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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1127-7738 | Other Identifier | WHO |
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The aim of the study is to assess the safety profile of ADACEL vaccine in a small number of participants in China.
Primary objective:
Secondary objective:
Participants will be enrolled sequentially into the study groups to receive one dose of ADACEL at Day 0 (Visit 1) and will be followed-up for 28-35 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Adults | Experimental | Participants 18 through 64 years of age will receive a single booster dose of Tdap vaccine (ADACEL). |
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| Group 2: Children | Experimental | Participants 4 through 8 years of age will receive a single booster dose of Tdap vaccine (ADACEL) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap | Biological | 0.5 mL, Intramuscular (IM) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacelâ„¢ Vaccine | Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling >30 mm; Fever (temperature) >39ËšC; Headache, Malaise, and Myalgia, significant, prevents daily activity. | Day 0 up to Day 28 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacelâ„¢ Vaccine | Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling >30 mm; Fever (temperature) >39ËšC; Headache, Malaise, and Myalgia, significant, prevents daily activity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu | Jiangsu | China |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 40 participants who met all of the inclusion and none of the exclusion criteria were enrolled and vaccinated in this study.
The study participants were enrolled from 27 August 2013 through 08 October 2013 at 1 clinic center in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | ADACELâ„¢ Vaccine Group 1 (Adults) | Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACELâ„¢) |
| FG001 | ADACELâ„¢ Vaccine Group 2 (Children) | Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACELâ„¢) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap | Biological | 0.5 mL, Intramuscular (IM) |
|
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| Day 0 up to Day 7 post-vaccination |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ADACELâ„¢ Vaccine Group 1 | Adults 18 to 64 years of age received a single booster dose of Tdap vaccine (ADACELâ„¢) |
| BG001 | ADACELâ„¢ Vaccine Group 2 | Children 4 to 8 years of age received a single booster dose of Tdap vaccine (ADACELâ„¢) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| 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 Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacelâ„¢ Vaccine | Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling >30 mm; Fever (temperature) >39ËšC; Headache, Malaise, and Myalgia, significant, prevents daily activity. | Serious adverse events and solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set. | Posted | Number | Participants | Day 0 up to Day 28 post-vaccination |
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| Secondary | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacelâ„¢ Vaccine | Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling >30 mm; Fever (temperature) >39ËšC; Headache, Malaise, and Myalgia, significant, prevents daily activity. | Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set. | Posted | Number | Participants | Day 0 up to Day 7 post-vaccination |
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Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 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 | ADACELâ„¢ Vaccine Group 1 | Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACELâ„¢) | 0 | 20 | 6 | 20 | ||
| EG001 | ADACELâ„¢ Vaccine Group 2 | Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACELâ„¢) | 0 | 20 | 9 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Injection site Pain | General disorders | MedDRA version 16.0 | Systematic Assessment |
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| Injection site Erythema | General disorders | MedDRA version 16.0 | Systematic Assessment |
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| Injection site Swelling | General disorders | MedDRA version 16.0 | Systematic Assessment |
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| Fever | General disorders | MedDRA version 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | 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 |
|---|---|
| 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 |
|---|---|
| D013745 | Tetanus Toxoid |
| C509326 | adacel |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| >=65 years |
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| Male |
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| Grade 3 Injection site Swelling |
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| Grade 3 Fever |
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| Grade 3 Headache |
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| Grade 3 Malaise |
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| Grade 3 Myalgia |
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| Serious adverse events |
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