Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
| |
| Group C | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boostrix™ (dTpa) | Biological | Intramuscular, 3 doses |
| |
| GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM) |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity with respect to components of the study vaccines | One month after the third dose (Month 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity with respect to components of the study vaccines | One month after each dose (Months 1, 2 and 7) | |
| Occurrence of solicited local and general symptoms | Within 15 days (day 0 -14) after each vaccine dose. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bruges | 8000 | Belgium | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17897485 | Background | Theeten H, Rumke H, Hoppener FJ, Vilatimo R, Narejos S, Van Damme P, Hoet B. Primary vaccination of adults with reduced antigen-content diphtheria-tetanus-acellular pertussis or dTpa-inactivated poliovirus vaccines compared to diphtheria-tetanus-toxoid vaccines. Curr Med Res Opin. 2007 Nov;23(11):2729-39. doi: 10.1185/03007x233034. | |
| 21718738 |
| 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 |
|---|---|---|---|
| 263855/034 | Study Protocol | 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Biological |
Intramuscular, single dose |
|
| Ditanrix™ Adult, TedivaxTM (Td) | Biological | Intramuscular, 2 doses |
|
| Ditanrix™ Adult, TedivaxTM (Td) | Biological | Intramuscular, 3 doses |
|
| Occurrence of unsolicited symptoms | Within 31 days (day 0-30) after each vaccine dose. |
| 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 |
| Leuven |
| 3000 |
| Belgium |
| GSK Investigational Site | Wilrijk | 2610 | Belgium |
| GSK Investigational Site | Rotterdam | 3015 GE | Netherlands |
| GSK Investigational Site | Utrecht | 3584 CJ | Netherlands |
| GSK Investigational Site | Alzira | 46600 | Spain |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Barcelona | 8025 | Spain |
| GSK Investigational Site | Centelles | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Mollet del Vallès | 08100 | Spain |
| GSK Investigational Site | Vic | 28500 | Spain |
| 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. |
| Background | 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. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 263855/034 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 263855/034 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 263855/034 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 263855/034 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 263855/034 | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C505143 | Boostrix |
| D004369 | Pentetic Acid |
| D013745 | Tetanus Toxoid |
| D011054 | Poliovirus Vaccine, Inactivated |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D015164 | Vaccines, Inactivated |
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
Not provided
Not provided