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

Merck Sharp & Dohme LLC1,551 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,551

Conditions

Measles Mumps Rubella Varicella

Interventions

Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine LiveBIOLOGICAL

a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90

Comparator: M-M-R IIBIOLOGICAL

A single 0.5 mL subcutaneous injection at Day 0

Comparator: PUVVBIOLOGICAL

A single 0.5 mL subcutaneous injection at Day 0

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 23 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units

Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer \<1.25 gpELISA units

Time frame: 6 weeks postvaccination

Secondary Outcomes

Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL

Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer \<207.5 mIU/mL) to measles at baseline

Time frame: 6 weeks postvaccination

Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL

Antibody response to Mumps at 6 weeks postvaccination in participants initially seronegative (a titer \< 2.0 Ab units/mL) to Mumps at baseline

Time frame: 6 weeks Postvaccination

Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL

Antibody response to Rubella at 6 weeks postvaccination in participants initially seronegative (a titer \<10 IU/mL) to Rubella at baseline

Time frame: 6 weeks Postvaccination

Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)

Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).

Time frame: 6 weeks Postvaccination Visit 1 or Visit 2

Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)

Data from ClinicalTrials.gov

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