Safety Study of ProQuad® rHA in Infants (V221-037)

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

NCT00560755

2007-002438-12 (EudraCT Number)

MRV01C (Other Identifier)

V221-037

Details and patient eligibility

About

Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured with recombinant human albumin (rHA) when administered to children in their second year of life.

Secondary objectives: To describe the safety profile of a first dose of ProQuad® manufactured with rHA when administered to children in their second year of life.

Enrollment: 3,388 patients

Sex: All

Ages: 12 to 22 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subject of either gender,
• Age from 12 to 22 months,
• Negative clinical history of infection with measles, mumps, rubella, varicella or zoster,
• Informed consent form signed by the parent(s) or by legal representative
• Parent(s) or legal representative able to attend all schedule visits with the subject and to understand and comply with the study procedures

Exclusion criteria

• Recent (≤ 3 days) history of febrile illness
• Prior receipt of measles, mumps, rubella and/or varicella vaccination, either alone or in any combination
• Recent (≤ 30 days) exposure to measles, mumps, rubella, varicella or zoster
• Prior known sensitivity/allergy to any component of the vaccine
• Severe chronic disease,
• Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic system
• Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
• Humoral or cellular immunodeficiency,
• Current immunosuppressive therapy
• Family history of congenital or hereditary immunodeficiency
• Hereditary problems of fructose intolerance
• Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
• Known active tuberculosis
• Recent (≤ 2 days) tuberculin test or scheduled tuberculin test through Visit 3
• Receipt of immunoglobulins or blood-derived products in the past 150 days
• Receipt of an inactivated vaccine in the past 14 days
• Receipt of a live vaccine in the past 28 days
• Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of study objectives
• Participation in another clinical study in the past 30 days

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,388 participants in 1 patient group

ProQuad®

Experimental group

Description:

Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.

Treatment:

Biological: ProQuad®