Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)
Primary Purpose
Acellular Pertussis, Tetanus, Diphtheria
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Boostrix™ (dTpa)
GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)
Ditanrix™ Adult, TedivaxTM (Td)
Ditanrix™ Adult, TedivaxTM (Td)
Sponsored by
About this trial
This is an interventional prevention trial for Acellular Pertussis focused on measuring DTPa, Td, IPV
Eligibility Criteria
Inclusion Criteria:
- Only subjects for whom the investigator believes the requirements of the protocol will be complied with will be enrolled in the study
- A male or female adult >= 40 years of age
- Written informed consent to be obtained from the subject prior to study entry
- No history of diphtheria or tetanus toxoid containing vaccination in the last 20 years, including those who have never been vaccinated and those with an unknown vaccination status.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- subject should not be pregnant or plan to become pregnant.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Pregnant or lactating female
- Female planning to become pregnant or planning to discontinue contraceptive precautions
- Previous vaccination with a meningococcal-conjugate vaccine, Prevenar™ or other experimental conjugated pneumococcal vaccines
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Any confirmed or suspected immunosuppressive or immunodeficient condition
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
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
Outcomes
Primary Outcome Measures
Immunogenicity with respect to components of the study vaccines
Secondary Outcome Measures
Immunogenicity with respect to components of the study vaccines
Occurrence of solicited local and general symptoms
Occurrence of unsolicited symptoms
Occurrence of serious adverse events
Occurrence of large local swelling reported
Use of concomitant medication taken
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01294605
Brief Title
Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)
Official Title
Double-blind, Randomized, Phase III Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of Three Consecutive Doses of dTpa, or of dTpa-IPV Followed by Two Doses of Td Vaccine , and Compared to Three Consecutive Doses of Td Vaccine Administered to Healthy Adults in a 0,1,6-month Schedule
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acellular Pertussis, Tetanus, Diphtheria
Keywords
DTPa, Td, IPV
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
460 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Experimental
Arm Title
Group C
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Boostrix™ (dTpa)
Intervention Description
Intramuscular, 3 doses
Intervention Type
Biological
Intervention Name(s)
GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)
Intervention Description
Intramuscular, single dose
Intervention Type
Biological
Intervention Name(s)
Ditanrix™ Adult, TedivaxTM (Td)
Intervention Description
Intramuscular, 2 doses
Intervention Type
Biological
Intervention Name(s)
Ditanrix™ Adult, TedivaxTM (Td)
Intervention Description
Intramuscular, 3 doses
Primary Outcome Measure Information:
Title
Immunogenicity with respect to components of the study vaccines
Time Frame
One month after the third dose (Month 7)
Secondary Outcome Measure Information:
Title
Immunogenicity with respect to components of the study vaccines
Time Frame
One month after each dose (Months 1, 2 and 7)
Title
Occurrence of solicited local and general symptoms
Time Frame
Within 15 days (day 0 -14) after each vaccine dose.
Title
Occurrence of unsolicited symptoms
Time Frame
Within 31 days (day 0-30) after each vaccine dose.
Title
Occurrence of serious adverse events
Time Frame
Until 31 days (day 0-30) after the last vaccine dose.
Title
Occurrence of large local swelling reported
Time Frame
Within 15 days (day 0-14) after each vaccine dose
Title
Use of concomitant medication taken
Time Frame
Within 31 days (day 0-30) after each vaccine dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Only subjects for whom the investigator believes the requirements of the protocol will be complied with will be enrolled in the study
A male or female adult >= 40 years of age
Written informed consent to be obtained from the subject prior to study entry
No history of diphtheria or tetanus toxoid containing vaccination in the last 20 years, including those who have never been vaccinated and those with an unknown vaccination status.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
subject should not be pregnant or plan to become pregnant.
Exclusion Criteria:
Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Pregnant or lactating female
Female planning to become pregnant or planning to discontinue contraceptive precautions
Previous vaccination with a meningococcal-conjugate vaccine, Prevenar™ or other experimental conjugated pneumococcal vaccines
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
Any confirmed or suspected immunosuppressive or immunodeficient condition
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
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
GSK Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
GSK Investigational Site
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3015 GE
Country
Netherlands
Facility Name
GSK Investigational Site
City
Utrecht
ZIP/Postal Code
3584 CJ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Alzira
ZIP/Postal Code
46600
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
Facility Name
GSK Investigational Site
City
Centelles
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
GSK Investigational Site
City
Mollet del Vallès
ZIP/Postal Code
08100
Country
Spain
Facility Name
GSK Investigational Site
City
Vic
ZIP/Postal Code
28500
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
17897485
Citation
Theeten H, Rumke H, Hoppener FJ, Vilatimo R, Narejos S, Van Damme P, Hoet B. Primary vaccination of adults with reduced antigen-content diphtheria-tetanus-acellular pertussis or dTpa-inactivated poliovirus vaccines compared to diphtheria-tetanus-toxoid vaccines. Curr Med Res Opin. 2007 Nov;23(11):2729-39. doi: 10.1185/03007x233034.
Results Reference
background
PubMed Identifier
21718738
Citation
Van Damme P, McIntyre P, Grimprel E, Kuriyakose S, Jacquet JM, Hardt K, Messier M, Van Der Meeren O. Immunogenicity of the reduced-antigen-content dTpa vaccine (Boostrix((R))) in adults 55 years of age and over: a sub-analysis of four trials. Vaccine. 2011 Aug 11;29(35):5932-9. doi: 10.1016/j.vaccine.2011.06.049. Epub 2011 Jun 28.
Results Reference
background
Citation
Van Damme P et al. Primary vaccination of adults with reduced antigen content diphtheria-tetanus-acellular pertussis (dTpa) vaccines. Abstract presented at the 27th Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID), Brussels, Belgium. 09-13 June 2009.
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
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
263855/034
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
263855/034
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
263855/034
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
263855/034
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
263855/034
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
263855/034
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)
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