NCT01294605CompletedPhase 4
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
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 460
- Locations
- 13
- Primary Endpoint
- Immunogenicity with respect to components of the study vaccines
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Group B
Experimental
Intervention: GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM) (Biological)
Group B
Experimental
Intervention: Ditanrix™ Adult, TedivaxTM (Td) (Biological)
Group C
Active Comparator
Intervention: Ditanrix™ Adult, TedivaxTM (Td) (Biological)
Group A
Experimental
Intervention: Boostrix™ (dTpa) (Biological)
Outcomes
Primary Outcomes
Immunogenicity with respect to components of the study vaccines
Time Frame: One month after the third dose (Month 7)
Secondary Outcomes
- 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)
- Occurrence of solicited local and general symptoms(Within 15 days (day 0 -14) 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 unsolicited symptoms(Within 31 days (day 0-30) after each vaccine dose.)
Investigators
Study Sites (13)
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