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| ID | Type | Description | Link |
|---|---|---|---|
| 208136/040 | |||
| 208136/041 |
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Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany & Austria. Blood samples were collected at three time points during the follow-up period (Year 1, 2 & 3). No new subjects will be enrolled in these follow-up phases of the study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMRV | Biological | |||
| MMR (Priorix®) | Biological | |||
| Varicella (Varilrix®) | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year | ||
| Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination |
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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 | Klagenfurt | A-9020 | Austria | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Habermehl P, Zepp F, Sänger R, Otto W, Helm K, Meister N, Knuf M, Kindler K, Willems P. Assessment of Varicella Breakthrough Cases One Year after Administration of Two Doses of a Measles, Mumps, Rubella, Varicella Vaccine in the Second Year of Life. Abstract presented at the 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 03-05 May 2006. | ||
| 18536786 | Background | Knuf M, Faber J, Barth I, Habermehl P. A combination vaccine against measles, mumps, rubella and varicella. Drugs Today (Barc). 2008 Apr;44(4):279-92. doi: 10.1358/dot.2008.44.4.1210755. | |
| 21935584 |
| 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 |
|---|---|---|---|
| 208136/039 | 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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| Neufeld/Leitha |
| A 2491 |
| Austria |
| GSK Investigational Site | Salzburg | A-5020 | Austria |
| GSK Investigational Site | Villach | A-9500 | Austria |
| GSK Investigational Site | Bindlach | Bavaria | 95463 | Germany |
| GSK Investigational Site | Marktredwitz | Bavaria | 95615 | 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 | Hamburg | Free and Hanseatic City of Hamburg | 22089 | Germany |
| GSK Investigational Site | Bad Camberg | Hesse | 65520 | Germany |
| GSK Investigational Site | Fulda | Hesse | 36037 | Germany |
| GSK Investigational Site | Hochheim am Main | Hesse | 65239 | Germany |
| GSK Investigational Site | Marburg/Lahn | Hesse | 35039 | Germany |
| GSK Investigational Site | Nidderau | Hesse | 61130 | Germany |
| GSK Investigational Site | Rüsselsheim am Main | Hesse | 65428 | 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 | Bochum | North Rhine-Westphalia | 44791 | Germany |
| GSK Investigational Site | Detmold | North Rhine-Westphalia | 32756 | Germany |
| GSK Investigational Site | Gütersloh | North Rhine-Westphalia | 33332 | Germany |
| GSK Investigational Site | Kirchlengern | North Rhine-Westphalia | 32278 | Germany |
| GSK Investigational Site | Löhne | North Rhine-Westphalia | 32584 | Germany |
| GSK Investigational Site | Münster | North Rhine-Westphalia | 48159 | Germany |
| GSK Investigational Site | Bad Kreuznach | Rhineland-Palatinate | 55543 | Germany |
| GSK Investigational Site | Bad Sobernheim | Rhineland-Palatinate | 55566 | Germany |
| GSK Investigational Site | Frankenthal | Rhineland-Palatinate | 67227 | Germany |
| GSK Investigational Site | Gau-Algesheim | Rhineland-Palatinate | 55435 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55116 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| GSK Investigational Site | Schoeneberg - Kuebelberg | Rhineland-Palatinate | 66901 | Germany |
| GSK Investigational Site | Trier | Rhineland-Palatinate | 54290 | Germany |
| GSK Investigational Site | Worms | Rhineland-Palatinate | 67547 | Germany |
| GSK Investigational Site | Altenholz | Schleswig-Holstein | 24161 | Germany |
| GSK Investigational Site | Bredstedt | Schleswig-Holstein | 25821 | Germany |
| GSK Investigational Site | Brunsbüttel | Schleswig-Holstein | 25541 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24937 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24943 | Germany |
| GSK Investigational Site | Husum | Schleswig-Holstein | 25813 | Germany |
| GSK Investigational Site | Neumünster | Schleswig-Holstein | 24534 | Germany |
| Background |
| Knuf M, Zepp F, Helm K, Maurer H, Prieler A, Kieninger-Baum D, Douha M, Willems P. Antibody persistence for 3 years following two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children. Eur J Pediatr. 2012 Mar;171(3):463-70. doi: 10.1007/s00431-011-1569-4. Epub 2011 Sep 21. |
| Background | Zepp F et al. Persistence of Functional Antibodies against Mumps Remains High One Year after Administration of Two Doses of a Measles, Mumps, Rubella, Varicella (MMRV) Vaccine in the Second Year of Life. Presented at 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 03-05 May 2006. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 208136/039 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208136/039 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208136/039 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208136/039 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208136/039 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D012409 | Rubella |
| D002644 | Chickenpox |
| D009107 | Mumps |
| D008457 | Measles |
| ID | Term |
|---|---|
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D019351 | Rubulavirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018185 | Morbillivirus Infections |
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| ID | Term |
|---|---|
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D008458 | Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |
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