Clinical trial NCT01311557: Study of Adacel® Vaccine Administered to Persons 10 Years of Age
Official title: Safety and Immunogenicity of Adacel® Vaccine Administered to Persons 10 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tetanus
Diphtheria
Pertussis
Keywords: Tetanus
Diphtheria
Pertussis
Tdap vaccine
Adacel®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-03-09
Enrollment: 1302
Sex: ALL
Minimum age (years): 10
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10 years of age.

Primary Objectives:

* To compare pertussis antibody responses induced by Adacel® in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age.
* To compare the booster responses against pertussis antigens induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age.
* To compare booster responses against tetanus and diphtheria induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age.

Secondary Objective:

* To compare seroprotection rates against tetanus and diphtheria induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age.

Detailed description: Study participants will receive a single dose of study vaccine and will then be monitored for safety from the day of vaccination for up to 30 days post-vaccination.

Eligibility criteria: Inclusion Criteria:

* Age is \> 10 to \< 12 years of age at the time of vaccination.
* Assent form has been signed and dated by the subject, and informed consent has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations).
* Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.
* For a female of childbearing potential, abstinence or use of an effective method of contraception from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.
* Documented vaccination history of receiving 5 previous doses of DTaP (combination diphtheria, tetanus, and acellular pertussis) vaccine (consisting of 3 infant doses in the first year of life, a 4th dose in the 2nd year of life, and a 5th dose at 4 through 6 years of age).

Exclusion Criteria:

* Any condition which, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
* Serious, acute, or chronic disease that is unstable or that, in the opinion of the Investigator, might: (i) interfere with the ability to participate fully in the study; or (ii) interfere with evaluation of the vaccine.
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
* Prior receipt of pertussis, diphtheria, or tetanus containing vaccines within the past 5 years.
* A personal history of physician-diagnosed or laboratory confirmed pertussis disease within the last 2 years.
* A previous severe reaction to pertussis, diphtheria or tetanus vaccine including immediate anaphylaxis, encephalopathy within 7 days or seizure within 3 days of receiving the vaccine.
* Receipt of blood or blood-derived products in the past 3 months, which might interfere with the assessment of the immune response.
* History of allergy to egg proteins, latex, or any constituents of the vaccine.
* Suspected or known hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
* Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before the 2nd visit; except that influenza vaccine may have been received between 30 and 15 days (but no less than 15 days) before receiving study vaccine.
* Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study.
* Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as reported by the parent/guardian.
* Laboratory-confirmed thrombocytopenia, bleeding disorders, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination, at the discretion of the Investigator.
* Known pregnancy, or a positive urine or serum pregnancy test.
* Prior personal history of Guillain-Barré syndrome.
* Identified as an investigator or employee of the investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study.

Primary outcomes:
measure: Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine
timeFrame: Day 30 post-vaccination
measure: Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine
timeFrame: 30 days post-vaccination
measure: Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine
timeFrame: 30 days post-vaccination
Secondary outcomes:
measure: Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine
timeFrame: Day 0 (pre-vaccination) and 30 days post-vaccination
measure: Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 30 post-vaccination
measure: Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
timeFrame: Day 0 up to Day 7 post-vaccination
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Sacramento
country: United States
state: California
city: Longmont
country: United States
state: Colorado
city: Norwich
country: United States
state: Connecticut
city: Miami Beach
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Bardstown
country: United States
state: Kentucky
city: Crestview Hills
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Madisonville
country: United States
state: Kentucky
city: Haughton
country: United States
state: Louisiana
city: Metairie
country: United States
state: Louisiana
city: Woburn
country: United States
state: Massachusetts
city: Plymouth
country: United States
state: Minnesota
city: Rochester
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Barnwell
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Kingsport
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Ft. Worth
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Orem
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: South Jordan
country: United States
state: Utah
city: Midlothian
country: United States
state: Virginia
city: Vienna
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Marshfield
country: United States
state: Wisconsin
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Marshall GS, Pool V, Greenberg DP, Johnson DR, Sheng X, Decker MD. Safety and immunogenicity of tetanus-diphtheria-acellular pertussis vaccine administered to children 10 or 11 years of age. Clin Vaccine Immunol. 2014 Nov;21(11):1560-4. doi: 10.1128/CVI.00474-14. Epub 2014 Sep 17.