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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Rubella; Varicella; Mumps; Measles

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00985166

V221-014

2009_668

Details and patient eligibility

About

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.

Enrollment: 801 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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801 participants in 3 patient groups

1

Experimental group

Description:

ProQuad + Placebo

Treatment:

Biological: Comparator: Placebo

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

2

Active Comparator group

Description:

M-M-R II + Placebo

Treatment:

Biological: Comparator: M-M-R II

Biological: Comparator: Placebo

3

Active Comparator group

Description:

M-M-R II + Varivax

Treatment:

Biological: Comparator: Varivax

Biological: Comparator: M-M-R II