Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents
Primary Purpose
Pertussis, Tetanus, Diphtheria
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
(ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis
Sponsored by
About this trial
This is an interventional prevention trial for Pertussis focused on measuring Pertussis, Tetanus, Diphtheria, Acellular pertussis, ADACEL®, Tdap vaccine
Eligibility Criteria
Inclusion Criteria:
- Aged 11 or 12 years on the day of inclusion
- Informed consent form and assent form signed and dated by the parent(s) / legal representative and the subject respectively
- Completed childhood vaccination against diphtheria, pertussis and tetanus (i.e, received 4 doses of Japanese-produced tetanus toxoid, diphtheria toxoid and acellular pertussis vaccine absorbed [DTaP vaccine]), confirmed by checking immunization records and have not yet undergone additional adsorbed Diphtheria and Tetanus toxoid (DT) vaccination
- Able to attend all scheduled visits and to comply with all trial procedures
- For female subjects, either pre-menarchal, or post-menarchal with a negative urine pregnancy test.
Exclusion Criteria:
- Any conditions or diseases which, in the opinion of the investigator
- would pose a health risk to the subject
- or might interfere with the ability to participate fully in the study
- or might interfere with evaluation of the vaccine
- or would otherwise make participation inappropriate according to the investigator's clinical judgment
- History of diphtheria, tetanus, pertussis, confirmed either clinically, serologically, or microbiologically
- Known systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine
- Vaccination in the last 5 years against tetanus, diphtheria, and/or pertussis
- Known or suspected congenital immunodeficiency, or current / previous acquired immunodeficiency, or current / previous receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or current / previous (within the last 6 months) systemic corticosteroid therapy
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion
- Planned participation in another clinical trial during the present trial period
- Receipt of blood or blood-derived products in the past 3 months, that might interfere with assessment of the immune response
- Receipt of any vaccine within the 4 weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least 2 weeks before the study vaccine
- Planned receipt of any vaccine during the trial period
- Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection
- At high risk for diphtheria, tetanus or pertussis infection during the trial
- Known pregnancy, or a positive urine pregnancy test
- Currently breastfeeding a child
- Known thrombocytopenia, contraindicating intramuscular (IM) vaccination, or a history of thrombocytopenia
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- History of acute disseminated encephalomyelitis, encephalopathy, Guillain-Barré Syndrome (GBS), or autoimmune disease
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- Identified as an employee of an Investigator, a study center, a study-affiliated vendor, or the Sponsor, with direct or indirect involvement in the proposed study or other studies under the direction of that Investigator or study center; or identified as a spouse or child (whether natural or adopted) of such an employee.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Group
Arm Description
Participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0.
Outcomes
Primary Outcome Measures
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®
Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.
Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®
Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.56 IU/mL.
Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.7 IU/mL.
Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL®
Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)
Secondary Outcome Measures
Full Information
NCT ID
NCT01689324
First Posted
September 17, 2012
Last Updated
February 19, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT01689324
Brief Title
Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents
Official Title
Immunogenicity and Safety of the Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306) as a Booster in Japanese Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose in adolescents in Japan.
Primary Objective:
To assess the immunogenicity of Tdap (SP306) when administered as a single dose in Japanese adolescents
Secondary Objective:
To assess the safety of Tdap vaccine when administered as a single dose in Japanese adolescents.
Detailed Description
All participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0 and undergo immunogenicity assessment from blood samples provided prior to, and 28 days post-vaccination. Tolerability and safety will be monitored up to 28 days post-vaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pertussis, Tetanus, Diphtheria
Keywords
Pertussis, Tetanus, Diphtheria, Acellular pertussis, ADACEL®, Tdap vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0.
Intervention Type
Biological
Intervention Name(s)
(ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis
Other Intervention Name(s)
ADACEL®, Tdap Vaccine
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®
Description
Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.
Time Frame
Day 28 post-vaccination
Title
Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®
Description
Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.56 IU/mL.
Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.7 IU/mL.
Time Frame
Day 28 post-vaccination
Title
Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL®
Description
Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)
Time Frame
Day 28 post-vaccination
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL®
Description
Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL.
Time Frame
Day 0 pre-vaccination
Title
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL®
Description
Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.01 IU/mL.
Time Frame
Day 0 (pre-vaccination) and day 28 post-vaccination
Title
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL®
Description
Seroprotection was defined as the percentage of participants with antibody concentration of ≥1.0 IU/mL.
Time Frame
Day 0 (pre-vaccination) and day 28 post-vaccination
Title
Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL®
Time Frame
Day 0 (pre-vaccination) and Day 28 post-vaccination
Title
Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL®
Time Frame
Day 0 (pre-vaccination) and Day 28 post-vaccination
Title
Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL®
Description
Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)
Time Frame
Day 28 post-vaccination
Title
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL®
Description
Solicited injection-site reactions: Pain, Redness, and Swelling. Grade 3: Pain, Significant, prevents daily activity; Redness and Swelling, >100 mm.
Solicited systemic reactions: Fever (Temperature); Headache, Malaise, and Myalgia. Grade 3: Fever, ≥ 39°C; Headache, Malaise and Myalgia, Significant, prevents daily activity.
Time Frame
Day 0 up to Day 7 post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 11 or 12 years on the day of inclusion
Informed consent form and assent form signed and dated by the parent(s) / legal representative and the subject respectively
Completed childhood vaccination against diphtheria, pertussis and tetanus (i.e, received 4 doses of Japanese-produced tetanus toxoid, diphtheria toxoid and acellular pertussis vaccine absorbed [DTaP vaccine]), confirmed by checking immunization records and have not yet undergone additional adsorbed Diphtheria and Tetanus toxoid (DT) vaccination
Able to attend all scheduled visits and to comply with all trial procedures
For female subjects, either pre-menarchal, or post-menarchal with a negative urine pregnancy test.
Exclusion Criteria:
Any conditions or diseases which, in the opinion of the investigator
would pose a health risk to the subject
or might interfere with the ability to participate fully in the study
or might interfere with evaluation of the vaccine
or would otherwise make participation inappropriate according to the investigator's clinical judgment
History of diphtheria, tetanus, pertussis, confirmed either clinically, serologically, or microbiologically
Known systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine
Vaccination in the last 5 years against tetanus, diphtheria, and/or pertussis
Known or suspected congenital immunodeficiency, or current / previous acquired immunodeficiency, or current / previous receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or current / previous (within the last 6 months) systemic corticosteroid therapy
Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion
Planned participation in another clinical trial during the present trial period
Receipt of blood or blood-derived products in the past 3 months, that might interfere with assessment of the immune response
Receipt of any vaccine within the 4 weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least 2 weeks before the study vaccine
Planned receipt of any vaccine during the trial period
Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection
At high risk for diphtheria, tetanus or pertussis infection during the trial
Known pregnancy, or a positive urine pregnancy test
Currently breastfeeding a child
Known thrombocytopenia, contraindicating intramuscular (IM) vaccination, or a history of thrombocytopenia
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
History of acute disseminated encephalomyelitis, encephalopathy, Guillain-Barré Syndrome (GBS), or autoimmune disease
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
Identified as an employee of an Investigator, a study center, a study-affiliated vendor, or the Sponsor, with direct or indirect involvement in the proposed study or other studies under the direction of that Investigator or study center; or identified as a spouse or child (whether natural or adopted) of such an employee.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur K.K
Official's Role
Study Director
Facility Information:
City
Aichi
Country
Japan
City
Ibaraki
Country
Japan
City
Nagano
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
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Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents
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