Study of Adacel® Vaccine Administered to Persons 10 Years of Age

Phase 4

Completed

Conditions: Tetanus
Pertussis
Diphtheria

Registration Number: NCT01311557

Lead Sponsor: Sanofi

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1302

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine	Day 30 post-vaccination	Anti-Pertussis titers (Pertussis toxoid \[PT\], Filamentous hemagglutinin \[FHA\], Pertactin \[PRN\], Fimbriae types 2 and 3 \[FIM\]) geometric mean titers were assessed by enzyme-linked immunosorbent assay (ELISA).
Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine	30 days post-vaccination	Anti-tetanus booster responses were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria booster responses were assessed by a toxin neutralization test. Booster response rate was defined as a four-fold increase in pre- to post-vaccination for subjects with pre-vaccination titers ≤ 2.56 EU/mL for diphtheria and ≤ 2.7 EU/mL for tetanus. If the pre-vaccination titers were \> 2.56 EU/mL for diphtheria or \> 2.7 EU/mL for tetanus, then a two-fold increase in response rate was defined as a booster response.
Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine	30 days post-vaccination	Anti-Pertussis booster responses were assessed by enzyme linked immunosorbent assay (ELISA). For pertussis antigens (Pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\], fimbriae types 2 and 3 \[FIM\]), a booster response rate was defined as a four-fold increase in pre- to post-vaccination titers for participants with pre vaccination titers ≤ 93 ELISA Unit (EU)/mL for PT, ≤ 170 EU/mL for FHA, ≤ 115 EU mL for PRN, and ≤ 285 EU/mL for FIM. If the pre-vaccination titers were \> 93 EU/mL for PT, \> 170 EU/mL for FHA, \> 115 EU mL for PRN, or \> 285 EU/mL for FIM then a two-fold increase in the antibody titer was defined as a booster response.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine	Day 0 (pre-vaccination) and 30 days post-vaccination	Anti-tetanus seroprotection rates were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria seroprotection was assessed by a toxin neutralization test. Seroprotection was defined as post-vaccination antibody titers ≥0.1 IU/mL.
Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine	Day 0 (pre-vaccination) and Day 30 post-vaccination	Anti-Pertussis titers (Pertussis toxoid \[PT\], Filamentous hemagglutinin \[FHA\], Pertactin \[PRN\], Fimbriae types 2 and 3 \[FIM\]) geometric mean titers were assessed by enzyme linked immunosorbent assay (ELISA).
Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine	Day 0 up to Day 7 post-vaccination	Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Grade 3 Solicited Injection-site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited systemic reactions: Fever, ≥39.0˚C or ≥102.1˚F; Headache, Malaise, and Myalgia Significant, prevents daily activity.