Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)
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
1 other identifier
interventional
460
3 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2003
13 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
April 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 11, 2011
CompletedSeptember 15, 2016
September 1, 2016
1.4 years
February 10, 2011
September 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immunogenicity with respect to components of the study vaccines
One month after the third dose (Month 7)
Secondary Outcomes (6)
Immunogenicity with respect to components of the study vaccines
One month after each dose (Months 1, 2 and 7)
Occurrence of solicited local and general symptoms
Within 15 days (day 0 -14) after each vaccine dose.
Occurrence of unsolicited symptoms
Within 31 days (day 0-30) after each vaccine dose.
Occurrence of serious adverse events
Until 31 days (day 0-30) after the last vaccine dose.
Occurrence of large local swelling reported
Within 15 days (day 0-14) after each vaccine dose
- +1 more secondary outcomes
Study Arms (3)
Group A
EXPERIMENTALGroup B
EXPERIMENTALGroup C
ACTIVE COMPARATORInterventions
Intramuscular, single dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (13)
GSK Investigational Site
Bruges, 8000, Belgium
GSK Investigational Site
Leuven, 3000, Belgium
GSK Investigational Site
Wilrijk, 2610, Belgium
GSK Investigational Site
Rotterdam, 3015 GE, Netherlands
GSK Investigational Site
Utrecht, 3584 CJ, Netherlands
GSK Investigational Site
Alzira, 46600, Spain
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Barcelona, 8025, Spain
GSK Investigational Site
Centelles, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Mollet del Vallès, 08100, Spain
GSK Investigational Site
Vic, 28500, Spain
Related Publications (3)
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.
PMID: 17897485BACKGROUNDVan 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.
PMID: 21718738BACKGROUNDVan 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.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2011
First Posted
February 11, 2011
Study Start
April 1, 2003
Primary Completion
September 1, 2004
Study Completion
September 1, 2004
Last Updated
September 15, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.