Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.

Tetanus Clinical Trial

Official title:

Evaluation of GSK Biologicals' Boostrix® Vaccine When Compared With Decavac™ in Adults Aged 65 Years or Older.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835237
• Other study ID #: 111413
• Status: Completed
• Phase: Phase 3
• Start date: February 17, 2009
• Est. completion date: October 15, 2009

Study information

• Verified date: December 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase IIIb, observer-blind study will evaluate the immunogenicity and safety of GSK Biologicals' Boostrix® vaccine in adults (extending indication) aged 65 years or older.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1332
• Est. completion date: October 15, 2009
• Est. primary completion date: July 23, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Subjects who the investigator believes that can and will comply with the requirements of the protocol should be enrolled in the study.

• Males or females 65 years of age and older at the time of study entry.

• Free of an acute aggravation of the health status as established by medical history and medical history and clinical examination before entering into the study.

• Written informed consent from all subjects.

Exclusion Criteria:

• Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.

• Administration of a Tdap vaccine at any time prior to study entry.

• History of diphtheria and/or tetanus and/or pertussis disease.

• Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period.

• Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study, with the exception of influenza, vaccine, which may be administered at any time up to or during the study period, including the day of study vaccination.

• Planned administration of any vaccine not foreseen by the study protocol up to 30 days following vaccination, with the exception of influenza, vaccine, which may be administered at any time up to or during the study period, including the day of study vaccination. Pneumococcal and zoster vaccines can be administered at the discretion of the investigator when the subject comes back at Visit 2.

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination or planned administration during the study period.

• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.

• History of serious allergic reaction following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.

• History of encephalopathy within seven days of administration of a previous booster dose of pertussis vaccine that is not attributable to another identifiable cause.

• Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy:

pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized.

• Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests.

• Acute disease at the time of vaccination.

• Administration of immunoglobulins and/or any blood products within the three months preceding vaccination, or planned administration during the study period.

• Any medical condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Diphtheria-Tetanus-acellular Pertussis Vaccines
• Tetanus
• Whooping Cough

Intervention

Biological:
• Boostrix®
Intramuscular, single dose.
• Decavac™
Intramuscular, single dose.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Columbia	Maryland
United States	GSK Investigational Site	DeLand	Florida
United States	GSK Investigational Site	Elkridge	Maryland
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	High Point	North Carolina
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Milford	Massachusetts
United States	GSK Investigational Site	Mogadore	Ohio
United States	GSK Investigational Site	Mount Pleasant	South Carolina
United States	GSK Investigational Site	Pratt	Kansas
United States	GSK Investigational Site	Stevensville	Michigan
United States	GSK Investigational Site	Stockbridge	Georgia
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Wadsworth	Ohio
United States	GSK Investigational Site	Wenatchee	Washington
United States	GSK Investigational Site	West Jordan	Utah
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Williamsburg	Virginia
United States	GSK Investigational Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Weston WM, Friedland LR, Wu X, Howe B. Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Boostrix(®)): results of two randomized trials. Vaccine. 2012 Feb 21;30(9):1721-8. doi: 10.1016/j.vaccine.2011.12.055. Epub 2011 Dec 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value	Antibodies against vaccine antigens assessed were: anti-diphtheria (anti-D) and anti-tetanus (anti-T).; Anti-D antibody cut-off value assessed was = 0.1 International Unit per milliliter (IU/mL); Anti-T antibody cut-off values assessed were = 0.1 IU/mL and = 1.0 IU/mL	One month after vaccination.
Primary	Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration	Concentration for anti-PT, anti-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per millilitre (EL.U/mL)	Before (PRE) and one month after vaccination (POST)
Secondary	Anti-T and Anti-D Antibody Concentrations	Concentrations for anti-T and anti-D antibodies given as GMC in IU/mL.	Before (PRE) and one month after vaccination (POST)
Secondary	Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off	Booster response defined as : For initially seronegative subjects (< 0.1 IU/mL), antibody concentration = 0.4 IU/mL one month after vaccination.; For initially seropositive subjects (= 0.1 IU/mL): antibody concentration one month after vaccination = 4 fold the pre-vaccination antibody concentration.	One month after vaccination
Secondary	Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off	Booster response defined as : For initially seronegative subjects (< 5 EL.U/mL), antibody concentration = 20 EL.U/mL one month after vaccination.; For initially seropositive subjects (= 5 EL.U/mL) with pre-vaccination antibody concentration < 20 EL.U/mL: antibody concentration one month after vaccination = 4 fold the pre-vaccination antibody concentration.; For initially seropositive subjects (= 5 EL.U/mL) with pre-vaccination antibody concentration = 20 EL.U/mL : antibody concentration one month after vaccination = 2 fold the pre-vaccination antibody concentration.	One month after vaccination
Secondary	Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.	Vaccine response using alternative definitions defined as: For initially seronegative subjects (< 5 EL.U/mL ), antibody concentration = 10 EL.U/mL one month after vaccination.; For initially seropositive subjects (= 5 EL.U/mL), antibody concentration one month after vaccination = 2 fold the pre-vaccination antibody concentration.	One month after vaccination
Secondary	Number of Subjects Reporting Solicited Local Symptoms	Solicited local symptoms assessed include pain, redness and swelling.	Within the 4-day (Day 0-3) post-vaccination period
Secondary	Number of Subjects Reporting Solicited General Symptoms	Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, and fever	Within the 4-day (Day 0-3) post-vaccination period
Secondary	Number of Subjects Reporting Unsolicited Adverse Events (AE)	An AE is 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.	Within the 31-day (Day 0-30) post-vaccination period
Secondary	Number of Subjects Reporting Serious Adverse Events (SAE)	An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.	From the vaccination up to Day 182

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