Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine
Primary Purpose
Diphteria, Tetanus and Pertussis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine
GSK Biologicals' reduced-antigen-content acellular pertussis vaccine
Tedivax-Adult™/ Td-Rix™
Sponsored by
About this trial
This is an interventional prevention trial for Diphteria, Tetanus and Pertussis focused on measuring Booster vaccination
Eligibility Criteria
Inclusion Criteria:
- A male or female aged ≥18 years at the time of vaccination
- Free of obvious health problems as established by medical history and clinical examination before entering into the study
- Written informed consent obtained from the subject
- If the subject is female, she must be of non-childbearing potential , i.e., either surgically sterilised or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
For the annex phase of this study, subjects must meet the inclusion criteria mentioned above. In addition, subjects must have received either reduced-antigen-content diphtheria-tetanus or diphtheria-tetanus-acellular pertussis vaccine in the initial phase of the study and not responded to either the diphtheria or tetanus toxoid..
Exclusion Criteria:
- Vaccination against diphtheria and/or tetanus within the previous five years
- Vaccination against pertussis since childhood
- History of diphtheria and/or tetanus
- Known history of pertussis within the previous five years
- Known exposure to diphtheria or pertussis within the previous five years
- Known history of non-response to diphtheria, tetanus or pertussis vaccine
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days/ 5 half-lives preceding the dose of study vaccine
- Administration of chronic immunosuppressants or other immune-modifying drugs within six months/ 5 half-lives of vaccination.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before vaccination and ending 30 days after
- Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration/ administration during the study period
- Any confirmed or suspected immunosuppressive or immunodeficient condition
- Pregnant or lactating female
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
- Hypersensitivity to any component of the vaccines
- Acute disease at the time of enrolment
- Oral temperature of ≥37.5°C (99.5°F)
- Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine or diptheria and tetanus vaccines
- An immediate anaphylactic reaction
- Signs of encephalopathy
- Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine alone or in combination with other antigens:
- Rectal temperature ≥40.5°C within 48 hours of vaccination and not due to another identifiable cause
- Collapse or shock-like state within 48 hours of vaccination
- Persistent, inconsolable screaming or crying lasting ≥3 hours within 48 hours of vaccination
- Convulsions with or without fever, occurring within 3 days of vaccination
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
dTPa vaccine
Pa vaccine
Tedivax-Adult™/ Td-Rix™
Outcomes
Primary Outcome Measures
Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa vaccine and Tedivax-Adult™/ Td-Rix™)
Secondary Outcome Measures
Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa, pa vaccines and Tedivax-Adult™/ Td-Rix™)
Occurrence of solicited local adverse experiences
Occurrence of solicited general adverse experiences
Occurrence of unsolicited symptoms
Occurrence of any serious adverse experiences
Lymphoproliferation specific for pertussis toxoid, filamentous haemagglutinin and pertactin/ Cell mediated immunity response
Immunogenicity with respect to components of the study vaccines (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Occurrence of solicited local adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Occurrence of solicited general adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Occurrenceof unsolicited symptoms (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Occurrence of any serious adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01262924
Brief Title
Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine
Official Title
A Phase III, Blinded, Randomised, Monocentre, Comparative Clinical Study of the Immunogenicity, Reactogenicity and Safety of a Single Booster Dose of SB Biologicals' Candidate dTpa and pa Vaccines and SB Biologicals' Licensed Td Vaccine in Healthy Adults Aged ≥18 Years
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
October 1997 (undefined)
Primary Completion Date
December 1998 (Actual)
Study Completion Date
December 1998 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly, SmithKline Beecham Biologicals) reduced-antigen-content acellular pertussis vaccine and reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine in comparison with Tedivax-Adult™/ Td-Rix™
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphteria, Tetanus and Pertussis
Keywords
Booster vaccination
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
dTPa vaccine
Arm Title
Group B
Arm Type
Experimental
Arm Description
Pa vaccine
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Tedivax-Adult™/ Td-Rix™
Intervention Type
Biological
Intervention Name(s)
GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine
Intervention Description
Intramuscular, single dose
Intervention Type
Biological
Intervention Name(s)
GSK Biologicals' reduced-antigen-content acellular pertussis vaccine
Intervention Description
Intramuscular, single dose
Intervention Type
Biological
Intervention Name(s)
Tedivax-Adult™/ Td-Rix™
Intervention Description
Intramuscular, single dose or 2 doses (in the annex phase)
Primary Outcome Measure Information:
Title
Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa vaccine and Tedivax-Adult™/ Td-Rix™)
Time Frame
One month after the booster dose (Month 1)
Secondary Outcome Measure Information:
Title
Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa, pa vaccines and Tedivax-Adult™/ Td-Rix™)
Time Frame
One month after the booster dose (Month 1)
Title
Occurrence of solicited local adverse experiences
Time Frame
During the 15-day (Day 0-14) follow-up period after vaccination
Title
Occurrence of solicited general adverse experiences
Time Frame
During the 15-day (Day 0-14) follow-up period after vaccination
Title
Occurrence of unsolicited symptoms
Time Frame
Within the 31-day (Day 0 -30) follow-up period after vaccination
Title
Occurrence of any serious adverse experiences
Time Frame
Within the 31-day (Day 0 -30) follow-up period after vaccination
Title
Lymphoproliferation specific for pertussis toxoid, filamentous haemagglutinin and pertactin/ Cell mediated immunity response
Time Frame
At pre-vaccination (Day 0) and Month 1 post-vaccination
Title
Immunogenicity with respect to components of the study vaccines (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time Frame
One month after the second and third booster dose (Month 12)
Title
Occurrence of solicited local adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time Frame
During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose
Title
Occurrence of solicited general adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time Frame
During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose
Title
Occurrenceof unsolicited symptoms (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time Frame
Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose
Title
Occurrence of any serious adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time Frame
Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A male or female aged ≥18 years at the time of vaccination
Free of obvious health problems as established by medical history and clinical examination before entering into the study
Written informed consent obtained from the subject
If the subject is female, she must be of non-childbearing potential , i.e., either surgically sterilised or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
For the annex phase of this study, subjects must meet the inclusion criteria mentioned above. In addition, subjects must have received either reduced-antigen-content diphtheria-tetanus or diphtheria-tetanus-acellular pertussis vaccine in the initial phase of the study and not responded to either the diphtheria or tetanus toxoid..
Exclusion Criteria:
Vaccination against diphtheria and/or tetanus within the previous five years
Vaccination against pertussis since childhood
History of diphtheria and/or tetanus
Known history of pertussis within the previous five years
Known exposure to diphtheria or pertussis within the previous five years
Known history of non-response to diphtheria, tetanus or pertussis vaccine
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days/ 5 half-lives preceding the dose of study vaccine
Administration of chronic immunosuppressants or other immune-modifying drugs within six months/ 5 half-lives of vaccination.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before vaccination and ending 30 days after
Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration/ administration during the study period
Any confirmed or suspected immunosuppressive or immunodeficient condition
Pregnant or lactating female
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Hypersensitivity to any component of the vaccines
Acute disease at the time of enrolment
Oral temperature of ≥37.5°C (99.5°F)
Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine or diptheria and tetanus vaccines
An immediate anaphylactic reaction
Signs of encephalopathy
Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine alone or in combination with other antigens:
Rectal temperature ≥40.5°C within 48 hours of vaccination and not due to another identifiable cause
Collapse or shock-like state within 48 hours of vaccination
Persistent, inconsolable screaming or crying lasting ≥3 hours within 48 hours of vaccination
Convulsions with or without fever, occurring within 3 days of vaccination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
14670310
Citation
Van Damme P, Burgess M. Immunogenicity of a combined diphtheria-tetanus-acellular pertussis vaccine in adults. Vaccine. 2004 Jan 2;22(3-4):305-8. doi: 10.1016/j.vaccine.2003.08.012.
Results Reference
result
Learn more about this trial
Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine
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