Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents
2 other identifiers
interventional
423
1 country
8
Brief Summary
The aim of this study is to describe immunogenicity of a single booster dose of Adacel vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to \<13 years of age. Primary objective:
- To describe seroprotection rates against tetanus and diphtheria in subjects randomized to receive either Adacel or Boostrix vaccine. Observational objectives:
- To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean antibody concentrations (GMCs) in subjects randomized to receive either Adacel or Boostrix vaccine.
- To describe booster response rates against tetanus, diphtheria, and pertussis in subjects randomized to receive either Adacel or Boostrix vaccine.
- To describe the rates of adverse events (AEs) immediately post-vaccination, and the rates of unsolicited AEs and serious adverse events (SAEs) following vaccination with Adacel or Boostrix vaccine from Visit 1 through Visit 2.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2012
Shorter than P25 for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 22, 2012
CompletedFirst Posted
Study publicly available on registry
June 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
October 21, 2013
CompletedMarch 2, 2016
February 1, 2016
9 months
June 22, 2012
August 16, 2013
February 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test. Antibody responses to tetanus and diphtheria components were defined as titers ≥0.1 IU/mL and ≥1.0 IU/mL
Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Secondary Outcomes (5)
Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Day 0 (pre-vaccination) to Day 28 post-vaccination
Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Day 28 post-vaccination
Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Day 0 (pre-vaccination) to Day 28 post-vaccination
Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Day 28 post-vaccination
Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Up to 15 minutes post-vaccination
Study Arms (2)
Adacel® Vaccine Group
EXPERIMENTALParticipants randomized to receive a single dose of Adacel® vaccine
Boostrix® Vaccine Group
ACTIVE COMPARATORParticipants randomized to receive a single dose of Boostrix® vaccine
Interventions
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Eligibility Criteria
You may qualify if:
- Subject is 11 to \< 13 years of age at the time of vaccination
- Received exactly 5 doses of pertussis vaccine at \< 7 years of age
- Informed consent and assent forms have been signed and dated
- Subject is able to attend all scheduled visits and to comply with all trial procedures.
You may not qualify if:
- Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence for at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination
- Any condition that, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- 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)
- Known or suspected receipt of any whole-cell pertussis-containing vaccine
- 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 immune globulins, blood or blood-derived products in the past 3 months
- 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, at the discretion of the Sponsor
- Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as reported by the subject's parent/guardian
- Laboratory-confirmed thrombocytopenia, which may be a contraindication for intramuscular (IM) vaccination, at the discretion of the Investigator
- Personal history of Guillain-Barré syndrome
- Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of vaccination. (A prospective subject should not be enrolled in the study until the condition has resolved or the febrile event has subsided.)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Sacramento, California, 95816, United States
Unknown Facility
Bardstown, Kentucky, 40040, United States
Unknown Facility
Woburn, Massachusetts, 07801, United States
Unknown Facility
Cleveland, Ohio, 44121, United States
Unknown Facility
Barnwell, South Carolina, 29812, United States
Unknown Facility
Kingsport, Tennessee, 37660, United States
Unknown Facility
Salt Lake City, Utah, 84124, United States
Unknown Facility
Vienna, Virginia, 22180, United States
Related Publications (1)
Decker MD, Greenberg DP, Johnson DR, Pool V. Randomized study of immune responses to two Tdap vaccines among adolescents primed with DTaP and comparison with results among adolescents primed with DTwP. Vaccine. 2019 Aug 14;37(35):5003-5008. doi: 10.1016/j.vaccine.2019.07.015. Epub 2019 Jul 10.
PMID: 31301919DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2012
First Posted
June 27, 2012
Study Start
June 1, 2012
Primary Completion
March 1, 2013
Study Completion
June 1, 2013
Last Updated
March 2, 2016
Results First Posted
October 21, 2013
Record last verified: 2016-02