Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years

Tetanus Clinical Trial

Official title:

A Study to Evaluate Immunogenicity and Safety of Boostrix Compared to Adacel When Administered as a Booster Vaccination in Adults Aged 19 to 64 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346073
• Other study ID #: 106316
• Status: Completed
• Phase: Phase 3
• Start date: July 13, 2006
• Est. completion date: March 7, 2007

Study information

• Verified date: February 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. The current study will provide pivotal data in support of extending the age range for Boostrix vaccine to include adults 19-64 years of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2337
• Est. completion date: March 7, 2007
• Est. primary completion date: March 1, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

Inclusion Criteria:

• A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday) at the time of study vaccination.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding administration of study vaccine, or planned use during the active phase of the study.

• Chronic administration of immunosuppressants or within six months prior to administration of study vaccine.

• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of study vaccine (with the exception of an influenza vaccine).

• Administration of a diphtheria-tetanus (Td) booster within previous five years.

• Administration of Tdap vaccine at any time prior to study entry. History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Tetanus
• Whooping Cough

Intervention

Biological:
• Boostrix™
Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine
• ADACEL®
Sanofi Pasteur

Locations

Country	Name	City	State
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Alliance	Nebraska
United States	GSK Investigational Site	Bardstown	Kentucky
United States	GSK Investigational Site	Bismarck	North Dakota
United States	GSK Investigational Site	Boise	Idaho
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Chandler	Arizona
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Grove City	Pennsylvania
United States	GSK Investigational Site	Hickory	North Carolina
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntsville	Alabama
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Melbourne	Florida
United States	GSK Investigational Site	Mesa	Arizona
United States	GSK Investigational Site	Mesa	Arizona
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	North Platte	Nebraska
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Pembroke Pines	Florida
United States	GSK Investigational Site	Peoria	Illinois
United States	GSK Investigational Site	Peoria	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pueblo	Colorado
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Richland	Michigan
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	South Bend	Indiana
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tempe	Arizona
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	West Jordan	Utah
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Blatter M, Friedland LR, Weston WM, Li P, Howe B. Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19-64 years of age. Vaccine. 2009 Jan 29;27(5):765-72. doi: 10.1016/j.vaccine.2008.11.028. Epub 2008 Nov 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies	A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( =) 0.1 international units per milliliter (IU/mL).	At Month 1
Primary	Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies	A seropositive subject was a subject whose antibody concentration was greater than or equal to the cut-off value. Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).	At Month 1
Primary	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).	At Month 1
Primary	Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies	Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below cut-off: smaller than (<) 5 EU/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration greater than or equal to (=) 20 EU/mL), one month after vaccination; for initially seropositive subjects with pre-vaccination concentration = 5 EU/mL and < 20 EU/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination; and for initially seropositive subjects with pre-vaccination concentration = 20 EU/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration, one month after vaccination.	At Month 1
Secondary	Number of Seropositive Subjects With Anti-diphteria (Anti-D) Antibodies	A seropositive subject was a subject whose antibody concentration was greater than or equal to the cut-off value. Cut-off values assessed were greater than or equal to (=) 1.0 international units per milliliter (IU/mL).	At Month 1
Secondary	Number of Subjects With Booster Responses for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)	Booster responses for anti-D and anti-T antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below cut-off: smaller than (<) 0.1 IU/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration greater than or equal to (= 0.4 IU/mL), one month after vaccination; and for initially seropositive subjects (pre-vaccination concentration = 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination.	At Month 1
Secondary	Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations	Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).	At Month 1
Secondary	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.	During the 15-day period (Day 0-14) following vaccination
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were fatigue, fever [defined as temperature measured orally, greater than or equal to (=) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [gastro sympt.] and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.	During the 15-day period (Day 0-14) following vaccination
Secondary	Number of Subjects With Any Unsolicited Adverse Events (AEs)	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.	During the 31-day period (Days 0-30) following vaccination
Secondary	Number of Subjects With Serious Adverse Events (SAEs).	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	During the active phase of the study (Day 0 - Day 30)
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	During the extended safety follow-up (ESFU) phase (Day 31 - Month 6)
Secondary	Number of Subjects Reporting Hospitalizations	Hospitalization signified that the subject had been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician's office or out patient setting.	During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)
Secondary	Number of Subjects Reporting Emergency Room Visits	Emergency room visits refer to AEs requiring immediate medical attention.	During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)
Secondary	Number of Subjects Reporting the Onset of New Chronic Illnesses	New onset chronic illnesses include diabetes, asthma, allergies, autoimmune diseases.	During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)

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