GENVIP

Vaccine trials unit

GENVIP has created a world-class clinical trial unit for vaccines, with specialized staff and facilities. This unit channels a large proportion of the clinical trials carried out in Spain for paediatric vaccines, from phases 1 to 3, and collaborates with several promoters in the design of protocols and clinical development programmes for a range of vaccine candidates. In the last years, we have participated and coordinated trials of different vaccine candidates against pneumococci, HPV, meningococci, flu and respiratory syncytial virus diseases, among others.

If you are interested in participating in any of our trials please contact at vacunas.chus@gmail.com

European projects

  1. Title: Personalised Risk assessment in febrile illness to Optimise Real-life Management across the European Union - PERFORM(Grant Agreement pending)
    Program: Horizon 2020
    Total budget: 17.997.665,50€ - SERGAS budget: 1.004.250€
    Coordinator: Imperial College London
    SERGAS Principal Investigator:Federico Martinón Torres
    Period: 2016-2021

  2. Title: Platform for ultra-sensitive Point-of-Care diagnostics for Infectious Diseases - POC-ID.
    Grant Agreement 634415
    Program: Horizon 2020
    Total budget: 5.963.147€ - SERGAS budget: 214.606€
    Coordinator: Technische Universitaet Berlin
    Principal Investigator at SERGAS: Federico Martinón Torres
    Period: 2015-2018

  3. Title: Platform foR European Preparedness Against (Re)-emerging Epidemics - PREPARE.
    Grant Agreement 602525
    Program: 7PM
    Total budget: 24.000.000 euros - SERGAS budget : 750.000 euros
    Coordinator: University of Antwerp
    SERGAS Principal Investigator: Federico Martinón Torres
    Period: 2013 - 2019

  4. Title: The genetic basis of meningococcal and other life threatening bacterial infections of childhood - EUCLIDS (EU childhood life threatening infectious diseases genetics study).
    Grant Agreement 279185
    Program: 7PM – Convocatoria Health 2011.2.1.1-3
    Total budget: 12.000.000 euros – SERGAS budget: 2.000.000 euros
    Coordinator: Imperial College London
    SERGAS Principal Investigator: Federico Martinón Torres
    Period: 2011 – 2017

National projects

  1. Title: Vaccinomics applied to rotavirus infection (ROTANEXT)
    Program: FIS - Instituto Carlos III PI13/02382
    Budget: 81.675 €
    Period:2014 - 2016

  2. Title: Genetics of meningoccocal disease: a multicenter study on mechanims of genetic predisposition and protection in pediatric meningococcal infection.
    Program: FIS - Instituto Carlos III PI070069
    Budget: 173.030€
    Period: 2008 a 2011

  3. Title: Evaluation of the influence of the genetic component and vitamin D levels in individual susceptibility and prognosis of the infection by influenza virus, respiratory syncytial virus and other respiratory virus.
    (GENDRES – www.gendres.org)
    Program: FIS - Instituto Carlos III PI10/00540
    Budget: 245.751 €
    Period:2011 - 2014

  4. Title: Evaluation of the indicrect costs related to the acute gastroenteritis due to rotavirus (ROTACOST).
    Program: Fundación Mutua Madrileña Investigación Médica
    Budget: 21.000 €
    Period: 2008 - 2009

  5. Title: Search etiology pneumonia with effussion (BEND protocol).
    Program: Fundación Mutua Madrileña Investigación Médica - MMA08
    Budget: 23.200 €
    Period: 2008 - 2009

  6. Title: Evaluation of the efectiveness of rotavirus vaccination in Spain (ROTEFEC project)
    Program: Fundación Mutua Madrileña Investigación Médica - MMA10
    Budget: 18.000 €
    Period: 2010

CLINICAL TRIALS (as international coordinator, national coordinator or principal investigator)


Since 2006, the following clinical trials have been performed at Dr. Martinon clinical trials unit:
  1. A multicenter, longitudinal, non-drug study to assess the suitability of neurocognitive tests and functioning scales for the measurement of cognitive and functioning changes in children with Down syndrome
    Protocol: BP29589 / Sponsor: Roche / Period: 2015-2016

  2. Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women
    Protocol: 116945/ Sponsor: GSK/Period: 2016-2017

  3. A double blind, randomized, stratified, multi-center trial evaluating conventional and double dose oseltamivir in the treatment of immunocompromised patients with influenza.
    Protocol: NV20234/C / Sponsor: Roche / Period: 2015-2017

  4. A multi-center, randomized, double-blind, placebo-controlled, phase 2 study of the efficacy, safety and tolerability of RO5186582 in adults and adolescents with Down Syndrome (CLEMATIS).
    Protocol: BP27832/ Sponsor: Sanofi Pasteur MSD / Period: 2016

  5. Booster Effect and Safety of a DTaP-IPV-Hib Combined Vaccine, with or without Hep B, in Healthy Subjects 11 to 18 Months of Age Who Received a Hexavalent or Hexavalent/Pentavalent Combined Vaccine during the Primary Series.
    Protocol: A3L40 / Sponsor: Sanofi Pasteur MSD / Period: 2016

  6. A Phase III, Stratified, Randomized, Observer Blind, Controlled, Multicenter Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non- Adjuvanted Trivalent Inactivated Influenza Vaccine in Children 6 to < 72 Months of Age.
    Protocol: V118-05/ Sponsor: Novartis /Period: 2014-2016

  7. A Phase I/IIa Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With Respiratory Syncytial Virus Lower Respiratory Tract Infection, Consisting of an Open-label Lead-in Part Followed by a Double-blind, Placebo-controlled Part, to Evaluate the Safety, Tolerability and Clinical Activity of ALX-0171, Administered via Inhalation, in Addition to Standard of Care.
    Protocol: ALX0171-C104 / Sponsor: Ablynx NV / Period: 2014-2016

  8. A Multicenter, Randomized, Double-Blinded Comparative Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daptomycin Versus Active Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis Due to Gram-Positive Organisms
    Protocol: DAP-PEDOST-11-03 / Sponsor: Cubist Pharmaceuticals /Period: 2013-2018

  9. Efficacy and Immunogenicity Study of Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Healthy Children Aged 6 to 35 Months.
    Protocol: GQM05 /Sponsor: Sanofi Pasteur MSD /Period: 2014-2016

  10. A Phase III, double-blind, randomized, multicenter study to assess safety and immunogenicity of GlaxoSmithKline Biologicals’ Quadrivalent Split Virion Influenza Vaccine (GSK2321138A) manufactured with a new process, in adults aged 18 to 49 years and in children aged 6 months to 17 years.
    Protocol: 201251 (FLU D-QIV-015) /Sponsor: GSK / Period: 2014-2015

  11. Phase IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety,Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine when administered to Immunocompromised Patients from 2 to 17 years of age who are at Increased Risk of Meningococcal Disease because of Complement Deficiency or Asplenia compared to matched Healthy Control.
    Protocol: V72_62 / Sponsor: Novartis / Period: 2014-2015

  12. Immunogenicity and Safety Study of a Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine in a 3-dose Primary Series in Healthy Infants in Europe
    Protocol: A3L39 / Sponsor: Sanofi Pasteur MSD / Period: 2014-2015

  13. A phase IIIb, Open Label, Multi Center extension study of V72_28 to assess antibody persistence, and the safety and tolerability of a booster dose after the completion of the vaccination course in study V72_28.
    Protocol: V72_28E1 / Sponsor: Novartis / Period: 2013-2015

  14. Immunogenicity and safety study of GSK Biologicals? Priorix® vaccine (209762) at an end of shelf-life potency compared to Merck & Co., Inc.?s MMR vaccine when both are given on a 2-dose schedule to healthy children in their 2nd year of life.
    Protocol: MMR-161 / Sponsor: GSK/Period: 2012-2015

  15. Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1
    Protocol: V72P12E2 / Sponsor: Novartis / Period: 2012 al 2014

  16. A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™
    Protocol: V260-035 / Sponsor: Merck / Period : 2013-2014

  17. A phase 3 open-label study to evaluate the immunogenicity and safety of a mixed (HEXA/PENTA/HEXA) primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel® at 4 months of age.
    Protocol: PRIO2C / Sponsor: Sanofi Pasteur MSD / Period: 2013-2014

  18. A Randomized, Double-Blinded, Controlled with GARDASILR (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)
    Protocol: GDS01C /Sponsor: Sanofi-Merck / Period:2011-2012

  19. 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
    Protocol: V72_28 / Sponsor:Novartis / Period: 2011-2014

  20. A Multicenter, Double-Blind Phase 2 Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevenar 13 in Healthy Infants
    Protocol: V114-003 / Sponsor: Merck / Period: 2010-2013

  21. A phase III, open-label, multicentre study to evaluate the immunogenicity, safety and reactogenicity of a revaccination dose of the GlaxoSmithKline Biologicals' quadrivalent seasonal influenza candidate vaccine GSK2321138A, administered to children who previously participated in study 115345 (FLU D-QIV-004 PRI).
    Protocol: 116023 / Sponsor: GlaxoSmithKline S.A. / Period: 2014

  22. A phase III, observer-blind, randomized, multicountry,non-influenza vaccine comparator-controlled study to demonstrate the efficacy of GlaxoSmithKline Biologicals’ quadrivalent seasonal influenza candidate vaccine GSK2321138A (FLU D-QIV), administered intramuscularly in children 6 to 35 months of age.
    Protocol: 115345 / Sponsor: GlaxoSmithKline S.A. / Period: 2011-2013

  23. 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
    Protocol: 6096A1-4001-EU / Sponsor: Pfizer / Period: 2010-2014

  24. 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 V72P12E.
    Protocol: V72P12E1 / Sponsor: Novartis / Period: 2009-2011

  25. An open label, prospective, pharmacokinetic/pharmacodynamic and safety evaluation of oseltamivir (Tamiflu®) in the treatment of infants 0 to < 12 months of age with confirmed influenza infection.
    Protocol: WP22849 / Sponsor: Roche / Period: 2011-2012

  26. Single blind, Randomized Phase 2 Trial of the Safety, Tolerability, and Immunogenicity of Meningococcal Group B rLP2086 Vaccine at dose of 60 µg., 120 µg. y 200 µg. in Healthy Adolescents aged 11 to 18 years.
    Protocol: B197105 / Sponsor: Wyeth /Period: 2009 - 2014.

  27. 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),
    Protocol: 6108K-2000-ES /Sponsor: Wyeth / Period: 2008-2010

  28. 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.
    Protocol: V72P12 / Sponsor: Novartis / Period: 2008-2010

  29. 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.
    Protocol: MRV01C / Sponsor: Sanofi Pasteur MSD / Period: 2007 - 2009.

  30. 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.
    Protocol: MICP178 / Sponsor: Medimmune Inc / Period: 2009 - 2013.

  31. 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 / Sponsor: Wyeth / Period: 2007-2010

  32. 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
    Protocol: 6096A1-501 / Sponsor: Wyeth SA/ Period: 2006 - 2009.

Principal Investigator’s Team
Coordinator: Federico Martinón-Torres
Director and Team leader: Lorenzo Redondo Collazo
Investigators: Jose María Martinón Sánchez
Carmen Rodríguez-Tenreiro Sánchez
Nazareth Martinón Torres
María Jose Fernández Seara
Silvia Dosil Gallardo
Antonio Justicia Grande e Irene Rivero Calle
Fatima Graña Silva
Beatriz Martínez Blanco
Verónica Varela Rey
Collaborating Sub-investigators: 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
Miguel Fernández Rodriguez
Juan Sánchez Lastres
Research Nurses: Mª Dolores Oreiro Vilacoba
Luisa García Vicente
Lucia Vilanova Trillo
Mª Pilar Lebroráns Iglesias
Marisol Porto Silva
Andrea Grela Beiroa
Sonia Serén Fernández
Pharmacy / Ethics: Carmen Rodriguez-Tenreiro Sánchez
Data Management: Carmen Rodriguez-Tenreiro Sánchez
Alba Elena Martínez Santos
Secretary: Belen Mosquera Perez

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 (protocol 6096A1-501)
Duration: 2005 a 2008-2009
Phase: 3
Promoter: Wyeth
Current Status: Closing phase and publishing of results
Contact: F. Martinón (coordinator regional)

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
Phase: 3
Promoter: Wyeth
Current Status: Closing phase and publishing of results
Contact: F. Martinón (Lead Investigator and Regional Coordinator)

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
Phase: 3b
Promoter: Sanofi Pasteur MSD
Current Status: Closing phase and publishing of results
Contact: F. Martinón (coordinator regional) o L. Redondo (principal investigator)

A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Centre 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 (protocol V72P12)
Duration: 2009 a 2011
Phase: 2b
Promoter: Novartis
Current Status: Active
Contact: F. Martinón (National Coordinator)


A Single blind, Randomized Phase 1/2 Trial of the Safety, Tolerability, and Immunogenicity of Meningococcal Group B rLP2086 Vaccine in Healthy Infants (protocol 6108K2-2000)
Duration: 2009 al 2013
Phase: 1-2
Promoter: Wyeth
Current Status: Active
Contact: F. Martinón (National Coordinator) or L. Redondo (Principal Investigator)

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
Phase: 1-2
Promoter: Medimmune
Current Status: Recruitment start April 2009
Contact: F. Martinón (National Coordinator) or L. Redondo (Principal Investigator)

A Phase 2b, Open Label, Multi-Centre, 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: Assessing, Consulting, National Coordinator, Regional Coordinator and principal investigator
Duration: 2010 to 2012
Phase: 2b
Promoter: Novartis
Code: V72P12E1
Contact: F. Martinón (coordinator) or L. Redondo (principal investigator)

Observer-blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Adjuvanted Quadrivalent Influenza Candidate Vaccines
Duration: 2010 al 2011
Phase: 3
Promoter: GlaxoSmithKline
Current Status: Recruitment start October 2010
Contact: F. Martinón (coordinator) or L. Redondo (principal investigator)

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
Duration: 2010 al 2012
Phase: 2
Promoter: Merck
Current Status: Recruitment start October 2010
Contact: F. Martinón (coordinator) or L. Redondo (principal investigator)

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 Trial: Phase1, multicenter, international
Duration: 2010 to 2012
Phase: 1
Promoter: Roche
Current Status: Recruitment start February 2010
Contact: F. Martinón (coordinator) or L. Redondo (principal investigator)

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)
Duration: 2011 al 2013
Phase: 3
Promoter: Merck
Current Status: Recruitment start March 2011
Contact: F. Martinón (coordinator) or L. Redondo (principal investigator)

A Phase 3B, Open Label, Multi-Centre 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
Duration: 2011 al 2013
Phase: 3b
Promoter: Novartis
Current Status: Recruitment start March 2011
Contact: F. Martinón (coordinator) or L. Redondo (principal investigator)

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 (protocol 6108a1-2001)
Duration: 2009 al 2013
Phase: 2b
Promoter: Pfizer
Current Status: Recruitment start June 2009
Contact: F. Martinón (National Coordinator) o L. Redondo (Principal Investigator)

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
Duration: From 2010 to 2013
Phase: 4
Promoter: Pfizer
Current Status: Recruitment start September 2010
Contact: F. Martinón (Coordinator) or L. Redondo (Principal Investigator)

An Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine GSK2321138A (FLU D-QIV) When Administered in Children
Duration: 2011 to 2013
Phase: 3
Promoter: GlaxoSmithKline S.A.
Current Status: Recruitment start January 2011
Contact: F. Martinón (National Coordinator) or L. Redondo (Principal Investigator)

Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Quadrivalent Seasonal Influenza Candidate Vaccine GSK2321138A, Administered to Children Who Previously Participated in Study 115345
Duration: 2012 to 2013
Phase: 3
Promoter: GlaxoSmithKline S.A.
Current Status: Recruitment start October 2012
Contact: F. Martinón (National Coordinator) or L. Redondo (Principal Investigator)

A Phase 3, Open Label, Multi-Center, Extension Study to Assess Antibody Persistence and Response to a Third or Fifth Dose of Novartis Meningococcal B Recombinant Vaccine in 4-Year-Old Children Who Previously Participated in Study V72P12E1
Duration: 2013 a 2014
Phase: 3
Promoter: Novartis
Current Status: Active
Contact: F. Martinón (National Coordinator)

Immunogenicity and Safety Study of GSK Biologicals' Priorix® Vaccine (209762) at an End of Shelf-life Potency Compared to Merck & Co., Inc.'s MMR Vaccine When Both Are Given on a 2-dose Schedule to Healthy Children in Their 2nd Year of Life
Duration: 2013 a 2014
Phase: 3a
Promoter: GSK
Current Status: Active
Contact: F. Martinón (National Coordinator)

A phase 3 open-label study to evaluate the immunogenicity and safety of a mixed (HEXA/PENTA/HEXA) primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel® at 4 months of age
Duration:  
Phase: 3
Promoter: Sanofi
Current Status: Active
Contact: F. Martinón (National Coordinator)

A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™
Duration: 2013 a 2014
Phase: 3
Promoter: Merck
Current Status: Active
Contact: F. Martinón (National Coordinator)

A phase IIIb, Open Label, Multi Center extension study of V72_28 to assess antibody persistence, and the safety and tolerability of a booster dose after the completion of the vaccination course in study V72_28.
Duration:  
Phase: 3
Promoter: Novartis
Current Status: Active
Contact: F. Martinón (National Coordinator)
  1. © 2013 www.genvip.org all rights reserved
  2. legal advice
  3. favorites
  4. contact
  5. home