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Objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Subjects in Study 494-01 and Study 494-03 who had received 4 doses of Pentacel™ vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®) | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function. Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash. | 0 to 3 days post-dose 5 vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose. | Anti-pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin). Fold-rise is calculated as Post-Dose 5/Pre-Dose 5 titer. | Day 28 to 48 Post-dose 5 |
| Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose |
Inclusion Criteria :
Exclusion Criteria :
Temporary contraindications:
Oral temperature ≥ 100.4°F (≥ 38.0ºC) (Note: A tympanic thermometer should not be used).
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonesboro | Arkansas | 72401 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 989 participants were enrolled and vaccinated with DAPTACEL as the fifth dose after receiving 4 doses of Pentacel vaccine in previous studies.
Participants were enrolled from 05 February through 30 November 2004 at 19 US sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | DAPTACEL® Vaccine Group | Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Booster response calculation: If Pre-Dose 5 titer < 4x limit of quantitation (LOQ), a 4-fold rise of Post-dose 5/Pre-dose 5; If Pre-dose 5 titer ≥ 4x LOQ, a 2-fold rise of Post-dose 5/Pre-dose 5. |
| Day 28 to 48 Post-dose 5 |
| Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Seroprotection is defined as a titer of ≥ 0.01 IU/mL for both Diphtheria and Tetanus before the fifth dose booster vaccination | Day 28 to 48 Post-dose 5 |
| Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Pre-dose 5 and Day 28 to 48 Post-dose 5 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Oakland | California | 94612 | United States |
| Torrance | California | 90502 | United States |
| Orlando | Florida | 32806 | United States |
| Atlanta | Georgia | 30322 | United States |
| Boston | Massachusetts | 02115 | United States |
| Woburn | Massachusetts | 01801 | United States |
| Omaha | Nebraska | 68131 | United States |
| Albany | New York | 12208 | United States |
| Rochester | New York | 14620 | United States |
| Chapel Hill | North Carolina | 27514 | United States |
| Sylva | North Carolina | 28779 | United States |
| Pittsburgh | Pennsylvania | 15241 | United States |
| Nashville | Tennessee | 37232 | United States |
| San Antonio | Texas | 78205 | United States |
| Layton | Utah | 84041 | United States |
| Vancouver | Washington | 98664 | United States |
| Marshfield | Wisconsin | 54449 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DAPTACEL® Vaccine Group | Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Other Pre-specified | Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose. | Anti-pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin). Fold-rise is calculated as Post-Dose 5/Pre-Dose 5 titer. | The vaccine antibody responses were evaluated in a subset of the per-protocol population for immunogenicity. | Posted | Number | Percentage of Participants | Day 28 to 48 Post-dose 5 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose | Booster response calculation: If Pre-Dose 5 titer < 4x limit of quantitation (LOQ), a 4-fold rise of Post-dose 5/Pre-dose 5; If Pre-dose 5 titer ≥ 4x LOQ, a 2-fold rise of Post-dose 5/Pre-dose 5. | The anti-Pertussis Booster response was evaluated in a subset of the per-protocol population for immunogenicity. | Posted | Number | Percentage of participants | Day 28 to 48 Post-dose 5 |
|
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| Other Pre-specified | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | Seroprotection is defined as a titer of ≥ 0.01 IU/mL for both Diphtheria and Tetanus before the fifth dose booster vaccination | The anti-Diphtheria and anti-Tetanus Toxoids Responses were evaluated in a subset of the per-protocol population for immunogenicity. | Posted | Number | Percentage of Participants | Day 28 to 48 Post-dose 5 |
|
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| Other Pre-specified | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose | The GMTs of anti-Pertussis, anti-Diphtheria, and anti-Tetanus Toxoids Responses were evaluated in a subset of the per-protocol population for immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Pre-dose 5 and Day 28 to 48 Post-dose 5 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function. Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash. | Safety analysis was on all enrolled and vaccinated participants intend-to-treat population. | Posted | Number | Percentage of Participants | 0 to 3 days post-dose 5 vaccination |
|
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Adverse event data were collected for 6 months post-vaccination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DAPTACEL® Vaccine Group | Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03. | 10 | 989 | 49 | 989 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Gastroenteritis nos | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Pneumonia nos | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Obstructive sleep apnoea syndrome | Nervous system disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Asthma nos | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| 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 |
|---|---|
| D013745 | Tetanus Toxoid |
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D004168 | Diphtheria Toxoid |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
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| Title | Measurements |
|---|---|
|
| Anti-Pertactin (EU/mL) ≥ 4-Fold Rise |
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