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

NCT01311557 | Completed Phase 4 Results

• 2 other identifiers: Td519U1111-1115-6619
• Study Type: interventional
• Target: 1,302
• Locations: 1 country
• Sites: 34

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.

Conditions

Tetanus; Diphtheria; Pertussis

Keywords

Tetanus; Diphtheria; Pertussis; Tdap vaccine; Adacel®

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Adacel Vaccine Group 1

EXPERIMENTAL

Participants enrolled at 10 to \< 11 years of age

Biological: Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed

Adacel Vaccine Group 2

EXPERIMENTAL

Participants enrolled at 11 to \< 12 years of age

Biological: Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed

Interventions

Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Adacel®

Adacel Vaccine Group 1

Eligibility Criteria

• Age: 10 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (34)

Unknown Facility

Chandler, Arizona, 85224, United States

Location

Unknown Facility

Jonesboro, Arkansas, 72401, United States

Location

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

Sacramento, California, 95816, United States

Location

Unknown Facility

Longmont, Colorado, 80501, United States

Location

Unknown Facility

Norwich, Connecticut, 06360, United States

Location

Unknown Facility

Miami Beach, Florida, 33141, United States

Location

Unknown Facility

Marietta, Georgia, 30062, United States

Location

Unknown Facility

Woodstock, Georgia, 30189, United States

Location

Unknown Facility

Bardstown, Kentucky, 40040, United States

Location

Unknown Facility

Crestview Hills, Kentucky, 41017, United States

Location

Unknown Facility

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

Madisonville, Kentucky, 42431, United States

Location

Unknown Facility

Haughton, Louisiana, 71037, United States

Location

Unknown Facility

Metairie, Louisiana, 70006, United States

Location

Unknown Facility

Woburn, Massachusetts, 01801, United States

Location

Unknown Facility

Plymouth, Minnesota, 55441, United States

Location

Unknown Facility

Rochester, New York, 14609, United States

Location

Unknown Facility

Cleveland, Ohio, 44121, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15241, United States

Location

Unknown Facility

Warwick, Rhode Island, 02886, United States

Location

Unknown Facility

Barnwell, South Carolina, 29812, United States

Location

Unknown Facility

Rapid City, South Dakota, 57701, United States

Location

Unknown Facility

Kingsport, Tennessee, 37660, United States

Location

Unknown Facility

Austin, Texas, 78705, United States

Location

Unknown Facility

Fort Worth, Texas, 76135, United States

Location

Unknown Facility

San Antonio, Texas, 78205, United States

Location

Unknown Facility

Orem, Utah, 84057, United States

Location

Unknown Facility

Salt Lake City, Utah, 84124, United States

Location

Unknown Facility

South Jordan, Utah, 84095, United States

Location

Unknown Facility

Midlothian, Virginia, 23113, United States

Location

Unknown Facility

Vienna, Virginia, 22180, United States

Location

Unknown Facility

Spokane, Washington, 99202, United States

Location

Unknown Facility

Marshfield, Wisconsin, 54449, United States

Location

Related Publications (1)

• 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.

  PMID: 25230939 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Tetanus; Diphtheria; Whooping Cough

Interventions

adacel

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 9, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: April 8, 2016
• Results First Posted: April 8, 2016

Record last verified: 2016-04

Locations

US (34)