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This is a study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals live attenuated measles-mumps-rubella-varicella vaccine given to healthy children in their second year of life.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measles, Mumps, Rubella and Chickenpox (live vaccine) | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody levels after vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the study vaccines. |
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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 | Espoo | 02100 | Finland | |||
| GSK Investigational Site |
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| 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 |
|---|---|---|---|
| 104020 | Dataset Specification | 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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| Lahti |
| 15140 |
| Finland |
| GSK Investigational Site | Oulu | 90100 | Finland |
| GSK Investigational Site | Pori | 28120 | Finland |
| GSK Investigational Site | Tampere | 33200 | Finland |
| GSK Investigational Site | Turku | 20520 | Finland |
| GSK Investigational Site | Vantaa | 01300 | Finland |
| GSK Investigational Site | Bayreuth | Bavaria | 95444 | Germany |
| GSK Investigational Site | Bindlach | Bavaria | 95463 | Germany |
| GSK Investigational Site | Bobingen | Bavaria | 86399 | Germany |
| GSK Investigational Site | Cham | Bavaria | 93413 | Germany |
| GSK Investigational Site | Kempten (Allgäu) | Bavaria | 87435 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81241 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81735 | Germany |
| GSK Investigational Site | Nördlingen | Bavaria | 86720 | Germany |
| GSK Investigational Site | Nuremberg | Bavaria | 90473 | Germany |
| GSK Investigational Site | Olching | Bavaria | 82140 | Germany |
| GSK Investigational Site | Tegernsee | Bavaria | 83684 | Germany |
| GSK Investigational Site | Tutzing | Bavaria | 82327 | Germany |
| GSK Investigational Site | Veitshöchheim | Bavaria | 97209 | Germany |
| GSK Investigational Site | Eschwege | Hesse | 37269 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60389 | Germany |
| GSK Investigational Site | Fulda | Hesse | 36037 | Germany |
| GSK Investigational Site | Nidderau | Hesse | 61130 | Germany |
| GSK Investigational Site | Wiesbaden | Hesse | 65205 | Germany |
| GSK Investigational Site | Salzgitter | Lower Saxony | 38226 | Germany |
| GSK Investigational Site | Wolfenbüttel | Lower Saxony | 38302 | Germany |
| GSK Investigational Site | Bad Oeynhausen | North Rhine-Westphalia | 32549 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44866 | Germany |
| GSK Investigational Site | Detmold | North Rhine-Westphalia | 32756 | Germany |
| GSK Investigational Site | Dortmund | North Rhine-Westphalia | 44329 | Germany |
| GSK Investigational Site | Espelkamp | North Rhine-Westphalia | 32339 | Germany |
| GSK Investigational Site | Goch | North Rhine-Westphalia | 47574 | Germany |
| GSK Investigational Site | Gütersloh | North Rhine-Westphalia | 33332 | Germany |
| GSK Investigational Site | Hille | North Rhine-Westphalia | 32479 | Germany |
| GSK Investigational Site | Kirchlengern | North Rhine-Westphalia | 32278 | Germany |
| GSK Investigational Site | Krefeld | North Rhine-Westphalia | 47798 | Germany |
| GSK Investigational Site | Löhne | North Rhine-Westphalia | 32584 | Germany |
| GSK Investigational Site | Minden | North Rhine-Westphalia | 32427 | Germany |
| GSK Investigational Site | Mönchengladbach | North Rhine-Westphalia | 41061 | Germany |
| GSK Investigational Site | Mönchengladbach | North Rhine-Westphalia | 41236 | Germany |
| GSK Investigational Site | Münster | North Rhine-Westphalia | 48159 | Germany |
| GSK Investigational Site | Wesseling | North Rhine-Westphalia | 50389 | Germany |
| GSK Investigational Site | Willich | North Rhine-Westphalia | 47877 | Germany |
| GSK Investigational Site | Arta | 471 00 | Greece |
| GSK Investigational Site | Athens | 11527 | Greece |
| GSK Investigational Site | Komotini | 69100 | Greece |
| GSK Investigational Site | Rhodes | 851 00 | Greece |
| GSK Investigational Site | Thessaloniki | 54636 | Greece |
| GSK Investigational Site | Bydgoszcz | 85-021 | Poland |
| GSK Investigational Site | Krakow | 31-202 | Poland |
| GSK Investigational Site | Poznan | 61-709 | Poland |
| GSK Investigational Site | Siemianowice Śląskie | 41-103 | Poland |
| GSK Investigational Site | Trzebnica | 55-100 | Poland |
For additional information about this study please refer to the GSK Clinical Study Register |
| 104020 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104020 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104020 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104020 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104020 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D009107 | Mumps |
| D012409 | Rubella |
| D008457 | Measles |
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D019351 | Rubulavirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
| D018185 | Morbillivirus Infections |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
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| ID | Term |
|---|---|
| D014613 | Vaccines, Attenuated |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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