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Primary Objectives:
Observational Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAPTACEL Primed | Experimental | Participants received Daptacel in Study P3T06. |
|
| Pentacel Primed | Experimental | Participants received Pentacel in Study P3T06 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAPTACEL®: DTaP | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | 0 to 7 days Post-Dose 5 | |
| Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination | 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-Dose 5 of DAPTACEL® Vaccination | 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 Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Day 0 and between Days 28-48 Post-dose 5 | |
| Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | Day 0 and between Days 28-48 post-dose 5 |
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Inclusion Criteria:
Exclusion Criteria:
Received a 5th dose of DTaP-containing vaccine
a. For subjects in the DAPTACEL® arm: Received a 4th dose of Inactivated Poliovirus Vaccine (IPV) vaccine and/or a 2nd dose of Measles, Mumps, and Rubella (MMR) vaccine scheduled at 4 to 6 years of age.
b. For subjects in the Pentacel™ arm: Received a 2nd dose of MMR vaccine scheduled at 4 to 6 years of age
Severe hypersensitivity to any component of the vaccine such as an anaphylactic reaction observed following a previous vaccination
Serious underlying chronic disease, including, but not limited to:·Diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder·Unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration. These may include progressive neurologic disorders (e.g., infantile spasms, uncontrolled progressive encephalopathy) and encephalopathy within 7 days following previous vaccination
Known or suspected primary or acquired disease of the immune system
Administration of immune globulin, other blood products within the last 3 months, injected or oral corticosteroids or other immunomodulator therapy within 6 weeks prior to study vaccination. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than 1 course within the last 2 weeks prior to enrollment
Had allergy shots started or had changes in regimen or dosing of allergy shots within 4 weeks prior to study vaccination
Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (if applicable)
Any other condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine
Enrolled in another vaccine trial
Personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the past 30 months
Known or suspected allergy to any of the vaccines or vaccine components intended for use in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayetteville | Arkansas | United States | ||||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 649 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 30 March 2005 to 02 March 2006 at 22 US sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | DAPTACEL®-Primed | Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study. |
| FG001 | Pentacel®-Primed |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| DAPTACEL®: DTaP | Biological | 0.5 mL, Intramuscular |
|
|
| Jonesboro |
| Arkansas |
| United States |
| Little Rock | Arkansas | United States |
| Fountain Valley | California | United States |
| Centennial | Colorado | United States |
| Norwich | Connecticut | United States |
| Marietta | Georgia | United States |
| Bardstown | Kentucky | United States |
| Bossier City | Louisiana | United States |
| Rochester | New York | United States |
| Pembroke | North Carolina | United States |
| Sylva | North Carolina | United States |
| Norristown | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Pittsburgh | Pennsylvania | 15241 | United States |
| Kingsport | Tennessee | United States |
| Fort Worth | Texas | United States |
| San Antonio | Texas | United States |
| Provo | Utah | United States |
| Spokane | Washington | United States |
| La Crosse | Wisconsin | United States |
| Marshfield | Wisconsin | United States |
Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DAPTACEL®-Primed | Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study. |
| BG001 | Pentacel®-Primed | Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study. |
| BG002 | Total | Total of all reporting groups |
| 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination | Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. | Posted | Number | Percentage of Participants | 0 to 7 days Post-Dose 5 |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination | 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 anti-Pertussis 4-fold rises were evaluated in the per-protocol immunology population. | Posted | Number | Percentage of Participants | Day 28 to 48 Post-dose 5 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination | 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 assessed in the per-protocol immunogenicity population. | Posted | Number | Percentage of Participants | Day 28 to 48 Post-Dose 5 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. | Antibody responses were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population. | Posted | Number | Percentage of Participants | Day 0 and between Days 28-48 Post-dose 5 |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | GMTs were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population. | Posted | Geometric Mean | 95% Confidence Interval | All units | Day 0 and between Days 28-48 post-dose 5 |
|
|
Adverse events data were collected from the day of vaccination 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®-Primed | Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study. | 5 | 487 | 62 | 487 | ||
| EG001 | Pentacel®-Primed | Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study. | 3 | 162 | 55 | 162 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Gastroenteritis NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Otitis media NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 6.0 | Non-systematic Assessment |
| |
| Skull fracture NOS | Injury, poisoning and procedural complications | MedDRA 6.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Staring | Psychiatric disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Asthma NOS | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Bronchospasm NOS | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site redness | General disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Injection site tenderness | General disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Crying | Psychiatric disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Anorexia | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Lethargy | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Otitis media NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| 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 |
| 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 |
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| ID | Term |
|---|---|
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| ID | Term |
|---|---|
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D004168 | Diphtheria Toxoid |
| D014121 | Toxoids |
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
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| >=65 years |
|
| Male |
|
| Grade 3 Redness (> 50 mm) |
|
| Any Swelling (> 5 mm) |
|
| Grade 3 Swelling (> 50 mm) |
|
| Any Tenderness |
|
| Grade 3 Tenderness (Incapacitating) |
|
| Any Change in Limb Circumference (> 5 mm) |
|
| Grade 3 Change in Limb Circumference (> 40 mm) |
|
| Any Functional Impairment |
|
| Grade 3 Functional Impairment (Incapacitating) |
|
| Any Solicited Systemic Reaction - Dose 5 |
|
| Any Fever (≥ 38.0 ºC) |
|
| Grade 3 Fever (> 39.5 ºC) |
|
| Any Irritability |
|
| Grade 3 Irritability (Incapacitating) |
|
| Any Crying |
|
| Grade 3 Crying (Incapacitating) |
|
| Any Lethargy |
|
| Grade 3 Lethargy (Incapacitating) |
|
| Any Anorexia |
|
| Grade 3 Anorexia (skipped 2 meals) |
|
| Any Vomiting (per 24 hours) |
|
| Grade 3 Vomiting (≥ 3 episodes) |
|
| Any Diarrhea (per 24 hours) |
|
| Grade 3 Diarrhea (> 5 diarrhea stools) |
|
| Any Rash |
|
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