Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Rubella; Varicella; Mumps; Measles

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00985153

2009_669

V221-012

Details and patient eligibility

About

This study will compare three consistency lots of ProQuad to each other as well as to M-M-R II and Varivax, administered concomitantly at different injection sites, with respect to immunogenicity, safety, and tolerability.

Enrollment: 3,927 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

3,927 participants in 4 patient groups

1

Experimental group

Description:

ProQuad Lot 1

Treatment:

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

2

Experimental group

Description:

ProQuad Lot 2

Treatment:

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

3

Experimental group

Description:

ProQuad Lot 3

Treatment:

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

4

Active Comparator group

Description:

M-M-R II + Varivax

Treatment:

Biological: Comparator: M-M-R II

Biological: Comparator: Varivax