ProQuad Dose Selection Study (V221-011)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Rubella; Varicella; Mumps; Measles

Treatments: Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live; Biological: Comparator: PUVV; Biological: Comparator: M-M-R II

Study type: Interventional

Funder types: Industry

Identifiers

NCT00986232

2009_667

V221-011

Details and patient eligibility

About

A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.

Enrollment: 1,551 patients

Sex: All

Ages: 12 to 23 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• In good health
• Negative clinical history of measles, mumps, rubella, varicella, and zoster

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,551 participants in 4 patient groups

1

Experimental group

Description:

ProQuad (low dose)

Treatment:

Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live

2

Experimental group

Description:

ProQuad (middle dose)

Treatment:

Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live

3

Experimental group

Description:

ProQuad (high dose)

Treatment:

Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live

4

Active Comparator group

Description:

M-M-R II + PUVV

Treatment:

Biological: Comparator: PUVV

Biological: Comparator: M-M-R II