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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™
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | dTPa vaccine |
|
| Group B | Experimental | Pa vaccine |
|
| Group C | Active Comparator | Tedivax-Adult™/ Td-Rix™ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine | Biological | Intramuscular, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa vaccine and Tedivax-Adult™/ Td-Rix™) | One month after the booster dose (Month 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa, pa vaccines and Tedivax-Adult™/ Td-Rix™) | One month after the booster dose (Month 1) | |
| Occurrence of solicited local adverse experiences | During the 15-day (Day 0-14) follow-up period after vaccination |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14670310 | Result | 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. |
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| GSK Biologicals' reduced-antigen-content acellular pertussis vaccine | Biological | Intramuscular, single dose |
|
| Tedivax-Adult™/ Td-Rix™ | Biological | Intramuscular, single dose or 2 doses (in the annex phase) |
|
| Occurrence of solicited general adverse experiences | During the 15-day (Day 0-14) follow-up period after vaccination |
| Occurrence of unsolicited symptoms | Within the 31-day (Day 0 -30) follow-up period after vaccination |
| Occurrence of any serious adverse experiences | Within the 31-day (Day 0 -30) follow-up period after vaccination |
| Lymphoproliferation specific for pertussis toxoid, filamentous haemagglutinin and pertactin/ Cell mediated immunity response | At pre-vaccination (Day 0) and Month 1 post-vaccination |
| 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) | One month after the second and third booster dose (Month 12) |
| Occurrence of solicited local adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) | During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose |
| Occurrence of solicited general adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) | During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose |
| Occurrenceof unsolicited symptoms (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) | Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose |
| Occurrence of any serious adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) | Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose |
| ID | Term |
|---|---|
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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