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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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Healthy children who received two doses of GlaxoSmithKline (GSK) Biologicals' live attenuated measles-mumps-rubella vaccine (MMR) or measles-mumps-rubella-varicella vaccine (MMRV) in their second year of life.The purpose of this study is to assess the effect of the age at administration of the first dose on the reactogenicity and immunogenicity of the measles component of these vaccines.
In addition, this study will evaluate if the effect of the age at first dose is modified by the type of vaccine administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 months | MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age |
| |
| 13 months | MMR vaccine / MMRV vaccine : administration of the first dose at 13 months of age |
| |
| 14 months | MMR vaccine / MMRV vaccine : administration of the first dose at 14 months of age |
| |
| 15 months or more | MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age or older |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMR vaccine / MMRV vaccine | Biological | Subcutaneous injection, two doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Short term seropositivity rates & anti-measles antibody titers after vaccination with MMR or MMRV | Antibody titers are expressed as Geometric Mean Concentrations (GMC) in mIU/mL. The cut-off for seropositivity is anti-measles antibody titer ≥ 150 mIU/mL (performed on seronegative subjects prior to vaccination). | At day 42 after administration of a dose of MMR or MMRV vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Injection site reaction | Injection site reaction is defined by the presence of pain, redness and swelling | Days 0-3 after vaccination |
| Systemic symptoms | Will include fever (defined as rectal temperature ≥38°C), general malaise and measles-like rash |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects aged 11 to 22 months selected to participate in clinical trials to assess the safety and immunogenicity of the GSK biological Priorix-Tetra™ in Germany, Austria, Finland, Greece, Poland, Czech Republic, Italy, Lithuania, Norway, Romania, Russian Federation, Slovakia, Sweden, United States and Puerto Rico.
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| Name | Affiliation | Role |
|---|---|---|
| Gaston De Serres, MD, PhD | CHU de Quebec-Universite Laval | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19665608 | Background | Czajka H, Schuster V, Zepp F, Esposito S, Douha M, Willems P. A combined measles, mumps, rubella and varicella vaccine (Priorix-Tetra): immunogenicity and safety profile. Vaccine. 2009 Nov 5;27(47):6504-11. doi: 10.1016/j.vaccine.2009.07.076. Epub 2009 Aug 7. | |
| 18600190 | Background | Schuster V, Otto W, Maurer L, Tcherepnine P, Pfletschinger U, Kindler K, Soemantri P, Walther U, Macholdt U, Douha M, Pierson P, Willems P. Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life. Pediatr Infect Dis J. 2008 Aug;27(8):724-30. doi: 10.1097/INF.0b013e318170bb22. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 2, 2021 | |
| Reset | Aug 26, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 2, 2021 | Aug 26, 2021 |
| ID | Term |
|---|---|
| D008457 | Measles |
| ID | Term |
|---|---|
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D022542 | Measles-Mumps-Rubella Vaccine |
| C050102 | measles, mumps, rubella, varicella vaccine |
| C577557 | Priorix-Tetra vaccine |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Days 0 - 42 after administration of a dose of MMR or MMRV vaccine |
| Long term seropositivity rates and anti-measles antibody titers after vaccination with MMR or MMRV | Antibody titers are expressed as Geometric Mean Concentrations (GMC) in mIU/mL The cut-off for seropositivity is anti-measles antibody titer ≥ 150 mIU/mL | 2 and 3 years after vaccination with 2 doses of MMR or MMRV vaccines |
| 16395096 | Background | Knuf M, Habermehl P, Zepp F, Mannhardt W, Kuttnig M, Muttonen P, Prieler A, Maurer H, Bisanz H, Tornieporth N, Descamps D, Willems P. Immunogenicity and safety of two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children. Pediatr Infect Dis J. 2006 Jan;25(1):12-8. doi: 10.1097/01.inf.0000195626.35239.58. |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D008458 |
| Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |