equal to 12 months of age

• Negative history of varicella, zoster, measles, mumps, and rubella

Exclusion Criteria:

• history of receiving more than once dose of M-M-R II or Varivax

• 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

• Receipt of immune globulin, or blood product in the past 5 months

Study Design

Allocation: Randomized, Endpoint Classification: 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:
• ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)
A Single 0.5 mL subcutaneous injection at Day 1
• Comparator: M-M-R II
A Single 0.5 mL subcutaneous injection at Day 1
• Comparator: Varivax
A Single 0.5 mL subcutaneous injection at Day 1
• Comparator: Placebo
A Single 0.5 mL subcutaneous placebo injection at Day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Reisinger KS, Brown ML, Xu J, Sullivan BJ, Marshall GS, Nauert B, Matson DO, Silas PE, Schödel F, Gress JO, Kuter BJ; Protocol 014 Study Group for ProQuad. A combination measles, mumps, rubella, and varicella vaccine (ProQuad) given to 4- to 6-year-old he — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer	Postvaccination observed Geometric Mean Titer of antibody to Varicella	6 weeks Postvaccination	No
Primary	Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer	Postvaccination observed Geometric Mean Titer of antibody to Measles	6 weeks Postvaccination	No
Primary	Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer	Postvaccination observed Geometric Mean Titer of antibody to Mumps	6 weeks Postvaccination	No
Primary	Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer	Postvaccination observed Geometric Mean Titer of antibody to Rubella	6 weeks Postvaccination	No

External Links

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