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This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adacel® Vaccine Group | Experimental |
| |
| BOOSTRIX® Vaccine Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed | Biological | 0.5 mL, IM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities. | Day 0 to 7 post-vaccination |
| Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. | Day 0 and 28 days post-vaccination | |
| Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. | Day 0 and 28 days post-vaccination | |
| Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Day 0 and 28 days post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc) that is unstable or that might:
Known or suspected impairment of immunologic function.
Febrile illness within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38°C) at the time of inclusion.
History of documented tetanus, diphtheria or pertussis disease within the preceding 5 years.
Known or suspected receipt of a tetanus or diphtheria-containing vaccine within the preceding 2 years.
Known or suspected receipt of a pertussis-containing vaccine within the preceding 5 years.
Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other therapy expected to materially alter immune function within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
Received any vaccine in the 21-day period prior to enrollment or scheduled to receive any vaccination after enrollment and prior to visit 2.
Suspected or known hypersensitivity to any of the vaccine components or to latex.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Annapolis | Maryland | 21401 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 647 participants who met the inclusion and exclusion criteria were enrolled, 644 were vaccinated and included in the analysis.
Participants were enrolled from 09 May 2006 to 02 October 2006 in 12 clinical centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adacel® Vaccine Group | |
| FG001 | Boostrix® Vaccine Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed | Biological | 0.5 mL, IM |
|
|
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Frederick | Maryland | 21702 | United States |
| Durham | North Carolina | 27704 | United States |
| Durham | North Carolina | 27705 | United States |
| Franklin | Tennessee | 37067 | United States |
| Bellevue | Washington | 98005 | United States |
| Mercer Island | Washington | 98040-2758 | United States |
| Sammamish | Washington | 98075 | United States |
| Seattle | Washington | 98105 | United States |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adacel® Vaccine Group | |
| BG001 | Boostrix® Vaccine Group | |
| 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 | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities. | Solicited injection site and Systemic reactions were analyzed in the intent-to-treat safety population | Posted | Number | Participants | Day 0 to 7 post-vaccination |
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| Primary | Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. | Tetanus antitoxin concentrations were analyzed in the per-protocol population. | Posted | Number | Percentage of Participants | Day 0 and 28 days post-vaccination |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. | Diphtheria antitoxin concentrations were analyzed in the per-protocol population | Posted | Number | Percentage of Participants | Day 0 and 28 days post-vaccination |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Geometric mean concentration of antibody to the pertussis antigens were analyzed in the per-protocol population | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Day 0 and 28 days post-vaccination |
|
|
Adverse events data were collected from the day of vaccination up to 1 month 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 | Adacel® Vaccine Group | 0 | 323 | 273 | 320 | |||
| EG001 | Boostrix® Vaccine Group | 0 | 321 | 257 | 317 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Solicited injection site Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Solicited injection site Erythema | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Solicited injection site Swelling | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Solicited Fever | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Solicited Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Solicited Malaise | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Solicited Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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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 |
|---|---|
| D014917 | Whooping Cough |
| D013742 | Tetanus |
| D004165 | Diphtheria |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
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| ID | Term |
|---|---|
| C509326 | adacel |
| C505143 | Boostrix |
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| >=65 years |
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| Male |
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| Any solicited injection site Pain |
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| Grade 3 solicited inj. site Pain (Incapacitating) |
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| Any solicited injection site Erythema |
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| Grade 3 solicited injection site Erythema (≥ 5 cm) |
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| Any solicited injection site Swelling |
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| Grade 3 solicited injection site Swelling (≥ 5 cm) |
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| Any solicited systemic reaction |
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| Grade 3 solicited systemic reaction |
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| Any solicited Fever |
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| Grade 3 solicited Fever (≥ 39.1°C or ≥ 102.3°F) |
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| Any solicited Headache |
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| Gr 3 solicited Headache: Prevents daily activities |
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| Any solicited Malaise |
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| Gr 3 solicited Malaise: Prevents daily activities |
|
| Any solicited Myalgia |
|
| Gr 3 solicited Myalgia: Prevents daily activities |
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