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

Tetanus Clinical Trial

Official title:

Safety and Immunogenicity of Adacel® Vaccine Administered to Persons 10 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311557
• Other study ID #: Td519
• Secondary ID: U1111-1115-6619
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2011
• Last updated: April 1, 2016
• Start date: March 2011
• Est. completion date: January 2012

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1302
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 11 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Tetanus

Intervention

Biological:
• Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed
0.5 mL, Intramuscular
• Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine	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).	Day 30 post-vaccination	No
Primary	Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine	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.	30 days post-vaccination	No
Primary	Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine	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.	30 days post-vaccination	No
Secondary	Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine	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.	Day 0 (pre-vaccination) and 30 days post-vaccination	No
Secondary	Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine	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).	Day 0 (pre-vaccination) and Day 30 post-vaccination	No
Secondary	Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine	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.	Day 0 up to Day 7 post-vaccination	No

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