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

• ClinicalTrials.gov Identifier: NCT01311557
• Recruitment Status: Completed
• First Posted: March 9, 2011
• Results First Posted: April 8, 2016
• Last Update Posted: April 8, 2016
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tetanus; Diphtheria; Pertussis	Biological: Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1302 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Safety and Immunogenicity of Adacel® Vaccine Administered to Persons 10 Years of Age
• Study Start Date: March 2011
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: January 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Adacel Vaccine Group 1; Participants enrolled at 10 to < 11 years of age	Biological: Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed; 0.5 mL, Intramuscular; Other Name: Adacel®
Experimental: Adacel Vaccine Group 2; Participants enrolled at 11 to < 12 years of age	Biological: Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed; 0.5 mL, Intramuscular; Other Name: Adacel®

Outcome Measures

Primary Outcome Measures :

1. Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine [ Time Frame: 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).
2. Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine [ Time Frame: 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.
3. Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine [ Time Frame: 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.

Secondary Outcome Measures :

1. Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine [ Time Frame: 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.
2. Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine [ Time Frame: 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).
3. Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 11 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Arizona

Chandler, Arizona, United States, 85224

United States, Arkansas

Jonesboro, Arkansas, United States, 72401

Little Rock, Arkansas, United States, 72205

United States, California

Sacramento, California, United States, 95816

United States, Colorado

Longmont, Colorado, United States, 80501

United States, Connecticut

Norwich, Connecticut, United States, 06360

United States, Florida

Miami Beach, Florida, United States, 33141

United States, Georgia

Marietta, Georgia, United States, 30062

Woodstock, Georgia, United States, 30189

United States, Kentucky

Bardstown, Kentucky, United States, 40040

Crestview Hills, Kentucky, United States, 41017

Louisville, Kentucky, United States, 40202

Madisonville, Kentucky, United States, 42431

United States, Louisiana

Haughton, Louisiana, United States, 71037

Metairie, Louisiana, United States, 70006

United States, Massachusetts

Woburn, Massachusetts, United States, 01801

United States, Minnesota

Plymouth, Minnesota, United States, 55441

United States, New York

Rochester, New York, United States, 14609

United States, Ohio

Cleveland, Ohio, United States, 44121

United States, Pennsylvania

Pittsburgh, Pennsylvania, United States, 15241

United States, Rhode Island

Warwick, Rhode Island, United States, 02886

United States, South Carolina

Barnwell, South Carolina, United States, 29812

United States, South Dakota

Rapid City, South Dakota, United States, 57701

United States, Tennessee

Kingsport, Tennessee, United States, 37660

United States, Texas

Austin, Texas, United States, 78705

Ft. Worth, Texas, United States, 76135

San Antonio, Texas, United States, 78205

United States, Utah

Orem, Utah, United States, 84057

Salt Lake City, Utah, United States, 84124

South Jordan, Utah, United States, 84095

United States, Virginia

Midlothian, Virginia, United States, 23113

Vienna, Virginia, United States, 22180

United States, Washington

Spokane, Washington, United States, 99202

United States, Wisconsin

Marshfield, Wisconsin, United States, 54449

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Medical Director; Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info 

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT01311557
• Other Study ID Numbers: Td519; U1111-1115-6619 ( Other Identifier: WHO )
• First Posted: March 9, 2011
• Results First Posted: April 8, 2016
• Last Update Posted: April 8, 2016
• Last Verified: April 2016

Keywords provided by Sanofi:

Tetanus; Diphtheria; Pertussis; Tdap vaccine; Adacel®

Additional relevant MeSH terms:

Whooping Cough; Tetanus; Diphtheria; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Respiratory Tract Infections; Infection; Respiratory Tract Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Corynebacterium Infections; Actinomycetales Infections