DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Measles; Mumps; Rubella; Varicella

Intervention: ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live) (Biological); Comparator: M-M-R II (Biological); Comparator: Varivax (Biological); Comparator: Placebo (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Clinical Details

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

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

Primary outcome:

Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer

Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer

Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer

Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer

Eligibility

Minimum age: 4 Years. Maximum age: 6 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site

Starting date: August 2000
Last updated: July 16, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017