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This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines.
Stage I Primary Objectives:
Stage II Primary Objectives:
This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAPTACEL Lot 1 | Experimental | Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 1 |
|
| DAPTACEL Lot 2 | Experimental | Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 2 |
|
| DAPTACEL Lot 3 | Experimental | Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 3 |
|
| Pentacel | Active Comparator | Participants receiving Pentacel vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity: To provide information concerning the immune response of DAPTACEL after vaccination. | 30 days post-vaccination 3 |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayetteville, AR 72703 | Arkansas | 72703 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19117896 | Result | Guerra FA, Blatter MM, Greenberg DP, Pichichero M, Noriega FR; Pentacel Study Group. Safety and immunogenicity of a pentavalent vaccine compared with separate administration of licensed equivalent vaccines in US infants and toddlers and persistence of antibodies before a preschool booster dose: a randomized, clinical trial. Pediatrics. 2009 Jan;123(1):301-12. doi: 10.1542/peds.2007-3317. |
| Label | URL |
|---|---|
| Related Info | View source |
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|
| Pentacel: DTaP-IPV/Hib | Biological | 0.5 mL, Intramuscular |
|
|
| Jonesboro, AR 72401 |
| Arkansas |
| 7240 |
| United States |
| Little Rock, AR 72211 | Arkansas | 72211 | United States |
| Fountain Valley, CA 92708 | California | 92708 | United States |
| Englewood, CO 80112 | Colorado | 80112 | United States |
| Norwich, CT 06360 | Connecticut | 06360 | United States |
| Orlando, FL 32856 | Florida | 32856 | United States |
| Marietta, GA 30062 | Georgia | 30062 | United States |
| Chicago, IL 60614 | Illinois | 60614 | United States |
| Bardstown, KY 40004 | Kentucky | 40004 | United States |
| Bossier City, LA 71111 | Louisiana | 71111 | United States |
| Bridgeton, MO 63044 | Missouri | 63044 | United States |
| Rochester, NY 14620 | New York | 14620 | United States |
| Chapel Hill, NC 27514 | North Carolina | 27514 | United States |
| Portland, OR 97201 | Oregon | 97201 | United States |
| Norristown, PA 19401 | Pennsylvania | 19401 | United States |
| Pittsburgh, PA 15213 | Pennsylvania | 15213 | United States |
| Pittsburgh, PA 15241 | Pennsylvania | 15241 | United States |
| Kingsport, TN 37664 | Tennessee | 37664 | United States |
| Austin, TX 78758 | Texas | 78758 | United States |
| Fort Worth, TX 76107 | Texas | 76106 | United States |
| San Antonio, TX 78205 | Texas | 78205 | United States |
| Provo, UT 84604 | Utah | 84604 | United States |
| Spokane, WA 99220 | Washington | 99220 | United States |
| LaCrosse, WI 54601 | Wisconsin | 54601 | United States |
| Marshfield, WI 54449 | Wisconsin | 54449 | United States |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D011051 | Poliomyelitis |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D016871 | Pasteurellaceae Infections |
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| ID | Term |
|---|---|
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| D013745 | Tetanus Toxoid |
| C512971 | pentacel |
| ID | Term |
|---|---|
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D004168 | Diphtheria Toxoid |
| D014121 | Toxoids |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
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