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Sponsored by: |
Sanofi Pasteur MSD |
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Information provided by: | Sanofi Pasteur MSD |
ClinicalTrials.gov Identifier: | NCT00402831 |
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:
Condition | Intervention | Phase |
---|---|---|
Measles Mumps Rubella Varicella |
Biological: ProQuad® (prevention of measles, mumps, rubella and varicella) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of ProQuad® When Administered by Intramuscular (IM) Route or Subcutaneous (SC) Route to Healthy Children Aged 12 to 18 Months |
Enrollment: | 405 |
Study Start Date: | October 2006 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Intramuscular
|
Biological: ProQuad® (prevention of measles, mumps, rubella and varicella)
route
|
2: Active Comparator
Subcutaneous
|
Biological: ProQuad® (prevention of measles, mumps, rubella and varicella)
route
|
Ages Eligible for Study: | 12 Months to 18 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
France | |
Aix les Bains, France | |
Ancenis, France | |
Antibes Juan les Pins, France | |
Cannes, France | |
Chambéry, France | |
Darnetal, France | |
Cannes la Bocca, France | |
Dijon, France | |
Draguignan, France | |
Dunkerque, France | |
Ecully, France | |
Essey-les-Nancy, France | |
Fréjus, France | |
Vence, France | |
Le Havre, France | |
Les Sables d'Olonne, France | |
Lyon, France | |
Nice, France | |
Oullins, France | |
Rouen, France | |
St Laurent du Var, France | |
St Priest, France | |
St Priest en Jarez, France | |
St Raphaël, France | |
Strasbourg, France | |
Vaulx en Velin, France | |
Illkirch, France |
Study Director: | Emilio Ledesma, MD | SPMSD |
Responsible Party: | Sanofi Pasteur MSD ( Emilio LEDESMA MD ) |
Study ID Numbers: | F05-MMRV-304 |
Study First Received: | November 21, 2006 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00402831 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Virus Diseases Herpes Zoster Measles Chickenpox DNA Virus Infections |
Chicken pox Healthy Rubella Mumps Herpesviridae Infections |