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The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in elderly. Subjects will be vaccinated twice with an interval of two months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation 1 | Experimental |
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| Formulation 2 | Experimental |
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| Formulation 3 | Experimental |
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| Formulation 4 | Experimental |
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| Formulation 5 | Experimental |
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| Formulation 6 | Experimental |
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| 23 valent pneumococcal vaccine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal vaccine GSK2189241A | Biological | Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of any vaccine related and grade 3 solicited local and general adverse events | During a 7-day follow up period after each vaccine dose | |
| Occurrence of any vaccine related and grade 3 unsolicited adverse events | During a 31-day follow up period after each vaccine dose | |
| Occurrence of any vaccine related serious adverse events (SAE) | From dose 1 to study conclusion | |
| Occurrence of any grade 3 laboratory abnormalities | At 1 and 7 days after each vaccine dose |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of any solicited local and general adverse events | During a 7-day follow up period after each vaccine dose | |
| Occurrence of any unsolicited adverse events | During a 31-day follow up period after each vaccine dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Malmö | SE-205 02 | Sweden | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24599529 | Derived | Pauksens K, Nilsson AC, Caubet M, Pascal TG, Van Belle P, Poolman JT, Vandepapeliere PG, Verlant V, Vink PE. Randomized controlled study of the safety and immunogenicity of pneumococcal vaccine formulations containing PhtD and detoxified pneumolysin with alum or adjuvant system AS02V in elderly adults. Clin Vaccine Immunol. 2014 May;21(5):651-60. doi: 10.1128/CVI.00807-13. Epub 2014 Mar 5. |
| Label | URL |
|---|---|
| Results for study 111652 can be found on the GSK Clinical Study Register | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 111652 | Individual Participant Data Set | 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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| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Pneumo 23™ | Biological | One dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2. |
|
| Occurrence of any laboratory abnormalities | At 1 and 7 days after each vaccine dose |
| Occurrence of any medically significant conditions prompting emergency room visits or physician visits regardless of casual relationship to vaccination or intensity | From dose 1 to study conclusion |
| Anti-pneumococcal and anti-NTHi candidate vaccine antigens | At Days 0, 30 and 90 |
| Örebro |
| SE-701 85 |
| Sweden |
| GSK Investigational Site | Uppsala | SE-751 85 | Sweden |
| 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 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111652 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111652 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111652 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111652 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |