Study of Adacel® Vaccine Administered to Persons 10 Years of Age
NCT ID: NCT01311557
Last Updated: 2016-04-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
1302 participants
INTERVENTIONAL
2011-03-31
2012-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age
NCT00524732
Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®
NCT00319553
Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine
NCT00347958
Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
NCT00467519
Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
NCT01439165
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Adacel Vaccine Group 1
Participants enrolled at 10 to \< 11 years of age
Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed
0.5 mL, Intramuscular
Adacel Vaccine Group 2
Participants enrolled at 11 to \< 12 years of age
Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed
0.5 mL, Intramuscular
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
10 Years
11 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chandler, Arizona, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Sacramento, California, United States
Longmont, Colorado, United States
Norwich, Connecticut, United States
Miami Beach, Florida, United States
Marietta, Georgia, United States
Woodstock, Georgia, United States
Bardstown, Kentucky, United States
Crestview Hills, Kentucky, United States
Louisville, Kentucky, United States
Madisonville, Kentucky, United States
Haughton, Louisiana, United States
Metairie, Louisiana, United States
Woburn, Massachusetts, United States
Plymouth, Minnesota, United States
Rochester, New York, United States
Cleveland, Ohio, United States
Pittsburgh, Pennsylvania, United States
Warwick, Rhode Island, United States
Barnwell, South Carolina, United States
Rapid City, South Dakota, United States
Kingsport, Tennessee, United States
Austin, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
Orem, Utah, United States
Salt Lake City, Utah, United States
South Jordan, Utah, United States
Midlothian, Virginia, United States
Vienna, Virginia, United States
Spokane, Washington, United States
Marshfield, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1115-6619
Identifier Type: OTHER
Identifier Source: secondary_id
Td519
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.