Clinical trial NCT01294605: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acellular Pertussis
Tetanus
Diphtheria
Keywords: DTPa
Td
IPV
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 460
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Immunogenicity with respect to components of the study vaccines
timeFrame: One month after the third dose (Month 7)
Secondary outcomes:
measure: Immunogenicity with respect to components of the study vaccines
timeFrame: One month after each dose (Months 1, 2 and 7)
measure: Occurrence of solicited local and general symptoms
timeFrame: Within 15 days (day 0 -14) after each vaccine dose.
measure: Occurrence of unsolicited symptoms
timeFrame: Within 31 days (day 0-30) after each vaccine dose.
measure: Occurrence of serious adverse events
timeFrame: Until 31 days (day 0-30) after the last vaccine dose.
measure: Occurrence of large local swelling reported
timeFrame: Within 15 days (day 0-14) after each vaccine dose
measure: Use of concomitant medication taken
timeFrame: Within 31 days (day 0-30) after each vaccine dose
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Utrecht
country: Netherlands
facility: GSK Investigational Site
city: Alzira
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Centelles
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Mollet del Vallès
country: Spain
facility: GSK Investigational Site
city: Vic
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
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.
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.
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.