Last updated: 11/04/2018 01:33:44
Immunogenicity and reactogenicity study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Immunogenicity with respect to components of the study vaccines
Timeframe: One month after the third dose (Month 7)
Secondary outcomes:
Immunogenicity with respect to components of the study vaccines
Timeframe: One month after each dose (Months 1, 2 and 7)
Occurrence of solicited local and general symptoms
Timeframe: Within 15 days (day 0 –14) after each vaccine dose.
Occurrence of unsolicited symptoms
Timeframe: Within 31 days (day 0-30) after each vaccine dose.
Occurrence of serious adverse events
Timeframe: Until 31 days (day 0-30) after the last vaccine dose.
Occurrence of large local swelling reported
Timeframe: Within 15 days (day 0-14) after each vaccine dose
Use of concomitant medication taken
Timeframe: Within 31 days (day 0-30) after each vaccine dose
Interventions:
Biological/vaccine: Boostrix™ (dTpa)
Biological/vaccine: GSK Biologicals’ reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)
Biological/vaccine: Ditanrix™ Adult, TedivaxTM (Td)
Enrollment:
460
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Theeten H et al. (2007) Primary vaccination of adults with reduced antigen content diphtheria-tetanus-acellular pertussis (dTpa)/-inactivated poliovirus (dTpa-IPV) vaccines. Curr Med Res Opin. 23(11):2729-2739.
Van Damme P et al. (2011) Immunogenicity of the reduced-antigen-content dTpa vaccine (Boostrix(®)) in adults 55 years of age and over: A sub-analysis of four trials. Vaccine. 29(35):5932-5939.
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.
Medical condition
acellular pertussis, Tetanus, Diphtheria
Product
SB263855
Collaborators
Not applicable
Study date(s)
April 2003 to September 2004
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
Yes
- 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
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Only subjects for whom the investigator believes the requirements of the protocol will be complied with will be enrolled in the study
Exclusion criteria:
- 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
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
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2004-29-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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