Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acellular Pertussis, Tetanus, Diphtheria

Intervention / Treatment
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* Biological: Boostrix™ (dTpa)
* Biological: GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)
* Biological: Ditanrix™ Adult, TedivaxTM (Td)
* Biological: Ditanrix™ Adult, TedivaxTM (Td)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Biological: Boostrix™ (dTpa)<br>* Intramuscular, 3 doses<br>|
| Experimental: Group B<br> | Biological: GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)<br>* Intramuscular, single dose<br>Biological: Ditanrix™ Adult, TedivaxTM (Td)<br>* Intramuscular, 2 doses<br>|
| Active Comparator: Group C<br> | Biological: Ditanrix™ Adult, TedivaxTM (Td)<br>* Intramuscular, 3 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity with respect to components of the study vaccines |  | One month after the third dose (Month 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Use of concomitant medication taken |  | Within 31 days (day 0-30) after each vaccine dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DTPa, Td, IPV