ProQuad® rHA Safety

Condition(s) targeted: Measles; Mumps; Rubella; Varicella

Intervention: ProQuad® manufactured with rHA (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi Pasteur MSD

Official(s) and/or principal investigator(s):
Anne FIQUET, MD, Study Director, Affiliation: Sanofi Pasteur MSD

Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured with 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

Official title: An Open-Label, Multi-Centre Study of the Safety of a 2-Dose Regimen of a Combined Measles, Mumps, Rubella and Varicella Live Vaccine (ProQuad®) Manufactured With Recombinant Human Albumin (rHA) When Administered to Children in Their Second Year of Life

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Solicited injection-site adverse reactions (erythema, swelling, pain)

Unsolicited injection-site adverse reactions, Numeric values of temperature, Systemic Adverse Event

Serious Adverse Events

Secondary outcome:

Solicited injection-site adverse reactions (erythema, swelling, pain)

Unsolicited injection-site adverse reactions, Numeric values of temperature, Systemic Adverse Event

Minimum age: 12 Months. Maximum age: 22 Months. Gender(s): Both.

Criteria:

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

Hvidovre, Denmark

Aalen, Germany

Bad Kreuznach, Germany

Bad Oeynhausen, Germany

Bad Säckingen, Germany

Bad Wimpfen, Germany

Bindlach, Germany

Bönnigheim, Germany

Darmstadt, Germany

Eisenberg, Germany

Ellhofen, Germany

Eschborn, Germany

Ettenheim, Germany

Falkensee, Germany

Gütersloh, Germany

Heilbronn, Germany

Herbolzheim, Germany

Jena, Germany

Langenselbold, Germany

Lauffen, Germany

Lörrach, Germany

Mannheim, Germany

Minden, Germany

Neuhaus, Germany

Nürnberg, Germany

Oberhausen, Germany

Schramberg, Germany

Solingen, Germany

Stuttgart, Germany

Traunreut, Germany

Velpke, Germany

Vilsbiburg, Germany

Wildeshausen, Germany

Zwiesel, Germany

Athens, Greece

Crete, Greece

Komotini, Greece

Larissa, Greece

Patras, Greece

Thessaloniki, Greece

Ferrara, Italy

Ragusa, Italy

Sassari, Italy

Rotterdam, Netherlands

Bueu (pontevedra), Spain

Burela (lugo), Spain

Catarroja, Spain

La Eliana, Spain

Ourense, Spain

Paiporta, Spain

Pamplona, Spain

Pontevedra, Spain

Puzol, Spain

Quart de Poblet, Spain

Redondela (pontevedra), Spain

Sagunto, Spain

San Cibrán. Aldán (pontevedra), Spain

Santiago de Compostela, Spain

Valencia, Spain

Vigo, Spain

Vilagarcía de Arosa (pontevedra), Spain

Bromma, Sweden

Eskilstuna, Sweden

Malmö, Sweden

Östersund, Sweden

Starting date: October 2007
Last updated: April 3, 2009