- Trials with a EudraCT protocol (76)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (22)

These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. |
Study title: Open, multicentre study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline Biologicals’ live attenuated Measles-Mumps-Rubella vaccine (PriorixTM) given to healthy children at the age of 12 to 15 months or 4- 6 years |
Active substance: trivalent attenuated measles (Schwarz strain) - mumps (RIT 4385 and RIT 4386) - rubella (RA 27/3 strain) |
Study summary document link (including results): |
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Document reference: 47874 |
Study title: Post-Marketing Surveillance Report of Priorix™ (Priorix™, Combined Measles-Mumps-Rubella vaccine) Surveillance period: (20 August 1999 ~ 19 August 2005) |
Active substance: trivalent attenuated measles (Schwarz strain) - mumps (RIT 4385 and RIT 4386) - rubella (RA 27/3 strain) |
Study summary document link (including results): |
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Document reference: 47873 |
Study title: Study of the live attenuated Rubella vaccine among adults (≥ 15 years old) |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
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Document reference: 47473 |
Study title: Study of the live attenuated Rubella vaccine among children and adolescent |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
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Document reference: 21212 |
Study title: Vaccination with a live attenuated RA27/3 strain rubella vaccine, a follow up study |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 41362 |
Study title: Rubella vaccine in school Children |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
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Document reference: 41364 |
Study title: Rubella vaccine in school Children |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
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Document reference: 41456 |
Study title: A randomized, double-blind, placebo-controlled trial to measure the antibody response to immunization with measles-mumbs-rubella vaccines using EMLA patch for the reduction of pain associated with subcutaneous injection in twelve month old infants, 1998 |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 13_DC-EMB-0001 CSR Synopsis.pdf |
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Document reference: 47245 |
Study title: A phase III, open, randomised, controlled multicentre study to evaluate the immunogenicity and safety of one dose of GlaxoSmithKline Biologicals’ combined measles-mumps-rubella-varicella vaccine (MeMuRu- OKA) given to healthy children 4 to 6 years of age previously primed with one dose of measles-mumpsrubella vaccine (either Priorix™ or M-M-R II™) in their second year of life and presumed seronegative for varicella. |
Active substance: Live attenuated measles, mumps, rubella, varicella vaccine |
Study summary document link (including results): |
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Document reference: 47878 |
Study title: A phase III, open, randomized, controlled study to evaluate the immunogenicity and safety of one dose of GlaxoSmithKline Biologicals’ measles-mumps-rubella-varicella vaccine (MeMuRu-OKA) given to healthy children of 4 to 6 years of age previously primed with one dose of measles-mumps-rubella vaccine (GlaxoSmithKline Biologicals’ PriorixÔ or Merck & Co.’s M-M-R IIÔ) |
Active substance: Live attenuated measles, mumps, rubella, varicella vaccine |
Study summary document link (including results): |
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Document reference: 47876 |
Study title: Clinical and immunological evaluation of the live attenuated RA27/3 rubella vaccine in seronegative children and adults in Switzerland |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 41359 |
Study title: Clinical and immunological study on RA27/3 and cendehill strains of rubella vaccines during a vaccination campaign in Brittany and Mayenne in France |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
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Document reference: 41361 |
Study title: Clinical and serological evaluation of the live attenuated RA27/3 strain rubella vaccine in a population of susceptible children in France |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
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Document reference: 41363 |
Study title: Clinical evaluation of the live attenuated rubella vaccine, RA27/3 on seronegative children in Dakar (Senegal) |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 41358 |
Study title: Clinical study of the vaccine against rubella rudivax Italy stydy |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
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Document reference: 41366 |
Study title: Comparative study of 3 different strains of rubella vaccines |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
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Document reference: 41360 |
Study title: Evaluation of the side effects occuring with two RA27/3 strains of rubella vaccine in a population of schoolgirl |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
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Document reference: 41365 |
Study title: Evaluation of the side effects occuring with two RA27/3 strains of rubella vaccine in a population of schoolgirl |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
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Document reference: 41457 |
Study title: Evaluation of the side effects occuring with two RA27/3 strains of rubella vaccine in a population of schoolgirls |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
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Document reference: 47475 |
Study title: Evaluation study of the side effects occumng after two RA27/3 strains of rubella vaccines in a population of schoolgirls. |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 47476 |