Acellular Pertussis, Diphtheria, Tetanus
Conditions
Keywords
DTPa, Td, IPV
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.
Interventions
BIOLOGICALBoostrix™ (dTpa)
Intramuscular, 3 doses
BIOLOGICALGSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)
Intramuscular, single dose
BIOLOGICALDitanrix™ Adult, TedivaxTM (Td)
Intramuscular, 2 doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity with respect to components of the study vaccines | One month after the third dose (Month 7) |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
| Immunogenicity with respect to components of the study vaccines | One month after each dose (Months 1, 2 and 7) |
| Occurrence of large local swelling reported | Within 15 days (day 0-14) after each vaccine dose |
| Use of concomitant medication taken | 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. |
Countries
Belgium, Netherlands, Spain
Outcome results
None listed