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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00772928 |
This study is designed to evaluate in a controlled manner, evaluate the effect of Prevnar® on the immune responses of Pentacel™
Primary Objective - Stage I:
To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®).
Primary Objective - Stage II:
To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.
Condition | Intervention | Phase |
---|---|---|
Diphtheria Tetanus Haemophilus Infection Pertussis Polio |
Biological: Liquid HCPDT-mIPV to reconstitute lyophilized ActHIB®: PRP-T |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Immunogenicity Assessment of Pentacel™ (Hybrid CP20/20/5/3DT-mIPV//PRP-T) When Given at Different Times From or Concurrently With a Pneumococcal Conjugate Vaccine |
Enrollment: | 1167 |
Study Start Date: | October 2003 |
Study Completion Date: | November 2006 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Pentacel™ concurrently administered with Prevnar®
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Biological: Liquid HCPDT-mIPV to reconstitute lyophilized ActHIB®: PRP-T
0.5 mL, Intramuscular
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2: Experimental
Pentacel™ given at different times from Prevnar® (using a standardized, staggered schedule).
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Biological: Liquid HCPDT-mIPV to reconstitute lyophilized ActHIB®: PRP-T
0.5 mL, Intramuscular
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This is a 2-staged study. Stage I of this study is designed to compare the immune responses elicited by an infant series (3 doses) of Pentacel™ when given at different times from or concurrently with Prevnar®.
Stage II is designed to describe the immune responses elicited by a 4th dose of Pentacel™ (all antigens) when given at different times from or concurrently with Prevnar®.
Ages Eligible for Study: | 42 Days to 89 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
United States, Alabama | |
Montgomery, Alabama, United States, 36106 | |
United States, Arkansas | |
Little Rock, Arkansas, United States, 72205 | |
Fayetteville, Arkansas, United States, 72703 | |
Jonesboro, Arkansas, United States, 72401 | |
United States, California | |
Rolling Hills Estate, California, United States, 90274 | |
Fountain Valley, California, United States, 92708 | |
Oakland, California, United States, 94612 | |
United States, Connecticut | |
Norwich, Connecticut, United States, 06360 | |
United States, Kentucky | |
Bardstown, Kentucky, United States, 40004 | |
Louisville, Kentucky, United States, 40202 | |
United States, Massachusetts | |
Boston, Massachusetts, United States, 02115 | |
United States, Missouri | |
Kansas City, Missouri, United States, 64112 | |
United States, New York | |
Brooklyn, New York, United States, 11201 | |
United States, Pennsylvania | |
Norristown, Pennsylvania, United States, 19401 | |
Pittsburgh, Pennsylvania, United States, 15241 | |
United States, Texas | |
Fort Worth, Texas, United States, 76107 | |
Austin, Texas, United States, 78745 | |
San Antonio, Texas, United States, 78229 | |
San Antonio, Texas, United States, 78745 | |
United States, Utah | |
Layton, Utah, United States, 84041 | |
United States, Washington | |
Vancouver, Washington, United States, 98864 | |
Spokane, Washington, United States, 99220 | |
United States, Wisconsin | |
Lacrosse, Wisconsin, United States, 54601 |
Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur Inc. ( Medical Monitor ) |
Study ID Numbers: | M5A07 |
Study First Received: | October 13, 2008 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00772928 |
Health Authority: | United States: Food and Drug Administration |
Pertussis Whooping cough Diphtheria |
Tetanus Haemophilus influenzae Poliovirus Types 1, 2, and 3. |
Haemophilus Infections Bacterial Infections Haemophilus influenzae Deferiprone Whooping Cough Cough Diphtheria Tetanus |
Whooping cough Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases Poliomyelitis Influenza, Human Clostridium Infections |
Bordetella Infections Pasteurellaceae Infections Corynebacterium Infections Infection Actinomycetales Infections |