ProQuad® rHA Safety - Full Text View

Sponsored by:	Sanofi Pasteur MSD
Information provided by:	Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:	NCT00560755

Purpose

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

Condition	Intervention	Phase
Measles Mumps Rubella Varicella	Biological: ProQuad® manufactured with rHA	Phase III

MedlinePlus related topics: Chickenpox Measles Mumps Rubella Shingles

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:

Solicited injection-site adverse reactions (erythema, swelling, pain) [ Time Frame: from day 0 to day 4 following second dose ] [ Designated as safety issue: Yes ]
Unsolicited injection-site adverse reactions, Numeric values of temperature, Systemic Adverse Event [ Time Frame: Day 0 to Day 28 following second dose ] [ Designated as safety issue: Yes ]
Serious Adverse Events [ Time Frame: from Day 0 to next visit (or last visit in case of premature discontinuation) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Solicited injection-site adverse reactions (erythema, swelling, pain) [ Time Frame: From Day 0 to Day 4 following first dose ] [ Designated as safety issue: Yes ]
Unsolicited injection-site adverse reactions, Numeric values of temperature, Systemic Adverse Event [ Time Frame: From Day 0 to Day 28 following first dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	3340
Study Start Date:	October 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: ProQuad® manufactured with rHA Measles-Mumps-Rubella-Varicella live vaccine

Eligibility

Ages Eligible for Study:	12 Months to 22 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560755

Show 67 Study Locations

Sponsors and Collaborators

Sanofi Pasteur MSD

Investigators

Study Director:

Emilio LEDESMA, MD

Sanofi Pasteur MSD

More Information

Responsible Party:	Sanofi Pasteur MSD ( Emilio LEDESMA MD )
Study ID Numbers:	MRV01C
Study First Received:	November 19, 2007
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00560755
Health Authority:	Germany: Paul-Ehrlich-Institut; Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; The Netherlands: Ministry VWS (Ministerie van Volksgezondheid, Welzijn en Sport); Greece: National Organization of Medicines; Spain: Spanish Agency of Medicines; Italy: The Italian Medicines Agency

Keywords provided by Sanofi Pasteur MSD:

Prevention of: measles, mumps, rubella and varicella

Study placed in the following topic categories:

Herpes Zoster
Mouth Diseases
Paramyxoviridae Infections
Measles
Chickenpox
Rubella
Togaviridae Infections

Herpesviridae Infections
Virus Diseases
DNA Virus Infections
Chicken pox
Stomatognathic Diseases
Salivary Gland Diseases
Mumps

Additional relevant MeSH terms:

Rubivirus Infections
Parotid Diseases
RNA Virus Infections
Morbillivirus Infections

Rubulavirus Infections
Parotitis
Mononegavirales Infections

ClinicalTrials.gov processed this record on January 15, 2009