Ensayos clínicos
UNIDAD DE INVESTIGACION EN VACUNAS PEDIATRICAS
GRUPO GALLEGO DE GENÉTICA, VACUNAS E INVESTIGACIÓN PEDIATRICA (G3VIP)
| Equipo investigador Principal | |
| Coordinador: | Federico Martinón-Torres |
| Director y Jefe de Equipo: | Lorenzo Redondo Collazo |
| Investigadores: |
Jose María Martinón Sánchez
Carmen Rodríguez-Tenreiro Sánchez Marta Bouzón Alejandro Silvia Rodríguez Blanco Nazareth Martinón Torres Natalia García Sánchez Manoel Muñiz Fontan Olalla Elena López Suarez María Jose Fernández Seara Silvia Dosil Gallardo María López Sousa Alicia Mirás Veiga |
| Subinvestigadores colaboradores: |
Mercedes Del Río Garma
Sacramento Garabal Sánchez Jose Manuel Gaciño Nieto Jorge Fernández Jimenez Inmaculada Pérez Castro Carmen Losada Pazo Pilar Pereira García Inés Del rio Cristina Perez Del olmo Jose Manuel Fernandez Bustillo |
| Enfermeras de investigación: |
Mª Dolores Oreiro Vilacoba
Luisa García Vicente |
| Secretaría: | Belen Mosquera Perez |
| A Phase 4, Open-label Trial Describing the Safety, Tolerability, and Immunogenicity of the 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants | |
|---|---|
| Duración: | 2010 al 2013 |
| Promotor: | Pfizer |
| Estado: | Inicio de reclutamiento Sept 2010 |
| Contacto: | F. Martinón (coordinador) o L. Redondo (investigador principal) |
| A Randomized, Double-Blinded, Controlled with GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-olds) | |
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| Duración: | 2011 al 2013 |
| Promotor: | Merck |
| Estado: | Inicio de reclutamiento MarzO 2011 |
| Contacto: | F. Martinón (coordinador) o L. Redondo (investigador principal) |
| A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children aged 2 to 10 Years | |
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| Duración: | 2011 al 2013 |
| Promotor: | Novartis |
| Estado: | Inicio de reclutamiento Marz 2011 |
| Contacto: | F. Martinón (coordinador) o L. Redondo (investigador principal) |
| A Multicenter, Double-Blind Phase 2 Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevnar 13 in Healthy Infants | |
|---|---|
| Duración: | 2010 al 2012 |
| Promotor: | Merck |
| Estado: | Inicio de reclutamiento Oct 2010 |
| Contacto: | F. Martinón (coordinador) o L. Redondo (investigador principal) |
| Estudio fase IIa, observador-ciego, multinacional, multicéntrico, aleatorizado para evaluar la inmunogenicidad, seguridad y reactogenicidad de la vacuna antigripal tetravalente (QIV) adyuvada con diferentes dosis de AS03 de GlaxoSmithKline Biologicals (GSK2584786A), administrada en niños de 6 a 35 meses de edad, y comparada con la vacuna QIV sin adyuvar y con Fluarix®. | |
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| Duración: | 2010 al 2011 |
| Promotor: | GlaxoSmithKline |
| Estado: | Inicio de reclutamiento Oct 2010 |
| Contacto: | F. Martinón (coordinador) o L. Redondo (investigador principal) |
| An open label, prospective, pharmacokinetic/pharmacodynamic and safety evaluation (phase 1b) of oseltamivir (Tamiflu®) in the treatment of infants 0 to < 12 months of age with confirmed influenza infection (protocol WP22849) | |
|---|---|
| Tipo de ensayo: | fase 1, multicéntrico, internacional |
| Duración: | 2010 A 2012 |
| Promotor: | Roche |
| Estado: | Inicio de reclutamiento febrero de 2010 |
| Contacto: | F. Martinón (coordinador) o L. Redondo (investigador principal) |
| A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 18 or 24 Months of Age in Subjects Who Previously Received a Three-Dose Primary Series of the Novartis Meningococcal B Recombinant Vaccine as Infants in Study V72P12A | |
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| Tipo de participación: | Asesor, Consultor, Coordinador nacional, Coordinador regional, e investigador principal |
| Duración: | 2010 a 2012 |
| Promotor: | Novartis |
| Código: | V72P12E1 |
| Contacto: | F. Martinón (coordinador) o L. Redondo (investigador principal) |
| A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Spain (protocolo 6096A1-501) | |
|---|---|
| Duración: | 2005 a 2008-2009 |
| Promotor: | Wyeth |
| Estado: | Fase de cierre y publicación de resultados |
| Contacto: | F. Martinón (coordinador regional) |
| An Open-label, Multi-centre Study of the Safety of a 2-dose Regimen of a Combined Measles, Mumps, Rubella and Varicella Live Vaccine (ProQuad®) Manufactured with rHA when administered to Children in their Second Year of Life | |
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| Duración: | 2007 a 2009 |
| Promotor: | Sanofi Pasteur MSD |
| Estado: | fase de cierre y publicación de resultados |
| Contacto: | F. Martinón (coordinador regional) o L. Redondo (investigador principal) |
| A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With a Meningococcal C-Tetanus Toxoid ConjugateVaccine and Other Routine Pediatric Vaccinations in Spain (protocol 6096A1-3007) | |
|---|---|
| Duración: | 2007 a 2009 |
| Promotor: | Wyeth |
| Estado: | fase de cierre y publicación de resultados |
| Contacto: | F. Martinón (lead investigator y coordinador regional) |
| A Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to <24 Month-Old Children and in 2 Month Old Infants | |
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| Duración: | 2009 a 2011 |
| Promotor: | Medimmune |
| Estado: | Inicio de reclutamiento Abril 2009 |
| Contacto: | F. Martinón (coordinador nacional) o L. Redondo (investigador principal) |
| A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered with or without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules (protocolo V72P12) | |
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| Duración: | 2009 a 2011 |
| Promotor: | Novartis |
| Estado: | Activo |
| Contacto: | F. Martinón (Coordinador nacional) |
| A Single blind, Randomized Phase 1/2 Trial of the Safety, Tolerability, and Immunogenicity of Meningococcal Group B rLP2086 Vaccine in Healthy Infants (protocolo 6108K2-2000) | |
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| Duración: | 2009 al 2013 |
| Promotor: | Wyeth |
| Estado: | Activo |
| Contacto: | F. Martinón (Coordinador nacional) o L. Redondo (Investigador principal) |
| A Single blind, Randomized Phase 2 Trial of the Safety, Tolerability, and Immunogenicity of Meningococcal Group B rLP2086 Vaccine at dose of 60 microg, 120 microg y 200 microgr in Healthy Adolescentes aged 11 to 18 years (protocolo 6108a1-2001) | |
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| Duración: | 2009 al 2013 |
| Promotor: | Wyeth |
| Estado: | Inicio de reclutamiento Junio 2009 |
| Contacto: | F. Martinón (Coordinador nacional) o L. Redondo (investigador principal) |