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Sponsored by: |
Sanofi Pasteur MSD |
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Information provided by: | Sanofi Pasteur MSD |
ClinicalTrials.gov Identifier: | NCT00560755 |
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 |
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 |
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
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Ages Eligible for Study: | 12 Months to 22 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Emilio LEDESMA, MD | Sanofi Pasteur MSD |
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 |
Prevention of: measles, mumps, rubella and varicella |
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 |
Rubivirus Infections Parotid Diseases RNA Virus Infections Morbillivirus Infections |
Parotitis Rubulavirus Infections Mononegavirales Infections |