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The purpose of this study is to collect additional immunogenicity and safety data on re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health need to establish broader population immunity against pertussis, as well as diphtheria and tetanus.
Primary Objective:
This is an open-label, multicenter study to describe the immunological response and safety of repeat administration of an adolescent/adult-formulation tetanus-diphtheria-acellular pertussis Tdap vaccine (ADACEL®), 10 years following initial administration of Tdap vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Previous Tdap or Tdap-IPV Recipients | Experimental | Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805) |
|
| Group 2: Tdap vaccine-naïve | Active Comparator | Participants are age-balanced Tdap vaccine-naïve and will receive Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose. |
|
| Group 3 | No Intervention | Past participants in Study TD9707 and TD9805 did not qualify for Tdap re-administration in this study or were unwilling to receive a second dose of Tdap. They were not included in the analysis for the study |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®) | Biological | 0.5 ml, IM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose | Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL. | Day 0 (pre-vaccination) and 30 post-vaccination |
| Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose | Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA). | Day 30 post-vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose | Anti-diphtheria or anti-tetanus booster responses were defined as: Pre-vaccination antibody concentrations of < 0.1 IU/mL and a post-vaccination levels ≥ 0.4 IU/mL; or a pre-vaccination antibody concentrations of ≥ 0.1 IU/mL to < 2 IU/mL and a 4-fold rise; or pre-vaccination antibody concentrations of ≥ 2.0 IU/mL and a 2-fold response. |
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 |
|---|---|---|---|---|---|---|
| Coquitlam | British Columbia | V3C 4J2 | Canada | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22115634 | Result | Halperin SA, Scheifele D, De Serres G, Noya F, Meekison W, Zickler P, Larrivee L, Langley JM, McNeil SA, Dobson S, Jordanov E, Thakur M, Decker MD, Johnson DR. Immune responses in adults to revaccination with a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine 10 years after a previous dose. Vaccine. 2012 Jan 20;30(5):974-82. doi: 10.1016/j.vaccine.2011.11.035. Epub 2011 Nov 21. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 769 participants who met the inclusion and exclusion criteria were enrolled, 768 were vaccinated and evaluated.
Participants were enrolled from 26 June 2008 to 27 February 2009 at 7 medical centers in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Previous Tdap or Tdap-IPV Recipients | Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805) |
| FG001 | Group 2: Tdap Vaccine-naïve |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®) | Biological | 0.5 mL, IM |
|
|
| Day 30 post-vaccination |
| Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose | Booster response for each anti-pertussis antibody was defined as a post-vaccination antibody concentration:
| Day 30 post-vaccination |
| Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Post-vaccination geometric mean concentrations (GMCs) against pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA). | Day 0 (pre-vaccination) and Day 30 post-vaccination |
| Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Post-vaccination geometric mean concentrations (GMCs) for Diphtheria was determined by neutralization assay; GMCs for tetanus was determined by enzyme-linked immunosorbent assay (ELISA). | Day 0 (pre-vaccination) and Day 30 post-vaccination |
| Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Solicited Injection Site Reactions: Pain, Erythema, and swelling. Solicited Systemic Reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 - Pain: Incapacitating, : Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema and Swelling: ≥5 cm; Fever: > 39.0°C, Headache, Malaise, and Myalgia Prevents daily activities. | Day 0 up to Day 7 post-vaccination |
| Surrey |
| British Columbia |
| V3R 8P8 |
| Canada |
| Vancouver | British Columbia | V6H 3V4 | Canada |
| Halifax | Nova Scotia | B3K 6R8 | Canada |
| Pierrefonds | Quebec | H9H 4Y6 | Canada |
| Québec | Quebec | G1E 7G9 | Canada |
| Sherbrooke | Quebec | J1H 4J6 | Canada |
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Previous Tdap or Tdap-IPV Recipients | Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805) |
| BG001 | Group 2: Tdap Vaccine-naïve | Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose. |
| 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 | Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose | Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL. | Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population. | Posted | Number | Percentage of Participants | Day 0 (pre-vaccination) and 30 post-vaccination |
|
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| ||||||||||||||||||||||||||||||||||||
| Primary | Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose | Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA). | Geometric mean concentrations were assessed in the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Day 30 post-vaccination |
|
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| Other Pre-specified | Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose | Anti-diphtheria or anti-tetanus booster responses were defined as: Pre-vaccination antibody concentrations of < 0.1 IU/mL and a post-vaccination levels ≥ 0.4 IU/mL; or a pre-vaccination antibody concentrations of ≥ 0.1 IU/mL to < 2 IU/mL and a 4-fold rise; or pre-vaccination antibody concentrations of ≥ 2.0 IU/mL and a 2-fold response. | Booster Response to Tetanus and Diptheria antigens were assessed in the per-protocol population. | Posted | Number | Percentage of Participants | Day 30 post-vaccination |
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| Other Pre-specified | Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose | Booster response for each anti-pertussis antibody was defined as a post-vaccination antibody concentration:
| Booster response for each anti-Pertussis antibody was assessed in the per-protocol population. | Posted | Number | Percentage of Particpants | Day 30 post-vaccination |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Post-vaccination geometric mean concentrations (GMCs) against pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA). | Geometric mean concentrations were assessed in the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Day 0 (pre-vaccination) and Day 30 post-vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Post-vaccination geometric mean concentrations (GMCs) for Diphtheria was determined by neutralization assay; GMCs for tetanus was determined by enzyme-linked immunosorbent assay (ELISA). | Geometric mean concentrations were assessed in the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Day 0 (pre-vaccination) and Day 30 post-vaccination |
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| Other Pre-specified | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Solicited Injection Site Reactions: Pain, Erythema, and swelling. Solicited Systemic Reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 - Pain: Incapacitating, : Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema and Swelling: ≥5 cm; Fever: > 39.0°C, Headache, Malaise, and Myalgia Prevents daily activities. | Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. | Posted | Number | Participants | Day 0 up to Day 7 post-vaccination |
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Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
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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 | Group 1: Previous Tdap or Tdap-IPV Recipients | Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805) | 3 | 361 | 309 | 361 | ||
| EG001 | Group 2: Tdap Vaccine-naïve | Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose. | 1 | 407 | 341 | 407 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arnold-Chiari Malformation | Congenital, familial and genetic disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Death | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Animal Bite | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
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| Vaginal Haematoma | Reproductive system and breast disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Solicited Injection Site Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Solicited Injection Site Erythema | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Solicited Injection Site Swelling | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Non-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 |
|---|---|
| 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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| Anti-Diphtheria Pre-vaccination |
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| Anti-Diphtheria Post-vaccination |
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| Participants |
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