Clinical trial NCT01689324: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pertussis
Tetanus
Diphtheria
Keywords: Pertussis
Tetanus
Diphtheria
Acellular pertussis
ADACEL®
Tdap vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 43
Sex: ALL
Minimum age (years): 11
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®
timeFrame: Day 28 post-vaccination
measure: Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®
timeFrame: Day 28 post-vaccination
measure: Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL®
timeFrame: Day 28 post-vaccination
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL®
timeFrame: Day 0 pre-vaccination
measure: Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL®
timeFrame: Day 0 (pre-vaccination) and day 28 post-vaccination
measure: Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL®
timeFrame: Day 0 (pre-vaccination) and day 28 post-vaccination
measure: Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL®
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL®
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL®
timeFrame: Day 28 post-vaccination
measure: Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL®
timeFrame: Day 0 up to Day 7 post-vaccination
Locations:
city: Aichi
country: Japan
city: Ibaraki
country: Japan
city: Nagano
country: Japan
Study officials:
affiliation: Sanofi Pasteur K.K
name: Medical Director
role: STUDY_DIRECTOR
References: