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Clinical trials



RESEARCH UNIT IN PEDIATRIC VACCINES

GALLEGO GROUP GENETICS, VACCINES AND RESEARCH PEDIATRIC (G3VIP)

Research Team Santiago
Coordinator: Federico Martinón-Torres
Researchers: Lorenzo Redondo Collazo
Jose María Martinón Sánchez
Carmen Rodríguez-Tenreiro Sánchez
Marta Bouzón Alejandro
Silvia Rodríguez Blanco
Nazareth Martinón Torres
Natalia García Sánchez
Manoel Muñiz Fontan
Research Nurses: Mª Dolores Oreiro Vilacoba
Luisa García Vicente
Secretariat: Belen Mosquera Perez



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)
Type of test: fase 1, multicéntrico, internacional
Duration: 2010 A 2012
Promotor: Roche
Status: Inicio de reclutamiento febrero de 2010
Contact: F. Martinón (Coordinator) 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
Type of participation: Asesor, Consultor, Coordinator nacional, Coordinator regional, e investigador principal
Duration: 2010 a 2012
Promotor: Novartis
Code: V72P12E1
Contact: F. Martinón (Coordinator) 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)
Duration: 2005 a 2008-2009
Promotor: Wyeth
Status: Fase de cierre y publicación de resultados
Contact: F. Martinón (Coordinator 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
Duration: 2007 a 2009
Promotor: Sanofi Pasteur MSD
Status: fase de cierre y publicación de resultados
Contact: F. Martinón (Coordinator 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)
Duration: 2007 a 2009
Promotor: Wyeth
Status: fase de cierre y publicación de resultados
Contact: F. Martinón (lead investigator y Coordinator 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
Duration: 2009 a 2011
Promotor: Medimmune
Status: Inicio de reclutamiento Abril 2009
Contact: F. Martinón (Coordinator 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)
Duration: 2009 a 2011
Promotor: Novartis
Status: Activo
Contact: F. Martinón (Coordinator 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)
Duration: 2009 al 2013
Promotor: Wyeth
Status: Activo
Contact: F. Martinón (Coordinator 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)
Duration: 2009 al 2013
Promotor: Wyeth
Status: Inicio de reclutamiento Junio 2009
Contact: F. Martinón (Coordinator nacional) o L. Redondo (investigador principal)