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This study will assess the immunogenicity and reactogenicity of the candidate GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine when administered to healthy subjects aged ≥ 15 years in Germany and ≥ 18 years in France compared to Boostrix™ and inactivated poliovirus vaccine administered separately, and with Revaxis®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
| |
| Group C | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine | Biological | Intramuscular, single |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity with respect to components of the study vaccines | One month after vaccination (Month 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity with respect to components of the study vaccines | One month after vaccination (Month 1) | |
| Immunogenicity with respect to some component of the study vaccines | At Day 10 after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
Absolute contraindications:
Precautions:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21718738 | Background | Van Damme P, McIntyre P, Grimprel E, Kuriyakose S, Jacquet JM, Hardt K, Messier M, Van Der Meeren O. Immunogenicity of the reduced-antigen-content dTpa vaccine (Boostrix((R))) in adults 55 years of age and over: a sub-analysis of four trials. Vaccine. 2011 Aug 11;29(35):5932-9. doi: 10.1016/j.vaccine.2011.06.049. Epub 2011 Jun 28. | |
| 15882526 |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 711866/003 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Boostrix™ | Biological | Intramuscular, single dose |
|
| GSK Biologicals' IPV vaccine | Biological | Intramuscular, single dose |
|
| Revaxis® | Biological | Intramuscular, single dose |
|
| Occurrence of solicited local and general symptoms | within 15 (Day 0-14) days after vaccination |
| Occurrence of unsolicited symptoms | within 30 days (Day 0-29) after vaccination |
| Occurrence of serious adverse events | Throughout the entire study (from Day 0 to Day 30) |
| Grimprel E, von Sonnenburg F, Sanger R, Abitbol V, Wolter JM, Schuerman LM. Combined reduced-antigen-content diphtheria-tetanus-acellular pertussis and polio vaccine (dTpa-IPV) for booster vaccination of adults. Vaccine. 2005 May 25;23(28):3657-67. doi: 10.1016/j.vaccine.2005.02.013. |
| Result | Wolter J et al. Boostrix polio: A new combined vaccine to fulfill emerging needs for pertussis vaccination of older age-groups. Abstract presented at the ESPID, Tampere, Finland, 26-28 May 2004. |
| 25882172 | Derived | Kovac M, Rathi N, Kuriyakose S, Hardt K, Schwarz TF. Immunogenicity and reactogenicity of a decennial booster dose of a combined reduced-antigen-content diphtheria-tetanus-acellular pertussis and inactivated poliovirus booster vaccine (dTpa-IPV) in healthy adults. Vaccine. 2015 May 21;33(22):2594-601. doi: 10.1016/j.vaccine.2015.03.104. Epub 2015 Apr 14. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 711866/003 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 711866/003 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 711866/003 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 711866/003 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 711866/003 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D013742 | Tetanus |
| D004165 | Diphtheria |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| C505143 | Boostrix |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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