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

Primary Purpose

Tetanus, Acellular Pertussis, Diphtheria

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Boostrix®
Decavac™
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tetanus focused on measuring Boostrix®, adults

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Boostrix Group

Decavac Group

Arm Description

Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)

Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

Anti-T and Anti-D Antibody Concentrations
Concentrations for anti-T and anti-D antibodies given as GMC in IU/mL.
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.
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.
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.
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, and fever
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.
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.

Full Information

First Posted
February 2, 2009
Last Updated
December 31, 2019
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00835237
Brief Title
Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.
Official Title
Evaluation of GSK Biologicals' Boostrix® Vaccine When Compared With Decavac™ in Adults Aged 65 Years or Older.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 17, 2009 (Actual)
Primary Completion Date
July 23, 2009 (Actual)
Study Completion Date
October 15, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus, Acellular Pertussis, Diphtheria, Diphtheria-Tetanus-acellular Pertussis Vaccines
Keywords
Boostrix®, adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Boostrix Group
Arm Type
Experimental
Arm Description
Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Arm Title
Decavac Group
Arm Type
Active Comparator
Arm Description
Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
Intervention Type
Biological
Intervention Name(s)
Boostrix®
Intervention Description
Intramuscular, single dose.
Intervention Type
Biological
Intervention Name(s)
Decavac™
Intervention Description
Intramuscular, single dose.
Primary Outcome Measure Information:
Title
Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value
Description
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
Time Frame
One month after vaccination.
Title
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration
Description
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)
Time Frame
Before (PRE) and one month after vaccination (POST)
Secondary Outcome Measure Information:
Title
Anti-T and Anti-D Antibody Concentrations
Description
Concentrations for anti-T and anti-D antibodies given as GMC in IU/mL.
Time Frame
Before (PRE) and one month after vaccination (POST)
Title
Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off
Description
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.
Time Frame
One month after vaccination
Title
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off
Description
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.
Time Frame
One month after vaccination
Title
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.
Description
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.
Time Frame
One month after vaccination
Title
Number of Subjects Reporting Solicited Local Symptoms
Description
Solicited local symptoms assessed include pain, redness and swelling.
Time Frame
Within the 4-day (Day 0-3) post-vaccination period
Title
Number of Subjects Reporting Solicited General Symptoms
Description
Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, and fever
Time Frame
Within the 4-day (Day 0-3) post-vaccination period
Title
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Description
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.
Time Frame
Within the 31-day (Day 0-30) post-vaccination period
Title
Number of Subjects Reporting Serious Adverse Events (SAE)
Description
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.
Time Frame
From the vaccination up to Day 182

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
GSK Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
GSK Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
GSK Investigational Site
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
GSK Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
GSK Investigational Site
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
GSK Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
GSK Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
GSK Investigational Site
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
GSK Investigational Site
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
GSK Investigational Site
City
Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
Facility Name
GSK Investigational Site
City
Stevensville
State/Province
Michigan
ZIP/Postal Code
49127
Country
United States
Facility Name
GSK Investigational Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
GSK Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
GSK Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
GSK Investigational Site
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
Facility Name
GSK Investigational Site
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
GSK Investigational Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
GSK Investigational Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
GSK Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
GSK Investigational Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
GSK Investigational Site
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23185
Country
United States
Facility Name
GSK Investigational Site
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://clinicalstudydatarequest.com/Posting.aspx?ID=150
Citations:
PubMed Identifier
22212127
Citation
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((R))): 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.
Results Reference
background
Citation
Weston WM et al. Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Boostrix™): results of a randomized clinical trial. Abstract presented at the 45th National Immunization Conference (NIC). Washington, USA, 28-31 March 2011.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111413
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111413
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111413
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111413
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111413
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111413
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111413
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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