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
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®
Condition
Pertussis
Intervention
(ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis
Study Arms / Comparison Groups
Study Group
Description: Participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
43
Start Date
September 2012
Completion Date
May 2013
Primary Completion Date
November 2012
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.
Gender
All
Ages
11 Years - 12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT01689324
Organization ID
Td540
Secondary IDs
U1111-1124-7671
Responsible Party
Sponsor
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Study Sponsor
Medical Director, Study Director, Sanofi Pasteur K.K
Verification Date
February 2014