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

Phase 3

Completed

• Conditions: Mumps; Rubella; Measles; Varicella

• Registration Number: NCT00985166
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-08
• Primary Completion: 2002-05
• Study Completion: 2003-05
• Study First Submitted: 2009-09-24
• Study First Submitted QC: 2009-09-25
• Study First Posted: 2009-09-28
• Results First Submitted: 2009-12-23
• Results First Submitted QC: 2009-12-23
• Results First Posted: 2010-01-29
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-16
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 801

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer	6 weeks Postvaccination	Postvaccination observed Geometric Mean Titer of antibody to Mumps
Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer	6 weeks Postvaccination	Postvaccination observed Geometric Mean Titer of antibody to Measles
Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer	6 weeks Postvaccination	Postvaccination observed Geometric Mean Titer of antibody to Rubella
Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer	6 weeks Postvaccination	Postvaccination observed Geometric Mean Titer of antibody to Varicella