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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00802867 |
Observational Objectives:
Condition | Intervention | Phase |
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Diphtheria Tetanus Pertussis Polio Haemophilus Influenzae Type B |
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Safety and Immunogenicity of DAPTACEL® (CP10/5/5/3DT Aventis Pasteur 5-Component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™ (HCP20/20/5/3DT-mIPV//PRP-T) |
Enrollment: | 989 |
Study Start Date: | February 2004 |
Study Completion Date: | September 2005 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Subjects in Study 494-01 and Study 494-03 who had received 4 doses of Pentacel™ vaccine.
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Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)
0.5 mL, Intramuscular
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This study is designed to assess the safety and immunogenicity of DAPTACEL® vaccine administered at 4 to 6 years of age according to the US standard of care. The study population consists of PENTACEL™-primed subjects from Aventis Pasteur's pivotal studies 494-01 and 494-03. These children will receive DAPTACEL® vaccine as a 5th dose immunization between 4 to 6 years of age.
Ages Eligible for Study: | 4 Years to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Temporary contraindications:
Oral temperature >= 100.4°F (>= 38.0ºC) (Note: A tympanic thermometer should not be used).
United States, Arkansas | |
Little Rock, Arkansas, United States, 72205 | |
Jonesboro, Arkansas, United States, 72401 | |
United States, California | |
Oakland, California, United States, 94612 | |
Torrance, California, United States, 90502 | |
United States, Florida | |
Orlando, Florida, United States, 32806 | |
United States, Georgia | |
Atlanta, Georgia, United States, 30322 | |
United States, Massachusetts | |
Boston, Massachusetts, United States, 02115 | |
Woburn, Massachusetts, United States, 01801 | |
United States, Nebraska | |
Omaha, Nebraska, United States, 68131 | |
United States, New York | |
Albany, New York, United States, 12208 | |
Rochester, New York, United States, 14620 | |
United States, North Carolina | |
Chapel Hill, North Carolina, United States, 27514 | |
Sylva, North Carolina, United States, 28779 | |
United States, Pennsylvania | |
Pittsburgh, Pennsylvania, United States, 15241 | |
United States, Tennessee | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
San Antonio, Texas, United States, 78205 | |
United States, Utah | |
Layton, Utah, United States, 84041 | |
United States, Washington | |
Vancouver, Washington, United States, 98664 | |
United States, Wisconsin | |
Marshfield, Wisconsin, United States, 54449 |
Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur Inc. ( Medical Monitor ) |
Study ID Numbers: | P3T10 |
Study First Received: | December 4, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00802867 |
Health Authority: | United States: Food and Drug Administration |
DAPTACEL® PENTACEL™ Diphtheria |
Tetanus Pertussis Haemophilus influenzae type b |
Bacterial Infections Haemophilus influenzae Whooping Cough Cough Diphtheria Orthomyxoviridae Infections Tetanus Whooping cough |
Gram-Negative Bacterial Infections Virus Diseases Gram-Positive Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases Poliomyelitis Influenza, Human Clostridium Infections |
Bordetella Infections RNA Virus Infections Corynebacterium Infections Infection Actinomycetales Infections |