ProQuad® Intramuscular vs Subcutaneous

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Rubella; Varicella; Mumps; Measles

Treatments: Biological: ProQuad®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00402831

2006-001986-40 (EudraCT Number)

V221-036

F05-MMRV-304 (Other Identifier)

Details and patient eligibility

About

Primary objective:

To demonstrate that two doses of ProQuad® administered by IM route are as immunogenic as two doses of ProQuad® administered by SC route to healthy children 12 to 18 months of age in terms of antibody response rates to measles, mumps, rubella and to varicella at 42 days following the second dose of ProQuad®

Secondary objectives:

• To describe the antibody response rates to measles, mumps, rubella and varicella measured 30 days following the first dose of ProQuad® administered by IM or SC route,
• To describe the antibody titres to measles, mumps, rubella and varicella at 30 days following the first dose and at 42 days following the second dose of ProQuad® both administered by IM or SC route,
• To describe the safety profile of two doses of ProQuad® both administered by IM or SC route.

Enrollment: 405 patients

Sex: All

Ages: 12 to 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy participant of either gender,
• Age 12 to 18 months,
• Negative clinical history of measles, mumps, rubella, varicella and zoster,
• Consent form signed by both holders of the parental authority or by the legal representative
• Holder(s) of the the parental authority / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion criteria

• Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination,
• Any recent (≤30 days) exposure to measles, mumps, rubella, varicella and/or zoster
• Any recent (≤3 days) history of febrile illness
• Any severe chronic disease,
• Active untreated tuberculosis,
• Known personal history of seizure disorder,
• Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems,
• Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
• Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity including those resulting from corticosteroid [any long-term (≥14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses (≥2 mg/kg/day prednisone equivalent or ≥20 mg/day if weight more than 10 kg) within the previous 30 days] or other immunosuppressive therapy,
• Any previous (≤ 150 days) receipt of immune globulin or any blood-derived product or scheduled to be administered through Visit 3,
• Any recent (≤7 days) tuberculin test or scheduled tuberculin test through Visit 3,
• Any recent (≤30 days) receipt of an inactivated or a live vaccine or scheduled vaccination through Visit 3,

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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405 participants in 2 patient groups

Intramuscular ProQuad®

Experimental group

Description:

Participants will receive doses of ProQuad® by IM injection on Day 1 and Day 30 into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm.

Treatment:

Biological: ProQuad®

Subcutaneous ProQuad®

Active Comparator group

Description:

Participants will receive doses of ProQuad® by SC injection on Day 1 and Day 30 in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm.

Treatment:

Biological: ProQuad®